Professional Information for Medicines for Human Use
Complementary Medicine: This unregistered medicine has not been evaluated by the SAHPRA for its quality, safety or intended use.
SCHEDULING STATUS:
| S0 |
1. NAME OF THE MEDICINE:
- Vicks® VapoLozenges – Orange menthol (lozenge)
- Vicks® VapoLozenges – Honey lemon menthol (lozenge)
- Vicks® VapoLozenges – Berry menthol (lozenge)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each lozenge contains dry extracts derived from - Glycyrrhiza glabra (Liquorice root) 15 mg
- Zingiber officinale (Common ginger rhizome) 10 mg
- Phyllanthus emblica (Indian gooseberry fruits)10 mg
- Mentha arvensis (leaf) (Levomenthol)7 mg
Preservatives: - Methyl Hydroxybenzoate 0,2 % w/w
- Propyl Hydroxybenzoate 0,02 % w/w
- Contains sugar (sucrose 1618 mg, liquid glucose 1037 mg & glycerine 1,5 mg per lozenge).
For full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Vicks VapoLozenges - Orange Menthol:
Orange coloured round biconvex lozenges having orange flavour with a sweet taste.
Vicks VapoLozenges - Honey Lemon menthol:
Light brown coloured round biconvex lozenges having lemon flavour with a sweet taste.
Vicks VapoLozenges - Berry Menthol:
Pink coloured round biconvex lozenges having raspberry flavour with a sweet taste.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Vicks VapoLozenges eases cough, blocked nose & sore throat.
4.2 Posology and method of administration
Adults and children over 12 years: Dissolve 1 lozenge in your mouth every 2 hours as needed. Do not exceed 8 lozenges in 24 hours.
Slowly dissolve one lozenge every two hours as needed. If symptoms persist longer than 3 days and/or increase in spite of treatment, consult your healthcare provider. If you forget to use it slowly dissolve one lozenge as soon as you remember.
4.3 Contraindications
Hypersensitivity to any of the ingredients. Not to be consumed by children under 12 years of age without medical advice.
4.4 Special warnings and precautions for use
Vicks VapoLozenges contains sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. Each lozenge contains sucrose 1618 mg, liquid glucose 1037 mg & glycerine 1,5 mg. This should be taken into account in patients with diabetes mellitus. There are no known side effects and do not take if you have any known allergies to any of the ingredients. For further information please consult your healthcare provider.
4.5 Interaction with other medicines and other forms of interaction
There are no known interactions. For further information please consult your healthcare provider.
4.6 Fertility, pregnancy and lactation.
Safety during pregnancy and lactation has not been established.
4.7 Effects on ability to drive and use machines
There are no known effects on the ability to drive or use machines.
4.8 Undesirable effects
There are no known undesirable effects.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorization of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Health care providers are requested to report any suspected adverse drug reactions to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website.
4.9 Overdose
There are no known symptoms of overdosage. In case of overdose please seek medical help.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic Properties
Category D: 33.3 Ayurveda
Vicks VapoLozenges:
Glycyrrhiza glabra (Liquorice root): Antibacterial, Anti-inflammatory, Demulcent, Expectorant, useful in cough, cold, sore throat, hoarseness, dry cough.
Zingiber officinale (Common ginger rhizome): Antiseptic, anti- inflammatory, inhibits coughing, useful in common cold, pharyngopathy, and asthma.
Mentha arvensis (leaf) (Levomenthol): Liquefies phlegm, Antiseptic, clears respiratory tract.
Phyllanthus emblica also called Emblica officinalis (Indian gooseberry fruits): Anti–inflammatory, Anti-bacterial.
5.2 Pharmacokinetic Properties
Not applicable.
5.3 Preclinical safety data
None available, Vicks VapoLozenges contains well-known and well-documented ingredients.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Vicks VapoLozenges - Orange Menthol:
Citric Acid Monohydrate, Essence mintol, Glycerine (Refined), Liquid Glucose, Methyl Hydroxybenzoate (Methyl Paraben), Orange menthol flavour, Propyl Hydroxybenzoate (Propyl Paraben), Purified water, Colour Sunset Yellow, Sucrose
Vicks VapoLozenges – Honey Lemon Menthol:
Citric Acid Monohydrate, Essence Lemon Oil, Liquid Glucose, Glycerine (Refined), Honey Flavour, Methyl Hydroxybenzoate (Methyl Paraben), Propyl hydroxybenzoate (Propyl Paraben), Purified water, Colour Quinoline Yellow, Sucrose.
Vicks VapoLozenges – Berry Menthol:
Liquid Glucose, Glycerine (Refined), Colour Carmoisine, Essence raspberry sweet, Methyl Hydroxybenzoate (Methyl Paraben), Propyl Hydroxybenzoate (Propyl Paraben), Purified water, Sucrose.
6.2 Incompatibilities
No known incompatibilities.
6.3 Shelf Life
Blisters: 36 months
Pouches: 24 months
6.4 Special precautions for storage
Store at or below 25 ºC in a dry area. Keep in original packaging until required for use.
6.5 Nature and contents of container
1 or 2 blisters of 8 lozenges packed in Alu-Triplex clear PVC/PE/ PVDC; packed in a carton; or
2 or 3 blisters of 12 lozenges packed in Alu-Triplex clear PVC/PE/ PVDC; packed in a carton or
6’s triplex laminated strip pack made of 12 micron Polyester/ 30 micron Aluminium/ 40 micron Polyethylene
1’s Laminate strip pouch pack made of 12 micron Polyester/ 30 micron Aluminium/ 40 micron Polyethylene
6.6 Special precautions for disposal
Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).
7. HOLDER OF CERTIFICATE OF REGISTRATION
P&G South African Trading (Pty) Ltd.
10th Floor, Alice Lane Towers,
15 Alice Lane, Sandton, 2196, South Africa
8. REGISTRATION NUMBER(S)
To be allocated.
9. DATE OF FIRST AUTHORISATION
To be allocated.
10. DATE OF REVISION OF THE TEXT
To be allocated.
Complementary Medicine: This unregistered medicine has not been evaluated by the SAHPRA for its quality, safety or intended use.
Scheduling status:
| S0 |
1. NAME OF THE MEDICINE
Vicks® VapoLozenges + Immune Support Orange Menthol
Vicks® VapoLozenges + Immune Support Blackcurrant Menthol
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Orange Menthol lozenge contains:
Mentha arvensis L. (Levomenthol) [Leaf] 10 mg
Sodium Ascorbate 74,9 mg providing Vitamin C 66,5 mg
Ascorbic Acid (Vitamin C) 33,5 mg
Zinc Gluconate 27,88 mg providing Zinc (elemental) 4 mg
Contains sugar (sucrose 1516,835 mg & liquid glucose 957,72 mg per lozenge)
Contains sweetener (sucralose 4,00 mg per lozenge)
Each Blackcurrant Menthol lozenge contains:
Mentha arvensis L. (Levomenthol) [Leaf] 10 mg
Sodium Ascorbate 74,9 mg providing Vitamin C 66,5 mg
Ascorbic Acid (Vitamin C) 33,5 mg
Zinc Gluconate 27,88 mg providing Zinc (elemental) 4 mg
Contains sugar (sucrose 1515,136 mg & liquid glucose 959,814 mg per lozenge)
Contains sweetener (sucralose 6,5 mg per lozenge)
For full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Vicks VapoLozenges + Immune Support Orange Menthol:
Orange coloured lozenge with orange menthol flavour.
Vicks Vapolozenges + Immune Support Blackcurrant Menthol:
Violet to opaque violet coloured lozenge with blackcurrant menthol flavour.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
For the temporary relief of Blocked Nose, Sore Throat, Cough and supports Immune System Health.
4.2 Posology and method of administration
For cough, blocked nose and sore throat relief:
Adults: Take 1 lozenge every 2-3 hours as needed. Maximum 6 lozenges per day, for not more than 7 consecutive days.
Children 6 years and above: Take 1 lozenge every 4-6 hours as needed. Maximum 3 lozenges per day, for not more than 7 consecutive days.
For immune system health:
Adults only: Take 1 lozenge daily.
4.3 Contraindications
Hypersensitivity to any of the ingredients. Not to be consumed by children under 6 years of age without medical advice
4.4 Special warnings and precautions for use
The following patient groups should use with caution or consult a doctor before use; those with diabetes mellitus, hypersensitivity to any of the ingredients, children under 6 years.
4.5 Interaction with other medicines and other forms of interaction
There are no known interactions.
4.6 Fertility, pregnancy and lactation
As with all medicines in pregnancy & lactation, care should be taken and as a precaution this product should not be used without medical advice during pregnancy or lactation
4.7 Effects on ability to drive and use machines
There are no known effects on the ability to drive or use machines.
4.8 Undesirable effects
None known. Hypersensitivity to any of the ingredients.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorization of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Health care providers are requested to report any suspected adverse drug reactions to SAHPRA via the Med
Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website.
4.9 Overdose
In case of overdose please seek medical help.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Category D: 33.7 Combination Product
Mentha arvensis L. (Levomenthol) [Leaf]: Clears respiratory tract, local analgesic, antitussive.
Sodium Ascorbate (Vitamin C): Supports immune system health, antioxidant properties.
Ascorbic Acid (Vitamin C): Supports immune system health, antioxidant properties.
Zinc Gluconate (Zinc): Supports immune system health.
5.2 Pharmacokinetic properties
Not Applicable
5.3 Preclinical safety data
None available. This product contains active ingredients of well-established use.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Vicks VapoLozenges + Immune Support - Orange Menthol
Sucrose, Liquid glucose, Anhydrous citric acid, Sucralose, Flavour Orange Oil Sweet Excellent, Colour Sunset Yellow.
Vicks VapoLozenges + Immune Support - Blackcurrant Menthol
Sucrose, Liquid glucose, Anhydrous citric acid, Sucralose, Blackcurrant Flavour 50211, Colour Carmioisine, Colour Brillant Blue.
6.2 Incompatibilities
None known
6.3 Shelf life
24 months
6.4 Special precautions for storage
Store at or below 25 ° C. KEEP OUT OF REACH OF CHILDREN. Keep in original packaging until required for use.
6.5 Nature and contents of container
16 lozenges packed in a PVC Blister.
6.6 Special precautions for disposal and other handling
Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).
7. HOLDER OF CERTIFICATE OF REGISTRATION
P&G South African Trading (Pty) Ltd.
10th Floor, Alice Lane Towers,
15 Alice Lane, Sandton, 2196, South Africa
8. REGISTRATION NUMBER(S)
To be allocated
9. DATE OF FIRST AUTHORISATION
To be allocated
10. DATE OF REVISION OF THE TEXT
To be allocated
Complementary Medicine: This unregistered medicine has not been evaluated by the SAHPRA for its quality, safety or intended use.
SCHEDULING STATUS:
| S0 |
1. NAME OF THE MEDICINE:
Vicks® VapoLozenges Xtra Strong Lemon Menthol Blast
Vicks® VapoLozenges Xtra Strong Honey Menthol Blast
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each lozenge contains:
- Mentha arvensis L. (Levomenthol) [Leaf extract] 21 mg
Vicks® Vapolozenges Xtra Strong Lemon Menthol Blast contains sugar (sucrose 1701,635 mg, liquid glucose 916,265 mg per lozenge, & glycerine 1,50 mg per lozenge)
Vicks® Vapolozenges Xtra Strong Honey Menthol Blast contains sugar (sucrose 1703,490 mg, liquid glucose 917,260 mg per lozenge)
For full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Vicks® VapoLozenges Xtra Strong Lemon Menthol Blast: Yellow to opaque yellow coloured round, flat shaped lozenges with beveled edges in lemon menthol flavour. Vicks® VapoLozenges Xtra Strong Honey Menthol Blast: Yellow to brownish yellow coloured round, flat shaped lozenges with beveled edges in honey menthol flavour.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Vicks® VapoLozenges Xtra Strong are used to temporarily relieve cough, blocked nose and painful sore throat.
4.2 Posology and method of administration
Adults and children over 12 years: Dissolve 1 lozenge slowly in the mouth every 2 hours as needed. Do not exceed 8 lozenges in 24 hours.
4.3 Contraindications
Hypersensitivity to any of the ingredients. Not to be consumed by children under 12 years of age without medical advice.
4.4 Special warnings and precautions for use
The following patient groups should use with caution or consult a doctor before use; those with diabetes mellitus, hypersensitivity to any of the ingredients, children under 12 years.
4.5 Interaction with other medicines and other forms of interaction
There are no known interactions.
4.6 Fertility, pregnancy and lactation
As with all medicines in pregnancy & lactation, care should be taken and as a precaution this product should not be used without medical advice during pregnancy or lactation.
4.7 Effects on ability to drive and use machines
There are no known effects on the ability to drive or use machines.
4.8 Undesirable effects
None known. Hypersensitivity to any of the ingredients.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorization of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Health care providers are requested to report any suspected adverse drug reactions to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website.
4.9 Overdose
There are no known symptoms of overdosage. In case of overdose please seek medical help.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Complementary Medicine: Category D - 33.3 Ayurveda
5.2 Pharmacokinetic properties
Not Applicable
5.3 Preclinical safety data
None available. This product contains active ingredients of well-established use.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Vicks® VapoLozenges Xtra Strong Lemon Menthol Blast
Anhydrous citric acid, colour Quinoline Yellow, essence lemon oil, flavour honey, flavour vapocool, glycerine, liquid glucose, sucrose.
Vicks® VapoLozenges Xtra Strong Honey Menthol Blast
Anhydrous citric acid, caramel NF, flavour honey, natural honey, flavour vapocool, liquid glucose, sucrose.
6.2 Incompatibilities
None known
6.3 Shelf life
24 months
6.4 Special precautions for storage
Store at or below 25 ° C
KEEP OUT OF REACH OF CHILDREN
Keep in original packaging until required for use.
6.5 Nature and contents of container
Packed in PVC Blister of 16 or 8 lozenges in carton + PIL insert.
6.6 Special precautions for disposal and other handling
Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).
7. HOLDER OF CERTIFICATE OF REGISTRATION
P&G South African Trading (Pty) Ltd.
10th Floor, Alice Lane Towers,
15 Alice Lane, Sandton, 2196, South Africa
8. REGISTRATION NUMBER(S)
To be allocated
9. DATE OF FIRST AUTHORISATION
To be allocated
10. DATE OF REVISION OF THE TEXT
To be allocate
SCHEDULING STATUS:
| S0 |
1. NAME OF THE MEDICINE:
Vicks® Inhaler
Pharmaceutical form:
Inhaler
2. QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each 1,0 g medication for nasal use contains:
- Levomenthol 415,4 mg
- Camphor 415,4 mg
For full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM:
A cellulose wick impregnated with a mobile, slightly oily liquid medication, slightly yellow in colour encased in a plastic holder.
4. CLINICAL PARTICULARS:
4.1 Therapeutic indications
The relief of nasal congestion associated with allergic and infectious upper respiratory tract disorders.
4.2 Posology and method of administration
Posology
Adults and children over 6 years: It can be used as frequently as needed.
Paediatric population:
Do not used in children under 6 years.
Method of administration:
Vicks Inhaler is used by inserting the inhaler into one nostril, while holding the other nostril closed and inhaling deeply.
Use only as intended. For external use only (see section 6.6).
4.3 Contraindications:
Use in patients hypersensitive to any of the ingredients.
4.4 Special warnings and precautions for use
If there is no improvement or if there is aggravation of the disorder consult your doctor.
Do not give Vicks Inhaler to children under 6 years.
4.5 Interaction with other medicines and other forms of interaction
None.
4.6 Fertility, pregnancy and lactation
There is no evidence to indicate that this product should not be used during pregnancy and lactation.
4.7 Effects on ability to drive and use machines
None.
4.8 Undesirable effects
Menthol may give rise to hypersensitivity reactions including contact dermatitis. Consult a doctor if symptoms persist.
In general no serious or severe side effects are expected with this product. Very rarely cases of nasal discomfort (e.g. temporary burning, stinging, sneezing, or increased nasal discharge) have been reported.
Reporting of suspected adverse reactions:
Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Health care providers are requested to report any suspected adverse drug reactions to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website.
4.9 Overdose
Treatment is symptomatic and supportive.
5. PHARMACOLOGICAL PROPERTIES:
5.1 Pharmacodynamic properties
Class of medicine: A.10.2.1 Inhalants
Vicks Inhaler contains special aromatic ingredients, having decongestant and cooling effects on the nasal mucosa.
5.2 Pharmacokinetic properties
The product exerts its action locally; little or no absorption is expected to occur.
5.3 Preclinical safety data
Not applicable.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients - Siberian Pine Needle Oil
- Methyl Salicylate
6.2 Incompatibilities
None.
6.3 Shelf life
36 months
6.4 Special precautions for storage
Store in a cool, dry place at or below 25 °C.
6.5 Nature and contents of container
Vicks Inhaler comprises a cellulose acetate wick impregnated with 1,0 ml of liquid medication. The impregnated wick is enclosed within a plug and nose piece and the unit is sealed with screw-thread closure.
6.6 Special precautions for disposal and other handling
Use only as intended. For external use only.
7. HOLDER OF CERTIFICATE OF REGISTRATION
P&G South African Trading (Pty) Ltd.
10th Floor, Alice Lane Towers,
15 Alice Lane, Sandton, 2196, South Africa
8. REGISTRATION NUMBER:
G1258 (Act 101 of 1965)
9. DATES OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
September 2009
10. DATE OF REVISION OF THE TEXT
10 September 2021
Complementary Medicine: This unregistered medicine has not been evaluated by the SAHPRA for its quality, safety or intended use.
SCHEDULING STATUS:
| S0 |
1. NAME OF THE MEDICINE:
Vicks® VapoRub Xtra Strong
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 g contains:
- Mentha arvensis L. (Menthol) (Leaf extract) 70 mg
- Eucalyptus globulus Labill. (Eucalyptus oil) (Leaf extract) 38,4 mg
- Pinus longifolia Roxb. (Camphor) (Stem extract) 52,1 mg
- Excipients: Cedarwood Oil, Cardamom, Ginger, Microcrystalline wax, Pine, Thymol.
3 PHARMACEUTICAL FORM
Soft, white or slightly yellow, unctuous ointment.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Temporary relief from headache, nasal congestion, cough, body ache, and muscular stiffness associated with a cold.
4.2 Posology and method of administration
FOR EXTERNAL USE
Do not place inside nostrils.
Avoid contact with eyes.
Topical Application:
Children 6 - 12 years: 1 - finger scoop
Adults and children older than 12 years: 2 - finger scoops
For relief from nasal congestion and cough: apply thinly and evenly to chest, neck, and back and massage for 3-5 minutes up to 3 times a day. Clothing should be loose to allow vapour to be inhaled easily. For temporary relief from minor aches and pains, apply thinly and evenly to the affected area up to 3 times day.
Do not heat or use with any source of heat.
Steam inhalation:
Adults and children older than 6 years: Dissolve 1 - 2 teaspoonfuls (5 - 10 ml) into a bowl of hot (not boiling) water (500 ml). Cover head with towel. Lean over bowl to form a tent. Gently breathe in the vapours for 10 - 15 minutes. Repeat up to 2 times per day for children 6 – 12 years and up to 4 times per day for adults and children older than 12 years. Do not reheat the mixture. Do not place in any container in which you are heating water.
Do not heat in a microwave oven. Children should be closely supervised
4.3 Contraindications
Hypersensitivity to any of the ingredients
Do not use on children under 6 years.
Epilepsy, asthma, persistent or chronic cough, or other chronic lung conditions. In peripheral vascular disease and trophic nervous disorders.
4.4 Special warnings and precautions for use
Contains CAMPHOR. Harmful if swallowed. For external use only. Do not exceed the recommended dose.
Avoid direct contact with the eyes, mucous membranes, genitals, nose, face and mouth. If symptoms persist or worsen, reoccur or are accompanied by a fever, rash or persistent headache, discontinue use and consult a relevant health care provider. If you experience pain, swelling or blistering, stop use and get medical help right away. Do not expose the area where applied to sunlight. If accidental ingestion occurs, seek urgent medical attention or contact a Poison Control Centre. Do not apply this product to broken, irritated or sensitive skin. Do not use with other products containing camphor, menthol, eucalyptol and/or eucalyptus essential oil. Do not bandage tightly.
4.5 Interaction with other medicines and other forms of interaction
No known interactions of ingredients
4.6 Fertility, pregnancy and lactation
As with all medicines in pregnancy, care should be taken and as a precaution this product should not be used without medical advice during pregnancy. Vicks® VapoRub Xtra Strong should not be used on the mother’s chest during lactation, due to the theoretical risk of apnoea reflex in the infant whilst feeding in close proximity to the site of application.
4.7 Effects on ability to drive and use machines
None known
4.8 Undesirable effects
Local effects
Skin and subcutaneous tissue disorders:
Rare: redness, skin irritation, allergic dermatitis.
Eye disorders:
Rare: eye irritation.
General disorders and administration site conditions:
Not known: application site burn
Irritations or allergic reactions are usually mild.
Systemic effects
Due to the recommended route of administration; systemic exposure is very low and undesirable effects due to systemic exposure have not been observed.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorization of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Health care providers are requested to report any suspected adverse drug reactions to SAHPRA via the Med
Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website.
4.9 Overdose
Over dosage may result in skin irritation.
Swallowing of the ointment might cause gastrointestinal symptoms like vomiting and diarrhea. Treatment is symptomatic. After significant accidental consumption, acute poisoning was observed with nausea, vomiting, abdominal pain, and headache, vertigo, feeling hot / flushing, convulsions, respiratory depression and coma. In case of accidental ingestion seek medical assistance.
Patients with severe gastrointestinal or neurological symptoms of poisoning should be observed and treated symptomatically. Do not induce vomiting.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Category D: 33.3 Ayurveda
Mentha arvensis L. (Menthol) (Leaf extract), Eucalyptus globulus Labill. (Eucalyptus oil) (Leaf extract), Pinus longifolia Roxb. (Camphor) (Stem extract) act locally in the respiratory tract.
5.2 Pharmacokinetic properties
The product exerts its action locally; little or no absorption is expected to occur.
5.3 Preclinical safety data
Not applicable
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Cedarwood Oil, Cardamom, Ginger, Microcrystalline wax, Pine, Thymol.
6.2 Incompatibilities
None known
6.3 Shelf life
24 months
6.4 Special precautions for storage
Store at or below 30 °C in a well closed container.
KEEP OUT OF REACH OF CHILDREN
6.5 Nature and contents of container
10 g and 50 g blue polypropylene jar with red cap.
6.6 Special precautions for disposal and other handling
No special requirements
7 HOLDER OF CERTIFICATE OF REGISTRATION
P&G South African Trading (Pty) Ltd.
10th Floor, Alice Lane Towers,
15 Alice Lane, Sandton, 2196, South Africa
8 REGISTRATION NUMBER(S)
To be allocated
9 DATE OF FIRST AUTHORISATION
To be allocated
10 DATE OF REVISION OF THE TEXT
To be allocate
Complementary Medicine: This unregistered medicine has not been evaluated by the SAHPRA for its quality, safety or intended use.
Scheduling status:
| S0 |
1. NAME OF THE MEDICINE
Vicks® VapoRub Vaporizing Ointment
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram contains:
Mentha arvensis L. (Menthol) (Leaf extract) 28,2 mg
Eucalyptus globulus Labill. (Eucalyptus oil) (Leaf extract) 13,5 mg
Pinus longifolia Roxb. (Camphor) (Stem extract) 52,5 mg
Excipients:
Pine, Thymol, White Soft Paraffin
3. PHARMACEUTICAL FORM
Soft, smooth white to pale yellow ointment.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Temporary relief from headache, nasal congestion, cough, body ache, and muscular stiffness associated with a cold.
4.2 Posology and method of administration
FOR EXTERNAL USE OR INHALATION ONLY.
Do not place inside nostrils.
Avoid contact with eyes.
Topical Application:
Children older than 2 years: 1-finger scoop
Adults and children older than 12 years: 2-finger scoop
For relief from blocked nose and cough, apply thinly and evenly to chest, neck, and back, and massage for 3-5 minutes up to 3 times a day. Clothing should be loose to allow vapour to be inhaled easily. Do not heat or use with any kind/source of heat.
For temporary relief from minor aches and pains, apply thinly and evenly to the affected area up to 3 times a day.
Steam inhalation:
Adults and children older than 6 years: Dissolve 2 teaspoonfuls (10 ml) of product in 500 ml of hot (not boiling) water and breathe in the resulting vapours for 10-15 minutes, with a towel over the head and bowl. Do not heat or reheat the mixture in a microwave. Do not place in any container in which you are heating water. Do not heat while inhaling.
Do not heat in a microwave oven. Children should be closely supervised.
4.3 Contraindications
Hypersensitivity to any of the ingredients
Do not use on children under 2 years.
Children under the age of 6 years should not use Vicks® VapoRub Vaporizing Ointment as steam inhalation. Children should always be supervised.
Epilepsy, asthma, persistent or chronic cough, or other chronic lung conditions.
In peripheral vascular disease and trophic nervous disorders.
4.4 Special warnings and precautions for use
Contains CAMPHOR. Harmful if swallowed. For external use only. Do not exceed the recommended dose.
Avoid direct contact with the eyes, mucous membranes, genitals, nose, face and mouth. If symptoms persist or worsen, reoccur or are accompanied by a fever, rash or persistent headache, discontinue use and consult a relevant health care provider. If you experience pain, swelling or blistering, stop use and get medical help right away. Do not expose the area where applied to sunlight. If accidental ingestion occurs, seek urgent medical attention or contact a Poison Control Centre. Do not apply this product to broken, irritated or sensitive skin.
Do not use with other products containing camphor, menthol, eucalyptol and/or eucalyptus essential oil.
Do not bandage tightly.
4.5 Interaction with other medicines and other forms of interaction
No known interactions of ingredients
4.6 Fertility, pregnancy and lactation
As with all medicines in pregnancy, care should be taken and as a precaution this product should not be used without medical advice during pregnancy Vicks® VapoRub Vaporizing Ointment should not be used on the mother’s chest during lactation, due to the theoretical risk of apnoea reflex in the infant whilst feeding in close proximity to the site of application.
4.7 Effects on ability to drive and use machines
None known
4.8 Undesirable effects
Local effects
Skin and subcutaneous tissue disorders:
Rare: redness, skin irritation, allergic dermatitis.
Eye disorders:
Rare: eye irritation.
General disorders and administration site conditions:
Not known: application site burn
Irritations or allergic reactions are usually mild.
Systemic effects
Due to the recommended route of administration; systemic exposure is very low and undesirable effects due to systemic exposure have not been observed
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorization of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Health care providers are requested to report any suspected adverse drug reactions to SAHPRA via the Med
Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website.
4.9 Overdose
Over dosage may result in skin irritation.
Swallowing of the ointment might cause gastrointestinal symptoms like vomiting and diarrhoea. Treatment is symptomatic. After significant accidental consumption, acute poisoning was observed after significant accidental consumption, with nausea, vomiting, abdominal pain, and headache, vertigo, feeling hot / flushing, convulsions, respiratory depression and coma. In case of accidental ingestion seek medical assistance.
Patients with severe gastrointestinal or neurological symptoms of poisoning should be observed and treated symptomatically. Do not induce vomiting.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Category D: 33.3 Ayurveda
Mentha arvensis L. (Menthol) (Leaf extract), Eucalyptus globulus Labill. (Eucalyptus oil) (Leaf extract), Pinus longifolia Roxb. (Camphor) (Stem extract) act locally in the respiratory tract.
5.2 Pharmacokinetic properties
The product exerts its action locally; little or no absorption is expected to occur.
5.3 Preclinical safety data
Not applicable
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Pine, Thymol & White soft paraffin.
6.2 Incompatibilities
None known
6.3 Shelf life
24 months
6.4 Special precautions for storage
Store at or below 30 °C in a well closed container
KEEP OUT OF REACH OF CHILDREN
6.5 Nature and contents of container
9 g, 10 g, 50 g, 90 g, and 100 g blue polypropylene jar with green cap.
6.6 Special precautions for disposal and other handling
No special requirements
7. HOLDER OF CERTIFICATE OF REGISTRATION
P&G South African Trading (Pty) Ltd.
10th Floor, Alice Lane Towers,
15 Alice Lane, Sandton, 2196, South Africa
8. REGISTRATION NUMBER(S)
To be allocated
9. DATE OF FIRST AUTHORISATION
To be allocated
10. DATE OF REVISION OF THE TEXT
To be allocated
Complementary Medicine: This unregistered medicine has not been evaluated by the SAHPRA for its quality, safety or intended use.
SCHEDULING STATUS:
| S0 |
1. NAME OF THE MEDICINE:
Vicks® Acta Plus Wet & Dry Cough Syrup
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 10 ml syrup contains extracts derived from:
Ocimum sanctum L. (Holy Basil) [Herb] 100 mg
Glycyrrhiza glabra L. (Liquorice) [Root] 60 mg
Curcuma longa L. (Turmeric) [Rhizome] 50 mg
Aloe barbadensis Mill. (Aloe Vera) [Leaf extract] 50 mg
Zingiber officinale Roscoe (Ginger) [Rhizome] 10 mg
Mentha arvensis L. (Levomenthol) [Leaf] 6 mg
*Piper cubeba L.f. *(Tailed Pepper) [Fruit] 1.4 mg
Contains Sugar (7,5 g Sucrose per 10 ml)
Preservatives:
Sodium Benzoate 0,35 % w/v
Sodium Methyl Hydroxybenzoate 0,10 % w/v
Sodium Propyl Hydroxybenzoate 0,05 % w/v
Sorbic Acid 0,05 % w/v
For full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Vicks® Acta Plus Wet & Dry Cough Syrup: Dark green liquid
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Vicks® Acta Plus Wet & Dry Cough Syrup helps to provide relief from both dry cough and wet cough.
4.2 Posology and method of administration
Not for use in children under 6 years of age. Shake well before use.
Follow dosing instructions below.
Adults & children 12 years and above: Take 10 ml (2 medicine measures) every four hours as needed.
Children 6-11 years: Take 5 ml (1 medicine measure) every 4 hours as needed.
Do not exceed more than 3 doses per day. Do not exceed the stated dose.
It is not recommended to take a double dose to make up for those forgotten.
4.3 Contraindications
Hypersensitivity to any of the ingredients. Not to be consumed by children under 6 years of age without medical advice.
4.4 Special warnings and precautions for use
The following patient groups should use with caution or consult a doctor before use; those with diabetes mellitus, hypersensitivity to any of the ingredients, children under 6 years.
4.5 Interaction with other medicines and other forms of interaction
There are no known interactions.
4.6 Fertility, pregnancy, and lactation.
If pregnant or breastfeeding or are planning to have a baby, it is recommended to consult a health care provider for advice before taking this medicine.
4.7 Effects on ability to drive and use machines
There are no known effects on the ability to drive or use machines.
4.8 Undesirable effects
None known. Hypersensitivity to any of the ingredients.
Reporting of suspected adverse reactions:
Reporting suspected adverse reactions after authorization of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Health care providers are requested to report any suspected adverse drug reactions to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website.
4.9 Overdose
There are no known symptoms of overdosage. In case of overdose please seek medical help.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic Properties
Category D: 33.3 Ayurveda
Ocimum sanctum L. (Holy Basil) [ Herb]: Expectorant & cough suppressant
Glycyrrhiza glabra L. (Liquorice) [ Root]: Expectorant & cough suppressant
Curcuma longa L. (Turmeric) [Rhizome]: Expectorant & cough suppressant
Zingiber officinale Roscoe (Ginger) [Rhizome]: Cough suppressant
Piper cubeba L.f. (Tailed Pepper) [Fruit]: Clears respiratory tract
Aloe barbadensis Mill. (Aloe Vera) [Leaf extract]: Clears respiratory tract
Mentha arvensis L.(Levomenthol) [Leaf]: Clears respiratory tract, local analgesic, antitussive.
5.2 Pharmacokinetic Properties
Not applicable
5.3 Preclinical safety data
Not applicable
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sucrose (Sugar), glycerine, citric acid, sodium benzoate, sodium methyl hydroxybenzoate, sodium propyl hydroxybenzoate, sorbic acid, colour BQ supra (Green Q3427), essence pineapple and purified water.
6.2 Incompatibilities
None known
6.3 Shelf Life
24 months
6.4 Special precautions for storage
Store at or below 30 ºC.
KEEP OUT OF REACH OF CHILDREN.
6.5 Nature and contents of container
50 ml, 100 ml and 200 ml amber PET bottles with white Polypropylene caps packed in a carton.
6.6 Special precautions for disposal
Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).
7 HOLDER OF CERTIFICATE OF REGISTRATION
P&G South African Trading (Pty) Ltd.
10th Floor, Alice Lane Towers,
15 Alice Lane, Sandton, 2196, South Africa
8 REGISTRATION NUMBER(S)
To be allocated.
9 DATE OF FIRST AUTHORISATION
To be allocated.
10 DATE OF REVISION OF THE TEXT
To be allocated.
Complementary Medicine: This unregistered medicine has not been evaluated by the SAHPRA for its quality, safety or intended use.
SCHEDULING STATUS:
| S0 |
1. NAME OF THE MEDICINE:
Vicks® Acta Plus Xtra Strong (Syrup)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 10 ml syrup contains extracts derived from:
- Ocimum sanctum L. (Holy Basil) 8:1 [leaf extract] 100 mg
- Glycyrrhiza glabra L. (Liquorice) 5:1 [root extract] 60 mg
- Curcuma longa L. (Turmeric) 10:1 [rhizome extract] 50 mg
- Zingiber officinale Roscoe (Ginger) 10:1 [rhizome extract] 50 mg
- Piper cubeba L.f. (Tailed Pepper) 12:1 [fruit extract] 10 mg
- Aloe barbadensis Mill. (Aloe Vera) 4:1 [leaf extract] 50 mg
- Mentha arvensis L. (Levomenthol) [leaf extract] 6 mg
Contains sugar (Sucrose 6750 mg, Glycerine 500 mg, Honey 400 mg, Caramel 1 mg per 10 ml)
Preservatives: Sodium Methyl Hydroxy Benzoate 0.1 % w/v, Sodium Propyl Hydroxy Benzoate 0.05 % w/v, Sorbic Acid 0.05 % w/v, Sodium Benzoate 0.35 % w/v.
For full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Vicks® Acta Plus Xtra Strong: Brown-coloured syrupy liquid
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Vicks® Acta Plus Xtra Strong helps to relieve dry cough, wet cough, sore throat, and blocked nose. Helps support immunity and recovery.
4.2 Posology and method of administration
Follow the dosing instructions below.
Adults & children 12 years and above: Take 10 ml (2 medicine measures) every four hours as needed.
Children 6 -11 years: Take 5 ml (1 medicine measure) every 4 hours as needed.
Do not exceed more than 3 doses per day. Do not exceed the stated dose.
Not for use in children under 6 years of age. Shake well before use.
If you forget to take a dose, take your next dose at the normal time and in the normal amount.
4.3 Contraindications
Do not take this medicine if you are allergic or hypersensitive to any of the ingredients (see section 6 below). Not to be consumed by children under 6 years of age.
4.4 Special warnings and precautions for use
Patients with diabetes mellitus should consult a doctor before use. This product contains 6.75 g sucrose, 500 mg Glycerine, 400 mg Honey, 1 mg Caramel per 10 ml dose.
4.5 Interaction with other medicines and other forms of interaction
There are no known interactions. Always tell your healthcare provider if you are taking any other medicine – including all complementary or traditional medicine.
4.6 Fertility, pregnancy and lactation
If you are pregnant, breastfeeding or are planning to have a baby, it is recommended to consult a healthcare provider for advice before taking this medicine.
4.7 Effects on ability to drive and use machines
There are no known effects on the ability to drive or use machines. However, it is not always possible to predict to what extent Vicks Acta Plus Xtra Strong may interfere with such activities. Please consult your doctor, pharmacist, or other healthcare provider for advice prior to use.
4.8 Undesirable effects
None known. Hypersensitivity to any of the ingredients.
Reporting of suspected adverse reactions:
Reporting suspected adverse reactions after authorization of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Health care providers are requested to report any suspected adverse drug reactions to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website.
4.9 Overdose
There are no known symptoms of overdosage. In case of overdose please seek medical help immediately.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Category D- 33.3 Ayurveda - Ocimum sanctum L. (Holy Basil) [Herb]: Expectorant & cough suppressant
- Glycyrrhiza glabra L. (Liquorice) [Root]: Expectorant & cough suppressant
- Curcuma longa L. (Turmeric) [Rhizome]: Expectorant & cough suppressant
- Zingiber officinale Roscoe (Ginger) [Rhizome]: Cough suppressant
- Piper cubeba L.f. (Tailed Pepper) [Fruit]: Clears respiratory tract
- Aloe barbadensis Mill. (Aloe Vera) [Leaf extract]: Clears respiratory tract
- Mentha arvensis L. (Levomenthol) [Leaf]: Clears respiratory tract, local analgesic, antitussive.
5.2 Pharmacokinetic properties
Not Applicable
5.3 Preclinical safety data
Not applicable
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sucrose (Sugar), Glycerine, Honey, Caramel, Sodium Methyl Hydroxy Benzoate, Sodium Propyl Hydroxy Benzoate, Sorbic Acid, Sodium Benzoate, Citric Acid, Xanthan Gum, Propylene Glycol and Flavourings
6.2 Incompatibilities
None known
6.3 Shelf life
24 months
6.4 Special precautions for storage
Store at or below 30 ºC.
KEEP OUT OF REACH OF CHILDREN.
6.5 Nature and contents of container
100 ml and 200 ml amber PET bottles with white Polypropylene caps packed in a carton.
6.6 Special precautions for disposal and other handling
Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).
7. HOLDER OF CERTIFICATE OF REGISTRATION
P&G South African Trading (Pty) Ltd.
10th Floor, Alice Lane Towers,
15 Alice Lane, Sandton, 2196, South Africa
8. REGISTRATION NUMBER(S)
To be allocated
9. DATE OF FIRST AUTHORISATION
To be allocated
10. DATE OF REVISION OF THE TEXT
To be allocated.
PROFESSIONAL INFORMATION FOR HUMAN MEDICINES
SCHEDULING STATUS
| S2 |
1 NAME OF THE MEDICINE
VICKS MEDINITE (Syrup)
Each 30 ml of syrup contains: Paracetamol 600,0 mg; Ephedrine sulphate 8,0 mg; Doxylamine succinate 7,5 mg; Dextromethorphan hydrobromide 15,0 mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 30 ml contains:
| Paracetamol | 600,0 mg |
| Ephedrine sulphate | 8,0 mg |
| Doxylamine succinate | 7,5 mg |
| Dextromethorphan hydrobromide | 15,0 mg |
Contains sugar: 8,25 g sucrose and 1,5 g glycerol
Excipients with known effect:
Sodium benzoate added as preservative 0,1 % m/v
Ethanol 96 % equivalent to 10 % v/v absolute ethanol
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Vicks Medinite is a clear, slightly viscous green liquid with an anise aroma and taste.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Vicks Medinite night time colds medicine may be taken at bedtime for relief of major symptoms, associated with colds and influenza, such as nasal congestion, sniffing, headache, minor aches and pains and coughing.
4.2 Posology and method of administration
Posology
Take Vicks Medinite at bedtime. Use dose cup provided and wash after use.
Adults 12 years and over: 30 ml in the dose cup provided (6 medicine measuresful) at bedtime.
DO NOT EXCEED RECOMMENDED DOSE.
Paediatric population
Do not give this medicine to children under 12 years of age, unless directed by a doctor.
Method of administration
Oral.
4.3 Contraindications
Vicks Medinite is contraindicated in:
- Patients with known hypersensitivity to the active ingredients or any of the excipients in Vicks Medinite (see section 6.1).
- Safety during pregnancy has not been established.
- Do not administer concurrently with monoamine oxidase inhibitors
4.4 Special warnings and precautions for use
| This product contains paracetamol which may be fatal in overdose. In the event of overdosage or suspected overdose and notwithstanding the fact that the person may be asymptomatic, the nearest doctor, hospital or poison centre must be contacted immediately. |
This medicine may lead to drowsiness and impaired concentration, which may be aggravated by simultaneous intake of alcohol, or other central nervous system depressant agents.
Severe cutaneous adverse reactions (SCARs):
Severe cutaneous adverse reactions (SCARs) such as toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), acute generalized exanthematous pustulosis (AGEP), eosinophilia and systemic (DRESS)/Drug-induced hypersensitivity syndrome (DIHS) and fixed drug irruptions (FDE) have been reported in patients treated with paracetamol containing medicines. If a patient develops SCAR, treatment with Vicks Medinite Syrup must immediately be discontinued and appropriate treatment be instituted.
Dosages in excess of those recommended may cause severe liver damage.
Patients suffering from kidney or liver disease should take paracetamol under medical supervision. Dextromethorphan hydrobromide should be administered with caution to patients with liver disease and to asthmatic patients.
Doxylamine should be used with care in conditions such as glaucoma and prostatic hypertrophy.
Ephedrine sulphate should be avoided in patients with most types of cardiovascular disease, hypertension, hyperthyroidism, hyperexcitability, pheochromocytoma and close-angle glaucoma.
In patients with prostatic enlargement, it may increase difficulty with micturition.
If symptoms persist after five days, consult a doctor. Do not use continuously for more than 10 days without consulting a doctor.
Vicks Medinite contains 10 % absolute ethanol v/v. Vicks Medinite contains 3,126 ml of alcohol (ethanol 96 %) in each 30 ml dosage unit.
Vicks Medinite contains 84,956 mg sodium per 30 ml, equivalent to 4,25 % of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Vicks Medinite contains 30 mg sodium benzoate in each 30 ml dose.
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take Vicks Medinite. Contains 8,25 g of sucrose per dose. This should be taken into account in patients with diabetes mellitus.
4.5 Interaction with other medicines and other forms of interaction
Doxylamine succinate may enhance the sedative effect of the central nervous system depressants, including alcohol, barbiturates, hypnotic analgesics, sedatives and tranquillizers.
Effects of anticholinergic medicines such as atropine and tricyclic antidepressants, may be enhanced by the concomitant administration of doxylamine succinate. Doxylamine succinate may affect the metabolism of medicines in the liver.
Ephedrine sulphate should be used with caution in patients receiving chloroform, cyclopropane, halothane or other halogenated anaesthetics.
The effects of ephedrine are diminished by guanethidine, reserpine and probably methyldopa and may be diminished or enhanced by tricyclic anti-depressants. Ephedrine may also diminish the effects of guanethidine and may increase the possibility of arrhythmias in digitalised patients.
4.6 Fertility, pregnancy and lactation
Pregnancy
The safety of this preparation in pregnancy has not been established.
Breastfeeding
The safety of this preparation in lactation has not been established.
4.7 Effects on ability to drive and use machines
Patients should be warned against taking charge of vehicles, or machinery or performing potentially hazardous tasks where loss of concentration may lead to accidents
4.8 Undesirable effects
Tabulated summary of adverse reactions
| Paracetamol | Dextromethorphan hydrobromide | Doxylamine succinate | Ephedrine sulphate | |
|---|---|---|---|---|
| Blood and the lymphatic system disorders | ||||
| Frequency not known | Blood disorders | Agranulocytosis, haemolytic anaemia | ||
| Immune system disorders | ||||
| Frequency not known | Sensitivity reactions | |||
| Psychiatric disorders | ||||
| Frequency not known |
Elation, depression, insomnia, nervousness, irritability, nightmares | |||
| Metabolism and nutrition disorders | ||||
| Frequency not known | Mental confusion | Dry mouth, anorexia | ||
| Nervous system disorders | ||||
| Frequency not known | Drowsiness, dizziness, excitation |
Headache, tremors, muscle twitching, convulsions, tingling, heaviness and weakness of the hands, sedation varying from slight drowsiness to deep sleep, inability to concentrate, lassitude, dizziness, incoordination. |
Giddiness, headache, tremors, anxiety, restlessness, insomnia. | |
| Eye disorders | ||||
| Frequency not known | Blurred vision | |||
| Ear and labyrinth disorders | ||||
| Frequency not known | Tinnitus | |||
| Respiratory, thoracic and mediastinal disorders | ||||
| Frequency not known | Tightness of the chest | |||
| Cardiac disorders | ||||
| Frequency not known | Tachycardia | Tachycardia, precordial pain, palpitations | ||
| Vascular disorders: | ||||
| Frequency not known | Hypotension | |||
| Gastrointestinal disorders | ||||
| Frequency not known | Gastrointestinal disturbances |
Gastrointestinal disturbances, nausea, vomiting, diarrhoea, constipation, epigastric pain | Nausea, vomiting | |
| Skin and subcutaneous tissue disorders | ||||
| Frequency not known |
Reversible skin rash, Serious cutaneous adverse reactions (SCARs) including fixed drug eruptions (FDE) and drug-induced hypersensitivity syndrome (DIHS) | |||
| Musculoskeletal, connective tissue and bone disorders | ||||
| Frequency not known | Muscular weakness | Muscular weakness | ||
| Renal and urinary disorders | ||||
| Frequency not known | Difficulty in micturition | Difficulty in micturition | ||
| General disorders and administrative site conditions | ||||
| Frequency not known | Sweating, thirst | |||
Description of selected adverse reactions
High doses of dextromethorphan hydrobromide causes respiratory depression.
Large doses of doxylamine succinate may precipitate fits in epileptics. Allergy and dermatological reactions may occur.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Health care providers are requested to report any suspected adverse drug reactions to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website.
4.9 Overdose
Paracetamol
Prompt treatment is essential. In the event of an overdosage, consult a doctor immediately, or take the person directly to a hospital. A delay in starting treatment may mean that antidote is given too late to be effective.
Evidence of liver damage is often delayed until after the time for effective treatment has lapsed.
Susceptibility to paracetamol toxicity is increased in patients who have taken repeated high doses (greater than 5 – 10 g/day) of paracetamol for several days, in chronic alcoholism, chronic liver diseases, AIDS, malnutrition, and with use of drugs that induce liver microsomal oxidation such as barbiturates, isoniazid, rifampicin, phenytoin and carbamazepine.
Symptoms of paracetamol overdosage in the 24 hours include pallor, nausea, vomiting, anorexia and possibly abdominal pain.
Mild symptoms during the first two days of acute poisoning do not reflect the potential seriousness of the overdosage.
Liver damage may be apparent 12 or 48 hours, or later after ingestion, initially by elevation of the serum transaminase and lactic dehydrogenase activity, increased serum bilirubin concentration and prolongation of the prothrombin time. Liver damage may lead to encephalopathy, coma and death.
Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage. Abnormalities of glucose metabolism and metabolic acidosis may occur. Cardiac arrhythmias have been reported.
Treatment for paracetamol overdosage
Although evidence is limited, it is recommended that any adult person who has ingested 5 – 10 grams or more of paracetamol (or a child who has had more than 140 mg/kg) within the preceding four hours, should have the stomach emptied by lavage (emesis may be adequate for children) and a single dose of 50 g activated charcoal given via the lavage tube. Ingestion of amounts of paracetamol smaller than this may require treatment in patients
susceptible to paracetamol poisoning. In patients who are stuperose or comatose, endotracheal intubation should precede gastric lavage in order to avoid aspiration.
N-acetylcysteine should be administered to all cases of suspected overdose as soon as possible preferably within eight hours of overdosage, although treatment up to 36 hours after ingestion may still be of benefit, especially if more than 150 mg/kg of paracetamol was taken. An initial dose of 150 mg/kg N-acetylcysteine in 200 ml dextrose injection is given intravenously over 15 minutes, followed by an infusion of 50 mg/kg in 500 ml dextrose injection over the next four hours, and then 100 mg/kg in 1000 ml dextrose injection over the next sixteen hours. The volume of intravenous fluid should be modified for children.
Although the oral formulation is not the treatment of choice, 140 mg/kg dissolved in water may be administered initially, followed by 70 mg/kg every four hours for seventeen doses.
A plasma paracetamol level should be determined four hours after ingestion in all cases of suspected overdosage. Levels done before four hours may be misleading. Patients at risk of liver damage, and hence requiring continued treatment with N-acetylcysteine, can be identified according to their 4-hour plasma paracetamol level.
The plasma paracetamol level can be plotted against time since ingestion in the nomogram below. The nomogram should be used only in relation to a single acute ingestion.
Those whose plasma paracetamol levels are above the “normal treatment line”, should continue N-acetylcysteine treatment with 100 mg/kg IV over sixteen hours repeatedly until recovery. Patients with increased susceptibility to liver damage, should continue treatment if concentrations are above the “high risk treatment line”. Prothrombin index correlates best with survival. Monitor all patients with significant ingestions for at least ninety-six hours.
Nomogram: acetaminophen plasma concentration vs time after acetaminophen ingestion (adapted with permission from Rumack and Matthew. Paediatrics. 1975;55:871 – 876). The nomogram has been developed to estimate the probability of whether a plasma acetaminophen concentration in relation to the interval post ingestion will result in hepatotoxicity and, therefore, whether acetylcysteine therapy should be administered.
CAUTIONS FOR USE OF THIS CHART:
- Time coordinates refer to time postingestion.
- Graph relates only to plasma concentrations following a single, acute overdose ingestion.
- The Treatment Line is plotted 25 % below the Rumack-Matthew Line to allow for potential errors in plasma acetaminophen assays and estimated time from ingestion of an overdose (Rumack et al. Arch Intern Med. 1981; 141 (suppl):380 – 385)
Semilogarithmic plot of plasma acetaminophen levels vs. time
Rumack BH. Matthew H. Acetaminophen Poisoning and Toxicity.
Pediatrics 1975 (55)871 – 876
Dextromethorphan Hydrobromide
Respiratory depression
Doxylamine Succinate
Symptoms of overdosage may include convulsions and excitation.
Ephedrine Sulphate
Symptoms of overdosage may include paranoid psychosis, delusions and hallucinations.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
A.10.1 Antitussives and expectorants
Paracetamol has analgesic and antipyretic properties. Doxylamine succinate has antihistamine properties with a prolonged effect. Dextromethorphan hydrobromide has antitussive properties. Ephedrine sulphate has sympathomimetic properties causing vasoconstriction. It also has smooth muscle relaxant effects.
5.2 Pharmacokinetic properties
Not Applicable
5.3 Preclinical safety data
Not Applicable
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Anethole; Citric Acid Monohydrate (pH buffer); E104 Quinoline Yellow; E133 Brilliant Blue FCF; Ethanol 96 % v/v; Glycerol; Macrogol 300; Purified water; Sodium Citrate (pH buffer); Sodium Benzoate; Sucrose
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
36 months
6.4 Special precautions for storage
Store at or below 25 °C.
6.5 Nature and contents of container
Vicks Medinite is packaged in a cylindrical clear glass bottle (Ph. Eur. Type III glass) with a four-part child resistant closure with a polyethylene (PE) liner sealing system. A polypropylene (PP) dosing cup is also included.
Bottles containing 90 ml or 180 ml.
6.6 Special precautions for disposal and other handling
No special requirements.
7 HOLDER OF CERTIFICATE OF REGISTRATION
P&G South African Trading (Pty) Ltd,
Alice Lane Towers,
15 Alice lane,
Sandton, Johannesburg, 2196
8 REGISTRATION NUMBER(S)
South Africa: H/10.1/140
| Namibia Reg. No: 90/10.1/001383 |
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
1 April 1998
10 DATE OF REVISION OF THE TEXT
09 December 2024