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
• Menthaarvensis (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. Healthcare providers are asked to report any suspected adverse reactions to SAHPRA via the “6.04 Adverse Drug Reactions Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/
  
  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.
  Menthaarvensis (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
  Procter & Gamble South African Trading (Pty) Ltd.
  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.

SCHEDULING STATUS: S0

PROPRIETARY NAME (AND DOSAGE FORM):
Vicks VapoRubᴺ (ointment)

COMPOSITION:
Each gram contains:

• Menthol 28,2 mg
• Camphor 52,6 mg
• Eucalyptus Oil 13,3 mg
  
  The other excipients are:
  
• Turpentine
• Thymol
• Cedar Leaf Oil
• Nutmeg Oil
  
  PHARMACOLOGICAL CLASSIFICATION:
  A/10.2.1 Medicines acting on the respiratory system. Inhalants.
  
  PHARMACOLOGICAL ACTION:
  Vicks VapoRubᴺ has decongestant properties.
  
  INDICATIONS:
  For the symptomatic relief of congestion associated with head cold, sinusitis, nasal congestion and nasal catarrh.
  
  CONTRA-INDICATIONS:
  Hypersensitivity to any of the ingredients. Children under 2 years of age.
  Children under the age of 6 years should not use Vicks VapoRubᴺ as a steam inhalation.
  
  WARNINGS:
  Vicks VapoRubᴺ should not be applied to the nostrils of infants as this may cause apnoea and instant collapse.
  
  Interactions:
  No known interaction of ingredients.
  
  Pregnancy and lactation:
  Please consult your doctor before using Vicks VapoRubᴺ during pregnancy. Do not use when lactating.
  
  DOSAGE & DIRECTIONS FOR USE:
  For external use only.
  Do not place inside nostrils.
  Avoid contact with eyes.
  
  Application:
  Apply only to the chest, throat and back and massage for 3 - 5 minutes. Clothing should be loose to allow vapours to be inhaled easily.
  
• Adults and children older than 12 years: 10 - 15 ml applied 2 - 4 times daily.
• Children 6 -12 years: 5 -10 ml applied 2 - 4 times daily.
• Children 2 - 5 years: 2,5 - 5 ml applied 2 - 3 times daily.
  
  Inhalation:
  Minimum age: Do not use on children younger than 6 years of age. Do not re-heat the mixture. Do not heat while inhaling. Do not heat in a microwave oven. Children should be closely supervised. Dissolve 5 -10 ml Vicks VapoRubᴺ into 500 ml hot (not boiling) water. Inhale the aromatic vapours for 10 - 15 minutes.
  
  SIDE EFFECTS AND SPECIAL PRECAUTIONS:
  Side-effects:
  MENTHOL:
  Skin and subcutaneous tissue disorders:
  The following side effects have been reported and the frequencies are unknown: May give rise to contact dermatitis.
  Nervous system disorders:
  The following side effects have been reported and the frequencies are unknown:
  Over-dosage may give rise to ataxia, euphoria, confusion, nystagmus and diplopia.
  Respiratory, thoracic and mediastinal disorders:
  The following side effects have been reported and the frequencies are unknown: Camphor is dangerous when applied to the nostrils of infants as even a small amount may cause immediate collapse.
  EUCALYPTUS OIL:
  Gastrointestinal disorders:
  The following side effects have been reported and the frequencies are unknown: May cause epigastric burning as well as nausea and vomiting when taken in excess.
  Injury, poisoning and procedural complications:
  The following side effects have been reported and the frequencies are unknown: Symptoms of poisoning may include: CNS depression, delirium, coma and convulsions, cyanosis, ataxia and miosis. Nutmeg oil poisoning may include nausea, vomiting, tachycardia, dry mouth, flushing and central nervous system stimulation.
  TURPENTINE OIL:
  General disorders and administration site conditions: The following side effects have been reported and the frequencies are unknown: May cause local irritation.
  Gastrointestinal disorders:
  The following side effects have been reported and the frequencies are unknown: Absorption of large amounts may cause gastrointestinal upset.
  Immune system disorders:
  Fever.
  Respiratory, thoracic and mediastinal disorders:
  The following side effects have been reported and the frequencies are unknown: Choking and coughing. Pulmonary oedema.
  Nervous system disorders:
  The following side effects have been reported and the frequencies are unknown: Coma. Excitement.
  Urinary tract:
  The following side effects have been reported and the frequencies are unknown: Haematuria.
  THYMOL:
  Skin and subcutaneous tissue disorders:
  The following side effects have been reported and the frequencies are unknown:
  May cause blanching and corrosion of the skin.
  
  Injury, poisoning and procedural complications:
  The following side effects have been reported and the frequencies are unknown:
  Poisoning may occur when thymol is absorbed through the skin or lungs (as vapours) in large quantities.
  Gastrointestinal disorders:
  The following side effects have been reported and the frequencies are unknown: May cause nausea and vomiting, sweating, diarrhoea.
  Nervous system disorders:
  The following side effects have been reported and the frequencies are unknown: Depression of the central nervous system.
  
  Special Precautions:
  Do not exceed the recommended dose. For external use only. Vicks VapoRubᴺ should not be swallowed and should not be placed inside the nostrils. Do not use on a broken skin. The mixture for inhalation should not be heated while inhaling and should not be reheated. Pregnancy and lactation: consult your doctor before use.Consult a doctor if symptoms, such as fever, wheezing and coughing, persist.
  
  KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
  See 'side effects'. Treatment is symptomatic and supportive.
  
  IDENTIFICATION:
  Vicks VapoRubᴺ is a soft smooth pale yellow opaque ointment with a menthol/camphor odour.
  
  PRESENTATION:
  12 g tin plate container.
  50 g and 100 g blue polypropylene jar with a green cap.
  
  STORAGE INSTRUCTIONS:
  Store at or below 25 ºC in a well closed container.
  KEEP OUT OF REACH OF CHILDREN.
  Registration Number:
  34/10.2.1/0019
  Namibia - NS0 - 04/10.2.2/0235
  Zimbabwe - HR - 76/22.3/591
  
  NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION:
  Procter & Gamble South African Trading (Pty) Ltd.
  Alice Lane Towers, 15 Alice Lane
  Sandton, 2196, South Africa
  
  DATE OF PUBLICATION OF THE PACKAGE INSERT:
  September 2001

SKEDULERINGSTATUS: S0

EIENDOMSNAAM (EN DOSEERVORM):
Vicks® VapoRubᴺ (salf)

SAMESTELLING:
Elke gram bevat:

• Mentol 28,2 mg
• Kamfer 52,6 mg
• Bloekomolie 13,3 mg
  Die ander bestanddele is:
  
• Terpentynolie
• Timol
• Sederblaarolie
• Muskaatolie
  
  FARMAKOLOGIESE KLASSIFIKASIE:
  A/10.2.1 Brongodilatore inasemmiddels.
  
  FARMAKOLOGIESE WERKING:
  Vicks VapoRubᴺ het dekongestiewe eienskappe.
  
  INDIKASIES:
  Vir die simptomatiese verligting van kongestie geassosieer met kopverkoue, sinusitis, neusverstopping en neuskatar.
  
  KONTRA-INDIKASIES:
  Hipersensitiwiteit vir enige van die bestanddele. Nie aanbeveel vir kinders jonger as 2 jaar nie. Stoom inaseming van Vicks VapoRubᴺ word nie aanbeveel vir kinders onder 6 jaar nie.
  
  WAARSKUWINGS:
  Vicks VapoRubᴺ moenie naby die neusgange van babas aangewend word nie. Dit kan apnee en onmiddellike ineenstorting tot gevolg hê.
  
  lnteraksies:
  Geen bekende interaksies met ander medikasie.
  
  Swangerskap en laktasie:
  Raadpleeg asseblief u dokter voor u Vicks VapoRubᴺ tydens swangerskap gebruik. Moet nie gebruik terwyl u lakteer nie.
  
  DOSIS EN GEBRUIKSAANWYSINGS:
  SLEGS VIR UITWENDIGE GEBRUIK.
  Moenie in die neusgange aanwend nie. Vermy kontak met die oë.
  
  Aanwending:
  Wend slegs aan die bors, nek en rug en masseer vir 3 - 5 minute. Klere moet lospassend wees sodat dampe maklik ingeasem kan word.
  
• Volwassenes en kinders ouer as 12 jaar: 10 - 15 ml 2 - 4 maal daagliks.
  
• Kinders 6 - 12 jaar: 5 - 10 ml 2 - 4 maal daagliks.
  
• Kinders 2 - 5 jaar: 2,5 - 5 ml 2 - 3 maal daagliks.
  
  lnaseming:
  Minimum ouderdom: Moenie gebruik vir kinders jonger as 6 jaar nie.
  Moenie die mengsel herverhit nie. Moenie inasem tydens verhitting nie. Moenie in 'n mikrogolfoond verhit nie. Kinders moet onder toesig wees wanneer die inasem metode gebruik word. Los 5 - 10 ml Vicks VapoRubᴺ op in 500 ml warm (nie kokende) water. Asem die aromatiese dampe in vir 10 - 15 minute.
  
  NEWE-EFFEKTE EN SPESIALE VOORSORGMAA TREELS:
  Newe-effekte:
  MENTOL:
  Aandoenings van die vel en subkutane weefsel:
  Die onderstaande newe-effekte is gerapporteer en die frekwensie daarvan is onbekend: Kan aanleiding gee tot kontakdermatitis.
  Aandoenings van die senuweestelsel:
  Die onderstaande newe-effekte is gerapporteer en die frekwensie daarvan is onbekend: ordosering kan aanleiding gee tot ataksie, euforie, verwarring, nistagmus en diplopie.
  Respiratoriese, torakale en mediastinale aandoenings:
  Kamfer is gevaarlik wanneer dit aan die neusholtes van klein kindertjies aangewend word aangesien selfs 'n klein hoeveelheid onmiddelike ineenstorting kan veroorsaak.
  BLOEKOMOLIE:
  Gastro-intestinale ongesteldhede:
  Die onderstaande newe-effekte is gerapporteer en die frekwensie daarvan is onbekend: Kan aanleiding gee tot epigastriese brandgevoel sowel as naarheid en braking wanneer dit in oormaat geneem word.
  Besering, vergiftiging en prosedurale komplikasies:
  Die onderstaande newe-effekte is gerapporteer en die frekwensie daarvan is onbekend:
  Simptome van vergiftiging kan die volgende insluit:
  
• SSS-onderdrukking, delirium, koma en stuiptrekkings, sianose, ataksie en miose.
  
• Muskaatolievergiftiging kan naarheid, braking, tagikardie, droë mond, gloede en stimulering van die sentrale senuweestelsel insluit.
  TERPENTYNOLIE:
  Algemene ongesteldhede en toedieningsplek toestande:
  Die onderstaande newe-effekte is gerapporteer en die frekwensie daarvan is onbekend:
  Kan aanleiding gee tot lokale irritasie.
  Gastro-intestinale ongesteldhede:
  Die onderstaande newe-effekte is gerapporteer en die frekwensie daarvan is onbekend:
  Absorpsie van groot hoeveelhede kan gastro-intestinale ongesteldheid veroorsaak.
  Aandoenings van die immuunstelsel:
  Koors.
  Respiratoriese, torakale en mediastinale aandoenings:
  Die onderstaande newe-effekte is gerapporteer en die frekwensie daarvan is onbekend:
  Verstikking en hoes.
  Pulmonêre edeem.
  Aandoenings van die senuweestelsel:
  Die onderstaande newe-effekte is gerapporteer en die frekwensie daarvan is onbekend:
  Koma.
  Opgewondenheid.
  Urienwee:
  Die onderstaande newe-effekte is gerapporteer en die frekwensie daarvan is onbekend:
  Hematurie.
  TIMOL:
  Aandoenings van die vel en subkutane weefsel:
  Die onderstaande newe-effekte is gerapporteer en die frekwensie daarvan is onbekend:
  Kan aanleiding gee tot verbleiking en wegvreting van die vel.
  Besering, vergiftiging en prosedurale komplikasies:
  Die onderstaande newe-effekte is gerapporteer en die frekwensie daarvan is onbekend:
  Vergiftiging kan voorkom wanneer timol in groot hoeveelhede deur die vel of longe (as dampe) geabsorbeer word.
  Gastro-intestinale ongesteldhede:
  Die onderstaande newe-effekte is gerapporteer en die frekwensie daarvan is onbekend:
  Kan naarheid en braking, sweet en diarree veroorsaak.
  Aandoenings van die senuweestelsel:
  Die onderstaande newe-effekte is gerapporteer en die frekwensie daarvan is onbekend:
  Onderdrukking van die sentrale senuweestelsel.
  
  Spesiale voorsorgmaatreëls:
  Moenie die aanbevele dosis oorskry nie. Slegs vir uitwendige gebruik. Vicks VapoRubᴺ moet nie ingesluk word nie en moet nie aan in die neusgange aangewend word nie. Moenie op stukkende vel gebruik nie. Die mengsel vir inaseming moenie verhit word terwyl dit ingeasem word nie en moenie herverhit word nie. Swangerskap en laktasie:
  raadpleeg u dokter voor gebruik. Raadpleeg 'n dokter indien simptome, soos koors, gehyg en hoes, voortduur.
  
  BEKENDE SIMPTOME VAN OORDOSERING EN DIE BEHANDELING DAARVAN:
  Sien 'Newe-effekte'. Behandeling is simptomaties en ondersteunend.
  
  IDENTIFIKASIE:
  Vicks VapoRubᴺ is 'n sagte, gladde, bleek-geel, ondeursigtige salf met 'n mentol/kamferreuk.
  
  AANBIEDINGS:
  12 g blikkie
  50 g en 100 g blou polipropileenflessie met'n groen prop.
  
  NAAM EN BESIGHEIDSADRES VAN APPLIKANT:
  Procter & Gamble South African Trading (Pty) Ltd.
  15 Alice Lane Towers, Alice Lane
  Sandton, 2196, South Africa
  
  BERGINGSAANWYSINGS:
  Bewaar by of benede 25 ºC in 'n dig geseëlde houer.
  HOU BUITE BEREIK VAN KINDERS.
  Registrasienommer:
  34/10.2.1/0019
  Namibia - NS0 - 04/10.2.2/0235
  Zimbabwe - HR - 76/22.3/591
  
  DATUM VAN PUBLIKASIE VAN HIERDIE VOUBILJET:
  September 2001

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 asked to report any suspected adverse reactions to SAHPRA via the “6.04 Adverse Drug Reactions Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8
  
  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
  Procter & Gamble South African Trading (Pty) Ltd.
  Alice Lane Towers, 15 Alice Lane
  Sandton, 2196, South Africa
  
  8. REGISTRATION NUMBER:
  G1258/Act 101/19659
  
  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 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. Healthcare providers are asked to report any suspected adverse reactions to SAHPRA via the “6.04 Adverse Drug Reactions Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8.

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
15 Alice Lane Tower
Alice Lane
Sandton, Johannesburg
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