Vicks Vaporub
Italy
Table of Contents
Package leaflet: Information for the patient
Vicks VapoRub
Please read all of this leaflet carefully before using this medicine because it contains important information for you.
Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.
- Keep this leaflet. You may need to read it again.
- If you need more information or advice, consult your pharmacist.
- If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
- Contact your doctor if you do not notice any improvement, or if your symptoms worsen after 3 days.
Contents of this leaflet:
- What Vicks VapoRub is and what it is used for
- What you need to know before using Vicks VapoRub
- How to use Vicks VapoRub
- Possible side effects
- How to store Vicks VapoRub
- Contents of the pack and other information
1. What Vicks VapoRub is and what it is used for
Vicks VapoRub contains camphor, turpentine essential oil, menthol, and eucalyptus essential oil,
substances with antiseptic, expectorant, and decongestant properties. Used for relief of symptoms
associated with colds.
Consult a doctor if you do not feel better or if you feel worse after 3 days.
2. What you need to know before using Vicks VapoRub
Do not use Vicks VapoRub
- if you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6);
- in children under 30 months of age;
- for inhaling vapours (inhalation) in children under 12 years of age;
- in children who currently have or have had epilepsy or febrile convulsions;
- during pregnancy, unless your doctor considers it strictly necessary;
- during breastfeeding;
- simultaneously with other products (medicinal or cosmetic) containing terpene derivatives;
- on wounds, abrasions, mucous membranes, nostrils, eyes, mouth or face;
- under tight bandages;
- with hot compresses or other heat sources.
Moreover, this medicine is intended for external use only. DO NOT ingest it, DO NOT heat it in a microwave, and DO NOT reheat it during or after use. Do not use boiling water for preparing inhalations, as this may expose you to the risk of severe burns (see also "How to take Vicks VapoRub").
Warnings and precautions
Talk to your doctor or pharmacist before using Vicks VapoRub.
Take particular care and consult your doctor before using Vicks VapoRub if:
- you are allergic to fragrances or solvents;
- you suffer from seizures or epilepsy (this product is contraindicated in children who currently have or have had epilepsy or febrile convulsions);
- you have marked respiratory hypersensitivity, including conditions such as asthma and chronic obstructive pulmonary disease (COPD), as it may cause bronchospasm in these patients.
Furthermore, stop treatment and inform your doctor if you experience any of the following adverse events, which occur rarely:
- mild irritation and allergic reactions, more specifically allergic dermatitis, skin irritation and pruritus following topical use;
- mild eye irritation following topical use or inhalation;
- difficulty breathing and coughing, as these may be symptoms of a hypersensitivity reaction.
DO NOT use a dose higher than recommended, and treatment should NOT be prolonged beyond 3 days, as this medicine contains terpene derivatives which, if accumulated in large quantities, particularly in brain tissue, may cause disturbances of the nervous system.
Keep the medicine away from open flames, as the product is flammable.
Other medicines and Vicks VapoRub
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, bear in mind that Vicks VapoRub should NOT be used simultaneously with other products (medicinal or cosmetic) containing terpene derivatives, regardless of whether they are administered orally, rectally, topically, nasally, or by inhalation.
Examples of terpene derivatives, in addition to those contained in this medicine, include:
cineole, niaouli, wild thyme, terpineol, terpina, citral, and essential oils of pine needles.
If you have any doubts, consult your doctor or pharmacist.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
The use of this medicine is not recommended during pregnancy or in fertile women not using contraceptive methods, without first consulting your doctor.
Breastfeeding
Do not use this medicine if you are breastfeeding.
Driving and using machines
This medicine does not affect the ability to drive or operate machinery.
3. How to use Vicks VapoRub
Use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
Vicks VapoRub can be used in two ways (the product MUST NOT be ingested):
1) Applied directly to the skin (suitable for adults and children over 30 months of age)
Apply the ointment by massaging it gently for 3–5 minutes onto the chest, throat, and back, then spread a thick layer on the chest. Repeat the treatment twice daily, one of which should be in the evening before bedtime. Do not massage more than twice a day on the front of the chest, neck, and back. Wear loose clothing to facilitate inhalation of vapours.
2) Dissolved in water (inhalation, suitable for adults and children over 12 years of age)
Dissolve 2 teaspoonfuls (2x5 ml) in half a litre of warm water (not boiling) and inhale the vapour for no longer than 10 minutes.
Pack with applicator stick: At first use, remove the cap and seal. To activate the product, rotate the bottom of the stick 3–4 times. Remove the cap and the aluminium cover to use the product; rotate the bottom of the stick to dispense. Clean with a tissue after use and replace the cap.
NEVER use boiling water to prepare inhalations, as this may expose you to the risk of severe burns.
The solution used for inhalation must not be reheated and must not be used a second time.
Do not heat Vicks VapoRub in the microwave.
Do not exceed the recommended doses or the 3-day treatment duration. If you do not experience noticeable improvement after this period, consult your doctor.
If you use more Vicks VapoRub than you should
In case of accidental ingestion or misuse of the medicine, contact your doctor immediately.
If you apply an excessive amount of Vicks VapoRub to the skin, skin irritation may occur. In such cases, remove the excess product with a paper towel and, on medical advice, apply appropriate treatment for the irritation.
If you inhale an excessive amount of Vicks VapoRub, or if the product is accidentally ingested, symptoms typical of poisoning may occur, such as nausea, vomiting, abdominal pain, headache, dizziness, sensation of warmth/flushing, seizures, breathing difficulties (respiratory depression), and coma.
Use of a dose different from the recommended one, or accidental ingestion—especially in infants and children—may cause disturbances of the nervous system, manifesting as ataxia (lack of coordination of voluntary muscular movements due to nervous system damage), seizures, and respiratory depression.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine may cause side effects, although not everybody gets them.
Stop treatment and contact your doctor immediately if you experience any of the following adverse events,
as they could be symptoms of a hypersensitivity reaction:
- difficulty breathing (dyspnoea) and cough.
Other allergic-type reactions that may occur, for which you must consult your doctor, include:
- mild skin irritations, more specifically allergic dermatitis, redness and itching after topical use;
- mild eye irritations.
Other possible side effects include:
Frequency not known (frequency cannot be estimated from the available data):
- skin redness and sensation of warmth (erythema or heat erythema);
- burns at the application site;
- seizures in children and newborns due to the presence of camphor and menthol. These effects may occur following excessive doses of the medicine.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You may also report side effects directly via the national reporting system at the following website: www.agenziafarmaco.gov.it/content/come-segnalare-una-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Vicks VapoRub
Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the packaging after "Exp.". The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.
6. Package contents and other information
What Vicks VapoRub contains
- The active substances are camphor, turpentine essential oil, menthol and eucalyptus essential oil. 100 g of ointment contain 5 g of camphor, 5 g of turpentine essential oil, 2.75 g of menthol and 1.5 g of eucalyptus essential oil.
- The other components are thymol, cedarwood essential oil and white petrolatum.
Description of the appearance of Vicks VapoRub and contents of the pack
Vicks VapoRub is supplied in 40 g, 50 g, 90 g and 100 g opaque blue containers closed with a green screw cap and containing a 2 mm thick PET/EPE/PET lid.
Vicks VapoRub is also supplied in a 35 g multidose container made of blue polypropylene (PP) for body, base and threaded parts; high-density polyethylene (HDPE) for the piston; and nitrile butadiene rubber (NBR) for the seal. The multidose container is placed in a carton box.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Procter & Gamble S.r.l. - Viale Giorgio Ribotta, 11 - 00144 Rome, Italy
Manufacturer
Procter & Gamble Manufacturing GmbH, Procter-&-Gamble Strasse 1, 64521 Gross-Gerau, Germany.