Vicks Vaporub - Package Leaflet

Indications Contraindications Precautions for use Interactions Warnings Dosage and method of use Overdose Undesirable Effects Shelf Life and Storage

Active ingredients: Camphor, Turpentine essential oil, Menthol, Eucalyptus essential oil

OIL FOR INHALATION USE

Why is Vicks Vaporub used? What is it for?

WHAT IS IT

VICKS VAPORUB is a balsamic ointment for inhalation use.

WHY IT IS USED

VICKS VAPORUB is used for the balsamic treatment in affections of the upper respiratory tract.

Contraindications When Vicks Vaporub should not be used

The product is contraindicated in children up to 30 months of age. The product should not be administered by inhalation to children under the age of six.

Hypersensitivity (allergy) to the active substances or to any of the excipients.

The product is contraindicated in children with a history of epilepsy or febrile seizures.

Generally contraindicated in pregnancy and lactation (see pregnancy and lactation section).

Precautions for use What you need to know before taking Vicks Vaporub

WHEN IT CAN ONLY BE USED AFTER CONSULTING YOUR DOCTOR

This product contains terpene derivatives which, in excessive doses, can cause neurological disorders such as convulsions in infants and children.

Vicks Vaporub should be used with caution or on medical advice by patients with:

  • Hypersensitivity reactions to perfumes or solvents.
  • Convulsions or epilepsy
  • Asthma and disorders or pronounced hypersensitivity of the respiratory tract.
  • Pregnancy and breastfeeding: (see "What to do during pregnancy and" breastfeeding ").

The product is contraindicated in children with a history of epilepsy or febrile seizures. It is also advisable to consult your doctor in cases where these disorders have occurred in the past. The treatment should not be prolonged for more than 3 days due to the risks associated with the accumulation of terpene derivatives, such as for example camphor, cineole, niaouli, wild thyme, terpineol, terpine, citral, menthol and essential oils of pine needles, eucalyptus and turpentine (due to their lipophilic properties the rate of metabolism and disposal is not known) in tissues and in the brain, in particular neuropsychological disorders.

A higher dose than recommended should not be used to avoid an increased risk of adverse drug reactions and disorders associated with overdose.

The product is flammable, it must not be approached to flames.

Interactions Which drugs or foods can modify the effect of Vicks Vaporub

Tell your doctor or pharmacist if you have recently taken any other medicines, even those without a prescription.

Vicks Vaporub must not be used concomitantly with other products (medicinal or cosmetic) containing terpene derivatives, regardless of the route of administration (oral, rectal, cutaneous, nasal or inhalation)

Warnings It is important to know that:

The use, especially if prolonged, of products for topical use, can give rise to sensitization phenomena and produce undesirable effects. In this case it is necessary to stop the treatment and consult your doctor.

WHAT TO DO DURING PREGNANCY AND BREASTFEEDING

Ask your doctor or pharmacist for advice before taking any medicine.

Pregnancy

There are no or limited data on the use of camphor, essential oil of turpentine, menthol, essential oil of eucalyptus in pregnant women.

Vicks Vaporub is not recommended during pregnancy and in women of childbearing potential who are not using contraceptive measures. The use of the drug during pregnancy should only take place after consulting your doctor.

Feeding time

There is insufficient information on the excretion of camphor, essential oil of turpentine, menthol, essential oil of eucalyptus in breast milk. There is no clinical data relating to the use of the components of Vicks Vaporub during lactation.

Vicks Vaporub should not be used while breastfeeding.

Vicks Vaporub should not be applied to the breast of the mother during breastfeeding due to the potential risk of apnoic reflex in the breast fed infant.

EFFECTS ON THE ABILITY TO DRIVE VEHICLES AND ON THE USE OF MACHINERY

No effects on the ability to drive and use machines have been observed.

Dosage and method of use How to use Vicks Vaporub: Dosage

Use the product according to the instructions. For external use only.

Vicks Vaporub is contraindicated in children up to 30 months of age and inhalations are contraindicated in children under six.

Children must always be supervised.

HOW: VICKS VAPORUB Balsamic Ointment can be used in two ways:

1. Apply externally by first rubbing the chest, throat and back for 3-5 minutes and then spread a thick layer on the chest.

WHEN AND FOR HOW LONG: Repeat the treatment 2 times a day, one of which in the evening before going to sleep. Do not rub on the front of the chest, neck and back more than twice a day. Wear loose clothing to facilitate the inhalation of vapors. Do not apply to wounds, abrasions, and mucous membranes. Do not ingest and do not apply directly into the nostrils, eyes, mouth or face. Do not make a tight bandage. Do not use with a hot pack or with any type of heat.

2. HOW LONG AND FOR HOW LONG: Dissolve 2 coffee spoons (2x5ml) in half a liter of hot water and suck the steam released for no more than 10 minutes. In order to avoid the risk of severe burns, do not use boiling water to prepare the inhalations. Do not reheat the mixture a second time. Do not heat the mixture while inhaling. Do not heat the mixture in the microwave or reheat it during and after use.

THE PRODUCT MUST NOT BE SWALLOWED

The duration of the treatment should not exceed 3 days

Warning: do not exceed the recommended doses.

Overdose What to do if you have taken too much Vicks Vaporub

In case of accidental oral intake or incorrect administration in infants and children there may be a risk of neurological disorders.

If necessary, administer appropriate symptomatic treatment in specialized treatment centers.

A) Topical administration

In the event of application of an excessive dose, skin irritation reactions may rarely occur. In this case, remove the excess product with a paper towel and inform your doctor who will administer, if necessary, an appropriate therapy. for such reactions.

B) Inhalation:

the symptoms and treatment are the same as in the case of accidental ingestion.

C) Accidental ingestion:

Symptoms are mainly due to the presence of camphor. These include gastrointestinal problems such as nausea, vomiting and diarrhea.

In the event that you have taken a severe overdose of Vicks Vaporub, notify your doctor immediately or go to the nearest hospital.

In the event of accidental ingestion of Vicks Vaporub by a child, it is important to immediately consult a doctor who can provide the necessary treatment. Don't try to induce vomiting.

If you have any questions about the use of Vicks Vaporub, ask your doctor or pharmacist.

Side Effects What are the side effects of Vicks Vaporub

Like all medicines, Vicks Vaporub can cause side effects, although not everybody gets them.

Due to the presence of camphor, essential oil of turpentine, menthol and essential oil of eucalyptus and in case of non-observance of the recommended doses there may be a risk of seizures in children and infants. If symptoms persist, consult your doctor.

Due to their characteristics it is expected that some components of Vicks Vaporub (camphor and menthol) cause redness and a sensation of heat in the skin. Mild irritation and allergic reactions may rarely occur. More specifically: allergic dermatitis, skin irritation and itching after topical use and mild eye irritation following topical application or inhalation.

Hypersensitivity reactions in the respiratory system (dyspnoea and cough) have rarely occurred.

If such events occur, the treatment should be suspended and your doctor should be consulted, who will decide on the most suitable treatment.

In order to avoid the risk of severe burns, do not use boiling water to prepare the inhalations. Do not reheat the mixture a second time. Do not heat the mixture while inhaling. Do not heat the mixture in the microwave or reheat it during and after use.

THE PRODUCT MUST NOT BE SWALLOWED

Other events may be linked to improper use of the product (ingestion); in this regard, see the previous paragraph.

Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects. These side effects are usually transient.

Systemic effects:

Due to the recommended route of administration, the systemic exposure is very low and no adverse effects from systemic exposure have been observed.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. Side effects can also be reported directly via the national reporting system at: www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.

Expiry and Retention

Expiry: see the expiry date printed on the package.

Warning: do not use the medicine after the expiry date indicated on the package.

The expiry date refers to the product in intact packaging, properly stored.

KEEP THE MEDICINAL PRODUCT OUT OF THE SIGHT AND REACH OF CHILDREN.

It is important to always have the information on the medicine available, so keep both the box and the package leaflet.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.

COMPOSITION

100 g of ointment contain: ACTIVE INGREDIENTS: Camphor 5.00 g, Essential oil of turpentine 5.00 g, Menthol 2.75 g, Eucalyptus essential oil 1.50 g. EXCIPIENTS: Thymol, essential oil of cedar wood, white Vaseline.

HOW IT LOOKS

VICKS VAPORUB comes in the form of an ointment for inhalation use. Packs of 40 g, 50 g, 90 g and 100 g

Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.

Further information on Vicks Vaporub can be found in the "Summary of Features" tab. 01.0 NAME OF THE MEDICINAL PRODUCT 02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION 03.0 PHARMACEUTICAL FORM 04.0 CLINICAL PARTICULARS 04.1 Therapeutic indications 04.2 Posology and method of administration 04.3 Contraindications 04.4 Special warnings and appropriate precautions for use 04.5 Interactions with other medicinal products and other forms of interaction04.6 Pregnancy and lactation04.7 Effects on ability to drive and use machines04.8 Undesirable effects04.9 Overdose05.0 PHARMACOLOGICAL PROPERTIES05.1 Pharmacodynamic properties05.2 Pharmacokinetic properties05.3 Preclinical safety data06.0 INFORMATION PHARMACEUTICALS 06.1 Excipients 06.2 Incompatibilities 06.3 Shelf life 06.4 Special precautions for storage 06.5 Nature of the immediate packaging and contents of the package 06.6 Instructions for use and handling 07.0 MARKETING AUTHORIZATION HOLDER08 .0 MARKETING AUTHORIZATION NUMBER 09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION 10.0 DATE OF REVISION OF THE TEXT 11.0 FOR RADIOPharmaceuticals, FULL DATA ON INTERNAL RADIATION DOSIMETRY 12.0 FOR RADIO DRUGS, ADDITIONAL DETAILED INSTRUCTIONS ON ESTEMPORANEA PREPARATION AND CONTROL

01.0 NAME OF THE MEDICINAL PRODUCT

NEURABEN

02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each hard capsule contains:

Active principles:

Benzoyloxymethylthiamine 100 mg

Pyridoxine hydrochloride 150 mg

Cyanocobalamin 500 mcg

03.0 PHARMACEUTICAL FORM

Hard capsules for oral use.

04.0 CLINICAL INFORMATION

04.1 Therapeutic indications

Polyneuritis from Vitamin B1, B6 and B12 deficiency states.

04.2 Posology and method of administration

Usually 1 capsule 3 times a day.

04.3 Contraindications

Individual hypersensitivity already known to the components.

04.4 Special warnings and appropriate precautions for use

Caution is recommended when administering to subjects undergoing treatment with levodopa because pyridoxine can antagonize its therapeutic effects.

Keep out of reach of children.

04.5 Interactions with other medicinal products and other forms of interaction

Vitamin B6 can antagonize the therapeutic effects of levodopa.

04.6 Pregnancy and breastfeeding

There are no contraindications to the use of NEURABEN in these conditions.

04.7 Effects on ability to drive and use machines

No negative effects are found with the use of Neuraben.

04.8 Undesirable effects

Neuraben is generally well tolerated and there are no known toxic and accumulation effects.

04.9 Overdose

There are no known symptoms of overdose.

05.0 PHARMACOLOGICAL PROPERTIES

05.1 Pharmacodynamic properties

NEURABEN is a "combination of Cyanocobalamin, Pyridoxine hydrochloride and Benzoyloxymethylthiamine, a new derivative of thiamine. Cyanocobalamin administered orally, is partly bound to intrinsic factor and through this bond is released into the circulation. Pyridoxine hydrochloride is easily absorbed by the intestine. and converted into coenzymes Benzoyloxymethyl-thiamine differs from Thiamine Hydrochloride essentially for a more rapid oral absorption, a higher blood and tissue concentration and a rapid transformation in vivo into thiamine.

Metabolism

Orally administered benzoyloxymethyl thiamine is rapidly converted into thiamine.

05.2 Pharmacokinetic properties

Absorption of Benzoyloxymethyl-thiamine was investigated after oral administration of the radioactive carbon-labeled compound. It was noted in rats that blood and tissue levels of Benzoyloxymethyl-thiamine are higher than those achieved with thiamine hydrochloride. Benzoyloxymethyl-thiamine concentrates in the nervous tissue from the 1st hour up to 24 hours after administration.

05.3 Preclinical safety data

Acute toxicity

Benzoyloxymethyl-thiamine administered orally in the rat did not show a detectable LD50. Intravenously in mice the LD50 is 100-140 mg / kg.

Chronic toxicity

Benzoyloxymethyl-thiamine in rats at a dose of 50-100-200 mg / kg, administered orally for 23 weeks, did not give rise to significant increases in mortality or changes in body weight, autopsy, urinary and humoral findings in animals. treated with respect to controls.

Fetal toxicity

Benzoyloxymethyl-thiamine administered to rats for the entire gestation period orally at a dose of 20 mg / kg per day, did not produce changes in either the number of survivors or the weight of individual animals or alterations in the morphological parameters in subjects born from mothers treated against controls.

06.0 PHARMACEUTICAL INFORMATION

06.1 Excipients

Talc, magnesium stearate, polyethylene glycol 6000.

Each operculum contains:

Head: Titanium dioxide (E171), medium orange (E110), gelatin.

Body: Titanium dioxide (E171), medium orange (E110), gelatin.

06.2 Incompatibility

Not relevant.

06.3 Period of validity

It is valid for 36 months when the packaging is intact.

06.4 Special precautions for storage

No special storage precautions are required.

06.5 Nature of the immediate packaging and contents of the package

Transparent PVC / Al blister.

Carton containing 30 hard capsules.

06.6 Instructions for use and handling

No special instructions.

07.0 MARKETING AUTHORIZATION HOLDER

Pfizer Italia S.r.l.

Via Isonzo, 71 - 04100 Latina

08.0 MARKETING AUTHORIZATION NUMBER

AIC N ° 023585019.

09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION

May 31, 2005.

10.0 DATE OF REVISION OF THE TEXT

March 2010

11.0 FOR RADIO DRUGS, COMPLETE DATA ON THE INTERNAL RADIATION DOSIMETRY

12.0 FOR RADIO DRUGS, FURTHER DETAILED INSTRUCTIONS ON EXEMPORARY PREPARATION AND QUALITY CONTROL

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