Active ingredients: Diphenhydramine (Diphenhydramine hydrochloride)
ALLERGAN 2g / 100g cream
Why is Allergan used? What is it for?
WHAT IS IT
ALLERGAN is an anti-itch, that is, it calms itching and discomfort deriving from irritation, insect bites and skin redness due to excessive exposure to the sun.
WHY IT IS USED
ALLERGAN is used for the local symptomatic treatment of itchy dermatitis, sunburn, insect bites (ie to soothe itching and discomfort deriving from irritation, insect bites and skin redness due to excessive exposure to the sun).
Contraindications When Allergan should not be used
WHEN IT SHOULD NOT BE USED
Children under the age of 2.
Known hypersensitivity to the components and to other antihistamines of similar chemical structure (dimenhydrinate, carbinoxamine maleate).
It is advisable to consult your doctor if these disorders have already occurred. See also chapter on PREGNANCY AND BREASTFEEDING.
WHEN IT CAN ONLY BE USED AFTER CONSULTING YOUR DOCTOR
Pregnancy and breastfeeding (see "What to do during pregnancy and" breastfeeding ").
WHAT TO DO DURING PREGNANCY AND BREASTFEEDING
In pregnant and breastfeeding women, the product should be used only in case of real need and under direct medical supervision.
Precautions for use What you need to know before taking Allergan
Do not use with occlusive dressing. The use of the product, especially if prolonged, can give rise to sensitization phenomena (allergic type reaction), if this occurs, stop the treatment and consult your doctor.
Interactions Which drugs or foods may change the effect of Allergan
There are no known incompatibilities with other medicines or foods.
If you are using other medicines, ask your doctor or pharmacist for help.
Warnings It is important to know that:
ALLERGAN must be applied to small areas of the skin.
ALLERGAN cream should not be applied to areas of the skin with blisters, to live sores and surfaces in the process of scarring.
Avoid contact with eyes or other mucous membranes. In the case of sunburn, do not subsequently expose the skin to the sun. If after a short period of treatment no improvement is noticed or if skin rashes, irritation and burning phenomena occur, stop the treatment and contact your doctor.
ALLERGAN has no effect on the ability to drive and use machines.
Dose, Method and Time of Administration How to use Allergan: Posology
- How much: spread a thin layer of cream on the affected area 2 or 3 times a day.
WARNING: DO NOT EXCEED THE INDICATED DOSES WITHOUT THE ADVICE OF THE DOCTOR.
- When and for how long: use only for short periods of treatment. Consult your doctor if the disorder occurs repeatedly or if you have noticed any recent changes in its characteristics.
Overdose What to do if you have taken too much Allergan
No phenomena occurred following excessive administration of the drug have been reported. In case of accidental ingestion / intake of an excessive dose of ALLERGAN, notify your doctor immediately or go to the nearest hospital.
Side Effects What are the side effects of Allergan
Burning, rash, photosensitivity reactions (appearance of spots on the skin after sun exposure) were found.
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.
These side effects are usually transient. However, when they occur, it is advisable to consult your doctor or pharmacist.
It is important to inform your doctor or pharmacist of any undesirable effects not described in the package leaflet.
Request and fill in the undesirable effects report form available at the pharmacy.
Expiry and Retention
See the expiry date indicated on the package. The expiry date indicated refers to the product in intact packaging, correctly stored.
CAUTION: DO NOT USE THE MEDICINAL PRODUCT AFTER THE EXPIRY DATE INDICATED ON THE PACKAGE.
KEEP THE MEDICINAL PRODUCT OUT OF THE REACH AND SIGHT OF CHILDREN
It is important to always have the information about the medicine available, so keep both the box and the package leaflet.
Composition and pharmaceutical form
COMPOSITION
1 gram of cream contains:
Active ingredient: diphenhydramine hydrochloride 20 mg equal to diphenhydramine 17.5 mg, for a total of 600 mg diphenhydramine hydrochloride equal to 525 mg diphenhydramine for the 30 g tube.
Excipients: stearic acid, glycerin, lanolin, triethanolamine, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, distilled water.
HOW IT LOOKS
ALLERGAN comes in the form of a cream for dermatological use (to be spread on the skin), contained in a metal tube. The package content is 30 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.
01.0 NAME OF THE MEDICINAL PRODUCT
ALLERGAN
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
100 g of cream contain:
Active principle. Diphenhydramine hydrochloride g 2.
Excipients:
Stearic acid, glycerin, lanolin, triethanolamine, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, distilled water.
03.0 PHARMACEUTICAL FORM
Cream, for topical use.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Local symptomatic treatment of itchy dermatitis, sunburn, insect bites.
04.2 Posology and method of administration
Spread a thin layer on the affected area, 2 or 3 times a day. Do not exceed the recommended dose.
04.3 Contraindications
Known hypersensitivity to the components and to other antihistamines of similar chemical structure.
Children under the age of 2.
04.4 Special warnings and appropriate precautions for use
Do not use with occlusive dressing. The use of the product, especially if prolonged, can give rise to sensitization phenomena, if this occurs, stop the treatment and consult your doctor.
Warnings
Apply the cream on small areas of the skin. ALLERGAN cream should not be applied to areas of the skin with blisters, to live sores and surfaces in the process of scarring.
Avoid contact with eyes or other mucous membranes. In the case of sunburn, do not subsequently expose the skin to the sun. If after a short period of treatment you do not notice any improvement or if skin rashes, irritation and burning phenomena occur, stop the treatment and contact your doctor.
Do not use the medicine after the expiry date indicated on the package. Keep this medicine out of the reach of children.
04.5 Interactions with other medicinal products and other forms of interaction
None known.
04.6 Pregnancy and lactation
In pregnant and lactating women, the product should be used only in case of real need and under direct medical supervision.
04.7 Effects on ability to drive and use machines
Not relevant.
04.8 Undesirable effects
Burning, rash, photosensitivity reactions were found.
Notify your doctor or pharmacist of any undesirable effects not described in the package leaflet.
04.9 Overdose
No overdosing phenomena reported.
If necessary, use symptomatic therapy.
05.0 PHARMACOLOGICAL PROPERTIES
Dinenhydramine is an antihistamine belonging to the group of H1 antagonists, that is able to compete with histamine at the level of the H1-receptors present in the smooth muscle of the respiratory tree, vessels, capillaries and some exocrine glands, especially those attached to the bronchi, the salivaries and the lacrimal.
On the other hand, it does not affect the H2-receptors of the stomach glands. Therefore it has no action on gastric secretion.
05.1 Pharmacodynamic properties
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05.2 Pharmacokinetic properties
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05.3 Preclinical safety data
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06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
06.2 Incompatibility
None known.
06.3 Period of validity
5 years in intact packaging.
06.4 Special precautions for storage
None.
06.5 Nature of the immediate packaging and contents of the package
Packs of 30 g in aluminum tube.
Over-the-counter product.
06.6 Instructions for use and handling
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07.0 MARKETING AUTHORIZATION HOLDER
S.p.A. Italian Laboratories BOUTY - Milan
08.0 MARKETING AUTHORIZATION NUMBER
A.I.C. N 001740051 (pack of 15 g)
A.I.C. N 001740063 (pack of 30 g).
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
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10.0 DATE OF REVISION OF THE TEXT
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