ALLERGAN

ALLERGAN cream
Diphenhydramine
BEFORE USE, READ CAREFULLY ALL INFORMATION CONTAINED IN THE PACKAGE LEAFLET
This is an over-the-counter medicine that you can use to treat mild and transient conditions which are easily recognizable and resolvable without medical assistance.
It can therefore be purchased without a prescription, but must be used correctly to ensure its effectiveness and reduce unwanted effects.

• For further information and advice, consult your pharmacist.
• Consult a doctor if symptoms do not resolve after a short period of treatment.

NAME OF THE MEDICINAL PRODUCT
ALLERGAN 2g/100g cream
Diphenhydramine hydrochloride

COMPOSITION
1 gram of cream contains:
Active substance: diphenhydramine hydrochloride 20 mg, equivalent to 17.5 mg of diphenhydramine, for a total of 600 mg of diphenhydramine hydrochloride (equivalent to 525 mg of diphenhydramine) in the 30 g tube.
Excipients: stearic acid, glycerin, lanolin, triethanolamine, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, distilled water.

WHAT IT LOOKS LIKE
ALLERGAN is presented as a dermatological cream (for topical application on the skin), contained in a metal tube. The package contains 30 g.

WHAT THIS MEDICINE IS
ALLERGAN is an antipruritic agent, i.e. it relieves itching and discomfort caused by skin irritations, insect bites, and redness due to excessive sun exposure.

MARKETING AUTHORISATION HOLDER
IBSA FARMACEUTICI ITALIA S.R.L.
VIA MARTIRI DI CEFALONIA, 2, 26900 - LODI (LO).

MANUFACTURER AND FINAL CONTROLLER
ALLERGAN is manufactured, packaged, controlled, and released by Alfa Wassermann, Via E. Fermi, 1 - 65020 Alanno (PE).

WHY IT IS USED
ALLERGAN is used for the local symptomatic treatment of pruritic dermatitis, sunburn (erythema), and insect bites (i.e. to relieve itching and discomfort due to irritations, insect bites, and skin redness caused by excessive sun exposure).

WHEN IT MUST NOT BE USED
Children under 2 years of age.
Known hypersensitivity to the components or to other antihistamines with a similar chemical structure (dimenhydrinate, carbinoxamine maleate).

ALLERGAN cream
Diphenhydramine
It is advisable to consult a doctor if such symptoms have occurred previously.
See also the section on PREGNANCY AND BREASTFEEDING.

WHEN IT SHOULD ONLY BE USED AFTER CONSULTING A DOCTOR
Pregnancy and breastfeeding (see "What to do during pregnancy and breastfeeding").

WHAT TO DO DURING PREGNANCY AND BREASTFEEDING
In pregnant women and during breastfeeding, the product should only be used if clearly needed and under direct medical supervision.

PRECAUTIONS FOR USE
Do not use under occlusive dressings. Prolonged use of the product may lead to sensitization (allergic-type reactions); if this occurs, discontinue treatment and consult a doctor.

WHICH MEDICINES OR FOODS CAN AFFECT THE MEDICINE’S EFFECT
No incompatibilities with other medicines or foods are known.
If you are taking other medicines, seek advice from your doctor or pharmacist.

IT IS IMPORTANT TO KNOW THAT
ALLERGAN should be applied only to small areas of skin.
ALLERGAN cream must not be applied to blistered skin, open wounds, or healing surfaces.
Avoid contact with eyes or other mucous membranes. In cases of sunburn, do not expose the skin to sunlight afterwards. If no improvement is seen after a short period of treatment, or if skin eruptions, irritation, or burning sensations occur, discontinue treatment and consult a doctor.
ALLERGAN has no effect on the ability to drive or operate machinery.

HOW TO USE THIS MEDICINE

• Dosage: apply a thin layer of cream to the affected area 2 or 3 times daily.
  ATTENTION: DO NOT EXCEED THE RECOMMENDED DOSES WITHOUT MEDICAL ADVICE.
• When and for how long: use only for short treatment periods. Consult a doctor if symptoms recur repeatedly or if you have noticed any recent changes in their characteristics.

WHAT TO DO IF YOU HAVE TAKEN AN EXCESSIVE DOSE
No adverse events have been reported following overdose of this medicine. In case of accidental ingestion or overdose of ALLERGAN, contact your doctor immediately or go to the nearest hospital.

UNDESIRABLE EFFECTS
Burning sensation, skin eruptions, and photosensitivity reactions (skin rash after sun exposure) have been reported.
Following the instructions in the package leaflet reduces the risk of undesirable effects.
These side effects are generally transient. However, if 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 this leaflet.
Request and complete the adverse reaction reporting form available at pharmacies.

EXPIRY DATE AND STORAGE
See expiry date on the packaging. The stated expiry date refers to the product stored unopened and under proper storage conditions.
WARNING: DO NOT USE THIS MEDICINE AFTER THE EXPIRY DATE STATED ON THE PACKAGE.
KEEP THIS MEDICINE OUT OF SIGHT AND REACH OF CHILDREN.
It is important to always keep the medicine’s information available; therefore, retain both the outer packaging and the package leaflet.

Revision of the Package Leaflet by AIFA
September 2009