FENISTIL

FENISTIL Gel

Important notes (mandatory information)

Fenistil Gel. Active ingredient: Dimetindene maleate. Areas of application: for short-term relief of itching in the case of small, itchy insect bites on intact skin; itching in the case of skin conditions such as chronic eczema, urticaria and other allergic skin conditions; first-degree burns, sunburn.

For risks and side effects, read the package leaflet and consult your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Fenistil Gel
Active ingredient: Dimetindene maleate 1 mg/g

Read the entire package leaflet carefully before you start using this medicine, because it contains important information. Always use this medicine exactly as described in this package leaflet or exactly as your doctor or pharmacist has told you.

• Keep the package leaflet. You may need to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not listed in this package leaflet. See section 4.
• If you do not feel better or if you feel worse, contact your doctor.

What this package leaflet contains

1. WHAT IS FENISTIL GEL AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING FENISTIL GEL?
3. HOW TO USE FENISTIL GEL?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE FENISTIL GEL?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS FENISTIL GEL AND WHAT IS IT USED FOR?

Fenistil Gel is an anti-allergic agent for local treatment/relief of itching in the case of skin conditions, insect bites, minor burns and sunburn. Area of application: For short-term relief of itching in the case of small, itchy insect bites on intact skin. Itching in the case of skin conditions such as chronic eczema, urticaria and other allergic skin conditions; first-degree burns, sunburn.

2. WHAT SHOULD YOU CONSIDER BEFORE USING FENISTIL GEL?

Fenistil Gel must not be used:

• if you are hypersensitive (allergic) to dimetindene maleate, methyl-4-hydroxybenzoate or any of the other ingredients of Fenistil Gel listed in section 6.
• for large-scale application.
• on damaged skin.

Warnings and precautions

Please talk to your doctor or pharmacist before using Fenistil Gel. Do not expose extensively treated skin areas to direct sunlight for a prolonged period of time. Please inform your doctor in the case of very severe itching or large-scale conditions. The product is not intended for use on large, particularly injured or inflamed skin areas, this applies in particular to infants and small children. Systemic dosage forms are available for the treatment of known insect venom allergy.

Use of Fenistil Gel together with other medicines

Please inform your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines. Interactions are not to be expected if used as intended.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy

Fenistil Gel should not be applied to large skin areas during pregnancy and breast-feeding, especially not on injured or inflamed skin.

Breast-feeding

There is insufficient experience with use during breast-feeding in humans. Dimetindene passes into the milk in rats, however, only low systemic availability is to be expected after topical application. Nursing mothers should not apply the product to large areas, especially not on injured or inflamed skin, and should not use it on the nipples.

Fertility

Animal studies have shown no evidence of direct or indirect harmful effects with respect to fertility.

Driving and using machines

No effects are known.

Fenistil Gel contains methyl-4-hydroxybenzoate and propylene glycol

Methyl-4-hydroxybenzoate (E 218) can cause hypersensitivity reactions, including delayed reactions. Propylene glycol can cause skin irritation.

3. HOW TO USE FENISTIL GEL?

Always use this medicine exactly as described in this package leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure. The recommended dose is: Apply thinly to the affected skin areas up to 3 times a day and rub in gently. Do not apply dressings.

Type of use

Gel for application to the skin.

Please talk to your doctor or pharmacist if you have the impression that the effect of Fenistil Gel is too strong or too weak.

If you have used more Fenistil Gel than you should

If you have applied more than you should, remove the excess gel from the skin with a cloth. If you or a child have accidentally swallowed Fenistil Gel, inform a doctor immediately. In the event of intentional or accidental overdose, please inform your doctor or pharmacist immediately so that they can decide on the severity and any further measures that may be necessary.

If you forget to use Fenistil Gel

Do not use double the dose, but continue using as described in the dosage instructions.

If you stop using Fenistil Gel

If you interrupt the treatment or stop using it prematurely, you must expect that the desired effect will not occur or that the symptoms will worsen again. Therefore, please consult your doctor or pharmacist if you want to stop or interrupt the treatment.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them. The frequency of side effects is not known (frequency cannot be estimated from the available data).

• Dryness of the skin.
• Burning sensation on the skin.
• Allergic dermatitis.

Methyl-4-hydroxybenzoate (E 218) can cause hypersensitivity reactions, including delayed reactions.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Department of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE FENISTIL GEL?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the folding box and the tube. Note on shelf life after first opening: Fenistil Gel can be stored for 6 months after first opening.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Fenistil Gel contains

The active ingredient is: Dimetindene maleate 1 mg per g of gel. The other ingredients are: Purified water; propylene glycol; carbomer 980; sodium hydroxide; methyl-4-hydroxybenzoate (E 218) (paraben).

What Fenistil Gel looks like and contents of the pack

Fenistil Gel is a colourless gel and is available in packs of 20 g gel, 30 g gel, 50 g gel and 100 g gel. Not all pack sizes may be marketed.

Pharmaceutical entrepreneur and manufacturer

GlaxoSmithKline Consumer Healthcare GmbH & Co. KG
80258 Munich

Postal address

Barthstraße 4
80339 Munich

Telephone (089)78 77-209
Telefax (089)78 77-304
E-mail: medical.contactcenter@gsk.com

This package leaflet was last revised in May 2017.

Source: Information from the package leaflet
Status: 05/2018
Active ingredient: Dimetindene maleate. Areas of application: for short-term relief of itching in the case of small, itchy insect bites on intact skin; itching in the case of skin conditions such as chronic eczema, urticaria and other allergic skin conditions; first-degree burns, sunburn.