Fenistil - Gel

What is Fenistil Gel?
Fenistil gel contains an active substance that belongs to a group of medicines called antihistamines.

Application

What is Fenistil Gel and what is it used for?

What is Fenistil Gel?
Fenistil Gel contains an active substance that belongs to a group of medicines called antihistamines.

Fenistil Gel is used to treat itching caused by dermatoses, insect bites, hives (urticaria), sunburn and minor superficial burns.

How does Fenistil Gel work?
Fenistil Gel stops itching by blocking the action of histamine, a substance released by the body during allergic reactions. The gel penetrates the skin quickly and relieves itching and skin irritation within minutes. Fenistil gel also has a local anaesthetic effect.

If you do not feel better or even worse after 1 week, consult your doctor.

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How is it applied?

What is Fenistil Gel and what is it used for?

What is Fenistil Gel?
Fenistil Gel contains an active substance that belongs to a group of medicines called antihistamines.

Fenistil Gel is used to treat itching caused by dermatoses, insect bites, hives (urticaria), sunburn and minor superficial burns.

How does Fenistil Gel work?
Fenistil Gel stops itching by blocking the action of histamine, a substance released by the body during allergic reactions. The gel quickly penetrates the skin and relieves itching and skin irritation within minutes. Fenistil gel also has a local anaesthetic effect.

If you do not feel better or even worse after 1 week, consult your doctor.

What should you pay attention to before taking it?

What you should be aware of before using Fenistil Gel?

Fenistil Gel must not be used,
- if you are allergic to dimetine maleate or any of the other ingredients of this medicine listed in section 6. If you are not sure, ask your doctor or pharmacist.

Warnings and precautions
Please talk to your doctor or pharmacist before using Fenistil Gel.

• Do not expose treated skin areas to sunlight for a prolonged period of time, as this may trigger light hypersensitivity reactions of the skin.
• See your doctor if your symptoms do not improve within a week.
• See your doctor if you have very severe itching or extensive skin damage.

It should not be applied over large areas, especially not on inflamed or injured
Skin, this is especially true for infants and young children.

Fenistil gel may irritate the eyes and mucous membranes. In case of accidental contact, rinse the affected area thoroughly under running water.

Use of Fenistil Gel with other medicines.
Inform your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines.

Interactions with other medicinal products are not known.

Pregnancy, lactation and reproductive capacity.
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.

There is no evidence of harmful effects on embryo or foetus.
Since no specific studies are available on use during pregnancy and breast-feeding, you should only use Fenistil Gel during pregnancy on the advice of your doctor. Do not apply Fenistil Gel to large areas of the skin, especially inflamed or sore skin.
Do not use on nipples of breastfeeding women.

Driving ability and ability to operate machinery.
The application of Fenstil Gel to the skin does not affect your ability to drive or operate machinery.

Fenistil Gel contains propylene glycol and benzalkonium chloride.

• 150 mg propylene glycol (E1520) per g gel.
  Propylene glycol may cause skin irritation.
• 0.05 mg of benzalkonium chloride per g of gel.
  Benzalkonium chloride may cause skin irritation.
  If you are breast-feeding, do not apply this medicine to the breast as your baby may absorb it with the milk.

How should the medicine be taken?

How to use Fenistil Gel?

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Children, adolescents and adults:
Apply 2-4 times daily to the affected area of skin unless otherwise advised by your doctor.

Contact your doctor if symptoms do not improve within a week.

If you have used a larger amount of Fenistil Gel than you should
No case of overdose with Fenistil Gel has been reported so far. Accidental ingestion of large quantities of Fenistil Gel may cause symptoms of poisoning. In this case, consult a doctor immediately.
Instructions for the doctor are at the end of the leaflet.

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

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What are the possible side effects?

How to store Fenistil Gel?

Do not store above 25 °C.
Do not use for longer than 3 months after first use.

Keep this medicine out of the reach of children.

Do not use this medicine after the expiry date which is stated on the carton after "EXP". The expiry date refers to the last day of the month indicated.

Do not dispose of medicines in waste water or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. In doing so, they contribute to the protection of the environment.

Special instructions for storage

5 How to store Fenistil Gel?

Do not store above 25°C.
Do not use for longer than 3 months after first use.

Keep this medicine out of the reach of children.

Do not use this medicine after the expiry date which is stated on the carton after "EXP". The expiry date refers to the last day of the month indicated.
Do not dispose of medicines in waste water or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. In this way, they contribute to the protection of the environment.

Special notes on the content

Contents of the pack and other information

What fenistil gel contains
- The active substance is: dimethene maleate.
1 g contains 1 mg dimethene maleate. 1 cm gel contains 0.24 mg dimetindene maleate.
- The other ingredients are: Benzalkonium chloride, sodium edetate, carbomer, propylene glycol, sodium hydroxide solution, purified water.

What Fenistil Gel looks like and contents of the pack
Odourless, colourless gel for application to the skin in aluminium tubes. It does not stain clothing.

Pack sizes: 20 g, 30 g, 50 g
Not all pack sizes may be marketed.