Fenistil - gel

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

Application

1. What is Fenistil Gel and what is it used for?

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

Fenistil Gel is used to treat itching in dermatoses, insect bites, nettle rash (urticaria), sunburn and minor superficial burns.

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

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

How is it used?

What is Fenistil Gel and what is it used for?

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

Fenistil Gel is used to treat itching in dermatoses, insect bites, nettle rash (urticaria), sunburn and minor superficial burns.

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

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

What should you consider before taking it?

What should you consider before using Fenistil Gel?

Fenistil Gel must not be used,
- if you are allergic to dimetindene 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 long period of time, as this may cause the skin to become more sensitive to light.
• 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 used over a large area, especially on inflamed or injured
skin, this applies especially to infants and toddlers.

Fenistil Gel can irritate the eyes and mucous membranes. In case of accidental contact, rinse the affected area thoroughly with running water.

Using Fenistil Gel with other medicines
Tell your doctor or pharmacist if you are taking/using, have recently taken/used or plan to take/use any other medicines.

Interactions with other medicines are not known.

Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, or if you think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

There is no evidence of harmful effects on the embryo or fetus.
Since no specific studies on the use during pregnancy and breastfeeding are available, you should only use Fenistil Gel during pregnancy on the doctor's instructions. Do not apply Fenistil Gel over a large area of the skin, especially on inflamed or sore skin.
Do not apply to the nipples of breastfeeding women.

Driving and using machines
Applying Fenstil Gel to the skin has no effect on your ability to drive or operate machinery.

Fenistil Gel contains propylene glycol and benzalkonium chloride

• 150 mg propylene glycol (E1520) per g of gel.
  Propylene glycol can cause skin irritation.
• 0.05 mg benzalkonium chloride per g of gel.
  Benzalkonium chloride can cause skin irritation.
  If you are breastfeeding, you must not apply this medicine to your breast, as your baby could ingest 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 exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Children, adolescents and adults:
Unless otherwise recommended by your doctor, apply to the affected area of skin 2–4 times a day.

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

If you have used more Fenistil Gel than you should
No case of overdose with Fenistil Gel has been reported to date. Accidental ingestion of larger amounts of Fenistil Gel can lead to poisoning. In this case, see a doctor immediately.
Instructions for the doctor can be found at the end of the package leaflet.

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

What side effects are possible?

How to store Fenistil Gel?

Do not store above 25 °C.
Do not use for more than 6 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 wastewater or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. You help to protect the environment.

Special storage instructions

5. How to store Fenistil Gel?

Do not store above 25 °C.
Do not use for more 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 wastewater or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. You help to protect the environment.

Special information on the content

Contents of the pack and further information

What Fenistil Gel contains
- The active ingredient is: Dimetindene maleate.
1 g contains 1 mg dimetindene maleate. 1 cm of 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
Odorless, colorless gel for application to the skin in aluminum tubes. It does not leave any stains on clothing.

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