Fenistil 1 mg - Dragees

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The active ingredient of Fenistil 1 mg dragées, dimetindene maleate, is a so-called "antihistamine".

How is it used?

What are Fenistil 1 mg dragées and what are they used for?

The active ingredient of Fenistil 1 mg dragées, dimetindene maleate, is a so-called "antihistamine". Fenistil 1 mg dragées are effective against the symptoms of allergic diseases and any type of itching.

This medicine is used for:
- Itching caused by:
- Eczema
- Childhood diseases (e.g. chickenpox)
- Insect bites and stings
- Food and drug allergies
- Hives
- Sneezing and itching of the nose in the case of allergic rhinitis and allergic conjunctivitis (hay fever).
- Itching without a skin condition

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

What should you consider before taking the medicine?

What should you consider before taking Fenistil 1 mg dragées ?

Fenistil 1 mg dragées must not be taken,
- if you are allergic to dimetindene maleate or any of the other ingredients of this medicine listed in section 6,
- by children under 12 years of age,
- if you are taking so-called MAO inhibitors (for depressive moods) at the same time.

Warnings and precautions
Please talk to your doctor or pharmacist before taking Fenistil 1 mg dragées if you or your child
- have glaucoma,
- urinary retention,
- epilepsy
suffer.

Inform your doctor or pharmacist if any of the above applies to you, as Fenistil 1 mg dragées is not suitable for you under these circumstances.

Elderly patients should consult their doctor before using this medicine, as side effects such as restlessness and tiredness may occur.

Children
Medicines in this class of substances can cause restlessness in younger children.

Taking Fenistil 1 mg dragées together with other medicines
Only take Fenistil 1 mg dragées on the advice of your doctor if you are taking any of the following medicines:
- certain medicines for depression
- certain painkillers (opioid analgesics, e.g. codeine)
- anticholinergics, such as bronchodilators (medicines for the treatment of asthma and bronchospasm), gastrointestinal antispasmodics (medicines for stomach or abdominal cramps), mydriatics (medicines that dilate your pupils), urological antimuscarinics (medicines for the treatment of symptoms of urge incontinence and overactive bladder)
- medicines with a sedative effect or sleeping pills
- medicines for epilepsy
- antihistamines (medicines for the treatment of coughs, colds and allergies)
- antiemetics (medicines for the treatment of vomiting)
- procarbazine (a medicine for the treatment of certain types of cancer)
- scopolamine (a medicine for travel sickness)

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

Taking Fenistil 1 mg dragées together with food, drink and alcohol
The drowsiness caused by alcohol may be intensified.

Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, or if you suspect you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Although no harmful effects on the foetus are known, Fenistil should only be taken during pregnancy on the express orders of a doctor. There have been no specific studies on use during pregnancy. It is assumed that small amounts of the active ingredient pass into breast milk. Use during breast-feeding is therefore not recommended.

Driving and using machines


Caution:
This medicine may impair your reactions and ability to drive. Caution is therefore required when operating machinery and in road traffic.

Fenistil 1 mg dragées contain sucrose, lactose, glucose and traces of gluten Please only take Fenistil 1 mg dragées after consulting your doctor if you know that you suffer from an intolerance to sugar.

Fenistil 1 mg dragées contain only a very small amount of gluten (wheat starch) and can be taken in the case of coeliac disease. However, Fenistil 1 mg dragées should not be used in the case of an allergy to wheat starch.

How should the medicine be taken?

How are Fenistil 1 mg dragées to be taken?

Always take this medicine exactly as described in this leaflet or exactly as instructed by your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure.

Do not exceed the recommended dose.

Adults and adolescents aged 12 and over:
Unless otherwise prescribed by your doctor, the usual dose is:
From the age of 12, 1-2 dragées 3 times a day.

For patients who tend to feel tired, the recommended dosage is 2 dragées in the evening before going to bed and 1 dragée in the morning with breakfast.

This dosage form is not suitable for children under 12 years of age; Fenistil-
drops are available.

Elderly patients (over 65 years of age):
The usual dosage for adults can be used.

Do not take Fenistil for longer than 14 days without consulting a doctor.

Method of administration
For oral use
Swallow the dragée whole with a little water.

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

If you have taken more Fenistil 1 mg dragées than you should
Depending on the extent of the overdose, adults may experience severe drowsiness (but children and elderly people may also experience states of excitement), gait disturbances, hallucinations, tremors, convulsions, urinary retention and fever. A drop in blood pressure, unconsciousness and circulatory failure may follow. In this case, consult a doctor immediately.
Instructions for the doctor can be found at the end of the package leaflet.

If you forget to take Fenistil 1 mg dragées
If you forget to take a dose, take it as soon as you remember, unless it is less than 2 hours until the next dose. In this case, skip the missed dose and return to your regular dosing schedule. Do not take double the amount to make up for a forgotten dose.

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

What side effects are possible?

How are Fenistil 1 mg dragées to be stored?

Store in the original package to protect the contents from light.
Do not store above 25° C.

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 "Use by:". 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. In doing so, you help to protect the environment.

Special notes on the content

Contents of the pack and further information

What Fenistil 1 mg dragées contain
- The active ingredient is dimetindene maleate: 1 dragée contains 1 mg dimetindene maleate.
- The other ingredients are:
Core: cellulose, magnesium stearate (E 572), highly dispersed silicon dioxide, lactose monohydrate
Coating: gelatine, glucose syrup, povidone (K 25), titanium dioxide (E 171), talc (E 553b), sucrose, macrogol (35000), montan glycol wax

What Fenistil 1 mg dragées look like and contents of the pack
Fenistil 1 mg dragées are small, white, biconvex (convex on both sides), coated tablets.
Pack sizes: 10, 30 and 200 pieces in blister packs
Not all pack sizes may be marketed.