The active ingredient in Fenistil drops, dimethene maleate, is a so-called "antihistamine".

How is it applied?

What are Fenistil drops and what are they used for?

The active ingredient of Fenistil - drops, dimethene maleate, is a so-called "antihistamine". Fenistil drops are effective against the symptoms of allergic diseases and itching of all kinds.

This medicinal product is used for:
- Itching caused by:
- eczema
- childhood diseases (e.g..
- Insect bites and stings
- Food and drug allergies
- Hives
- Sneezing and itching in the nose in allergic rhinitis and allergic conjunctivitis (hay fever)
- Itching in the nose in allergic rhinitis and allergic conjunctivitis.Itching without skin disease

Fenistil drops are used in adults, adolescents and children from 1 year of age.

Fenistil drops should only be given to children under 3 years of age on a doctor's prescription.

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

What should you pay attention to before taking it?

What should you be aware of before taking Fenistil - Drops?

Fenistil - Drops must not be taken
- if you are allergic to dimetamine maleate or any of the other ingredients of this medicine listed in section 6. other ingredients of this medicinal product,
- if you are taking MAO inhibitors (against depressive moods) at the same time,
- by babies under 1 month of age, especially premature babies.

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

Inform your doctor or pharmacist if any of the above apply to you, as Fenistil - drops are not suitable for you in these circumstances.

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

Children
Medicines of this substance class may cause restlessness in younger children.
Fenistil drops should only be given to children under 3 years of age on a doctor's prescription.
Do not exceed the prescribed dose.

Use of Fenistil in infants over one month and up to 1 year of age:
Caution is advised in children under 1 year of age (especially premature babies). Extremely rare problems with breath control (apnoeic phases) can be prolonged. Therefore, use in this patient group is generally not recommended (see end of the instructions for use for information for the doctor).

Taking Fenistil - drops with other medicines

Inform your doctor or pharmacist if you are taking/using, have recently taken/used or do not intend to take/use any other medicines.

Take Fenistil - drops only 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 to treat asthma and bronchospasm), gastrointestinal antispasmodics (medicines to treat stomach or abdominal cramps), mydriatics (medicines that dilate your pupils), urological antimuscarinics (medicines to treat 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 (medicines for the treatment of certain types of cancer)
- Scopolamine (medicine for motion sickness)

Taking Fenistil - drops with food, drink and alcohol
The fatigue-inducing effect of alcohol may be increased.

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 taking this medicine.
Although there are no known adverse effects on fertility, Fenistil should only be taken during pregnancy if specifically ordered by a doctor. Targeted studies on the use in pregnancy are lacking. It is assumed that small amounts of the active substance pass into breast milk. Use during breastfeeding is therefore not recommended.

Driving and ability to operate machinery

This medicine may impair your ability to react and drive! Caution:

Caution is therefore advised when operating machinery and in road traffic.

Fenistil drops contain benzoic acid, propylene glycol and sodium

.

• 1 mg benzoic acid (E 210) per ml (= 20 drops).
• 100 mg propylene glycol (E 1520) per ml (= 20 drops)
• Less than 1 mmol sodium (23 mg) per ml (= 20 drops), i.e. it is almost "sodium-free".

How should the medicine be taken?

How should Fenistil drops be taken?

Always take 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.

Do not exceed the recommended dose.

Fenistil is used in adults, adolescents and children from 1 year of age.
Must be given to children under 3 years of age only on a doctor's prescription.

Children from 1 to 12 years
The recommended daily dose is 2 drops per kg of body weight per day, divided into three doses, e.g..For example, 8 drops three times a day for a 2-year-old child weighing 12 kg.

Adults and children from 12 years
3 times daily 20 - 40 drops each.
For patients prone to drowsiness, it is recommended to take 40 drops before bedtime and 20 drops in the morning.
Type of application
Ingestion.
Administer the drops undiluted by teaspoon.
Hold the vial vertically when counting drops!


correct


incorrect

Do not add to hot liquid, add to lukewarm liquid of a baby feeding bottle just before use. As soon as possible, infants should take it with a spoon (the solution tastes pleasant).

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

If you have taken more Fenistil drops than you should Depending on how much you have taken, adults may experience severe drowsiness (in children and elderly people also agitation).Depending on the amount taken, adults may experience severe drowsiness (in children and elderly people also agitation), gait disturbances, hallucinations, tremors, convulsions, urinary retention and fever. Blood pressure drop, unconsciousness and circulatory failure may follow.
In this case, consult a doctor immediately.
Instructions for the doctor are at the end of the instructions for use.

If you forget to take Fenistil - drops
If you forget a dose, take it as soon as you remember, unless it is less than 2 hours until your next dose. In this case, skip the missed dose and return to your regular dosing schedule. Do not take double the amount if you have forgotten to take it before.

If you have any further questions about taking this medicine, ask your doctor or pharmacist.

.

What are the possible side effects?

How to store Fenistil - drops?

Store in the original packaging to protect the contents from light.
Do not store above 25ºC.

Keep this medicine out of the reach of children.

You must not use this medicinal product after the expiry date which is stated on the outer carton after "Use by:". The expiry date refers to the last day of the month indicated.

Burns for 3 months after opening.

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 notes on the content

Contents of the pack and other information

What Fenistil - Drops contain
- The active substance is: dimethene maleate. 1 ml contains 1 mg dimetindene maleate. 1 ml = 20 drops
- The other ingredients are:
Sodium monohydrogen phosphate dodecahydrate (E 339), citric acid monohydrate
(E 330), benzoic acid (E 210), sodium edetate (E 386), saccharin sodium (E 954), propylene glycol (E 1520), purified water.

What Fenistil - drops look like and contents of the pack
Fenistil drops for oral use are a clear and colourless solution and are available in 10 ml or 20 ml bottles.
Not all pack sizes may be placed on the market.