Fenistil

Package Leaflet: Information for the Patient

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Fenistil

1 mg/ml, oral drops, solution
Dimetindene maleate

Before taking the medicine, carefully read the contents of this leaflet, as it contains important information for the patient.

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist.

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If after 7 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of Contents of the Leaflet:

• 1. What is Fenistil and what is it used for
• 2. Important information before taking Fenistil
• 3. How to take Fenistil
• 4. Possible side effects
• 5. How to store Fenistil
• 6. Contents of the pack and other information

1. What is Fenistil and what is it used for

Fenistil contains dimetindene maleate, which belongs to the group of antihistamine medicines.
It inhibits the action of histamine - a substance responsible for allergic reactions. It relieves itching and
irritation caused by skin rash, reduces swelling, and also relieves symptoms of allergic rhinitis, such as
runny nose (cold), sneezing, nasal itching, and eye itching and tearing.
After oral administration, the effect of the medicine starts after 30-60 minutes and lasts for 8 to 12
hours.
Fenistil is used to treat symptoms of allergic diseases:

• skin: urticaria, itching in atopic dermatitis, allergic contact dermatitis, endogenous eczema,
• respiratory system: seasonal allergic rhinitis (hay fever) and chronic allergic rhinitis (e.g., house dust allergy, pet hair, feathers). The medicine is used to treat symptomatic food and drug allergies, as well as: relieves itching associated with infectious diseases (e.g., chickenpox). It can be used to relieve symptoms after insect bites and to prevent allergic reactions during desensitization treatment. If after 7 days there is no improvement or the patient feels worse, they should contact their doctor.

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2. Important information before taking Fenistil

When not to take Fenistil in the form of oral drops:

• if the patient is allergic to dimetindene maleate or any of the other ingredients of this medicine (listed in section 6),
• in newborns up to the age of 1 month, especially premature babies.

Warnings and precautions

Before starting to take Fenistil, the patient should discuss it with their doctor or pharmacist, or
nurse.
The patient should consult their doctor before taking this medicine if they have:

• glaucoma,
• urinary retention caused by, for example, prostate enlargement,
• epilepsy,
• are elderly.

Elderly patients should consult their doctor before taking this medicine, as they are more susceptible to the side effects of this medicine, such as excitement and fatigue. The medicine should not be taken by elderly patients with disorientation.

Children and adolescents

Antihistamines in small children can cause excitement.
Fenistil should be used in infants from 1 month to 1 year of age and in children under 6 years of age only on the advice of a doctor.
A higher dose than recommended should not be taken.
The medicine should be stored in a place that is invisible and inaccessible to children.

Fenistil and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, including those that are available without a prescription.
Without the advice of a doctor, Fenistil should not be taken if the patient is taking any of the following medicines:

• antidepressants,
• anticholinergic medicines, such as: bronchodilators (medicines used to treat asthma and bronchospasm), medicines used to treat spasms in the abdominal cavity (medicines used to prevent stomach and intestinal cramps), medicines that dilate the pupils, urological antispasmodic medicines (medicines used to treat symptoms of urinary incontinence and overactive bladder),
• sedatives,
• antiepileptic medicines (medicines used to treat epilepsy),
• opioid analgesics,
• antihistamines (medicines used to treat common cold, cough, or other allergies),
• antiemetic medicines,
• procarbazine (a medicine used to treat certain types of cancer),
• scopolamine (a medicine used to prevent motion sickness),
• alcohol.

Taking Fenistil with alcohol

Like other antihistamines, Fenistil may enhance the effects of alcohol.
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Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Fenistil should not be taken during pregnancy, unless the benefits to the mother outweigh the potential risk to the fetus. The medicine should only be used under medical supervision.
Fenistil should not be taken by breastfeeding women.

Driving and using machines

As with other antihistamines, Fenistil may impair psychomotor performance in some patients. Therefore, patients taking Fenistil in the form of oral drops should be cautious when driving vehicles or operating machinery.

Fenistil contains benzonic acid (E 210), propylene glycol (E 1520), and sodium.

The medicine contains 2 mg of benzonic acid per dose (40 drops), which corresponds to 1 mg/ml.
Benzonic acid may increase the risk of jaundice (yellowing of the skin and whites of the eyes) in newborns (up to 4 weeks of age).
The medicine contains 200 mg of propylene glycol per dose (40 drops), which corresponds to 100 mg/ml.
Before administering the medicine to a child under 4 weeks of age, the patient should consult their doctor or pharmacist, especially if the child is taking other medicines that contain propylene glycol or alcohol.
The medicine contains less than 1 mmol (23 mg) of sodium per dose (40 drops), which means the medicine is considered "sodium-free".

3. How to take Fenistil

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor, pharmacist, or nurse. In case of doubt, the patient should consult their doctor, pharmacist, or nurse.
The recommended dose should not be exceeded.
The use of Fenistil in infants from 1 month to 1 year of age and in children under 6 years of age should be done on the advice of a doctor. The medicine should not be taken by children under 1 month of age.

Adults and children over 6 years:

The medicine should not be taken for more than 7 days.
If after 7 days there is no improvement or the patient feels worse, they should contact their doctor.
Adults and children over 12 years
The daily dose is 3-6 mg of dimetindene, given in 3 divided doses.
It is recommended to take 20 to 40 drops 3 times a day.
In patients with a tendency to drowsiness, 40 drops should be taken before bedtime and 20 drops in the morning, during breakfast.
Children under 12 years
The recommended daily dose is 0.1 mg/kg body weight/day, given in 3 divided doses, e.g.,
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6 drops 3 times a day in the case of an 8-month-old infant weighing 9 kg
8 drops 3 times a day in the case of a 2-year-old child weighing 12 kg.
The maximum daily dose should not be exceeded, which is:

Age Maximum daily dose

1 month-1 year
1.5 mg 30 drops
1-3 years
2.25 mg 45 drops
3-12 years
3 mg 60 drops
20 drops = 1 ml = 1 mg dimetindene maleate

Infants from 1 month to 1 year of age and children under 6 years of age:

The use of Fenistil in infants from 1 month to 1 year of age and in children under 6 years of age should be done on the advice of a doctor.

Fenistil should not be exposed to high temperatures. If the infant is bottle-fed, the medicine should be added to the bottle with warm food immediately before feeding. If the infant is spoon-fed, the drops can be given undiluted, on a small teaspoon.

Elderly patients

Elderly patients should consult their doctor before taking this medicine.

Overdose of Fenistil

In case of overdose, the patient should immediately consult their doctor or pharmacist.
Symptoms of overdose are: drowsiness (mainly in adults), central nervous system stimulation (mainly in children and elderly patients), including stimulation, coordination disorders, hallucinations, tremors, convulsions, as well as urinary retention and fever. There may be a drop in blood pressure, coma, and cardiovascular and respiratory collapse.

Missed dose of Fenistil

In case of a missed dose, the patient should take it as soon as possible, unless there are less than 2 hours left before the next dose. In this case, the patient should take the medicine at the usual time. A double dose should not be taken to make up for a missed dose.
In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Fenistil can cause side effects, although not everybody gets them.
The patient should STOP taking the medicine and immediately consult their doctor if they experience any of the following symptoms, which may be signs of an allergic reaction:

• difficulty breathing or swallowing,
• swelling of the face, lips, tongue, or throat,
• severe itching of the skin with red rash or blisters, muscle cramps.

These symptoms are very rare( may occur in less than 1 in 10,000 patients).
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Other side effects that may occur are usually mild and temporary. The most common side effects occur especially at the beginning of treatment.
Very common ( may occur in more than 1 in 10 patients taking the medicine): fatigue.
Common ( occur in less than 1 in 10 patients taking the medicine): drowsiness, nervousness.
Rare ( may occur in less than 1 in 1,000 patients taking the medicine): stimulation, headaches, dizziness, gastrointestinal disorders, nausea, dry mouth, dry throat.
If any of the side effects get worse or if the patient experiences any side effects not listed in this leaflet, they should inform their doctor or pharmacist.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Pharmacovigilance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Fenistil

Store in a temperature below 25°C.
Store in the outer packaging to protect from light.
The medicine should be stored in a place that is invisible and inaccessible to children.
The medicine should not be taken after the expiry date stated on the packaging. The expiry date refers to the last day of the given month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Fenistil contains

• The active substance of the medicine is dimetindene maleate. One milliliter of Fenistil contains 1 mg of dimetindene maleate .
• Other ingredients of the medicine are: propylene glycol (E 1520), benzonic acid (E 210), disodium edetate (E 386), disodium phosphate dodecahydrate (E 339), citric acid monohydrate (E 330), sodium saccharin (E 954), purified water.

What Fenistil looks like and contents of the pack

Fenistil is a solution, clear, colorless to slightly yellowish-brown, in a bottle made of orange glass, type III, with a polyethylene dropper and a polypropylene cap, child-resistant, in a cardboard box.
Available packs:1 bottle of 20 ml.
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For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Bulgaria, the country of export:

Haleon Hungary Kft.
Csörsz utca 43
1124 Budapest
Hungary

Manufacturer:

Haleon Germany GmbH
Barthstrasse 4
80339 Munich
Germany

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing authorization number in Bulgaria, the country of export: 20000512

Parallel import authorization number: 22/18

Date of approval of the leaflet: 18.06.2025

[Information about the trademark]
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