PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet – information on the immediate packaging is in a foreign language!
Fenistil
1 mg/ml, oral drops, solution
Dimetindeni maleas
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
the doctor or pharmacist.

Keep this leaflet for future reference.
If you need advice or further information, please consult your pharmacist.
If the patient experiences any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
If there is no improvement after 7 days, or if the patient feels worse, consult a doctor.

Leaflet contents:

What Fenistil is and what it is used for
Important information before taking Fenistil
How to take Fenistil
Possible side effects
How to store Fenistil
Contents of the pack and other information

1. What Fenistil is and what it is used for

Fenistil contains dimethindene maleate, which belongs to a group of medicines called antihistamines.
It blocks the action of histamine – a substance responsible for allergic reactions. It relieves itching and
skin irritation caused by skin rashes, reduces swelling, and also alleviates symptoms of allergic
rhinitis, such as watery nasal discharge (runny nose), sneezing, nasal itching, and itchy, watery eyes.
After oral administration, the effect of the medicine begins within 30–60 minutes and lasts for 8 to 12
hours.
Fenistil is used to treat symptoms of allergic conditions:

of the skin: urticaria, itching in atopic dermatitis, allergic contact dermatitis, endogenous eczema,
of the respiratory system: seasonal allergic rhinitis (hay fever) and perennial allergic rhinitis (e.g., allergy to house dust, animal fur, feathers).

The medicine is used for symptomatic treatment of food and drug allergies, and also relieves itching
associated with infectious diseases (e.g., chickenpox).
It may be used to relieve symptoms following insect bites and to prevent allergic reactions during
desensitization therapy.
If there is no improvement after 7 days, or if the patient feels worse, consult a doctor.

2. Important information before using Fenistil

When not to use Fenistil oral drops:

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

Warnings and precautions
Before starting to use Fenistil, discuss it with your doctor, pharmacist, or nurse.
Consult a doctor before using this medicine in patients:

with glaucoma,
with urinary retention caused, for example, by benign prostatic hyperplasia,
with epilepsy,
in elderly patients. Elderly patients should contact a doctor before using this medicine, as they are more susceptible to adverse effects of this medicine, such as excitation and fatigue. This medicine should not be used in elderly patients with disorientation.

Children and adolescents
Antihistamine medicines may cause excitation in young children.
The use of Fenistil in infants aged 1 month to 1 year and in children under 6 years of age should be under medical advice.
Do not exceed the recommended dose.
Keep the medicine out of sight and reach of children.

Fenistil and other medicines
Tell your doctor about all medicines the patient is currently taking or has recently taken, including those obtained without a prescription.
Do not use Fenistil without a doctor's recommendation if the patient is taking any of the following medicines:

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

Using Fenistil with alcohol
Like other antihistamines, Fenistil may enhance the effects of alcohol.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Fenistil should not be used during pregnancy unless the benefits to the mother outweigh the potential risks to the fetus. The medicine may be used only under medical supervision.
Fenistil should not be used in breastfeeding women.

Driving and operating machinery
As with other antihistamine medicines, Fenistil may impair psychomotor performance in some patients. Therefore, individuals taking Fenistil oral drops should exercise caution when driving motor vehicles or performing other activities requiring concentration (e.g., operating machinery).

Fenistil contains benzoic acid (E 210), propylene glycol (E 1520), and sodium.
The medicine contains 2 mg of benzoic acid (E 210) per dose (40 drops), equivalent to 1 mg/ml. Benzoic acid (E 210) 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 (E 1520) per dose (40 drops), equivalent to 100 mg/ml.
Before administering the medicine to a child under 4 weeks of age, consult a doctor or pharmacist, especially if the child is taking other medicines containing propylene glycol (E 1520) or alcohol.
The medicine contains less than 1 mmol (23 mg) of sodium per dose (40 drops), meaning the medicine is considered "sodium-free".

3. How to use Fenistil

This medicine should always be taken exactly as described in this patient information leaflet or as directed by a doctor, pharmacist, or nurse. If in doubt, consult a doctor, pharmacist, or nurse.
Do not exceed the recommended dose.
Use of this medicine in infants aged 1 month to 1 year and in children under 6 years of age should be under medical supervision. This medicine should not be used in children under 1 month of age.
Adults and children over 6 years of age:
Do not use this medicine for longer than 7 days.
If there is no improvement after 7 days or if symptoms worsen, consult a doctor.
Adults and children over 12 years of age
The daily dose is 3–6 mg of dimetindene, given in 3 equal divided doses.
It is recommended to take 20 to 40 drops three times daily.
In patients prone to drowsiness, 40 drops should be taken at bedtime and 20 drops in the morning with breakfast.
Children under 12 years of age
The recommended daily dose is 0.1 mg/kg body weight/day, i.e. 2 drops per kg of body weight per day, given in 3 divided doses, for example:
6 drops three times daily for a 8-month-old infant weighing 9 kg.
8 drops three times daily for a 2-year-old child weighing 12 kg.
Do not exceed the maximum daily dose, 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
Infants aged 1 month to 1 year and children under 6 years of age:
Use in infants aged 1 month to 1 year and in children under 6 years of age should be under medical supervision.
Fenistil should not be exposed to high temperatures. If the infant is bottle-fed, add the medicine to a bottle of warm food immediately before feeding. If the infant is fed with a spoon, the drops may be administered undiluted, on a small teaspoon.
Elderly patients
Elderly patients should consult a doctor before using this medicine.
Use of a higher than recommended dose of Fenistil
If a higher than recommended dose of Fenistil has been taken, seek immediate advice from a doctor or pharmacist.
Symptoms of overdose include: drowsiness (mainly in adults), central nervous system stimulation (mainly in children and elderly patients), including agitation, coordination disturbances, hallucinations, tremors, seizures, as well as urinary retention and fever. Hypotension, coma, and circulatory-respiratory collapse may occur.
Missed dose of Fenistil
If a dose of Fenistil is missed, take it as soon as possible, provided that less than 2 hours remain until the next scheduled dose. Otherwise, take the medicine at the usual time. Do not take a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, Fenistil may cause adverse reactions, although not everyone experiences them.

STOP taking the medicine and contact your doctor immediately if any of the following symptoms occur, as they may be signs of an allergic reaction:

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

These symptoms occur very rarely (may occur in fewer than 1 in 10,000 people).

Other adverse reactions that may occur are usually mild and temporary. The most common ones appear particularly at the beginning of treatment.

Very common (may affect more than 1 in 10 people using the medicine): tiredness.

Common (affects fewer than 1 in 10 people using the medicine): drowsiness, nervousness.

Rare (may affect fewer than 1 in 1,000 people using the medicine): agitation, headache, dizziness, gastrointestinal discomfort, nausea, dryness of the mouth, dryness of the throat.

If any of the adverse effects worsen or if any adverse effects not listed in this leaflet occur, inform your doctor, pharmacist or nurse.

Reporting of adverse reactions

If any adverse reactions occur, including any adverse reactions not listed in this leaflet, tell your doctor, pharmacist or nurse. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw,
Tel: +48 22 49 21 301,
Fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl.

Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Fenistil

Store below 25°C. Keep in the original packaging to protect from light.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box and bottle. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the pack and other information

What Fenistil contains

The active substance is dimetindene maleate. Each millilitre of Fenistil contains 1 mg of dimetindene maleate.
Other ingredients are: disodium phosphate dodecahydrate (E 339), citric acid monohydrate (E 330), benzoic acid (E 210), disodium edetate (E 386), sodium saccharinate (E 954), propylene glycol (E 1520), purified water.

What Fenistil looks like and contents of the pack
Fenistil is a solution, clear, colourless to slightly yellowish-brown, supplied in an amber glass bottle with a polyethylene dropper and a polypropylene cap or a child-resistant polypropylene cap, placed in a cardboard box.
Pack size available: 20 ml bottle.
For further information, please contact the responsible party or the parallel importer.
Marketing Authorisation Holder in Bulgaria, country of export:
Haleon Hungary Kft.
Csörsz utca 43
1124 Budapest
Hungary
Manufacturer:
Haleon Germany GmbH
Barthstrasse 4
80339 Munich
Germany
Parallel Importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Bulgaria, country of export, Marketing Authorisation Number: 20000512
Parallel Import Licence Number: 312/22