Package leaflet: Information for the patient

Warning! The immediate packaging is in a foreign language! Keep the leaflet!
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 the patient leaflet or as directed by a
physician or pharmacist.

Keep this leaflet, so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 7 days, or if you feel worse, consult your doctor.

Table of contents of the leaflet:

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 package and other information

1. What Fenistil is and what it is used for

Fenistil contains dimetindene 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
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 eye itching and watering.
After oral administration, the effect of the medicine begins within 30–60 minutes and lasts for 8 to 12
hours.
Fenistil is indicated for the treatment of symptoms of allergic conditions:

of the skin: urticaria, itching associated with atopic dermatitis, allergic contact dermatitis, endogenous eczema;
of the respiratory system: seasonal allergic rhinitis (hay fever) and chronic 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 alleviate symptoms following insect bites and to prevent allergic reactions occurring during desensitization therapy. If there is no improvement after 7 days, or if you feel worse, consult your doctor.

2. Information before using Fenistil

When not to use Fenistil 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 during the first month of life, 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,
urinary retention caused, for example, by benign prostatic hyperplasia,
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
Antihistamines may cause excitation in young children.
The use of Fenistil in infants aged from 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 medical advice 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 in the treatment of urinary incontinence and overactive bladder symptoms),
sedatives, hypnotics,
anticonvulsants (medicines used in the treatment of epilepsy),
opioid analgesics,
antihistamines (medicines used in the treatment of common cough, cold, 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

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

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her 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 antihistamines, Fenistil may impair psycho-physical performance in some patients. Therefore, individuals taking Fenistil oral drops should exercise caution when driving motor vehicles or performing other tasks requiring concentration (e.g., operating machinery).

Fenistil contains benzoic acid, propylene glycol, and sodium.
The medicine contains 2 mg of benzoic acid per dose (40 drops), equivalent to 1 mg/ml.
Benzoic 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), 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 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 leaflet or as directed by
your doctor, pharmacist, or nurse. If in doubt, consult your doctor,
pharmacist, or nurse.
Do not exceed the recommended dose.
The 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 must not be used in children under 1 month of age.
Adults and children over 6 years of age:
This medicine should not be used for longer than 7 days.
If there is no improvement after 7 days, or if symptoms worsen, consult your
doctor.
Adults and children over 12 years of age:
The daily dose is 3–6 mg of dimetindene, administered in 3 equal divided doses.
It is recommended to take 20 to 40 drops 3 times daily.
In patients prone to drowsiness, it is recommended to take 40 drops 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 body weight per day,
divided into 3 doses, for example:
6 drops 3 times daily for a 8-month-old infant weighing 9 kg.
8 drops 3 times daily for a 2-year-old child weighing 12 kg.
The maximum daily dose must not be exceeded, which is as follows:
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 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 must not be exposed to high temperatures. If the infant is bottle-fed, add the medicine to the
bottle with warm food immediately before feeding. If the infant is fed with a spoon, the drops may be
administered undiluted, using a small teaspoon.
Elderly patients
Elderly patients should consult their doctor before using this medicine.
Overdose of Fenistil
If an overdose 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. A drop in blood pressure, coma, and circulatory-respiratory collapse may occur.
Missed dose of Fenistil
If a dose of Fenistil is missed, take it as soon as possible, unless less than 2 hours remain before the
next scheduled dose. In this case, 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 will experience them.
You should STOP using the medicine and contact your doctor immediately if any of the following symptoms occur, as they may be symptoms of an allergic reaction:

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

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 especially at the beginning of treatment.
Very common (may affect more than 1 in 10 people taking the medicine): fatigue.
Common (affect fewer than 1 in 10 people taking the medicine): drowsiness, nervousness.
Rare (may affect fewer than 1 in 1,000 people taking the medicine):
Excitement, 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 or pharmacist.
Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can 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
Phone: +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 the medicine.

5. How to store Fenistil

Fenistil should be stored at a temperature below 25°C. Keep in the outer packaging to protect from light.
The medicine should be stored out of sight and reach of children.
Do not use the 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. This will help protect the environment.

6. Contents of the packaging and other information

What Fenistil contains

The active substance is dimethindene maleate. One millilitre of Fenistil contains 1 mg of dimethindene maleate.
Other ingredients are propylene glycol, benzoic acid, disodium edetate, disodium phosphate dodecahydrate, citric acid monohydrate, sodium saccharin, purified water.

What Fenistil looks like and contents of the pack
Fenistil is a solution, clear, colourless to slightly yellowish-brown.
Pack size available: 20 ml.
For more detailed 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:
Aga Kommerz spol. s r.o.
Frydecka 2006
737 01 Český Těšín
Czech Republic
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
Euceryn Manufacturing Site Laboratoire Pharmaceutique COEL S.J. E.Z.M. KONSTANTY
ul. Wł. Żeleńskiego 45
31-353 Kraków
Marketing Authorisation Number in Bulgaria, country of export: 20000512
Parallel Import Authorisation Number: 326/20