Patient Information Leaflet

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.
Fenistil
1 mg/ml, oral drops, solution
Dimetindene maleate
Please read all of this leaflet carefully before taking this medicine, as it contains important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor 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 not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
If there is no improvement after 7 days, or if you feel worse, consult your doctor.

Table of 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 dimetindene maleate, which belongs to a group of medicines called antihistamines.
It blocks the action of histamine, a substance in the body 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 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 used to treat 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 perennial allergic rhinitis (e.g. allergy to house dust, animal fur, feathers). It 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 stings, and for prevention of allergic reactions during desensitization therapy. If there is no improvement after 7 days, or if you feel worse, consult your doctor.

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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 during the first month of life, especially premature infants.

Warnings and precautions
Before starting treatment with 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 consult 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 currently taken or taken recently, including those obtained without a prescription.
Do not use Fenistil without a doctor's recommendation if taking any of the following medicines:

antidepressants,
anticholinergic medicines, such as: bronchodilators (medicines used in the treatment of asthma and bronchial spasms), 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 symptoms and overactive bladder),
sedatives, tranquilizers,
anticonvulsants (medicines used in the treatment of epilepsy),
opioid analgesics,
antihistamines (medicines used in the treatment of common cough, colds 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.
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Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, 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 psycho-physical 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 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 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 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 the patient feels worse, consult a doctor.

Adults and children over 12 years of age
The daily dose is 3–6 mg of dimetindene, administered in three equal divided doses.
It is recommended to take 20 to 40 drops three times daily.
In patients prone to drowsiness, 40 drops at bedtime and 20 drops in the morning with breakfast are recommended.

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 three times daily for a 9 kg 8-month-old infant
8 drops three times daily for a 12 kg 2-year-old child.

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 of this medicine 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 given undiluted on a small teaspoon.

Elderly patients
Elderly patients should consult a doctor before using this medicine.

Overdose of Fenistil
In case of an overdose of Fenistil, seek immediate medical 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, impaired motor coordination, hallucinations, tremors, convulsions, as well as urinary retention and fever. A drop in blood pressure, coma, and circulatory-respiratory collapse may also occur.

Missed dose of Fenistil
If a dose of Fenistil is missed, take it as soon as possible, provided that less than 2 hours do not remain until the next scheduled dose. In that 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 experiences them.
You should 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 ).
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Other adverse reactions that may occur are usually mild and transient. The most common ones appear particularly 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 ): excitation, headache,
dizziness, gastrointestinal discomfort, nausea, dry mouth, dry 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 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 be reported directly to the Department of Monitoring of 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
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Fenistil

Store below 25°C.
Keep in the outer packaging to protect from light.
Keep the medicine out of sight and reach of children.
Do not use the medicine after the expiry date stated on the packaging. 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 in use. This will help protect the environment.

6. Contents of the packaging and other information

What Fenistil contains

The active substance is dimetindene maleate. One millilitre of Fenistil contains 1 mg of dimetindene maleate.
Other ingredients are: propylene glycol (E 1520), benzoic 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, colourless to slightly yellowish-brown, in a 20 ml amber glass bottle, type III, fitted with a polyethylene dropper and a child-resistant polypropylene cap, packed in a cardboard box.
Available pack sizes: 1 bottle of 20 ml.
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For further information, please contact the Marketing Authorisation Holder 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:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing Authorisation number in Bulgaria, country of export: 20000512
Parallel Import Licence number: 22/18
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