Fenistil

Package leaflet: Information for the user

Warning! Keep this 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, because it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
the 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 or pharmacist. See section 4.
• If there is no improvement after 7 days, or if your condition worsens, consult your doctor.

Table of contents of the leaflet:

1. What Fenistil is and what it is 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 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
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 in 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 hair, 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 to prevent allergic reactions occurring during desensitization therapy. If there is no improvement after 7 days, or if your condition worsens, consult your doctor.

2. 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 one month of age, especially premature infants.

Warnings and precautions
Before starting treatment with Fenistil, discuss this with your doctor, pharmacist, or nurse.

Consult a doctor before using this medicine in patients:

• with glaucoma,
• with urinary retention, e.g. due to enlarged prostate gland,
• 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
Antihistamines may cause excitation in young children.
The use of Fenistil in infants from 1 month to 1 year of age 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.
Without medical advice, do not use Fenistil if the patient is taking any of the following medicines:

• antidepressants,
• anticholinergic medicines, such as: bronchodilators (medicines used in asthma and bronchospasm), medicines used for spasms 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, tranquilizers,
• anticonvulsants (medicines used in the treatment of epilepsy),
• opioid analgesics,
• antihistamines (medicines used in the treatment of 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.

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 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 using machines
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 (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 your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse.
Do not exceed the recommended dose.
Use in infants aged 1 month to 1 year and in children under 6 years of age should only be carried out on the advice of a doctor. This medicine should 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, divided into 3 equal 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 of 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, 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

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 carried out only on the advice of a doctor.

Fenistil should not be exposed to high temperatures. If bottle-feeding, add the medicine directly to the bottle containing warm food immediately before feeding. If feeding with a spoon, drops may be administered undiluted on a small teaspoon.

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

Taking more Fenistil than recommended
If more Fenistil than recommended 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, 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.

If you miss a 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 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.

STOP taking the medicine and contact a 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 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 transient. The most common ones occur 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): restlessness, headache, dizziness, gastrointestinal discomfort, nausea, dry mouth, dry throat.

If any of the adverse reactions worsen or if any adverse reactions not listed in this leaflet occur, inform a doctor or pharmacist.

Reporting of adverse reactions

If any adverse reactions occur, including those not listed in this leaflet, inform a 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

Keep this medicine out of sight and reach of children.
Store below 25°C. Keep in the original packaging to protect from light.
Do not use this 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 required. Such measures help protect the environment.

6. Contents of the packaging 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 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 clear, colourless to slightly yellowish-brown solution in an amber glass bottle with a polyethylene dropper and a polypropylene screw cap, packed in a cardboard box.
Pack size available: 1 bottle of 20 ml.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Bulgaria, country of export:
GlaxoSmithKline Dungarvan Limited
Knockbrack, Dungarvan
Co. Waterford, Ireland
Manufacturer:
GlaxoSmithKline Consumer Healthcare GmbH & Co. KG
Barthstrasse 4
80339 Munich
Germany
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorisation number in Bulgaria, country of export: 20000512
Parallel import authorisation number: 382/16