Fenistil

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Fenistil, 1 mg/ml, oral drops, solution

Dimetindene maleate

Read the leaflet carefully before taking the medicine, 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.

• Keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.
• If there is no improvement after 7 days 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 packaging and other information

1. What is Fenistil and what is it used for

Fenistil contains dimetindene maleate, which belongs to a group of antihistamine medicines. It counteracts 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 action 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 itching accompanying infectious diseases (e.g., chickenpox). It can be used to relieve symptoms after insect bites and to prevent allergic reactions during desensitization treatment. If there is no improvement after 7 days or the patient feels worse, they should contact their doctor.

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 end of the first month of life, 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, e.g., prostate enlargement,
• epilepsy,
• are elderly.

Elderly patients should contact 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.

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 in a dose higher than recommended.

The medicine should be kept out of sight and reach of children.

Fenistil and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, including those available without a prescription.

Without a doctor's recommendation, 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 spastic conditions in the abdominal cavity (medicines used to prevent stomach and intestinal cramps), pupil dilators, urological antispasmodic medicines (medicines used to treat symptoms of urinary incontinence and overactive bladder),
• sleeping pills, 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 effect of alcohol.

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 can 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 psychophysical 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 containing 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 patient should not exceed the recommended dose.

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 in children under 1 month of age.

Adults and children over 6 years of age:

The medicine should not be taken for more than 7 days.

If there is no improvement after 7 days or the patient feels worse, they should contact their doctor.

Adults and children over 12 years of age:

The daily dose is 3-6 mg of dimetindene, given in 3 divided doses.

It is recommended to take 20-40 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 of age:

The recommended daily dose is 0.1 mg/kg body weight/day, given in 3 divided doses.

For example, 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 patient should 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 of dimetindene

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 contact their doctor before taking this medicine.

Taking a higher dose of Fenistil than recommended

In case of taking a higher dose of Fenistil than recommended, 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 excitement, coordination disorders, hallucinations, tremors, convulsions, as well as urinary retention and fever. There may be a decrease in blood pressure, coma, and cardiovascular and respiratory collapse.

Missing a dose of Fenistil

In case of missing a 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. The patient should not take a double dose to make up for the missed dose.

In case of any further doubts about taking 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 STOPtaking the medicine and contact their doctor immediately 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 increasing blisters, muscle cramps.

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

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 people taking the medicine): fatigue.

Common(occur in less than 1 in 10 people taking the medicine): drowsiness, nervousness.

Rare(may occur in less than 1 in 1,000 people taking the medicine): excitement, 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 any side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance 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 side effects, more information can be collected on the safety of the medicine.

5. How to store Fenistil

The medicine should be kept out of sight and reach of children.

Store in a temperature below 25°C. Store in the original packaging to protect from light.

Do not take this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.

Medicines should not be disposed of via wastewater or household waste containers. 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 packaging 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 what the packaging contains

Fenistil is a clear, colorless to slightly yellowish-brown solution in an orange glass bottle with a polyethylene dropper and a polypropylene cap, in a cardboard box.

Available packaging:1 bottle of 20 ml.

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:

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 by:

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 authorization number in Bulgaria, the country of export:20000512
Parallel import authorization number:382/16

Date of leaflet approval: 06.05.2024

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