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 (0.1%), oral drops, solution

Dimetindene maleate

You should carefully read the contents of the leaflet 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 your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If after 7 days there is no improvement 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 using Fenistil
• 3. How to use 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 inhibits 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 (common cold), sneezing, nasal itching, and eye itching and tearing. After oral administration, the effect of the medicine starts within 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., allergy to house dust, animal dander, feathers). The medicine is used to treat symptomatic food and drug allergies, as well as itching associated with infectious diseases (e.g., chickenpox). It can be used to relieve symptoms that occur after insect bites and to prevent allergic reactions that occur during desensitization treatment.

2. Important information before using Fenistil

When not to use Fenistil in the form of oral drops:

• if the patient has been diagnosed with an allergy (hypersensitivity) to dimetindene maleate or any of the other ingredients of this medicine,
• in newborns up to the age of one month, especially premature babies.

Warnings and precautions

Before starting to use Fenistil, you should discuss it with your doctor or pharmacist or nurse. You should consult a doctor before using this medicine in patients:

• with glaucoma,
• with urinary retention caused by, for example, prostate enlargement,
• with epilepsy,
• in the elderly.

Elderly patients should contact their doctor before using this medicine, as they are more susceptible to the side effects of this medicine, such as excitement and fatigue. The medicine should not be used in elderly patients with disorientation.

Children and adolescents

Antihistamines in young 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 used in children under 1 month of age. The medicine should be stored in a place that is invisible and inaccessible to children.

Fenistil and other medicines

You should tell your doctor about all medicines you are currently taking or have recently taken, including those that are available without a prescription. Without a doctor's recommendation, you should not use Fenistil if you are taking any of the following medicines:

• antidepressants,
• anticholinergic medicines, such as: bronchodilators (medicines used to treat asthma and bronchospasm), medicines used to treat spasms in the abdominal cavity (medicines used to prevent stomach and intestinal cramps), medicines that dilate the pupils, urological antispasmodic medicines (medicines used to treat symptoms of urinary incontinence and excessive bladder activity),
• sleeping pills, sedatives,
• anticonvulsant medicines (medicines used to treat epilepsy),
• opioid painkillers,
• 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.

Using Fenistil with alcohol

Like other antihistamines, Fenistil may enhance the effect of alcohol.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you 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 risk to the fetus. The medicine may only be used under medical supervision. Fenistil should not be used in breastfeeding women.

Driving and using machines

As with other antihistamines, Fenistil may impair psychophysical performance in some patients. Therefore, people who take Fenistil in the form of oral drops should be cautious when driving vehicles or operating machinery.

Fenistil contains benzoesic acid, propylene glycol, and sodium.

The medicine contains 2 mg of benzoesic acid per dose (40 drops), which corresponds to 1 mg/ml. Benzoesic 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, you should consult a doctor or pharmacist, especially if the child is taking other medicines that contain 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 use Fenistil

Fenistil should always be used as directed by your doctor. In case of doubt, you should contact your doctor or pharmacist again. You should not exceed the recommended dose. The use of the medicine 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 used in children under 1 month of age.

Adults and children over 6 years:

The medicine should not be used for more than 7 days. If after 7 days there is no improvement or the patient feels worse, they should contact their doctor. Adults and children over 12 yearsThe daily dose is 3-6 mg of dimetindene, administered in 3 equal divided doses. It is recommended to use 20-40 drops 3 times a day. In patients with a tendency to drowsiness, 40 drops should be used before bedtime and 20 drops in the morning, during breakfast. Children under 12 yearsThe recommended daily dose is 0.1 mg/kg body weight/day, i.e., 2 drops per kg body weight per day, administered in 3 divided doses, e.g., 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. You 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 using this medicine.

Using a higher dose of Fenistil than recommended

In case of using a higher dose of Fenistil than recommended, you should immediately contact a doctor or pharmacist. Symptoms of overdose are: drowsiness (mainly in adults), central nervous system stimulation (mainly in children and the elderly), including stimulation, coordination disorders, hallucinations, tremors, convulsions, as well as urinary retention and fever. There may be a drop in blood pressure, coma, and cardiovascular and respiratory collapse.

Missing a dose of Fenistil

In case of missing a dose of the medicine, you should take it as soon as possible, unless there are less than 2 hours left before the next dose. In this case, you should take the medicine at the usual time. You should not take a double dose to make up for the missed dose. In case of doubts about using the medicine, you should contact a doctor or pharmacist.

4. Possible side effects

Like all medicines, Fenistil can cause side effects, although not everybody gets them. You should STOPusing the medicine and contact a doctor immediately if you 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 less often than in 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 using the medicine): fatigue. Common (occur in less than 1 in 10 people using the medicine): drowsiness, nervousness. Rare (may occur in less than 1 in 1,000 people using the medicine): stimulation, headaches, dizziness, gastrointestinal disorders, nausea, dry mouth, dry throat. If any of the side effects get worse or if you experience any side effects not listed in the leaflet, you should inform your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocides, 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, you can help gather more information on the safety of the medicine.

5. How to store Fenistil

Do not store above 25°C. Store in the original packaging to protect from light. The medicine should be stored in a place that is invisible and inaccessible to children. Do not use the medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the given month. Medicines should not be disposed of via wastewater or household waste containers. You should ask your pharmacist how to dispose of medicines that are no longer used. 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, benzoesic acid, disodium edetate, disodium phosphate dodecahydrate, citric acid monohydrate, sodium saccharin, purified water.

What Fenistil looks like and what the packaging contains

Fenistil is a solution, clear, colorless to slightly yellowish-brown, in a type III glass bottle with a polyethylene pipette, with a white polypropylene child-resistant cap, in a cardboard box. Available packaging:20 ml. For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Belgium, the country of export:

GlaxoSmithKline Consumer Healthcare s.a./n.v. Site Apollo Avenue Pascal, 2-4-6 B-1300 Wavre, Belgium

Manufacturer:

GlaxoSmithKline Consumer Healthcare s.a./n.v. Site Apollo Avenue Pascal, 2-4-6 B-1300 Wavre, Belgium

Parallel importer:

InPharm Sp. z o.o. ul. Strumykowa 28/11 03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k. ul. Chełmżyńska 249 04-458 Warsaw Belgian marketing authorization number:BE051563

Parallel import authorization number: 323/22 Date of leaflet approval: 05.09.2022

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