Flonidan

Package Leaflet: Information for the Patient

Flonidan, 1 mg/ml, Oral Suspension

Loratadine

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Flonidan and what is it used for
• 2. Important information before taking Flonidan
• 3. How to take Flonidan
• 4. Possible side effects
• 5. How to store Flonidan
• 6. Contents of the pack and other information

1. What is Flonidan and what is it used for

Loratadine, the active substance of Flonidan, belongs to a group of antihistamine medicines. During an allergic reaction, various substances (so-called mediators) are released, causing the development of allergy symptoms. One of the most important mediators is histamine. Flonidan inhibits the activity of histamine, thus showing anti-allergic activity. The medicine relieves the following symptoms caused by histamine during an allergic reaction: itching, redness, swelling, and nasal discharge. Flonidan relieves symptoms associated with: allergic rhinitis, such as sneezing, runny nose, or nasal itching, itching of the palate, redness or tearing of the eyes; chronic urticaria of unknown cause (i.e., chronic idiopathic urticaria), such as blisters on the skin, swelling, and itching.

2. Important information before taking Flonidan

When not to take Flonidan:

if you are allergic to loratadine or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Discuss with your doctor or pharmacist if: the medicine is taken for a long time; after taking Flonidan, the symptoms of the allergy do not subside or worsen; you have severe liver function disorders. Flonidan should be discontinued at least 2 days before skin allergy tests, as it may mask the symptoms of hypersensitivity and inhibit or weaken the positive reaction to allergens detected by these tests. After the test, the medicine can be taken as before.

Flonidan and other medicines

Tell your doctor about all medicines you are taking now or have taken recently, as well as those you plan to take. This is especially important for medicines such as: cimetidine (a medicine used to reduce stomach acid production); ketoconazole or fluconazole (medicines used to treat fungal infections); erythromycin (an antibiotic); fluoxetine (a medicine used to treat certain mental disorders).

Flonidan with food, drink, and alcohol

Flonidan can be taken independently of meals. Flonidan does not enhance the effect of alcohol, but it is not recommended to drink alcohol while taking this medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine. Although loratadine has not been shown to be harmful to the fetus or newborn, as a precaution, the use of Flonidan should be avoided during pregnancy. Loratadine passes into breast milk, so it is not recommended to take Flonidan during breastfeeding.

Driving and using machines

Studies have shown that loratadine, when taken in recommended doses, does not affect or has a negligible effect on the ability to drive or operate machinery. However, very rarely, taking the medicine may cause drowsiness, which can impair the ability to perform these activities.

Flonidan contains sucrose, propylene glycol, sodium benzoate, coumarin, and sodium

5 ml of the suspension (1 measuring spoon) contains 1500 mg of sucrose. If you have previously been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine. The medicine contains 261.5 mg of propylene glycol in each 5 ml of the suspension (1 measuring spoon). The medicine contains 10 mg of sodium benzoate in each 5 ml of the suspension (1 measuring spoon). The medicine contains coumarin (a component of the cherry flavor), which may cause allergic reactions in people with a history of coumarin allergy or not. The medicine contains 26.712 mg of sodium (the main component of common salt) in each 10 ml of the suspension (2 measuring spoons). This corresponds to 1.34% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to take Flonidan

This medicine should always be taken as directed by your doctor. Do not change the dose or stop taking the medicine without consulting your doctor first. If in doubt, consult your doctor or pharmacist. Adults and children over 12 years of age: 2 measuring spoons (10 mg) once a day. Children from 2 to 12 years of age: with a body weight greater than 30 kg: 2 measuring spoons (10 mg) once a day; with a body weight less than 30 kg: 1 measuring spoon (5 mg) once a day. Flonidan should not be taken by children under 2 years of age.

Patients with liver function disorders

Adults and children with a body weight greater than 30 kg: 2 measuring spoons (10 mg) every other day. Children with a body weight less than 30 kg: 1 measuring spoon (5 mg) every other day. Method of administrationThe medicine should be taken orally. Shake before use. Flonidan can be taken independently of meals. If you feel that the effect of Flonidan is too strong or too weak, consult your doctor or pharmacist.

Taking more than the recommended dose of Flonidan

If you have taken more medicine than you should, contact your doctor immediately. Overdose may cause drowsiness, headache, and rapid heartbeat. The medicine should be removed from the gastrointestinal tract as soon as possible. Treatment of overdose is symptomatic.

Missing a dose of Flonidan

If you forget to take the medicine at the usual time, take it as soon as you remember, and then return to your regular dosing schedule. Do not take a double dose to make up for the missed dose. If you have any further questions about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Flonidan can cause side effects, although not everybody gets them. Frequent side effects(may occur in less than 1 in 10 people): headache, nervousness, drowsiness, feeling of fatigue (in children); drowsiness (in adults and adolescents). Uncommon side effects(may occur in less than 1 in 100 people): headache, increased appetite, and sleep disorders (in adults and adolescents). Rare side effects(may occur in less than 1 in 10,000 people): hypersensitivity reactions(including angioedema - swelling of the skin and/or mucous membranes, e.g., in the face, limbs, joints), severe allergic reactionswith sudden difficulty breathing, severe dizziness, or fainting, swelling of the face or throat (anaphylaxis). If you experience any of these symptoms, seek medical help immediately. rapid heartbeat, palpitations, fainting, arrhythmias, gastritis, nausea, liver function disorders, dry mouth, dizziness, feeling of fatigue, rash, hair loss, seizures. Side effects with unknown frequency(frequency cannot be estimated from available data): weight gain.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Flonidan

Keep the medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month. Store in a temperature below 25°C. Medicines should 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 pack and other information

What Flonidan contains

• The active substance of Flonidan is loratadine. 5 ml of the oral suspension (1 measuring spoon) contains 5 mg of loratadine.
• The other ingredients are: polysorbate 80, citric acid monohydrate, sodium citrate dihydrate, sodium benzoate, Avicel RC 591 FMC (sodium carboxymethylcellulose and microcrystalline cellulose), sucrose, cherry flavor (contains, among others, coumarin), glycerol, propylene glycol, purified water.

What Flonidan looks like and contents of the pack

Flonidan oral suspension is a homogeneous, white or almost white suspension. The medicine is available in an orange glass bottle with an HDPE cap (with an LDPE sealing insert), in a cardboard box. The pack contains 120 ml of the suspension. A measuring spoon is attached to the pack.

Marketing authorization holder

Sandoz GmbH, Biochemiestrasse 10, A-6250 Kundl, Austria

Manufacturer

Lek Pharmaceuticals d.d., Verovškova 57, 1526 Ljubljana, Slovenia. For more detailed information, please contact: Sandoz Polska Sp. z o.o., ul. Domaniewska 50 C, 02-672 Warsaw, phone: 22 209 70 00, {Logo Sandoz}

Date of last revision of the leaflet: