Flonidan

Patient Information Leaflet

Flonidan, 1 mg/ml, oral suspension
Loratadine
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• 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 a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist immediately. See section 4.

Leaflet Contents

1. What Flonidan is and what it is used for
2. What you need to know 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 Flonidan is and what it is used for

Loratadine, the active substance in Flonidan, belongs to a group of medicines called antihistamines. During an allergic reaction, various substances (so-called mediators) are released, causing allergy symptoms. One of the most important mediators is histamine. Flonidan inhibits the activity of histamine, thereby exerting an antiallergic effect. 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, watery nasal discharge, nasal itching, itching of the palate, redness or watering of the eyes;
chronic idiopathic urticaria (i.e. chronic urticaria of unknown cause), such as skin wheals, swelling, and itching.

2. Information before using Flonidan

When not to use Flonidan:
if the patient is allergic to loratadine or to any of the other ingredients of this medicine
(listed in section 6).

Warnings and precautions
Consult a doctor or pharmacist if:
the medicine is used for a prolonged period;
allergic symptoms do not improve or worsen after taking Flonidan;
the patient has severe liver function impairment.

Flonidan should be discontinued at least 2 days before undergoing skin allergy tests, as it may mask hypersensitivity symptoms and suppress or weaken the positive reaction to allergens detected by these tests. The medicine may be resumed as previously prescribed after the test.

Flonidan and other medicines
Inform the doctor about all medicines currently taken or recently used, as well as any medicines the patient intends to take.
This particularly concerns the following medicines:
cimetidine (a medicine used to reduce gastric acid secretion);
ketoconazole or fluconazole (medicines used in the treatment of fungal infections);
erythromycin (an antibiotic);
fluoxetine (a medicine used in the treatment of certain psychiatric disorders).

Flonidan with food, drink and alcohol
Flonidan may be taken regardless of meals.
Flonidan does not enhance the effects of alcohol; however, alcohol consumption is not recommended during treatment with this medicine.

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Although harmful effects of loratadine on the fetus or newborn have not been demonstrated, as a precautionary measure, the use of Flonidan should be avoided during pregnancy.
Loratadine passes into breast milk; therefore, the use of Flonidan is not recommended during breastfeeding.

Driving and operating machinery
Studies have shown that loratadine, when used at recommended doses, has no effect or only negligible effect on the ability to drive or operate machinery. However, very rarely, somnolence may occur in some individuals after taking the medicine, which may impair the ability to perform these activities.

Flonidan contains sucrose, propylene glycol, sodium benzoate, coumarin and sodium
5 ml of syrup (1 measuring spoon) contains 1500 mg of sucrose. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
The medicine contains 261.5 mg of propylene glycol in each 5 ml of syrup (1 measuring spoon).
The medicine contains 10 mg of sodium benzoate in each 5 ml of syrup (1 measuring spoon).
The medicine contains coumarin (a component of cherry flavoring), which may cause allergic reactions in individuals with or without a history of coumarin allergy.
The medicine contains 26.712 mg of sodium (the main component of table salt) in each 10 ml of syrup (2 measuring spoons). This corresponds to 1.34% of the maximum recommended daily dietary intake of sodium for adults.

3. How to use Flonidan

This medicine should always be taken exactly as prescribed by the doctor. Do not change the dose or
discontinue treatment without first consulting your doctor.
If in doubt, consult your doctor or pharmacist.
Adults and children over 12 years of age:
2 measuring spoons (10 mg) once daily.
Children aged 2 to 12 years:
with body weight above 30 kg: 2 measuring spoons (10 mg) once daily.
with body weight below 30 kg: 1 measuring spoon (5 mg) once daily.
Flonidan should not be used in children under 2 years of age.
Patients with impaired liver function
Adults and children with body weight above 30 kg: 2 measuring spoons (10 mg) every other day.
Children with body weight below 30 kg: 1 measuring spoon (5 mg) every other day.
Method of administration
The medicine should be administered orally. Shake well before use.
Flonidan may be taken regardless of meals.
If you feel that the effect of Flonidan is too strong or too weak, consult your doctor or pharmacist.
Taking more Flonidan than recommended
If a patient has taken more medicine than prescribed, contact your doctor immediately.
Overdose may cause drowsiness, headache, and increased heart rate. The medicine should be
removed from the gastrointestinal tract as quickly as possible. Treatment of overdose is symptomatic.
Missing a dose of Flonidan
If a patient forgets to take the medicine at the usual time, they should take it as soon as they
remember, then return to the regular dosing schedule.
Do not take a double dose to make up for a missed dose.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Common adverse reactions (may occur in fewer than 1 in 10 people):
headache, nervousness, drowsiness, feeling of fatigue (in children)
drowsiness (in adults and adolescents)
Uncommon adverse reactions (may occur in fewer than 1 in 100 people):
headache, increased appetite and sleep disturbances (in adults and adolescents)
Very rare adverse reactions (may occur in fewer 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 reactions with sudden breathing difficulty, severe dizziness or collapse, facial or throat swelling (anaphylaxis). If any of these symptoms occur, seek immediate medical advice or emergency help.
increased heart rate, palpitations, fainting, cardiac arrhythmias, gastric mucosal inflammation, nausea, liver function disorders, dry mouth, dizziness, feeling of fatigue, rash, hair loss, convulsions.
Adverse reactions with unknown frequency (frequency cannot be estimated from available data):
weight gain
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
Adverse reactions may also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Flonidan

Keep this 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 stated month.
Store below 25°C.
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 Flonidan contains

• The active substance is loratadine. 5 ml of 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 carboxymethylstarch and microcrystalline cellulose), sucrose, cherry flavour (containing, 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 liquid.
The medicine is available in an amber glass bottle with a screw cap made of HDPE (with an LDPE sealing insert), placed in a cardboard box.
The pack contains 120 ml of suspension. A measuring spoon is provided with the packaging.
Marketing Authorisation Holder
Sandoz GmbH
Biochemiestrasse 10
A-6250 Kundl, Austria
Manufacturer
Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana, Slovenia
For further information, please contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw, Poland
tel. 22 209 70 00