Package leaflet: Information for the patient

Flonidan, 10 mg, tablets
Loratadine
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

What Flonidan is and what it is used for
Important information before taking Flonidan
How to take Flonidan
Possible side effects
How to store Flonidan
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 the
development of allergic 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, or 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. Important 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
Please discuss with your doctor or pharmacist if:

the medicine is being used for a prolonged period;
allergy symptoms do not improve or worsen after taking Flonidan;
the patient has severe liver function disorders.

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. After testing, the medicine may be taken again as before.

Children
This medicine should not be used in children under 2 years of age or in children weighing less than 30 kg.

Flonidan with other medicines
Inform your doctor about all medicines currently taken or recently taken, as well as any medicines the patient plans to take.
This particularly includes the following medicines:

cimetidine (a medicine used to reduce gastric acid secretion);
ketoconazole or fluconazole (medicines used to treat fungal infections);
erythromycin (an antibiotic);
fluoxetine (a medicine used in the treatment of certain psychiatric disorders).

Flonidan with food, drink and alcohol
The medicine can be taken regardless of meals.
The tablet should be swallowed whole, without chewing, with a drink.
Flonidan does not enhance the effects of alcohol; however, drinking alcohol is not recommended during treatment with this medicine.

Pregnancy and breastfeeding
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.
Although loratadine has not been shown to have harmful effects on the fetus or newborn, as a precautionary measure, the use of Flonidan in pregnant women should be avoided.
Loratadine passes into breast milk; therefore, the use of Flonidan during breastfeeding is not recommended.

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

Flonidan contains lactose
One tablet contains 71.3 mg of monohydrate lactose. If the patient has previously been diagnosed with intolerance to certain sugars, he or she should consult a doctor before taking this medicine.
One tablet of Flonidan contains less than 0.01 IU.

3. How to take 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: 1 tablet (10 mg) once daily.
Children aged 2 to 12 years (with body weight greater than 30 kg): 1 tablet (10 mg) once daily.
The use of 10 mg tablets is not recommended in children with body weight less than 30 kg.
In children aged 2 to 12 years, Flonidan oral suspension is recommended.
Flonidan should not be given to children under 2 years of age.
Patients with impaired liver function
Adults and children with body weight greater than 30 kg: 1 tablet of Flonidan (10 mg) every other day.
Method of administration: see "Flonidan with food, drink and alcohol" in section 2.
If you feel that the effect of Flonidan is too strong or too weak, consult your doctor or pharmacist.
Taking more Flonidan than prescribed
If a patient has taken more tablets than recommended, they should contact a 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.
Missed dose of Flonidan
If a patient forgets to take the medicine at the usual time, they should take it as soon as they remember.
However, if it is almost time for the next dose, the missed dose should be skipped and the regular
dosing schedule should be resumed.
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 side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Common side effects (may occur in fewer than 1 in 10 people):
headache, nervousness, drowsiness, feeling of fatigue (in children)
drowsiness (in adults and adolescents)
Uncommon side effects (may occur in fewer than 1 in 100 people):
headache, increased appetite and sleep disturbances (in adults and adolescents)
Very rare side effects (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, swelling of the face or throat (anaphylaxis). If any of the described symptoms occur, seek immediate medical advice from a doctor or emergency medical help.
increased heart rate, palpitations, inflammation of the stomach lining, nausea, liver function disorders, dry mouth, dizziness, feeling of fatigue, rash, hair loss, convulsions.
Side effects with unknown frequency (frequency cannot be estimated from available data):
weight gain
Reporting of side effects
If any side effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Side effects can also 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.
Side effects may also be reported to the Marketing Authorisation Holder.
Reporting side effects helps 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 stated month.
Store below 25°C. Protect from light and moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures help protect the environment.

6. Contents of the pack and other information

What Flonidan contains

The active substance is loratadine. Each tablet contains 10 mg of loratadine.
The other ingredients are: maize starch, lactose monohydrate, magnesium stearate, pregelatinized starch.

What Flonidan looks like and contents of the pack
Flonidan tablets are white or almost white, round, with a break line on one side, which allows
the tablet to be divided into two equal parts.
The medicine is packed in PVC/Aluminum blisters, contained in a cardboard box.
Pack sizes contain 10, 30, 60 or 90 tablets.

Marketing Authorization Holder
Sandoz GmbH
Biochemiestrasse 10
A-6250 Kundl, Austria

Manufacturer
Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana, Slovenia
Lek Pharmaceuticals d.d.
Trimlini 2d
9220 Lendava, Slovenia

For further information, please contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw, Poland
tel. +48 22 209 70 00