Patient Information Leaflet

Warning! Keep this leaflet, information on the immediate packaging in a foreign language!
Rupafin 10 mg (Rupatall)
10 mg, tablets
Rupatadinum
Rupafin 10 mg and Rupatall are different trade names of the same medicinal product.
Please read this leaflet carefully before taking the medicine, as it contains important information for the patient.

Keep this leaflet so that you can read it again if necessary.
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. It may harm other people, 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 Rupafin 10 mg is and what it is used for
Important information before taking Rupafin 10 mg
How to take Rupafin 10 mg
Possible side effects
How to store Rupafin 10 mg
Contents of the pack and other information

1. What Rupafin 10 mg is and what it is used for

Rupatadine is an antihistamine medicine.
Rupafin 10 mg relieves symptoms of allergic rhinitis, such as sneezing, runny nose, and itching of the eyes and nose.
Rupafin 10 mg is also used to relieve symptoms associated with urticaria (allergic skin rash), such as itching and hives (localized redness and swelling of the skin).

2. Important information before taking Rupafin 10 mg

When not to take Rupafin 10 mg

if the patient is allergic to rupatadine or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting to take Rupafin 10 mg, discuss this with your doctor or pharmacist.
If the patient has kidney or liver impairment, medical advice should be sought. Currently, the use of Rupafin 10 mg is not recommended in patients with renal or hepatic dysfunction.
If the patient has low potassium levels and/or a known abnormal heart rhythm (known as QTc prolongation on ECG), which may occur in certain heart conditions, they should consult their doctor.
If the patient is over 65 years of age, they should consult their doctor or pharmacist.
Children
This medicine is not intended for use in children under 12 years of age.
Rupafin 10 mg and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including those obtained without a prescription.
If the patient is taking Rupafin 10 mg, they should not take medicines containing ketoconazole (a medicine used for fungal infections) or erythromycin (a medicine used for bacterial infections).
If the patient is taking medicines that depress the central nervous system, statins (medicines used to treat high cholesterol), or midazolam (a short-acting sedative and hypnotic), they should consult their doctor before using Rupafin 10 mg.
Rupafin 10 mg with food, drink and alcohol
Rupafin 10 mg should not be taken with grapefruit juice, as this may increase the concentration of Rupafin 10 mg in the body.
Rupafin 10 mg at the recommended dose (10 mg) does not increase alcohol-induced drowsiness.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Driving and using machines
Rupafin 10 mg at the recommended doses is not expected to affect the ability to drive or operate machinery. However, if the patient is taking Rupafin 10 mg for the first time, caution should be exercised and the patient should observe their response to the medicine before driving or operating machinery.
Rupafin 10 mg contains monohydrate lactose
If the patient has been previously diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.

3. How to take Rupafin 10 mg

This medicine should always be taken as directed by the physician. In case of doubt, consult
the physician or pharmacist.
Rupafin 10 mg is intended for use in adolescents (aged 12 years and older) and adults. The usual
dose is one tablet (10 mg rupatadine) once daily, with or without food. The tablet should be
swallowed with an adequate amount of liquid (e.g. a glass of water).
The physician will inform the patient how long treatment with Rupafin 10 mg should last.
Taking more than the recommended dose of Rupafin 10 mg
If the patient accidentally takes a large dose of the medicine, they should contact the physician
or pharmacist immediately.
Missing a dose of Rupafin 10 mg
The missed dose should be taken as soon as possible, then continue taking the tablets according
to the recommended dosing schedule. Do not take a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, Rupafin 10 mg can cause adverse reactions, although not everyone experiences them.
Common adverse reactions (may occur in up to 1 in 10 patients) include:
drowsiness, headache, dizziness, dry mouth, feeling of weakness and fatigue.
Uncommon adverse reactions (may occur in up to 1 in 100 patients) include:
increased appetite, irritability, difficulty concentrating, nosebleeds, dryness of the nasal mucosa, sore throat, cough, dry throat, nasal mucositis, nausea, abdominal pain, diarrhoea, indigestion, vomiting, constipation, rash, back pain, joint pain, muscle pain, increased thirst, general malaise, fever, abnormal liver function test results and weight gain.
Rare adverse reactions (may occur in up to 1 in 1000 patients) include:
palpitations, tachycardia, and allergic reactions (itching, urticaria, swelling of the face, lips, tongue or throat).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can also be reported directly to the Department of Monitoring of Adverse Drug Reactions of 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
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Rupafin 10 mg

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Store the blister pack in the outer packaging to protect from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the pack and other information

What Rupafin 10 mg contains

The active substance is rupatadine. Each tablet contains 10 mg of rupatadine (as rupatadine fumarate).
The other ingredients are: monohydrate lactose, pregelatinized starch, corn starch, microcrystalline cellulose, ferric oxide red (E 172), ferric oxide yellow (E 172), magnesium stearate. See section 2 "Rupafin 10 mg contains monohydrate lactose".

What Rupafin 10 mg looks like and contents of the pack
Rupafin 10 mg tablets are round, light purple tablets, packed in blisters divided into single doses containing 10 tablets. The pack contains 30 tablets.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing Authorisation Holder in Belgium, country of export:
Noucor Health S.A.
Av. Cami Reial, 51-57
E-08184 Palau-solita i Plegamans (Barcelona)
Spain

Manufacturer:
Noucor Health S.A.
Av. Cami Reial, 51-57
E-08184 Palau-solita i Plegamans (Barcelona)
Spain

Parallel Importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Marketing Authorisation number in Belgium, country of export: BE272045
Parallel Import Licence number: 115/20

This medicinal product is authorised in the European Economic Area countries under the following names:
Rupatall 10 mg Belgium, Luxembourg
Rinialer 10 mg Malta, Portugal
Rupafin 10 mg Austria, Bulgaria, Croatia, Cyprus, Denmark, Estonia, Greece,
Spain, the Netherlands, Ireland, Iceland, Lithuania, Liechtenstein,
Latvia, Germany, Norway, Poland, Slovakia, Slovenia,
Italy.
Rupatadine 10 mg United Kingdom
Wystamm 10 mg France
Tamalis 10 mg Czech Republic, Romania, Hungary
Pafinur 10 mg Finland, Sweden