Rupafin 10 mg

Package Leaflet: Information for the User

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Rupafin 10 mg(Rupatall)

10 mg, tablets

Rupatadine
Rupafin 10 mg and Rupatall are different trade names for the same medicine.

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, you should ask your doctor or pharmacist.
• This medicine has been prescribed to you specifically. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Rupafin 10 mg and what is it used for
• 2. Important information before taking Rupafin 10 mg
• 3. How to take Rupafin 10 mg
• 4. Possible side effects
• 5. How to store Rupafin 10 mg
• 6. Contents of the pack and other information

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

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

2. Important information before taking Rupafin 10 mg

When not to take Rupafin 10 mg

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

Warnings and precautions

Before taking Rupafin 10 mg, you should discuss it with your doctor or pharmacist.
If you have kidney or liver failure, you should consult your doctor. Currently, it is not recommended to use Rupafin 10 mg in patients with kidney or liver function disorders.
If you have low potassium levels and (or) an abnormal heart rhythm (known as QTc interval prolongation in the ECG), which may occur in some heart diseases, you should consult your doctor.
If you are over 65 years old, you should consult your doctor or pharmacist.

Children

This medicine is not intended for use in children under 12 years of age.

Rupafin 10 mg and other medicines

You should tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, including those that are available without a prescription.
If you are taking Rupafin 10 mg, you should not take medicines containing ketokonazole (a medicine used to treat fungal infections) or erythromycin (a medicine used to treat bacterial infections).
If you are taking medicines that affect the central nervous system, statins (medicines used to treat high cholesterol) or midazolam (a short-acting sedative and anxiolytic medicine), you should consult your doctor before taking Rupafin 10 mg.

Rupafin 10 mg with food, drink, and alcohol

Rupafin 10 mg should not be taken with grapefruit juice, as it may increase the level of Rupafin 10 mg in the body.

Rupafin 10 mg at the recommended dose (10 mg) does not increase the sedative effect of alcohol.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

It is not expected that Rupafin 10 mg at the recommended dose will affect your ability to drive or use machines. However, if you are taking Rupafin 10 mg for the first time, you should be careful and observe your reaction to the medicine before driving or using machines.

Rupafin 10 mg contains lactose monohydrate

If you have been told that you have an intolerance to some sugars, you should contact your doctor before taking this medicine.

3. How to take Rupafin 10 mg

This medicine should always be taken exactly as your doctor has told you. If you are not sure, you should ask your doctor or pharmacist.
Rupafin 10 mg is intended for use in adolescents (12 years and older) and adults. The usual dose is one tablet (10 mg rupatadine) once a day, with or without food. The tablet should be swallowed with a sufficient amount of liquid (e.g., a glass of water).
Your doctor will tell you how long you will need to take Rupafin 10 mg.

Taking a higher dose of Rupafin 10 mg than recommended

If you accidentally take a large dose of the medicine, you should contact your doctor or pharmacist immediately.

Missing a dose of Rupafin 10 mg

You should take the dose as soon as possible and then continue taking the tablets as recommended. Do not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, Rupafin 10 mg can cause side effects, although not everybody gets them.
Common side effects (may affect up to 1 in 10 people) include:
drowsiness, headache, dizziness, dry mouth, feeling weak and tired.
Uncommon side effects (may affect up to 1 in 100 people) include: increased appetite, irritability, difficulty concentrating, nosebleeds, dryness of the nasal mucosa, sore throat, cough, dryness of the throat, nasal congestion, nausea, abdominal pain, diarrhea, indigestion, vomiting, constipation, rash, back pain, joint pain, muscle pain, increased thirst, general malaise, fever, abnormal liver function test results, and weight gain.
Rare side effects (may affect up to 1 in 1,000 people) include: palpitations, rapid heartbeat, and allergic reactions (itching, hives, swelling of the face, lips, tongue, or throat).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Rupafin 10 mg

The medicine should be stored 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 month.
Store the blister in the outer packaging to protect from light.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will 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 rupatadine (as rupatadine fumarate).
• The other ingredients are: lactose monohydrate, maize starch, microcrystalline cellulose, red iron oxide (E 172), yellow iron oxide (E 172), magnesium stearate. See section 2 "Rupafin 10 mg contains lactose monohydrate".

What Rupafin 10 mg looks like and contents of the pack

Rupafin 10 mg tablets are light orange, round tablets, packaged in blisters divided into single doses, containing 10 tablets. The pack contains 30 tablets.
For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Belgium, the 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

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorization number in Belgium, the country of export: BE272045
Parallel import authorization number: 115/20

This medicine is authorized in the Member States of the European Economic Area 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, 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

Date of revision of the leaflet: 24.04.2025

[Information about the trademark]