Rupafin 10 mg

Leaflet attached to the packaging: information for the user

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Rupafin 10 mg (Rupatall), tablets

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

It is necessary to carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any further doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. 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 packaging 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 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, the patient should discuss it with their doctor or pharmacist.
If the patient has kidney or liver failure, they should consult their doctor. Currently, it is not recommended to use Rupafin 10 mg in patients with kidney or liver function disorders.
If the patient has low potassium levels and (or) an abnormal heart rhythm (known as QTc interval prolongation in the ECG), which may occur in some heart diseases, they should consult their doctor.
If the patient is over 65 years old, 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

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

Rupafin 10 mg with food, drink, and alcohol

Rupafin 10 mg should not be taken at the same time as 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 drowsiness caused by alcohol.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.

Driving and using machines

It is not expected that Rupafin 10 mg at the recommended doses will affect the ability to drive or use machines. However, if the patient is taking Rupafin 10 mg for the first time, they should be cautious and observe their reaction to the medicine before driving or using machines.

Rupafin 10 mg contains lactose monohydrate

If the patient has been diagnosed with an intolerance to some sugars, they should consult their doctor before taking this medicine.

3. How to take Rupafin 10 mg

This medicine should always be taken according to the doctor's instructions. In case of doubts, the patient should consult their 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 of 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).
The doctor will inform the patient how long the treatment with Rupafin 10 mg will last.

Taking a higher dose of Rupafin 10 mg than recommended

If the patient has accidentally taken a large dose of the medicine, they should immediately contact their doctor or pharmacist.

Missing a dose of Rupafin 10 mg

The dose should be taken as soon as possible, and then the patient should continue taking the tablets according to the recommended dosing schedule. A double dose should not be taken 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 1000 people) include: palpitations, rapid heartbeat, and allergic reactions (itching, hives, swelling of the face, lips, tongue, or throat).

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181 C, 02-222 Warsaw, tel.: +48 22 49 21 301,
fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Rupafin 10 mg

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
The blister pack should be stored in the outer packaging to protect it from light.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging 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: maize starch, microcrystalline cellulose, red iron oxide (E 172), yellow iron oxide (E 172), lactose monohydrate, and 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 round, light orange tablets, packaged in blisters containing 10 tablets. The outer packaging contains 30 tablets.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Belgium, the country of export:

• J. Uriach y Compañia S.A. Av. Camí Reial, 51-57 08184 Palau-solità i Plegamans, Spain

Manufacturer:

• J. Uriach y Compañia S.A. Av. Camí Reial, 51-57 08184 Palau-solità i Plegamans, Spain

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Belgian marketing authorization number, in the country of export: BE272045

Parallel import authorization number: 259/18

This medicinal product 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:29.08.2023
[Information about the trademark]