Rupafin 10 mg

PATIENT INFORMATION LEAFLET

Information leaflet attached to the packaging: information for the user

Rupafin 10 mg, tablets

Rupatadine

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, 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.
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, discuss it with your doctor or pharmacist.
If you have kidney or liver failure, 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) have 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

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 in fungal infections) or erythromycin (a medicine used in 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 medicine with a sedative and calming effect), 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 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 you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

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

Rupafin 10 mg contains lactose

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

3. How to take Rupafin 10 mg

Always take this medicine exactly as your doctor has told you. If you are not sure, 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. Swallow the tablet with a sufficient amount of liquid (e.g., a glass of water).
Your doctor will tell you how long 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, contact your doctor or pharmacist immediately.

Missing a dose of Rupafin 10 mg

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 the 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, dry 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 you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring 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.
Side effects can also be reported to the marketing authorization holder or its representative in Poland.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Rupafin 10 mg

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

What Rupafin 10 mg looks like and contents of the pack

Rupafin 10 mg tablets are round, light orange tablets, packaged in blisters divided into single doses, containing 3, 7, 10, or 15 tablets. The outer packaging contains 3, 7, 10, 15, 20, 30, 50, or 100 tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

NOUCOR HEALTH, S.A.
Av. Cami Reial, 51-57
08184 Palau-solitá i Plegamans
Barcelona, Spain
To obtain more detailed information, contact the representative of the marketing authorization holder:
Zentiva Polska Sp. z o. o.
ul. Bonifraterska 17
00-203 Warsaw
Tel. (22) 375 92 00

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 last revision of the leaflet:July 2022