Rupafin 10 mg
Poland
Table of Contents
Package leaflet: Information for the user
Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Rupafin 10 mg (Rupatall), 10 mg, tablets
Rupatadinum
Rupafin 10 mg and Rupatall are different brand names of the same medicine.
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 give it to others. This medicine may harm someone else, even if their symptoms are the same.
- If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
Table of contents of the leaflet
- What is Rupafin 10 mg and what is it 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 is Rupafin 10 mg and what is it used for
Rupatadine is an antihistamine medicine.
Rupafin 10 mg relieves symptoms of allergic rhinitis, such as sneezing,
nasal discharge, 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 renal or hepatic 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 has an 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 inhibit the central nervous system, statins (medicines used to treat high cholesterol levels), or midazolam (a short-acting sedative and hypnotic medicine), 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 at the same time as grapefruit juice, as this may lead to increased levels 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 is not expected to affect the ability to drive or operate machinery when used at recommended doses. However, if the patient is taking Rupafin 10 mg for the first time, they should exercise caution before driving or operating machinery and observe their reaction to the medicine.
Rupafin 10 mg contains lactose monohydrate
If the patient has previously been 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 exactly as prescribed by the doctor. In case of any doubts, consult the doctor 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 doctor will inform the patient how long the treatment with Rupafin 10 mg should last.
Taking more than the recommended dose of Rupafin 10 mg
If the patient accidentally takes more than the prescribed dose, they should immediately contact their doctor or pharmacist.
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 prescribed dosing schedule. Do not take a double dose to make up for the missed dose.
4. Possible adverse reactions
Like any medicine, Rupafin 10 mg can cause adverse reactions, although they do not occur in everyone.
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, facial swelling, swelling of lips, tongue or throat).
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +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 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: pregelatinized maize starch, microcrystalline cellulose, iron oxide red (E 172), iron oxide yellow (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 greyish-blue tablets, packed in blisters of 10 tablets.
The outer packaging contains 10, 20, 30, 50 or 100 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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorisation number in Belgium, country of export: BE272045
Parallel import authorisation number: 46/19
This medicinal product is authorised for marketing in the European Economic Area under the following trade 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