Rupafin 10 mg tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: Information for the user
Rupafin 10 mg tablets
Rupatadine
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
Contents of the leaflet
- What Rupafin is and what it is used for
- What you need to know before taking Rupafin
- How to take Rupafin
- Possible side effects
- How to store Rupafin
- Contents of the pack and other information
1. What Rupafin is and what it is used for
Rupatadine is an antihistamine.
Rupafin is indicated for the relief of symptoms of allergic rhinitis such as sneezing, rhinorrhea, and itching of the eyes and nose.
Rupafin is indicated for the relief of symptoms associated with urticaria (allergic skin rash) such as itching and cutaneous wheals (redness and swelling of the skin).
2. What you need to know before taking Rupafin
Do not take Rupafin
- If you are allergic to rupatadine or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Consult your doctor or pharmacist before starting to take Rupafin.
If you have renal or hepatic impairment, consult your doctor. The use of Rupafin is not currently recommended in patients with renal or hepatic impairment.
If you have low blood potassium levels and/or if you have a known abnormal heart rhythm pattern (known QTc interval prolongation on ECG), which may occur in certain heart conditions, consult your doctor.
If you are over 65 years of age, consult your doctor or pharmacist.
Children
This medicine should not be used in children under 12 years of age.
Other medicines and Rupafin
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
If you are taking Rupafin, do not take medicines containing ketoconazole (a medicine for fungal infections) or erythromycin (a medicine for bacterial infections).
If you are taking central nervous system depressants, medicines containing statins (medicines used to treat high cholesterol levels), or midazolam (a medicine used for short-term sedation), consult your doctor before taking Rupafin.
Taking Rupafin with food, drinks and alcohol
Do not take Rupafin together with grapefruit juice, as it may increase the level of rupatadine in your body.
Rupafin, at the recommended dose of 10 mg, does not increase the drowsiness caused by alcohol.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Driving and using machines
Rupafin is not expected to affect your ability to drive or operate machinery at the recommended dose. However, when you first start using Rupafin, you should take caution and assess how the treatment affects you before driving or operating machinery.
Rupafin contains lactose.
If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.
3. How to take Rupafin
Follow exactly the administration instructions for this medicine given by your doctor. If in doubt, consult your doctor or pharmacist again.
Rupafin is administered in adolescents (from 12 years of age) and adults. The recommended dose is one tablet (10 mg of rupatadine) once daily, with or without food. Swallow the tablet with a sufficient amount of liquid (e.g., a glass of water).
Your doctor will determine the duration of your treatment with Rupafin.
If you take more Rupafin than you should
In case of accidental ingestion of high doses of the medicine, consult your doctor or pharmacist immediately, or contact the Toxicology Information Service at telephone number 915 620 420.
If you forget to take Rupafin
Take your dose as soon as possible and then continue taking your tablets at the usual times. Do not take a double dose to make up for missed doses.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
Frequent adverse effects (may affect up to 1 in 10 patients) are somnolence, headache, dizziness, dry mouth, feeling of weakness and fatigue.
Uncommon adverse effects (may affect up to 1 in 100 patients) are increased appetite, irritability, difficulty concentrating, nosebleed, nasal dryness, sore throat, cough, dry throat, rinitis, nausea, abdominal pain, diarrhoea, indigestion, vomiting, constipation, rash, back pain, joint pain, muscle pain, thirst, malaise, fever, abnormal liver function tests and weight gain.
Rare adverse effects (may affect up to 1 in 1,000 patients) are palpitations, increased heart rate, and allergic reactions (itching, urticaria, and swelling of the face, lips, tongue or throat).
Reporting of adverse effects:
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Rupafin
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack. The expiry date refers to the last day of the month indicated.
Store in the original carton to protect the tablets from light.
Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be returned to the SIGRE collection point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of any unused medicines and their packaging. This will help protect the environment.
6. Contents of the pack and other information
Composition of Rupafin
- The active substance is rupatadine. Each tablet contains 10 mg of rupatadine (as fumarate).
- The other components are: pregelatinized corn starch, microcrystalline cellulose, red iron oxide (E-172), yellow iron oxide (E-172), monohydrate lactose, and magnesium stearate. See section 2 “Rupafin contains lactose”.
Appearance of the product and contents of the pack
Rupafin are round, light salmon-coloured tablets, presented in unit-dose blisters containing 3, 7, 10, 15, 20, 30, 50 or 100 tablets. Not all pack sizes are marketed.
Marketing Authorization Holder
LABORATORIOS ERN, S.A.
Perú, 228
08020 Barcelona
Spain
Manufacturer
NOUCOR HEALTH, S.A.
Av. Camí Reial 51-57
08184 Palau-solità i Plegamans (Barcelona-Spain)
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Rupatall 10 mg Tablets Belgium, Luxembourg
Rinialer 10 mg Tablets Portugal, Malta
Rupafin 10 mg Tablets Austria, Bulgaria, Croatia, Cyprus, Denmark, Estonia, Germany, Greece, Iceland, Italy, Ireland, Latvia, Liechtenstein, Lithuania, Netherlands, Norway, Poland, Slovenia, Slovakia, Spain
Rupatadine 10 mg Tablets United Kingdom
Wystamm 10 mg Tablets France
Tamalis 10 mg Tablets Hungary, Czech Republic, Romania
Pafinur 10 mg tablets Finland, Sweden
Date of the most recent review of this leaflet: 08/2020
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es