RUPAFIN 10 mg TABLETS
How to use RUPAFIN 10 mg TABLETS
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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.
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Introduction
Package Leaflet: Information for the User
Rupafin 10mg 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 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 signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
Contents of the pack
- What is Rupafin and what is it used for
- What you need to know before you take Rupafin
- How to take Rupafin
- Possible side effects
- Storage of Rupafin
- Contents of the pack and other information
1. What is Rupafin and what is it used for
Rupatadine is an antihistamine.
Rupafin is indicated for the relief of symptoms associated with allergic rhinitis such as sneezing, runny nose, itchy eyes and nose.
Rupafin is indicated for the relief of symptoms associated with urticaria (allergic skin rash) such as itching and hives (redness and swelling of the skin).
2. What you need to know before you take 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 taking Rupafin.
If you have kidney or liver problems, consult your doctor. The use of Rupafin is not currently recommended in patients with kidney or liver problems.
If you have low potassium levels in your blood and/or if you have a certain abnormal heart rhythm (known prolongation of the QTc interval in the ECG) that may occur in certain heart diseases, consult your doctor.
If you are over 65 years old, consult your doctor or pharmacist.
Children
This medicine must not be used in children under 12 years of age.
Other medicines and Rupafin
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
If you are taking Rupafin, do not take medicines that contain ketoconazole (a medicine for fungal infections) or erythromycin (a medicine for bacterial infections).
If you are taking medicines that depress the central nervous system, medicines with statins (medicines used to treat high cholesterol) 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 in combination 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 produced by alcohol.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, 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
It is unlikely that at the recommended dose, Rupafin will have an effect on your ability to drive or use machines. However, when you first start taking Rupafin, be careful to see how it affects you before driving or using machines.
Rupafincontains lactose.
If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.
3. How to take Rupafin
Take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.
Rupafin is given to adolescents (from 12 years of age) and adults. The recommended dose is one tablet (10 mg of 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.
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 the Toxicology Information Service, telephone 915 620 420.
If you forget to take Rupafin
Take your dose as soon as possible and continue with your tablets at the usual times. Do not take a double dose to make up for forgotten doses.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common side effects (may affect up to 1 in 10 people) are drowsiness, headache, dizziness, dry mouth, feeling of weakness and fatigue.
Uncommon side effects (may affect up to 1 in 100 people) are increased appetite, irritability, difficulty concentrating, nosebleeds, dry nose, sore throat, cough, dry throat, rhinitis, nausea, abdominal pain, diarrhea, indigestion, vomiting, constipation, rash, back pain, joint pain, muscle pain, thirst, malaise, fever, abnormal liver function tests and weight gain.
Rare side effects (may affect up to 1 in 1,000 people) are palpitations and increased heart rate and allergic reactions (itching, urticaria and swelling of the face, lips, tongue or throat).
Reporting of side effects:
If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.
5. Storage of Rupafin
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister. The expiry date is the last day of the month stated.
Store in the outer carton to protect the tablets from light.
Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to the pharmacy or take it to a designated collection point. Ask your pharmacist how to dispose of medicines no longer required. This will help to 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 ingredients are: pregelatinized corn starch, microcrystalline cellulose, red iron oxide (E-172), yellow iron oxide (E-172), lactose monohydrate and magnesium stearate. See section 2 "Rupafin contains lactose".
Appearance of the product and pack contents
Rupafin are light salmon-colored, round tablets and are presented in unit dose blisters containing 3, 7, 10, 15, 20, 30, 50 or 100 tablets. Not all packs are marketed.
Marketing Authorisation 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 medicine is authorised 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 last revision of this leaflet: 08/2020
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es
- Country of registration
- Average pharmacy price6.98 EUR
- Active substance
- Prescription requiredYes
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
- Alternatives to RUPAFIN 10 mg TABLETSDosage form: ORAL SOLUTION/SUSPENSION, 1 mg/ml (as rupatadine)Active substance: rupatadineManufacturer: Urquima S.A.Prescription requiredDosage form: TABLET, 10 mgActive substance: rupatadineManufacturer: Urquima S.A.Prescription requiredDosage form: ORAL SOLUTION/SUSPENSION, 1 MG/ML (as Rupatadine)Active substance: rupatadineManufacturer: Noucor Health S.A.Prescription required
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