Rinialer 10 mg tablets
SpainTable of Contents
Package Leaflet: Information for the User
Introduction
Package Leaflet: Information for the User
Rinialer 10mg tablets
Rupatadine
Read the entire 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 others, 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 the adverse effects are not listed in this leaflet. See section 4.
Leaflet Contents
1. What Rinialer is and what it is used for
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What you need to know before taking Rinialer
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How to take Rinialer
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Possible side effects
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How to store Rinialer
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Contents of the pack and other information.
1. What Rinialer is and what it is used for
Rupatadine is an antihistamine.
Rinialer is indicated for the relief of symptoms of allergic rhinitis such as sneezing, rhinorrhea, itching of the eyes and nose.
Rinialer is indicated for the relief of symptoms associated with urticaria (allergic skin rash) such as itching and skin wheals (redness and swelling of the skin).
2. What you need to know before starting to take Rinialer
Do not take Rinialer:
- If you are allergic to rupatadine or to any of the other components of this medicine (listed in section 6).
Warnings and precautions
Consult your doctor or pharmacist before starting to take Rinialer.
If you have renal or hepatic impairment, consult your doctor. The use of Rinialer is currently not 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 old, consult your doctor or pharmacist.
Children
This medicine must not be used in children under 12 years of age.
Other medicines and Rinialer
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
If you are taking Rinialer, 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 Rinialer.
Taking Rinialer with food, drinks and alcohol
Do not take Rinialer together with grapefruit juice, as it may increase the level of rupatadine in your body.
Rinialer, at the recommended dose of 10 mg, does not increase drowsiness caused by alcohol.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Driving and using machines
Rinialer is not expected to affect your ability to drive or operate machinery at the recommended dose. However, when you first start using Rinialer, you should take caution and assess how the treatment may affect you before driving or operating machinery.
Rinialer 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 Rinialer
Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.
Rinialer is administered to 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 how long your treatment with Rinialer should last.
If you take more Rinialer than you should
In case of accidental ingestion of high doses of the medicine, contact your doctor or pharmacist immediately, or contact the Poison Information Service at telephone number 915 620 420.
If you forget to take Rinialer
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 may produce adverse effects, although not everyone will experience 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 may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Rinialer
Keep this 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 indicated.
Store in the original outer packaging to protect the tablets from light.
Medicines must not be disposed of via wastewater or household waste. Return the pack and any unused medicines to the SIGRE point at your pharmacy. If in doubt, ask your pharmacist how to dispose of any unused packaging and medicines. This will help protect the environment.
6. Contents of the pack and other information
Composition of Rinialer
The active substance is rupatadine. Each tablet contains 10 mg of rupatadine (as fumarate).
The other components are: pregelatinized maize starch, microcrystalline cellulose, red iron oxide (E-172), yellow iron oxide (E-172), lactose monohydrate and magnesium stearate. See section 2, “Rinialer contains lactose”.
Appearance of the product and pack contents:
Rinialer are round, light salmon-coloured tablets, supplied in unit-dose blisters containing 15 or 20 tablets. Not all pack sizes are marketed.
Marketing Authorization Holder
NOUCOR HEALTH, S.A.
Av. Camí Reial 51-57
08184 Palau-solità i Plegamans (Barcelona-Spain)
Manufacturer
Bial-Portela & Cía. S.A.
Av. Da Siderurgia Nacional; 4745-457S- Mamede do Coronado (Portugal)
Or
NOUCOR HEALTH, S.A.
Av. Camí Reial 51-57
08184 Palau-solità i Plegamans (Barcelona-Spain)
For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:
Laboratorios BIAL, S.A.
C/ Alcalá 265, Edificio 2, Planta 2ª
28027 Madrid (Spain)
Date of the most recent revision of this leaflet: November 2020
Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es