Rupatadine Teva 10 mg tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Rupatadina Teva 10 mg tablets EFG
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
- Keep this leaflet, as 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, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet contents
- What Rupatadina Teva is and what it is used for
- What you need to know before taking Rupatadina Teva
- How to take Rupatadina Teva
- Possible adverse effects
- How to store Rupatadina Teva
- Contents of the pack and other information
1. What Rupatadina Teva is and what it is used for
Rupatadine, the active substance in Rupatadina Teva, is an antihistamine.
Rupatadina Teva is indicated for the relief of symptoms of allergic rhinitis such as sneezing, runny nose, and itching of the eyes and nose.
Rupatadina Teva 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 taking Rupatadina Teva
Do not take Rupatadina Teva:
- If you are allergic to rupatadine or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Consult your doctor or pharmacist before starting to take this medicine.
If you have renal or hepatic impairment, consult your doctor. The use of Rupatadina Teva 10 mg tablets is not currently recommended in patients with renal or hepatic impairment.
If you have low blood potassium levels and/or a certain abnormal heart rhythm pattern (known QTc interval prolongation on ECG) that may occur in certain heart conditions, consult your doctor.
If you are over 65 years of age, consult your doctor or pharmacist.
Children and adolescents
This medicine must not be used in children under 12 years of age.
Taking Rupatadina Teva with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
If you are taking Rupatadina Teva, do not take medicines containing ketoconazole (used to treat Cushing's syndrome, when the body produces excess cortisol) or erythromycin (a medicine used for bacterial infections).
If you are taking central nervous system depressants, statins (medicines used to treat high cholesterol levels), or midazolam (a medicine used for short-term sedation), consult your doctor before taking this medicine.
Taking Rupatadina Teva with food and drink
Do not take Rupatadina Teva together with grapefruit juice, as it may increase the level of rupatadine in your body.
Rupatadina Teva, 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 may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Do not take Rupatadina Teva during pregnancy or breastfeeding unless clearly instructed by your doctor.
Consult your doctor or pharmacist before taking any medicine.
Driving and using machines
The recommended dose of Rupatadina Teva is not expected to affect your ability to drive or operate machinery. However, when you first start using Rupatadina Teva, you should take care to assess how the treatment may affect you before driving or operating machinery.
Rupatadina Teva contains lactose.
If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.
3. How to take Rupatadina Teva
Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.
Rupatadina Teva 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 advise you on the duration of your treatment with Rupatadina Teva.
If you take more Rupatadina Teva than you should
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Poison Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.
If you forget to take Rupatadina Teva
Take your missed 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 the forgotten dose.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.
Frequent adverse effects (may affect up to 1 in 10 people):
Somnolence, headache, dizziness, dry mouth, feeling of weakness and fatigue.
Uncommon adverse effects (may affect up to 1 in 100 people):
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 people):
Palpitations, increased heart rate, and allergic reactions (including anaphylactic reactions, angioedema, and urticaria).
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 Rupatadina Teva
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and blister after EXP. The expiry date refers to the last day of the month indicated.
This medicine does not require any special storage conditions.
Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE Point located at pharmacies. If you have any doubts, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.
6. Contents of the pack and other information
Composition of Rupatadina Teva
- The active substance is rupatadine. Each tablet contains 10 mg of rupatadine (as fumarate).
- The other components are monohydrate lactose, microcrystalline cellulose PH 102, pregelatinized corn starch, red iron oxide, yellow iron oxide and magnesium stearate.
Appearance of the product and contents of the pack
Rupatadina Teva are round, light salmon-coloured tablets, supplied in unit-dose blisters containing 20x1, 30x1, 50x1 and 100x1 tablets.
Only some pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Teva Pharma, S.L.U.
C/Anabel Segura, 11 Edificio Albatros B, 1st Floor
28108 Alcobendas, Madrid
Spain
Manufacturer
MEIJI PHARMA SPAIN S.A
Avda de Madrid, 94
28802 Alcala de Henares, Madrid
Spain
Or
Merckle GmbH
Ludwig-Merckle-Straße 3,
Blaubeuren 89143
Germany
Or
MARTIN DOW PHARMACEUTICALS
Goualle Le Puy, Champ de Lachaud
Meymac 19250
France
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
PT: Rupatadina ratiopharm
ES: Rupatadina Teva 10 mg tablets EFG
NL: Rupatadine Teva 10 mg, tablets
Date of the most recent review of the package leaflet: December 2025
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).
You can access detailed and up-to-date information about this medicinal product by scanning the QR code included on the packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/81020/P_81020.html
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