RUPATADINE TEVA 10 mg TABLETS

Introduction

Patient Information Leaflet

Rupatadina Teva 10 mg tablets EFG

Read 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 symptoms are the same as yours.
• If you experience 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

1. What Rupatadina Teva is and what it is used for
2. What you need to know before you take Rupatadina Teva
3. How to take Rupatadina Teva
4. Possible side effects
5. Storage of Rupatadina Teva
6. Contents of the pack and further information

1. What Rupatadina Teva is and what it is used for

Rupatadina, the active substance of Rupatadina Teva, is an antihistamine.

Rupatadina Teva is indicated for the relief of symptoms associated with allergic rhinitis such as sneezing, runny nose, itchy eyes, and itchy nose.

Rupatadina Teva is indicated for the relief of symptoms associated with urticaria (allergic skin rash) such as itching and skin rash (redness and swelling of the skin).

2. What you need to know before you take Rupatadina Teva

Do not take Rupatadina Teva:

• If you are allergic to rupatadina or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before taking this medicine.

If you have kidney or liver problems, consult your doctor. The use of Rupatadina Teva 10 mg tablets 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 should not be used in children under 12 years of age.

Taking Rupatadina Teva with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

If you are taking Rupatadina Teva, do not take medicines that contain ketoconazole or erythromycin.

If you are taking medicines that depress the central nervous system or medicines with statins, consult your doctor before taking this medicine.

Taking Rupatadina Teva with food and drinks

Do not take Rupatadina Teva in combination with grapefruit juice because it may increase the level of rupatadina in your body.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not take Rupatadina Teva during pregnancy and breastfeeding, unless your doctor advises you to do so.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

It is unlikely that the recommended dose of Rupatadina Teva will have an effect on your ability to drive or use machines. However, when you first start taking Rupatadina Teva, you should be careful to see how you react to the treatment before driving or using machines.

Rupatadina Teva contains 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 Rupatadina Teva

Take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Rupatadina Teva is for use in adolescents (from 12 years of age) and adults. The recommended dose is one tablet (10 mg of rupatadina) 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 Rupatadina Teva.

If you take more Rupatadina Teva than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Rupatadina Teva

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 the forgotten dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The common side effects(may affect up to 1 in 10 people) are:

Somnolence, headache, dizziness, dry mouth, feeling of weakness, and fatigue.

The 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.

The rare side effects(may affect up to 1 in 1,000 people) are:

Palpitations, increased heart rate, and allergic reactions (including anaphylactic reactions, angioedema, and urticaria).

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 to the Spanish Medicines Agency via their website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Rupatadina Teva

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 after EXP. The expiry date is the last day of the month shown.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Rupatadina Teva

• The active substance is rupatadina. Each tablet contains 10 mg of rupatadina (as fumarate).
• The other ingredients are lactose monohydrate, microcrystalline cellulose PH 102, pregelatinized starch, red iron oxide, yellow iron oxide, and magnesium stearate.

Appearance and packaging

Rupatadina Teva are round, pale salmon-colored tablets and are available in unit-dose blisters containing 20x1, 30x1, 50x1, and 100x1 tablets.

Not all 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, 1ª Planta

28108 Alcobendas, Madrid

Manufacturer

MEIJI PHARMA SPAIN S.A

Avda de Madrid, 94

28802 Alcala de Henares, Madrid

Spain

Or

Merckle GmbH

Ludwig-Merckle-StraBe 3,

Blaubeuren 89143

Germany

Or

MARTIN DOW PHARMACEUTICALS

Goualle Le Puy, Champ de Lachaud

Meymac 19250

France

This medicine 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 last revision of the leaflet:January 2016

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/

You can access detailed and up-to-date information about this medicine by scanning the QR code included in the packaging with your 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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