Rupatadine CINFA 10 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

rupatadina cinfa 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 other people, 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 such effects are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What rupatadina cinfa is and what it is used for
2. What you need to know before taking rupatadina cinfa
3. How to take rupatadina cinfa
4. Possible side effects
5. How to store rupatadina cinfa
6. Contents of the pack and other information

1. What rupatadina cinfa is and what it is used for

rupatadina cinfa is an antihistamine.

rupatadina cinfa is indicated for the relief of symptoms of allergic rhinitis, such as sneezing, runny nose, and itching of the eyes and nose.

rupatadina cinfa is also indicated for the relief of symptoms associated with urticaria (allergic skin rash), such as itching and skin wheals (localized redness and swelling of the skin).

2. What you need to know before starting to take rupatadina cinfa

Do not take rupatadina cinfa

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take rupatadina cinfa.

If you have renal or hepatic impairment, consult your doctor. The use of rupatadine is not currently recommended in patients with renal or hepatic impairment.

If you have low blood potassium levels and/or if you have a certain 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.

Taking rupatadina cinfa with other medicines

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

Do not take medicines containing ketoconazole or erythromycin while taking rupatadine.

If you are taking central nervous system depressants or statin-containing medicines, consult your doctor before taking rupatadine.

Taking rupatadina cinfa with food, drinks and alcohol

Do not take rupatadine in combination with grapefruit juice, as it may increase rupatadine levels in your body.

Rupatadine, 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.

Do not take rupatadine during pregnancy or breastfeeding unless clearly advised by your doctor.

Consult your doctor or pharmacist before starting to take any medicine.

Driving and using machines

The recommended dose of rupatadine is not expected to affect your ability to drive or operate machinery. However, when you first use rupatadine, you should take caution and observe how the treatment may affect you before driving or operating machinery.

rupatadina cinfa 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 cinfa

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Rupatadina 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 rupatadine.

If you take more rupatadina cinfa than you should

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

If you forget to take rupatadina cinfa

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 forgotten doses.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Frequent adverse effects (may affect up to 1 in 10 patients):

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

Uncommon adverse effects (may affect up to 1 in 100 patients):

Increased appetite, irritability, difficulty concentrating, nosebleeds, nasal dryness, sore throat, cough, dry throat, rhinitis, 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):

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 through 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 rupatadine cinfa

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging and blister pack, after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their packaging to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of rupatadina cinfa

• 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 (E-172), yellow iron oxide (E-172) and magnesium stearate.

Nature and content of the container

rupatadina cinfa are round, soft salmon-coloured tablets.

They are presented in PVC-PVDC/ALU blisters. Each pack contains 20 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Manufacturer

Meiji Pharma Spain, S.A.

Avda. de Madrid, 94

28802 Alcalá de Henares, Madrid

Spain

Or

Martin Dow Pharmaceuticals

Goualle Le Puy, Champ de Lachaud

19250 Meymac

France

Date of the most recent review of this leaflet: August 2020

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): www.aemps.gob.es

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/80877/P_80877.html

QR code to: https://cima.aemps.es/cima/dochtml/p/80877/P_80877.html