Leaflet: information for the user

Rupatadine Cinfa 10 mg tablets EFG

Read this 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 must not give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

rupatadina cinfa is an antihistamine.

rupatadina cinfa is indicated for the relief of symptoms of allergic rhinitis, such as sneezing, nasal discharge, itchy eyes and nose.

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

Do not take rupatadine cinfa

-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 rupatadine cinfa.

If you have kidney or liver insufficiency, consult your doctor. The use of rupatadine is not currently recommended in patients with kidney or liver insufficiency.

If you have low potassium levels in the blood and/or if you have a certain abnormal heart rhythm pattern (prolongation of the QTc interval in the ECG), which 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 rupatadine cinfa with other medicines

Inform your doctor or pharmacist if you are taking,have taken recentlyor may have to take any other medicine.

Do not take rupatadine with medicines that contain ketoconazole or erythromycin.

If you are taking central nervous system depressants or statins, consult your doctor before taking rupatadine.

Taking rupatadine cinfa with food, drinks, and alcohol

Do not take rupatadine in combination with grapefruit juice, as it may increase the level of rupatadine 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, or if you think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medicine.

Do not take rupatadine during pregnancy and breastfeeding, unless clearly indicated by your doctor.

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

Driving and operating machines

It is not expected that the recommended dose of rupatadine will affect your ability to drive vehicles or operate machinery. However, when you first use rupatadine, you should be cautious and see how the treatment affects you before driving or operating machines.

Rupatadine cinfa contains lactose

If your doctor has told youthat you have an intolerance to certain sugars, consult him before taking this medicine.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Rupatadine is administered to adolescents (12 years of age and older) 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 indicate the duration of your treatment with rupatadine.

If you take more rupatadine cinfa than you should

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

If you forgot to take rupatadine cinfa

Take your dose as soon as possible and continue with your tablets at the usual times. Do not take a double dose to compensate for the missed doses.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Frequent Adverse Effects(may affect up to 1 in 10 patients):

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

Less Frequent Adverse Effects(may affect up to 1 in 100 patients):

Increased appetite, irritability, difficulty concentrating, nasal bleeding, nasal dryness, sore throat, cough, dry throat, rhinitis, nausea, abdominal pain, diarrhea, indigestion, vomiting, constipation, rash, back pain, joint pain, muscle pain, thirst, discomfort, 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 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not use this medication after the expiration date that appears on the packaging and blister, after CAD.The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be thrown down the drain or in the trash.Deposit the packaging and medications you no longer need at the SIGRE collection pointof the pharmacy.In case of doubt,ask your pharmacist how to dispose ofthe packaging and medications you no longerneed.By doing so, you will help protect the environment.

Composition of rupatadine cinfa

• The active ingredient is rupatadine. Each tablet contains 10 mg of rupatadine (as fumarate).
• The other components are lactose monohydrate, microcrystalline cellulose PH 102, pregelatinized cornstarch, red iron oxide (E-172), yellow iron oxide (E-172), and magnesium stearate.

Appearance of the product and contents of the packaging

rupatadine cinfaare round, salmon-colored tablets.

It is presented in PVC-PVDC/ALU blisters. Each package contains 20 tablets

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Industrial Park Areta

31620 Huarte (Navarra) - Spain

Responsible for manufacturing

Meiji Pharma Spain, S.A.

Avda. de Madrid, 94

28802 Alcalá de Henares, Madrid

Spain

O

Martin Dow Pharmaceuticals

Goualle Le Puy, Champ de Lachaud

19250 Meymac

France

Last review date of this leaflet:August 2020

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)www.aemps.gob.es

You can access detailed and updated information about this medication by scanning the QR code included in the leaflet and packaging with your smartphone. 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