Leaflet: Information for the user

Rupatadina Kern Pharma 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, consult 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.

1.What Rupatadina is and what it is used for

2.What you need to know before you start taking Rupatadina

3.How to take Rupatadina

4.Possible side effects

5.Storage of Rupatadina

6.Contents of the pack and additional information

Rupatadina is an antihistamine.

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

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

Do not take Rupatadine

- If you are allergic to rupatadine or to any of the other ingredients of this medication (listed in section 6).

Warnings and precautions

If you have liver or kidney failure, consult your doctor. The use of Rupatadine 10 mg tablets is not currently recommended in patients with liver or kidney failure.

If you have low potassium levels in your blood and/or if you have a certain abnormal heart rhythm pattern (prolongation of the QTc interval on 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 medication should not be used in children under 12 years of age.

Taking Rupatadine with other medications

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

When taking Rupatadine, do not take medications that contain ketoconazole or erythromycin.

If you are taking central nervous system depressants or statin medications, consult your doctor before taking Rupatadine.

Taking Rupatadine 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 drowsiness caused by alcohol.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

No significant effect on your ability to drive vehicles or operate machinery is expected from the recommended dose of Rupatadine. However, when you first use Rupatadine, you should be cautious and see how it affects you before driving or operating machinery.

Rupatadinecontains lactose.

If your doctor has informed you that you have an intolerance to some sugars, consult your doctor before taking this medication.

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

Rupatadina is administered in adolescents (12 years of age and older) 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 inform you of the duration of your treatment with Rupatadina.

If you take more Rupatadina than you should

In case of accidental ingestion of high doses of the medication, consult your doctor or pharmacist immediately or the Toxicological Information Service, phone 915 620 420.

If you forget to take Rupatadina

Do not take a double dose to compensate for the missed doses.

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

The frequent adverse effects (may affect up to 1 in 10 patients) are drowsiness, headache, dizziness, dry mouth, feeling of weakness and fatigue. The infrequent adverse effects (may affect up to 1 in 100 patients) are 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.

The 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 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 the 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. The expiration date is the last day of the month indicated.

Store in the outer carton to preserve the tablets from light.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Rupatadina

–The active ingredient is rupatadine. Each tablet contains 10mg of rupatadine (as fumarate).

–The other components are: pregelatinized cornstarch, microcrystalline cellulose, red iron oxide (E-172), yellow iron oxide (E-172), lactose monohydrate, and magnesium stearate.

Appearance of the product and content of the packaging

Rupatadina are round, salmon-colored tablets and are presented in unit dose blisters containing 20 tablets.

Holder of the authorization

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Responsible for manufacturing

NOUCOR HEALTH, S.A.

Av. Camí Reial 51-57

08184 Palau-solità i Plegamans (Barcelona-Spain)

Last review date of this leaflet: November 2015

The detailed and updated information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es