RUPATADINE KERN PHARMA 10 mg TABLETS

Introduction

Package Leaflet: Information for the User

Rupatadine Kern Pharma 10 mg tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Rupatadine and what is it used for
2. What you need to know before taking Rupatadine
3. How to take Rupatadine
4. Possible side effects
5. Storage of Rupatadine
6. Package Contents and Additional Information

1. What is Rupatadine and what is it used for

Rupatadine is an antihistamine.

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

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

2. What you need to know before taking Rupatadine

Do not take Rupatadine

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

Warnings and Precautions

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

If you have low potassium levels in your blood and/or if you have a certain abnormal heart rhythm pattern (known QTc interval prolongation 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

Tell your doctor or pharmacist if you are taking, have recently taken, 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 depressant medications or statin medications, consult your doctor before taking Rupatadine.

Taking Rupatadine with food, beverages, 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 produced by alcohol.

Pregnancy and Breastfeeding

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

Driving and Using 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 machinery.

Rupatadinecontains lactose.

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

3. How to take Rupatadine

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

Rupatadine is administered to adolescents (from 12 years of age) 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 than you should

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

If you forget to take Rupatadine

Do not take a double dose to make up for forgotten doses.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Common side effects (may affect up to 1 in 10 patients) are drowsiness, headache, dizziness, dry mouth, feeling of weakness, and fatigue. Uncommon side effects (may affect up to 1 in 100 patients) are increased appetite, irritability, difficulty concentrating, nasal bleeding, dry nose, 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 side 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 side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Rupatadine

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

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

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

Medications should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medication in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Rupatadine

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

Appearance of the Product and Package Contents

Rupatadine is a light salmon-colored, round tablet and is presented in unit dose blisters containing 20 tablets.

Marketing Authorization Holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer

NOUCOR HEALTH, S.A.

Av. Camí Reial 51-57

08184 Palau-solità i Plegamans (Barcelona-Spain)

Date of the Last Revision of this Package Leaflet: November 2015

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es