RUPATADINE MABO 10 mg TABLETS

Introduction

Package Leaflet: Information for the User

Rupatadina Mabo 10 mg Tablets EFG

Read all of 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 signs of illness are the same as yours.
• If you get 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 Mabo is and what it is used for
2. What you need to know before you take Rupatadina Mabo
3. How to take Rupatadina Mabo
4. Possible side effects
5. Storage of Rupatadina Mabo
6. Contents of the pack and other information

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

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 rash) such as itching and skin rash (redness and swelling of the skin).

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

Do not takeRupatadina Mabo

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 rupatadina:

• If you have kidney or liver failure. In this case, consult your doctor. The use of rupatadina 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 (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 must not be used in children under 12 years of age.

Other medicines and Rupatadina Mabo

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

• When taking rupatadina, 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 rupatadina.

Taking Rupatadina Mabo with food, drinks and alcohol

You must not take this medicine in combination with grapefruit juice because it may increase the level of rupatadina in your body.

Rupatadina, 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

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

Rupatadina Mabo contains lactose.

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Rupatadina Mabo

Follow exactly the administration instructions of this medicine given by your doctor. In case of doubt, consult your doctor or pharmacist again.

Rupatadina is administered 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 indicate the duration of your treatment with rupatadina.

If you take more Rupatadina Mabo than you should

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

If you forget to take Rupatadina Mabo

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 forgotten doses.

4. Possible side effects

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

Common side effects (may affect up to 1 in 10 people):are drowsiness, headache, dizziness, dry mouth, feeling of weakness and fatigue.

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.

Rare side effects (may affect up to 1 in 1,000 people):are palpitations and increased heart rate and allergic reactions (itching, urticaria and swelling of the face, lips, tongue or throat).

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Rupatadina Mabo

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.

This medicine does not require any special storage conditions. Keep the blister in the outer packaging to protect it from light.

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 other information

Composition of Rupatadina Mabo

• The active substance is rupatadina. Each tablet contains 10 mg of rupatadina (as fumarate).
• The other ingredients are lactose monohydrate, microcrystalline cellulose, pregelatinized corn starch, red iron oxide (E172), yellow iron oxide (E172) and magnesium stearate.

Appearance of the product and pack contents

Rupatadina Mabo are round, biconvex, smooth, uncoated tablets, pink in color and packaged in blisters containing 20 tablets.

Pack size: 20 tablets.

Marketing Authorisation Holder

MABO-FARMA, S.A.

Calle Vía de los Poblados, 3,

Edificio 6, 28033 Madrid,

Spain.

Manufacturer

APL Swift Services (Malta) LTD.

HF26, Hal Fal Industrial Estate

Hal Far, Birzebbugia 3000, Malta

Date of last revision of this leaflet: September 2020

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