Rupatadine Mabo 10 mg tablets EFG

Package leaflet: Information for the user

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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Rupatadina Mabo is and what it is used for
2. What you need to know before taking Rupatadina Mabo
3. How to take Rupatadina Mabo
4. Possible adverse effects
5. How to store 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, rhinorrhea, and itching of the eyes and nose.

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

2. What you need to know before taking Rupatadina Mabo

Do not take Rupatadina Mabo

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 rupatadine:

• If you have renal or hepatic impairment. In such cases, consult your doctor. The use of rupatadine 10 mg tablets 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) that may occur in certain heart conditions, consult your doctor.
• If you are over 65 years of age, consult your doctor or pharmacist.

Children

This medicine must not be used in children under 12 years of age.

Other medicines and Rupatadina Mabo

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

• When taking rupatadine, do not take medicines containing ketoconazole or erythromycin.
• If you are taking central nervous system depressants or medicines containing statins, consult your doctor before taking rupatadine.

Taking Rupatadina Mabo with food, beverages and alcohol

Do not take this medicine in combination with grapefruit juice, as it may increase the levels 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, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this 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 affects you before driving or operating machinery.

Rupatadina Mabo contains lactose.

This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Rupatadina Mabo

Follow exactly the instructions for use of this medicine given by your doctor. 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 determine the duration of your treatment with rupatadine.

If you take more Rupatadina Mabo than you should

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

If you forget to take Rupatadina Mabo

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 people): somnolence, headache, dizziness, dry mouth, feeling of weakness and fatigue.

Uncommon adverse effects (may affect up to 1 in 100 people): increased appetite, irritability, difficulty concentrating, nosebleed, nasal dryness, sore throat, cough, dry throat, 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 people): 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 Rupatadina Mabo

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 after EXP. The expiry date refers to the last day of the month indicated.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused containers and medicines. This way, you will help protect the environment.

6. Contents of the container and additional information

Composition of Rupatadina Mabo

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

Appearance of the product and contents of the container

Rupatadina Mabo is a round, biconvex, smooth, uncoated tablet, salmon-colored, packaged in blisters containing 20 tablets.

Pack size: 20 tablets.

Marketing Authorization 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 the most recent review of this leaflet: September 2020

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es