RUPATADINE AUROVITAS 10 mg TABLETS

Introduction

Package Leaflet: Information for the User

Rupatadina Aurovitas 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 symptoms 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 Aurovitas is and what it is used for
2. What you need to know before you take Rupatadina Aurovitas
3. How to take Rupatadina Aurovitas
4. Possible side effects
5. Storage of Rupatadina Aurovitas
6. Contents of the pack and other information

1. What Rupatadina Aurovitas 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 also 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 Aurovitas

Do not takeRupatadina Aurovitas

• 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 Aurovitas.

• If you have kidney or liver failure, 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 some 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.

Other medicines andRupatadina Aurovitas

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

• If you are taking rupatadina, do not take medicines that contain ketoconazole (a medicine for fungal infections) or erythromycin (a medicine for bacterial infections).
• If you are taking medicines that depress the central nervous system, statins (medicines used to treat high cholesterol levels) or midazolam (a medicine used for short-term sedation), consult your doctor before taking rupatadina.

TakingRupatadina Aurovitaswith food, drinks and alcohol

Do not takerupatadinain 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, breast-feeding and fertility

If you are pregnant or breast-feeding, 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, be careful to see how it affects you before driving or using machines.

Rupatadina Aurovitascontains 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 Aurovitas

Follow exactly the administration instructions of this medicine given by your doctor. If you are unsure, 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 moreRupatadina Aurovitasthan you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to takeRupatadina Aurovitas

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):

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

Uncommon side effects(may affect up to 1 in 100 people):

Increased appetite, irritability, difficulty concentrating, nosebleeds, dry nose, sore throat, cough, dry throat, rhinitis, nausea, abdominal pain, diarrhea, indigestion, vomiting, constipation, skin 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):

Palpitations, 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 they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Rupatadina Aurovitas

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 stated.

Store 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. If you are unsure, 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 ofRupatadina Aurovitas

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

Appearance and packaging

Uncoated salmon-colored tablets, round, 6.35 mm ± 0.1 mm, biconvex, flat on both sides.

Package sizes:10, 20 and 30 tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

O

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

This medicine is authorised in the Member States of the European Economic Area under the following names:

Date of last revision of this leaflet: December 2022

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