RUPATADINE AUROVITAS 10 MG TABLETS EFG

Package leaflet: Information for the user

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, as 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, and you should not give it 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 Aurovitas is and what it is used for
2. What you need to know before taking Rupatadina Aurovitas
3. How to take Rupatadina Aurovitas
4. Possible side effects
5. How to store Rupatadina Aurovitas
6. Contents of the pack and other information

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

Rupatadine is an antihistamine.

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

Rupatadine is also 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 Aurovitas

Do not take Rupatadina Aurovitas

• 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 to take Rupatadina Aurovitas.

• If you have renal or hepatic impairment, 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 a known abnormal heart rhythm pattern (prolonged QTc interval 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 Aurovitas

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

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

Taking Rupatadina Aurovitas with food, beverages and alcohol

Do not take rupatadine together with grapefruit juice, as it may increase rupatadine levels in your body.

Rupatadine, at the recommended dose of 10 mg, does not increase drowsiness caused by alcohol.

Pregnancy, breastfeeding and fertility

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 start taking rupatadine, you should take precautions and observe how the treatment affects you before driving or operating machinery.

Rupatadina Aurovitas contains lactose

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

3. How to take Rupatadina Aurovitas

Follow exactly the instructions for use of this medicine as 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 Aurovitas than you should

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

If you forget to take Rupatadina Aurovitas

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 everybody gets 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, rhinitis, nausea, abdominal pain, diarrhoea, indigestion, vomiting, constipation, skin 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 adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Conservation of Rupatadina Aurovitas

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month indicated.

Store the blister in the outer packaging to protect it from light.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This way, you will help protect the environment.

6. Contents of the container and other information

Composition of Rupatadina Aurovitas

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

Appearance of the product and contents of the container

Salmon-coloured, round, biconvex, flat-faced, uncoated tablets, 6.35 mm ± 0.1 mm in diameter.

Pack sizes: 10, 20 and 30 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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

Or

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of the most recent review of this leaflet: December 2022

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