Leaflet: Information for the User

Rupatadina Aurovitas 10 mg Tablets EFG

Read 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 must not give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2.What you need to know before you start taking Rupatadina Aurovitas

3.How to take Rupatadina Aurovitas

4.Possible side effects

5.Storage of Rupatadina Aurovitas

6.Contents of the pack and additional information

Rupatadina is an antihistamine.

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

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

Do not takeRupatadina Aurovitas

-If you are allergic torupatadinaor to any of the other ingredients of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Rupatadina Aurovitas.

•If you have kidney or liver failure, consult your doctor. The use ofrupatadina10 mg tablets is not currently recommended in patients with kidney or liver failure.

•If you have low potassium levels in the blood and/or if you have a certain abnormal heart rhythm pattern (prolongation of the QTc interval on 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 medication should not be used in children under 12 years old.

Other medications andRupatadina Aurovitas

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

•If you are taking rupatadina, do not take medications that contain ketoconazole (antifungal medication) or erythromycin (antibacterial medication).

•If you are taking central nervous system depressants, statins (medications used to treat high cholesterol levels) or midazolam (sedative medication), consult your doctor before taking rupatadina.

TakingRupatadina Aurovitaswith food, drinks, and alcohol

Do not takerupatadinain combination with grapefruit juice as it may increase the level of rupatadina in your body.

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

Pregnancy, breastfeeding, and fertility

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 operating machinery

No significant effect on your ability to drive vehicles or operate machinery is expected from the recommended dose of rupatadina. However, when you first use rupatadina, be cautious and see how it affects you before driving or operating machinery.

Rupatadina Aurovitascontains lactose

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with him before taking this medication.

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

Rupatadina is administered to adolescents (12 years of age and older) 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 inform you of the duration of your treatment with rupatadina.

If you take more Rupatadina Aurovitas than you should

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

If you forgot to take Rupatadina Aurovitas

Take your dose as soon as possible and continue with your tablets at the usual times. Do not take a double dose to compensate for the missed dose.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Frequent Adverse Effects(may affect up to 1 in 10 people):

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

Less Frequent Adverse Effects(may affect up to 1 in 100 people):

Increased appetite, irritability, difficulty concentrating, nasal bleeding, nasal dryness, sore throat, cough, dry throat, rhinitis, nausea, abdominal pain, diarrhea, indigestion, vomiting, constipation, skin rash, back pain, joint pain, muscle pain, thirst, discomfort, 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 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

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

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

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition ofRupatadina Aurovitas

-The active ingredient is rupatadina. Each tablet contains 10 mg of rupatadina (as fumarate).

-The other components are: lactose monohydrate, microcrystalline cellulose, pregelatinized cornstarch, red iron oxide (E172), yellow iron oxide (E172), and magnesium stearate.

Appearance of the product and contents of the packaging

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

Packaging sizes:10, 20, and 30 tablets.

Only some packaging sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible 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 authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet: December 2022

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