Leaflet: information for the patient

Rupatadina Desgen 10 mg tablets EFG

Rupatadina

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, consult 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 Rupatadina Desgen is and for what it is used

2. What you need to know before starting to take Rupatadina Desgen

3. How to take Rupatadina Desgen

4. Possible side effects

5. Storage of Rupatadina Desgen

6. Contents of the pack and additional information

Rupatadina, the active substance of Rupatadina Desgen, is an antihistamine.

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

Rupatadina Desgenis 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 take Rupatadina Desgen:

- If you are allergic to rupatadina or to any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication.

If you have kidney or liver insufficiency, consult your doctor. The use of Rupatadina Desgen 10 mg tablets is not currently recommended for patients with kidney or liver insufficiency.

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 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 medication should not be used in children under 12 years of age.

Taking Rupatadina Desgen with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may have to take any other medication, including those that do not require a prescription.

If you are taking Rupatadina Desgen, do not take medications that contain ketoconazole or erythromycin.

If you are taking central nervous system depressants or statin medications, consult your doctor before taking this medication.

Taking Rupatadina Desgen with food and drinks

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Do not take Rupatadina Desgen during pregnancy and breastfeeding unless your doctor has clearly indicated that you should.

Consult your doctor or pharmacist before taking any medication.

Driving and operating machinery

It is not expected that the recommended dose of Rupatadina Desgen will affect your ability to drive vehicles or operate machinery. However, when you first use Rupatadina Desgen, you should exercise caution and see how the treatment affects you before driving or operating machinery.

Rupatadina Desgen contains lactose.

If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor 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 Desgen is administered to adolescents (12 years of age or 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 Desgen.

If you take more Rupatadina Desgen 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 ingested.

If you forgot to takeRupatadina Desgen

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.

Thefrequent adverse effects(may affect up to 1 in 10 patients) are:

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

Theinfrequent adverse effects(may affect up to 1 in 100 patients) are:

Increased appetite, irritability, difficulty concentrating, nasal bleeding, nasal dryness, sore throat, cough, dry throat, rhinitis, nausea, abdominal pain, diarrhea, indigestion, vomiting, constipation, rash, back pain, joint pain, muscle pain, thirst, discomfort, fever, abnormal liver function tests, and weight gain.

Therare adverse effects(may affect up to 1 in 1,000 patients) are:

Palpitations, increased heart rate, and allergic reactions (including anaphylactic reactions, angioedema, and urticaria).

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 the prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://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 packaging and blister.

No special storage conditions are required.

Medications should not be disposed of through drains or in the trash. Dispose of the 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 the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Rupatadina Desgen

• The active ingredient is rupatadine. Each tablet contains 10 mg of rupatadine (as fumarate).
• The other components are lactose monohydrate, microcrystalline cellulose PH 102, pregelatinized cornstarch, red iron oxide, yellow iron oxide, and magnesium stearate.

Appearance of the product and content of the packaging

Rupatadina Desgen are round tablets, of a light salmon color, 6.35 mm in diameter, and are presented in single-dose blisters containing 15, 20, 30, 50, and 100 tablets.

Only some sizes of packaging may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Generfarma S.L.

Ronda Isaac Peral 6,

Parque Tecnológico

46980 Paterna (Valencia)

Spain

Responsible for manufacturing

Martin Dow Pharmaceuticals

Goualle Le Puy, Champ de Lachaud

19250 Meymac

France

This medicine is authorized in the Member States of the European Economic Area with the following names:

ES : Rupatadina Desgen 10 mg tablets EFG

NL :DROOPIAN 10mg compresse

Last review date of the leaflet: December 2022

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