Rupatadina desgen 10 mg comprimidos efg
Como utilizar Rupatadina desgen 10 mg comprimidos efg
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Introduction
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
1. What is Rupatadina Desgen and what is it used for
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).
2. What you need to know before starting Rupatadina Desgen
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.
3. How to Take Rupatadina Desgen
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.
4. Possible Adverse Effects
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.
5. Conservation of Rupatadina Desgen
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.
6. Content of the packaging and additional information
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 Desgenare 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 Desgen10 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/
- País de registo
- Preço médio em farmácia6.98 EUR
- Substância ativa
- Requer receita médicaSim
- Fabricante
- Esta informação é apenas para fins informativos e não constitui aconselhamento médico. Consulte sempre um médico antes de tomar qualquer medicamento.
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