RUPATADINE CINFA 10 mg TABLETS
How to use RUPATADINE CINFA 10 mg TABLETS
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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.
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Introduction
Package Leaflet: Information for the User
rupatadina cinfa 10 mg tablets EFG
Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.
- Keep this package leaflet, as you may need to read it again.
- If you have any questions, consult your doctor or pharmacist.
- This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
- If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.
Contents of the Package Leaflet
- What is rupatadina cinfa and what is it used for
- What you need to know before taking rupatadina cinfa
- How to take rupatadina cinfa
- Possible side effects
- Storage of rupatadina cinfa
- Package Contents and Additional Information
1. What is rupatadina cinfa and what is it used for
rupatadina cinfa is an antihistamine.
rupatadina cinfa is indicated for the relief of symptoms of allergic rhinitis, such as sneezing, nasal secretion, itchy eyes, and itchy nose.
rupatadina cinfa is also indicated for the relief of symptoms associated with urticaria (allergic skin rash), such as itching and skin rashes (localized redness and swelling of the skin).
2. What you need to know before taking rupatadina cinfa
Do not take rupatadina cinfa
- if you are allergic to rupatadina or any of the other components of this medication (listed in section 6).
Warnings and Precautions
Consult your doctor or pharmacist before starting to take rupatadina cinfa.
If you have kidney or liver failure, consult your doctor. The use of rupatadina 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 pattern (known QTc interval prolongation on the ECG), which can 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 cinfa with other medications
Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.
When taking rupatadina, do not take medications that contain ketoconazole or erythromycin.
If you are taking central nervous system depressant medications or statins, consult your doctor before taking rupatadina.
Taking rupatadina cinfa with food, drinks, and alcohol
You should not take rupatadina in 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 produced by alcohol.
Pregnancy and Breastfeeding
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.
Do not take rupatadina during pregnancy and breastfeeding, unless clearly indicated by your doctor.
Consult your doctor or pharmacist before starting to take any medication.
Driving and Using Machines
It is not expected that the recommended dose of rupatadina will have an effect on your ability to drive vehicles or operate machinery. However, when you first use rupatadina, you should be cautious and see how the treatment affects you before driving or using machines.
rupatadina cinfa contains lactose
If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.
3. How to take rupatadina cinfa
Follow the instructions for administration of this medication exactly as indicated by your doctor or pharmacist. In case of 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 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 more rupatadina cinfa than you should
In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medication and the amount ingested.
If you forget to take rupatadina cinfa
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 medications, this medication can cause side effects, although not everyone will experience them.
Common Side Effects(may affect up to 1 in 10 patients):
Drowsiness, headache, dizziness, dry mouth, feeling of weakness and fatigue.
Uncommon Side Effects(may affect up to 1 in 100 patients):
Increased appetite, irritability, difficulty concentrating, nasal bleeding, dry nose, 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.
Rare Side Effects(may affect up to 1 in 1,000 patients):
Palpitations, increased heart rate, and allergic reactions (itching, urticaria, and swelling of the face, lips, tongue, or throat).
Reporting Side Effects
If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.
5. Storage of rupatadina cinfa
Keep this medication out of the sight and reach of children.
Do not use this medication after the expiration date stated on the packaging and blister, after CAD. The expiration date is the last day of the month indicated.
This medication does not require special storage conditions.
Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.
6. Package Contents and Additional Information
Composition of rupatadina cinfa
- The active ingredient is rupatadina. Each tablet contains 10 mg of rupatadina (as fumarate).
- The other ingredients are lactose monohydrate, microcrystalline cellulose PH 102, pregelatinized corn starch, red iron oxide (E-172), yellow iron oxide (E-172), and magnesium stearate.
Appearance of the Product and Package Contents
rupatadina cinfa are soft pink, round tablets.
They are presented in PVC-PVDC/ALU blisters. Each package contains 20 tablets.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Laboratorios Cinfa, S.A.
Carretera Olaz-Chipi, 10. Polígono Industrial Areta
31620 Huarte (Navarra) - Spain
Manufacturer
Meiji Pharma Spain, S.A.
Avda. de Madrid, 94
28802 Alcalá de Henares, Madrid
Spain
O
Martin Dow Pharmaceuticals
Goualle Le Puy, Champ de Lachaud
19250 Meymac
France
Date of the Last Revision of this Package Leaflet:August 2020
Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) www.aemps.gob.es
You can access detailed and updated information about this medication by scanning the QR code included in the package leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/80877/P_80877.html
QR code to: https://cima.aemps.es/cima/dochtml/p/80877/P_80877.html
- Country of registration
- Average pharmacy price6.98 EUR
- Active substance
- Prescription requiredYes
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
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