RUPATADINE STADA 10 mg TABLETS
How to use RUPATADINE STADA 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 Patient
Rupatadina Stada 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 Stada and what is it used for
- What you need to know before taking Rupatadina Stada
- How to take Rupatadina Stada
- Possible side effects
- Storage of Rupatadina Stada
- Contents of the pack and further information
1. What is Rupatadina Stada and what is it used for
Rupatadina, the active substance of Rupatadina Stada, is an antihistamine.
Rupatadina Stada is indicated for the relief of symptoms of allergic rhinitis such as sneezing, runny nose, itchy eyes, and itchy nose.
Rupatadina Stada is indicated for the relief of symptoms associated with urticaria (allergic skin rash) such as itching and skin rash (redness and swelling of the skin).
2. What you need to know before taking Rupatadina Stada
Do not take Rupatadina Stada:
- 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 Stada.
If you have kidney or liver failure, consult your doctor. The use of rupatadina 10 mg tablets 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 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 and adolescents
This medication should not be used in children under 12 years of age.
Other medications and Rupatadina Stada
Tell your doctor or pharmacist if you are taking, have recently taken, or may take any other medication.
If you are taking rupatadina, do not take medications that contain ketoconazole or erythromycin.
If you are taking central nervous system depressants or statins, consult your doctor before taking rupatadina.
Taking Rupatadina Stada with food and drinks
Do not take rupatadina 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, 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 your doctor clearly indicates it.
Consult your doctor or pharmacist before taking 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 operating machinery.
Rupatadina Stada contains lactose.
If your doctor has informed you that you have an intolerance to some sugars, consult your doctor before taking this medication.
3. How to take Rupatadina Stada
Follow the administration instructions 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. Take 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 Stada.
If you take more Rupatadina Stada than you should
In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.
If you forget to take Rupatadina Stada
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.
The common side effects(may affect up to 1 in 10 people) are:
Somnolence, headache, dizziness, dry mouth, feeling of weakness, and fatigue.
The uncommon side effects(may affect up to 1 in 100 people) are:
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.
The rare side effects(may affect up to 1 in 1,000 people) are:
Palpitations, increased heart rate, and allergic reactions (including anaphylactic reactions, angioedema, and urticaria).
Reporting side effects
If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in the package leaflet. You can also report them directly through the Spanish Medicines Monitoring System: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.
5. Storage of Rupatadina Stada
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.
No special storage conditions are required.
Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.
6. Contents of the pack and further information
Composition of Rupatadina Stada
- The active substance is rupatadina. Each tablet contains 10 mg of rupatadina (as fumarate).
- The other components are lactose monohydrate, microcrystalline cellulose PH 102, pregelatinized corn starch, red iron oxide, yellow iron oxide, and magnesium stearate.
Appearance of the product and contents of the pack
Rupatadina Stada are round, light salmon-colored tablets and are presented in blisters containing 20, 30, 50, and 100 tablets.
Not all pack sizes may be marketed.
Marketing authorization holder and manufacturer
Marketing authorization holder
Laboratorio STADA, S.L.
Frederic Mompou, 5
08960 Sant Just Desvern (Barcelona)
Spain
Manufacturer
Meiji Pharma Spain, S.A.
Avda. de Madrid, 94
28802 Alcalá de Henares (Madrid)
Spain
or
Centrafarm Services B.V.
Van de Reijtstraat 31-E
4814 NE Breda
Netherlands
or
STADA Arzneimittel AG
Stadastrasse 2 - 18
61118 Bad Vilbel
Germany
or
Martin Dow Pharmaceuticals
Goualle Le Puy, Champ de Lachaud,
Meymac, 19250,
France
This medication is authorized in the Member States of the European Economic Area under the following names:
Belgium: Rupatadine EG 10 mg tablets
Germany: Rupatadin AL 10 mg tablets
Italy: Rupatadina EG 10 mg, tablets
Netherlands: Rupatadine CF 10 mg, tablets
Slovakia: Rupastad 10 mg tablets
Spain: Rupatadina Stada 10 mg tablets EFG
Date of the last revision of the package leaflet:August 2018
Detailed information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)
- 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.
- Alternatives to RUPATADINE STADA 10 mg TABLETSDosage form: ORAL SOLUTION/SUSPENSION, 1 mg/ml (as rupatadine)Active substance: rupatadineManufacturer: Urquima S.A.Prescription requiredDosage form: TABLET, 10 mgActive substance: rupatadineManufacturer: Urquima S.A.Prescription requiredDosage form: ORAL SOLUTION/SUSPENSION, 1 MG/ML (as Rupatadine)Active substance: rupatadineManufacturer: Noucor Health S.A.Prescription required
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