RUPATADINE NORMON 10 mg TABLETS
How to use RUPATADINE NORMON 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
Prospective: patient information
Rupatadine Normon 10 mg tablets EFG
Read the entire prospectus carefully before starting to take this medication, as it contains important information for you.
- Keep this prospectus, as you may need to read it again.
- If you have any doubts, 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 adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. See section 4.
Contents of the prospectus
- What Rupatadine Normon is and what it is used for
- What you need to know before taking Rupatadine Normon
- How to take Rupatadine Normon
- Possible adverse effects
- Storage of Rupatadine Normon
- Package contents and additional information
1. What Rupatadine Normon is and what it is used for
Rupatadine, the active substance of Rupatadine Normon, is an antihistamine.
Rupatadine Normon is indicated for the relief of symptoms of allergic rhinitis such as: sneezing, runny nose, itchy eyes and nose.
Rupatadine Normon is indicated for the relief of symptoms associated with urticaria (allergic skin rash) such as itching and skin hives (redness and swelling of the skin).
2. What you need to know before taking Rupatadine Normon
Do not take Rupatadine Normon:
- If you are allergic to rupatadine 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 this medication.
If you have kidney or liver failure, consult your doctor. The use of Rupatadine Normon 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) 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 Rupatadine Normon with other medications
Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.
If you are taking Rupatadine Normon, 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 Rupatadine Normon.
Taking Rupatadine Normon with food, drinks, and alcohol
Do not take Rupatadine Normon in combination with grapefruit juice, as it may increase the level of rupatadine in your body.
Rupatadine, at the recommended dose of 10 mg, does not increase the drowsiness produced by alcohol.
Pregnancy and lactation
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 Rupatadine Normon during pregnancy and breastfeeding, unless clearly indicated by your doctor.
Consult your doctor or pharmacist before taking any medication.
Driving and using machines
It is not expected that the recommended dose of Rupatadine Normon will have an effect on your ability to drive vehicles or operate machinery. However, when you first use Rupatadine Normon, you should observe how the treatment affects you before driving or using machinery.
Rupatadine Normon contains lactose.
This medication 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 Rupatadine Normon
Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.
Rupatadine Normon is administered to adolescents (from 12 years of age) and adults. The recommended dose is one tablet (10 mg of rupatadine) 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 Rupatadine Normon.
If you take more Rupatadine Normon 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 Rupatadine Normon
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 adverse effects
Like all medications, this medication can cause adverse effects, although not all people experience them.
Common adverse effects(may affect up to 1 in 10 patients) are:
Drowsiness, headache, dizziness, dry mouth, feeling of weakness and fatigue.
Uncommon adverse effects(may affect up to 1 in 100 patients) are:
Increased appetite, irritability, difficulty concentrating, nosebleeds, 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 adverse effects(may affect up to 1 in 1,000 patients) are:
Palpitations, increased heart rate, and allergic reactions (itching, urticaria, and swelling of the face, 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 that is not listed in the prospectus. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.
5. Storage of Rupatadine Normon
Keep this medication out of sight and reach of children.
Do not use this medication after the expiration date shown on the packaging and blister pack after CAD. The expiration date is the last day of the month indicated.
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. Package contents and additional information
Composition of Rupatadine Normon
- The active ingredient is rupatadine. Each tablet contains 10 mg of rupatadine (as fumarate).
- The other ingredients are lactose monohydrate, microcrystalline cellulose, pregelatinized cornstarch, red iron oxide, yellow iron oxide, and magnesium stearate.
Appearance of the product and package contents
Rupatadine Normon are round, flat tablets, light salmon in color, serigraphed with "R10" on one of their faces, and packaged in blister packs containing 20 tablets.
Marketing authorization holder and manufacturer
Laboratorios Normon, S.A.
Ronda de Valdecarrizo, 6, 28760 Tres Cantos (Madrid), Spain
Date of the last revision of the prospectus: July 2018
Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/
You can access detailed and updated information about this medication by scanning the QR code included in the prospectus and packaging with your mobile phone (smartphone). You can also access this information at the following internet address:
https://cima.aemps.es/cima/dochtml/p/83302/P_83302.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.
- Alternatives to RUPATADINE NORMON 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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