Rupatadine Kern Pharma 10 mg tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: Information for the user
Rupatadina Kern Pharma 10 mg tablets EFG
Read all of 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, ask your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What Rupatadina is and what it is used for
- What you need to know before taking Rupatadina
- How to take Rupatadina
- Possible side effects
- How to store Rupatadina
- Contents of the pack and other information
1. What Rupatadine is and what it is used for
Rupatadine is an antihistamine.
Rupatadine is indicated for the relief of symptoms of allergic rhinitis such as sneezing, rhinorrhea, itching of the eyes and nose.
Rupatadine is indicated for the relief of symptoms associated with urticaria (allergic skin rash), such as itching and skin wheals (redness and swelling of the skin).
2. What you need to know before taking Rupatadine
Do not take Rupatadine
- If you are allergic to rupatadine or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
If you have renal or hepatic impairment, consult your doctor. The use of Rupatadine 10 mg tablets is not currently recommended in patients with renal or hepatic impairment.
If you have low blood potassium levels and/or a known abnormal heart rhythm pattern (prolonged QTc interval on ECG) that may occur in certain heart conditions, consult your doctor.
If you are over 65 years of age, consult your doctor or pharmacist.
Children
This medicine must not be used in children under 12 years of age.
Taking Rupatadine with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
When taking Rupatadine, do not take medicines containing ketoconazole or erythromycin.
If you are taking central nervous system depressants or statin-containing medicines, consult your doctor before taking Rupatadine.
Taking Rupatadine with food, drinks and alcohol
Do not take Rupatadine together 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 caused by alcohol.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Driving and using machines
The recommended dose of Rupatadine is not expected to affect your ability to drive or operate machinery. However, when you first start using Rupatadine, you should take care to observe how the treatment affects you before driving or operating machinery.
Rupatadine contains lactose.
If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.
3. How to take Rupatadina
Follow exactly the instructions given by your doctor for taking this medicine. If in 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 rupatadine) once daily, with or without food. Swallow the tablet with sufficient liquid (e.g., a glass of water).
Your doctor will determine the duration of your treatment with Rupatadina.
If you take more Rupatadina than you should
In case of accidental ingestion of high doses of the medicine, contact your doctor or pharmacist immediately, or contact the Poison Information Service at telephone number 915 620 420.
If you forget to take Rupatadina
Do not take a double dose to make up for missed doses.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.
Frequent adverse effects (may affect up to 1 in 10 patients) are somnolence, 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, nosebleed, nasal dryness, sore throat, cough, dry throat, rinitis, nausea, abdominal pain, diarrhoea, indigestion, vomiting, constipation, rash, back pain, joint pain, muscle pain, thirst, malaise, 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, lips, tongue or throat).
Reporting of 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 this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Rupatadine
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and blister. The expiry date is the last day of the month indicated.
Store inside the outer carton to protect the tablets from light.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you are unsure, please ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.
6. Contents of the pack and other information
Composition of Rupatadine
- The active substance is rupatadine. Each tablet contains 10 mg of rupatadine (as fumarate).
- The other components are: pregelatinized maize starch, microcrystalline cellulose, red iron oxide (E-172), yellow iron oxide (E-172), monohydrate lactose and magnesium stearate.
Description of the product and pack contents
Rupatadine are round, light salmon-coloured tablets, presented in unit dose blisters containing 20 tablets.
Marketing Authorization Holder
Kern Pharma, S.L.
Venus, 72 - Pol. Ind. Colón II
08228 Terrassa - Barcelona
Spain
Manufacturer
NOUCOR HEALTH, S.A.
Av. Camí Reial 51-57
08184 Palau-solità i Plegamans (Barcelona-Spain)
Date of the most recent revision of this leaflet: November 2015
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es