Rupatadine Mylan Pharma
ItalyPackage leaflet: Information for the user
Rupatadina Mylan Pharma 10 mg tablets
rupatadine
Generic medicine
Read this leaflet carefully before taking this medicine as it contains
important information for you.
- Keep this leaflet. 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. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
- If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What Rupatadina Mylan Pharma is and what it is used for
- What you need to know before taking Rupatadina Mylan Pharma
- How to take Rupatadina Mylan Pharma
- Possible side effects
- How to store Rupatadina Mylan Pharma
- Contents of the pack and other information
1. What Rupatadina Mylan Pharma is and what it is used for
The active substance of Rupatadina Mylan Pharma is rupatadine, an antihistamine.
Rupatadina Mylan Pharma relieves symptoms of allergic rhinitis such as sneezing, runny nose, itching of the eyes and nose.
Rupatadina Mylan Pharma is also used to relieve symptoms associated with urticaria (an allergic skin rash) such as itching and wheals (localized redness and swelling of the skin).
2. What you need to know before taking Rupatadina Mylan Pharma
Do not take Rupatadina Mylan Pharma
- if you are allergic to rupatadine or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine.
If you have renal or hepatic impairment, consult your doctor. The use of Rupatadina Mylan Pharma 10 mg
tablets is not recommended in patients with renal or hepatic impairment.
If you have low potassium levels in the blood and/or an abnormal heart rhythm pattern (known QTc
prolongation on ECG), which may occur in certain forms of heart disease, consult your doctor.
If you are over 65 years old, consult your doctor or pharmacist.
Children and adolescents
Rupatadina Mylan Pharma is not indicated for children under 12 years of age.
Other medicines and Rupatadina Mylan Pharma
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
If you are taking Rupatadina Mylan Pharma, do not take medicines containing ketoconazole (a medicine for fungal infections) or erythromycin (a medicine for bacterial infections).
If you are taking medicines that depress the central nervous system, statins (medicines used to treat high cholesterol levels), or midazolam (a medicine used for short-term sedation), consult your doctor before taking Rupatadina Mylan Pharma.
Rupatadina Mylan Pharma with food, beverages and alcohol
This medicine must not be taken with grapefruit juice, as this drink can increase the level of rupatadine in the body. Rupatadina Mylan Pharma, taken at the recommended dose, does not significantly enhance the effect of alcohol.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Do not take Rupatadina Mylan Pharma during pregnancy or breastfeeding unless clearly prescribed by your doctor.
Driving and using machines
At the recommended dose, Rupatadina Mylan Pharma is not known to affect the ability to drive or operate machinery. However, when starting treatment with Rupatadina Mylan Pharma, you should exercise caution and monitor how the treatment affects you before driving or operating machinery.
Rupatadina Mylan Pharma contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
3. How to take Rupatadina Mylan Pharma
Take this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Rupatadina Mylan Pharma is indicated for adolescents (over 12 years of age) and adults. The usual dose
is one tablet (10 mg of rupatadine) once daily, with or without food. Swallow the
tablet with a sufficient amount of liquid (e.g., a glass of water).
Your doctor will advise you on the duration of treatment with Rupatadina Mylan Pharma.
If you take more Rupatadina Mylan Pharma than you should
Contact your doctor or pharmacist immediately if you have accidentally taken an excessive dose of
the medicine.
If you forget to take Rupatadina Mylan Pharma
Take the missed dose as soon as possible and continue with your regular dosing schedule. Do not take a double dose to make up for the missed dose.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Contact a doctor immediately if you experience any of the following side effects:
Rare side effects (may affect up to 1 in 1,000 people):
Hypersensitivity reactions including allergic (anaphylactic) reactions, angioedema (swelling of the face, lips, mouth, tongue or throat which may cause breathing difficulties), and urticaria (itching with red bumps/welts).
Other possible side effects:
Common side effects (may affect up to 1 in 10 people):
Drowsiness, headache, dizziness, dry mouth, feeling of weakness and fatigue.
Uncommon side effects (may affect up to 1 in 100 people):
Increased appetite, irritability, difficulty concentrating, nosebleeds, nasal dryness, sore throat, cough, dry throat, rinite, feeling of discomfort (nausea), abdominal pain, diarrhoea, indigestion, vomiting, constipation, skin rash, back pain, joint pain, muscle pain, thirst, general feeling of discomfort, fever, abnormal blood test results, weight gain.
Rare side effects (may affect up to 1 in 1,000 people):
Palpitations, increased heart rate.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Rupatadina Mylan Pharma
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and packaging.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.
6. Package contents and other information
What Rupatadina Mylan Pharma contains
The active substance is rupatadine. Each tablet contains 10 mg of rupatadine (as fumarate).
The other components are monohydrate lactose, microcrystalline cellulose, pregelatinized starch, red iron oxide (E-172), yellow iron oxide (E-172), and magnesium stearate.
Rupatadina Mylan Pharma is presented as round, light salmon-coloured tablets, packaged in blisters containing 20, 30, 50 or 100 tablets.
It is possible that not all pack sizes are marketed.
Marketing Authorization Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milano, Italy
Manufacturer
Meiji Pharma Spain S.A., Avda de Madrid, 94, 28802 Alcala de Henares, Madrid, Spain
Martin Dow, Goualle Le Puy, Champ de Lachaud, 19250 Meymac, France
This medicinal product is authorized in the European Economic Area countries under the following names:
Italy Rupatadina Mylan Pharma
Portugal Rupatadina Mylan
Slovak Republic Rupatadine Mylan 10 mg