Rupatadine Doc Generici
Italy
Package leaflet: Information for the user
RUPATADINA DOC Generici 10 mg tablets
Generic medicine
Read this entire leaflet carefully before taking this medicine because 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 adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What RUPATADINA DOC Generici is and what it is used for
- What you need to know before taking RUPATADINA DOC Generici
- How to take RUPATADINA DOC Generici
- Possible side effects
- How to store RUPATADINA DOC Generici
- Contents of the pack and other information
1. WHAT RUPATADINA DOC Generici IS AND WHAT IT IS USED FOR
Rupatadine, the active substance in RUPATADINA DOC Generici, is an antihistamine.
RUPATADINA DOC Generici relieves symptoms of allergic rhinitis such as sneezing, runny nose,
and itching of the eyes and nose.
RUPATADINA DOC Generici 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 SHOULD KNOW BEFORE TAKING RUPATADINA DOC Generici
Do not take RUPATADINA DOC Generici
- 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 DOC Generici 10 mg tablets is currently 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 interval prolongation on ECG), which may occur in certain types of heart disease, consult your doctor.
If you are over 65 years old, consult your doctor or pharmacist.
Children and adolescents
RUPATADINA DOC Generici is not indicated for children under 12 years of age.
Other medicines and RUPATADINA DOC Generici
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take medicines containing ketoconazole or erythromycin while using RUPATADINA DOC Generici.
If you are taking centrally acting antidepressant medicines or statin-based medicines, consult your doctor before taking RUPATADINA DOC Generici.
RUPATADINA DOC Generici with food and beverages
RUPATADINA DOC Generici must not be taken with grapefruit juice, as this beverage may increase the levels of RUPATADINA DOC Generici in the body.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take RUPATADINA DOC Generici during pregnancy or breastfeeding unless clearly prescribed by a doctor.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
At the recommended dose, RUPATADINA DOC Generici has no known effect on the ability to drive vehicles or operate machinery. However, when starting treatment with RUPATADINA DOC Generici, you should exercise caution and monitor how the treatment affects you before driving or operating machinery.
RUPATADINA DOC Generici contains lactose.
If you have been diagnosed by your doctor with an intolerance to certain sugars, contact your doctor before taking this medicine.
3. HOW TO TAKE RUPATADINA DOC Generici
Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
RUPATADINA DOC Generici 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 determine how long you should take RUPATADINA DOC Generici.
If you take more RUPATADINA DOC Generici 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 DOC Generici
Take the missed dose as soon as possible and then continue with your regular dosing schedule. Do not take a double dose to make up for forgotten doses.
4. POSSIBLE ADVERSE REACTIONS
Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Common adverse reactions (may affect up to 1 in 10 people) are:
drowsiness, headache, dizziness, dry mouth, feeling of weakness and fatigue.
Uncommon adverse reactions (may affect up to 1 in 100 people) are:
increased appetite, irritability, difficulty concentrating, nosebleeds,
nasal dryness, sore throat, cough, dry throat, rhinitis, nausea, abdominal pain,
diarrhea, indigestion, vomiting, constipation, skin rash, back pain, joint pain, muscle pain, thirst, general feeling of discomfort, fever, changes in liver function tests and weight gain.
Rare adverse reactions (may affect up to 1 in 1000 people) are:
palpitations, increased heart rate and hypersensitivity reactions (including anaphylactic reactions, angioedema and urticaria).
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, please contact your doctor or pharmacist. You may also report adverse reactions directly through the national reporting system at the website
www.agenziafarmaco.gov.it/it/responsabili. By reporting adverse reactions, you can help provide further information on the safety of this medicine.
5. HOW TO STORE RUPATADINE DOC Generici
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and packaging.
No special storage conditions required.
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. PACK CONTENTS AND OTHER INFORMATION
What RUPATADINA DOC Generici contains
The active substance is rupatadine. Each tablet contains 10 mg of rupatadine (as fumarate).
The other ingredients are monohydrate lactose, microcrystalline cellulose PH102, pregelatinized starch, red iron oxide (E-172), yellow iron oxide (E-172), and magnesium stearate.
RUPATADINA DOC Generici is presented as round, light salmon-coloured tablets, packed in blisters containing 20, 30, 50 and 100 tablets.
It is possible that not all pack sizes are marketed.
Marketing Authorization Holder:
DOC Generici Srl, Via Turati 40, 20121 Milano
Manufacturer:
Medreich PLC
Warwick House, Plane Tree Crescent, Feltham,
TW13 7HF,
United Kingdom