Rupatadine EG
Italy
Table of Contents
Package leaflet: Information for the patient
RUPATADINA EG 10 mg tablets
Equivalent medicine
Please read this 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 other people, even if their symptoms are the same as yours, as it may be harmful.
- If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What Rupatadina EG is and what it is used for
- What you need to know before taking Rupatadina EG
- How to take Rupatadina EG
- Possible side effects
- How to store Rupatadina EG
- Contents of the pack and other information
1. What Rupatadina EG is and what it is used for
Rupatadine, the active substance in Rupatadina EG, is an antihistamine.
Rupatadina EG relieves symptoms of allergic rhinitis such as sneezing, runny nose, and itching of the eyes and nose.
Rupatadina EG 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 EG
Do not take Rupatadina EG
- 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 EG 10 mg tablets is currently not recommended in patients with renal or hepatic impairment.
If you have low levels of potassium in the blood and/or an abnormal heart rhythm pattern (known QTc prolongation on ECG), which may occur in certain forms of heart disease, seek medical advice.
If you are over 65 years of age, consult your doctor or pharmacist.
Children and adolescents
Rupatadina EG is not intended for children under 12 years of age.
Other medicines and Rupatadina EG
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 EG.
If you are taking antidepressant medicines acting on the central nervous system or statin-based medicines, consult your doctor before taking Rupatadina EG.
Rupatadina EG with food and drink
Rupatadina EG must not be taken with grapefruit juice, as this beverage may increase the level of Rupatadina EG 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 EG 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 EG is not known to affect the ability to drive or operate machinery. However, when starting treatment with Rupatadina EG, you should exercise caution and monitor how the treatment affects you before driving or operating machinery.
Rupatadina EG 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 EG
Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, consult your doctor or pharmacist.
Rupatadina EG 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 continue treatment with Rupatadina EG.
If you take more Rupatadina EG 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 EG
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 the missed dose.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Common side effects (may affect up to 1 in 10 people) are:
drowsiness, headache, dizziness, dry mouth, feeling weak and tired.
Uncommon side effects (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, diarrhoea, indigestion, vomiting, constipation,
rash, back pain, joint pain, muscle pain, thirst, general feeling of discomfort,
fever, changes in liver function tests and weight gain.
Rare side effects (may affect up to 1 in 1,000 people) are:
palpitations, increased heart rate, and hypersensitivity reactions (including anaphylactic reactions,
angioedema, and urticaria).
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your
doctor or pharmacist. You may also report side effects directly through the national reporting system at
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety
of this medicine.
5. How to store Rupatadina EG
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.
No special storage conditions required.
Do not dispose of any medicine 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 EG contains
The active substance is rupatadine. Each tablet contains 10 mg of rupatadine (as fumarate).
The other components are monohydrate lactose, microcrystalline cellulose PH102, pregelatinized starch,
red iron oxide, yellow iron oxide and magnesium stearate.
Rupatadina EG is presented as round, light salmon-coloured tablets, packaged in blisters containing 20, 30, 50 and 100 tablets.
It is possible that not all pack sizes are marketed.
Marketing Authorization Holder
EG S.p.A., Via Pavia, 6 - 20136 Milan, Italy
Manufacturer
Medreich PLC, Warwick House, Plane Tree Crescent, Feltham, TW13 7HF - United Kingdom
DELORBIS PHARMACEUTICALS LTD, 17 Athinon Street, Ergates Industrial Area, 2643 Ergates,
Lefkosia - Cyprus
Centrafarm Services B.V., Nieuwe Donk 9 NL-4879 AC Etten-Leur - Netherlands
STADA Arzneimittel AG, Stadastrasse 2–18, 61118 Bad Vilbel - Germany
This medicinal product is authorized in the European Economic Area countries under the following names:
Belgium Rupatadine EG 10 mg tabletten
Germany Rupatadin AL 10 mg Tabletten
Italy RUPATADINA EG 10 mg tablets
Netherlands Rupatadine CF 10 mg, tabletten
Slovakia Rupastad 10 mg tablety
Spain Rupatadina STADA 10 mg, comprimidos EFG