Rupatadine Aurobindo

Package leaflet: Information for the user

Rupatadina Aurobindo 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, because it could 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:

1. What Rupatadina Aurobindo is and what it is used for
2. What you need to know before taking Rupatadina Aurobindo
3. How to take Rupatadina Aurobindo
4. Possible side effects
5. How to store Rupatadina Aurobindo
6. Contents of the pack and other information

1. What Rupatadina Aurobindo is and what it is used for

Rupatadina Aurobindo is an antihistamine.
Rupatadina Aurobindo relieves symptoms of allergic rhinitis such as sneezing, runny nose, and itching of the eyes and nose.
Rupatadina Aurobindo 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 Aurobindo

Do not take Rupatadina Aurobindo
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 Rupatadina Aurobindo.

• If you suffer from renal or hepatic impairment, consult your doctor. The use of Rupatadina Aurobindo 10 mg tablets is currently not recommended in patients with impaired renal or hepatic function.
• If you have low potassium levels in the blood and/or a known 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 of age, consult your doctor or pharmacist.

Children
This medicine is not intended for use in children under 12 years of age.
Other medicines and Rupatadina Aurobindo
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.

• If you are taking Rupatadina Aurobindo, do not take medicines containing ketoconazole or erythromycin.
• If you are taking antidepressant medicines acting on the central nervous system or statin-containing medicines, consult your doctor before taking Rupatadina Aurobindo.

Rupatadina Aurobindo with food, drinks and alcohol
Rupatadina Aurobindo must not be taken with grapefruit juice, as it may
increase the level of Rupatadina Aurobindo in the body.
Rupatadina Aurobindo, at the recommended dose (10 mg), does not increase alcohol-induced drowsiness.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, ask your
doctor or pharmacist for advice before taking this medicine.
Driving and using machines
At the recommended dose, Rupatadina Aurobindo is not expected to affect the ability to drive
vehicles or operate machinery. However, when starting treatment with Rupatadina Aurobindo, you
should exercise caution and assess how the treatment affects you before driving or operating
machinery.
Rupatadina Aurobindo 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 Aurobindo

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Rupatadina Aurobindo 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).
The duration of treatment with Rupatadina Aurobindo will be determined by your doctor.
If you take more Rupatadina Aurobindo than you should
Contact your doctor or pharmacist immediately if you have accidentally taken an excessive dose of this medicine.
If you forget to take Rupatadina Aurobindo
Take the missed dose as soon as possible and continue taking the tablets at your usual time. Do not take a double dose to make up for forgotten individual doses.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common side effects (may affect up to 1 in 10 people):
Drowsiness, headache, dizziness, dry mouth, feeling weak and tired.
Uncommon side effects (may affect up to 1 in 100 people):
Increased appetite, irritability, difficulty concentrating, nosebleed, dry nose, sore throat, cough, dry throat, rinite, nausea, abdominal pain, diarrhoea, 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 side effects (may affect up to 1 in 1,000 people):
Palpitations, increased heart rate, and allergic reactions (itching, hives, and swelling of the face, lips, tongue, or mouth).
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website: http://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 Aurobindo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after
EXP. The expiry date refers to the last day of that month.
Store the blister in the original packaging to protect the medicine from light.
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 Aurobindo 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 (maize), red iron oxide (E 172), yellow iron oxide (E 172) and magnesium stearate.

Description of the appearance of Rupatadina Aurobindo and pack contents
Tablet.
Rupatadina Aurobindo tablets are salmon-coloured, 6.35 mm ± 0.1 mm, round,
biconvex, uncoated, smooth on both sides.
Packs: 10, 20 and 30 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Aurobindo Pharma (Italia) s.r.l.
Via S. Giuseppe 102
21047 Saronno (VA)

Manufacturers
APL Swift Services (Malta) Limited, HF26, Hal Far Industrial Estate, Hal Far, Birzebbugia, BBG 3000,
Malta
Generis Farmacêutica, S.A., Rua João de Deus, 19, 2700-487 Amadora, Portugal

This medicinal product is authorized in the European Economic Area countries under the
following names:
Italy: Rupatadina Aurobindo
Poland: Rupurix
Portugal: Rupatadina Generis Phar
Spain: Rupatadina Aurovitas 10 mg tablets EFG