Rinialer 10 mg Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

RUPATADINE

Available from:

Bial - Portela & C S.A. À Av. da Siderurgia Nacional, 4745-457 S. Mamede do Coronado, Portugal

ATC code:

R06AX28

INN (International Name):

RUPATADINE 10 mg

Pharmaceutical form:

TABLET

Composition:

RUPATADINE 10 mg

Prescription type:

POM

Therapeutic area:

ANTIHISTAMINES FOR SYSTEMIC USE

Authorization status:

Authorised

Authorization date:

2007-08-23

Patient Information leaflet

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
RINIALER 10 MG TABLETS
Rupatadine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
medicine
BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, please ask your doctor or your
pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What RinialerRinialer is and what it is used for
2.
What you need to know before you take RinialerRinialer
3.
How to take RinialerRinialer
4.
Possible side effects
5.
How to store RinialerRinialer
6.
Contents of the pack and other information
1.
WHAT RINIALER IS AND WHAT IT IS USED FOR
Rupatadine is an antihistamine.
Rinialer relieves the symptoms of allergic rhinitis such as sneezing,
runny nose, itching in the eyes and
nose.
Rinialer is also used to relieve the symptoms associated with
urticaria (an allergic skin rash) such as
itching and hives (localised skin redness and swelling).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE RINIALER
DO NOT TAKE RINIALER
-
If you are allergic to rupatadine or any of the other ingredients of
this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Rinialer.
If you suffer from kidney or liver insufficiency, ask your doctor for
advice. The use of Rinialer 10 mg
tablets is at present not recommended in patients with impaired kidney
or liver functions.
If you have low blood levels of potassium and/or if you have a certain
abnormal pattern to your heart
beat (known prolongation of the QTc interval on the ECG) which can
occur in some forms of heart
disease, ask your doctor for advice.
If you are older than 65, ask your doctor or your pharmacist.
CHILDREN
This medicine is n

Summary of Product characteristics

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1. NAME OF THE MEDICINAL PRODUCT
Rinialer 10 mg Tablets
_ _
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
10 mg of rupatadine (as fumarate)
Excipient with known effect:
Lactose 57.57 mg as lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
Round, light salmon coloured tablets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Symptomatic treatment of allergic rhinitis and urticaria in adults and
adolescents (over 12 years of
age).
_ _
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Adults and adolescents (over 12 years of age)
The recommended dose is 10 mg (one tablet) once a day, with or without
food.
Elderly
Rupatadine should be used with caution in elderly people (see section
4.4).
_ _
Paediatric patients
Rupatadine 10 mg Tablets is not recommended for use in children below
age 12. In children aged 2
to 11 years, the administration of rupatadine 1 mg/ml oral solution is
recommended.
Patients with renal or hepatic insufficiency
As there is no clinical experience in patients with impaired kidney or
liver functions, the use of
rupatadine 10 mg Tablets is at present not recommended in these
patients.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
The administration of rupatadine with grapefruit juice is not
recommended (see section 4.5).
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The combination of rupatadine with potent CYP3A4 inhibitors should be
avoided and with
moderate CYP3A4 inhibitors should be administered with caution (see
section 4.5).
Dose
adjustment
of
sensitive
CYP3A4
substrates
(e.g.
simvastatin,
lovastatin)
and
CYP3A4
substrates with a narrow therapeutic index (e.g. ciclosporin,
tacrolimus, sirolimus, everolimus,
cisapride) could be required as rupatadine may increase plasma
concentrations of these drugs (see
section 4.5).
Cardiac safety of rupatadine was assessed in a Thorough QT/QTc study.
Rupatadine up to 10 times
therapeutic dose did not p