Rinialer 1mg/ml Oral Solution

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 1 mg/ml

Pharmaceutical form:

ORAL SOLUTION

Composition:

RUPATADINE 1 mg/ml

Prescription type:

POM

Therapeutic area:

ANTIHISTAMINES FOR SYSTEMIC USE

Authorization status:

Authorised

Authorization date:

2012-03-16

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
RINIALER 1 MG/ML ORAL SOLUTION
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, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their sins 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 Rinialer is and what it is used for
2.
What you need to know before you take Rinialer
3.
How to take Rinialer
4.
Possible side effects
5.
How to store Rinialer
6.
Contents of the pack and other information
1.
WHAT RINIALER IS AND WHAT IT IS USED FOR
Rinialer contains the active substance rupatadine which is an
antihistamine.
Rinialer oral solution relieves the symptoms of allergic rhinitis such
as sneezing, runny nose, nasal
congestion, itching in the eyes and nose in children aged 2 to 11
years.
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) in children
aged 2 to 11 years.
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 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.
Page

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
Rinialer 1 mg/ml Oral solution
_ _
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of oral solution contains:
1 mg of rupatadine (as fumarate)
Excipients with known effect
Sucrose 300 mg/ml
Methyl Parahydroxybenzoate (E218) 1.00 mg/ml
Propylene glycol (E-1520) 200 mg/ml
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral solution.
Clear yellow solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rinialer 1 mg/ml Oral solution is indicated for the symptomatic
treatment of:
-Allergic rhinitis (including persistent allergic rhinitis) in
children aged 2 to 11 years (see section
5.1).
-Urticaria in children aged 2 to 11 years (see section 5.1).
_ _
_ _
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
-
Children aged 2 to 11 years
_Dosage in children weighing equal or more than 25 kg_
: 5 ml (5 mg of rupatadine) of oral solution
once a day, with or without food.
_Dosage in children weighing equal or more than 10 kg up to less than
25 kg_
: 2.5 ml (2.5 mg of
rupatadine) of oral solution once a day, with or without food.
-
Children aged under 2 years
The administration of the product to children aged under 2 years is
not recommended due to the
lack of data in this population (see section 4.4).
-
Adults and adolescents (over 12 years of age)
In adults and adolescents (over 12 years of age), the administration
of rupatadine 10 mg tablets is
more appropriate.
-
Patients with renal or hepatic insufficiency
As there is no clinical experience in patients with impaired kidney or
liver functions, the use of
rupatadine is at present not recommended in these patients.
Method of administration
For oral use.
_ _
_Instructions of use: _
-
To open the bottle press the cap and turn it anticlockwise.
-
Take the syringe and put it in the perforated stopper and turn the
bottle upside down.
-
Fill the syringe with the prescribed dose.
- Administer directly from the dosing syringe.
-
Wash the syringe after use.
4.3
CONTRAINDICATIONS
Hypersensitivity to rupatadine or t