Rupafin Tablet 10mg

Country: Singapura

Bahasa: Inggeris

Sumber: HSA (Health Sciences Authority)

Bahan aktif:

Rupatadine Fumarate 12.8mg eqv Rupatadine

Boleh didapati daripada:

HYPHENS PHARMA PTE. LTD.

Kod ATC:

R06AX28

Dos:

10mg

Borang farmaseutikal:

TABLET

Komposisi:

Rupatadine Fumarate 12.8mg eqv Rupatadine 10mg

Laluan pentadbiran:

ORAL

Jenis preskripsi:

Prescription Only

Dikeluarkan oleh:

Noucor Health S.A.

Status kebenaran:

ACTIVE

Tarikh kebenaran:

2012-01-25

Risalah maklumat

PACKAGE INSERT
1.
NAME OF THE MEDICINAL PRODUCT
Rupafin 10 mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
10 mg of rupatadine (as fumarate)
Excipients: lactose 57.57 mg as lactose monohydrate
For a 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 due to
a lack of data on safety and efficacy.
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 rupatadine or to any of the excipients.
4.4
Special warnings and precautions for use
The administration of rupatadine with grapefruit juice is not
recommended (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 produce any effect on the ECG and
hence raises no
cardiac safety concerns. However rupatadine should be used with
caution in patients
with known prolongation of the QT interval, patients with uncorrected
hypokalemia,
patients
with
ongoing
proarrhythmic
conditions,
such
as
clinically
significant
bradycardia, acute myocardial ischemia.
Rupatadine 10 mg Tablets should be used with caution in elderly
patients (65 years and
older). Although no overall differences in effectiveness or safety
were observed in
clinical trials, higher sensitivity of some older individuals cannot
be excluded due to the

Ciri produk

PACKAGE INSERT
1.
NAME OF THE MEDICINAL PRODUCT
Rupafin 10 mg Tablets
_ _
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
10 mg of rupatadine (as fumarate)
Excipients: lactose 57.57 mg as lactose monohydrate
For a 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 (12
years of age and above).
_ _
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Adults and adolescents (12 years of age and above)
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 due to
a lack of data on safety and efficacy.
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 rupatadine or to any of the excipients.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
The administration of rupatadine with grapefruit juice is not
recommended (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 produce any effect on the ECG and
hence raises no
cardiac safety concerns. However rupatadine should be used with
caution
_ _
in patients
with known prolongation of the QT interval, patients
_ _
with uncorrected hypokalemia,
patients
with
ongoing
proarrhythmic
conditions,
such
as
clinically
significant
bradycardia, acute myocardial ischemia.
Rupatadine 10 mg Tablets should be used with caution in elderly
patients (65 years and
older). Although no overall differences in effectiveness or safety
were observed in
clinical trials, higher sensitivity of some older individuals