CLARINASE REPETABS

País: Israel

Idioma: anglès

Font: Ministry of Health

ingredients actius:

LORATADINE; PSEUDOEPHEDRINE SULFATE

Disponible des:

BAYER ISRAEL LTD

Codi ATC:

R06AX13

formulario farmacéutico:

TABLETS PROLONGED RELEASE

Composición:

LORATADINE 5 MG; PSEUDOEPHEDRINE SULFATE 120 MG

Vía de administración:

PER OS

tipo de receta:

Required

Fabricat per:

BAYER CONSUMER CARE LTD, SWITZERLAND

Grupo terapéutico:

LORATADINE

Área terapéutica:

LORATADINE

indicaciones terapéuticas:

Relief of symptoms of seasonal allergic rhinitis when both the antihistaminic properties and the nasal decongestant activity are desired.

Data d'autorització:

2017-02-28

Informació per a l'usuari

2
Patient leaflet in accordance with the Pharmacists' Regulations
(Preparations) - 1986
This medicine is dispensed with a doctor's prescription only
Clarinase
Repetabs
Prolonged-release tablets
Each tablet contains:
Loratadine 5 mg
Pseudoephedrine sulphate 120 mg
Inactive ingredients and allergens: see section 2 ‘Important
information about some of this medicine’s
ingredients’, and section 6 ‘Additional information’.
Read the entire leaflet carefully before you start using this
medicine. This leaflet contains
concise information about this medicine. If you have any further
questions, consult your doctor or
pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if it
seems to you that their medical condition is similar to yours.
1) What is this medicine intended for?
Clarinase Repetabs is intended for the relief of symptoms of seasonal
allergic rhinitis when both the
antihistaminic properties and the nasal decongestant activity are
desired.
Therapeutic group: Clarinase Repetabs contains a combination of two
active substances (loratadine
and pseudoephedrine sulphate). Loratadine is an antihistamine.
Pseudoephedrine sulphate is a
decongestant. Antihistamines help reduce allergy symptoms by stopping
the effects of a substance
called histamine, which is produced by the body when you are allergic
to something. Decongestants
help reduce nasal congestion.
2) Before using this medicine
Do not use this medicine:
•
If you are sensitive (allergic) to loratadine, pseudoephedrine or to
any of the other ingredients in
this medicine. For a list of the inactive ingredients, see section 6
“Additional information”.
Due to the presence of pseudoephedrine, do not take Clarinase
Repetabs:
•
If you are taking medicine to lower blood pressure or for heart
disease.
•
If you have glaucoma, difficulty in urinating, urinary tract blockage,
high blood pressure, heart or
blood vessel disease, a history of haemorrhagic stroke, you have other
risk factors that increase
the

Fitxa tècnica

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
CLARINASE REPETABS
Prolonged Release Tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg loratadine and 120 mg pseudoephedrine
sulphate.
Excipients with known effect: The quantities of sucrose and lactose
monohydrate in each prolonged-release
tablet are 173.23 mg and 156.80 mg respectively.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Round, biconvex, lustrous, white, coated tablet.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
CLARINASE REPETABS_ _is indicated for the relief of symptoms of
seasonal allergic rhinitis when both the
antihistaminic properties and the nasal decongestant activity are
desired.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
_ADULTS AND CHILDREN 12 YEARS OF AGE AND OVER: _
One CLARINASE REPETABS_ _tablet twice daily with a glass of water.
The duration of treatment should be kept as short as possible and
should not be continued after the
symptoms have disappeared. It is advisable to limit treatment to about
10 days, as during chronic
administration the activity of pseudoephedrine may diminish. After
improvement of the congestive
condition of the mucosae of the upper airway, treatment may be
maintained with loratadine alone, if
necessary.
_PAEDIATRIC POPULATION _
The safety and efficacy of _Clarinase Repetabs _in children below the
age of 12 years have not been
established. No data are available. Clarinase Repetabs are not
recommended for use in children below the
age of 12 years.
_ELDERLY PATIENTS _
The combination product should not be administered to patients above
60 years of age. Patients 60 years
or older are more likely to experience adverse reactions to
sympathomimetic medications (see section 4.4).
PATIENTS WITH RENAL OR HEPATIC IMPAIRMENT
The combination product should not be used in patients with impaired
renal function, renal tubular acidosis
or impaired hepatic function (see section 4.4).
METHOD OF ADMINISTRATION
Oral use. The tablet must be swall