Clarinase Repetabs 5mg/120mg prolonged-release Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

LORATADINE, PSEUDOEPHEDRINE SULFATE

Available from:

Bayer SA-NV J.E. Mommaertslaan 14, B-1831 Diegem (Machelen), Belgium

ATC code:

R01BA52

INN (International Name):

LORATADINE 5 mg PSEUDOEPHEDRINE SULFATE 120 mg

Pharmaceutical form:

PROLONGED-RELEASE TABLET

Composition:

LORATADINE 5 mg PSEUDOEPHEDRINE SULFATE 120 mg

Prescription type:

OTC

Therapeutic area:

NASAL PREPARATIONS

Authorization status:

Authorised

Authorization date:

2007-01-02

Patient Information leaflet

Clarinase Repetabs BE/H/0121/001
Package leaflet: Information for the user
Clarinase Repetabs 5 mg/120 mg prolonged-release tablets
loratadine/pseudoephedrine sulphate
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 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.
Read all of this leaflet carefully before you start taking this
medicine because it contains important
information for you.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist
have told you.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- If you get any side effects, talk to your doctor . This includes any
possible side effects not listed in this
leaflet. See section 4.
- You must talk to a doctor if you do not feel better or if you feel
worse after 10 days.
What is in this leaflet
1.
What Clarinase Repetabs is and what it is used for
2.
What you need to know before you take Clarinase Repetabs
3.
How to take Clarinase Repetabs
4.
Possible side effects
5.
How to store Clarinase Repetabs
6.
Contents of the pack and other information
1
What Clarinase Repetabs is and what it is used for
What Clarinase Repetabs is
Clarinase Repetabs contains a combination of two medicines (loratadine
and pseudoephedrine
sulphate). Loratadine is an antihistamine and pseudoephedrine sulphate
is a decongestant.
How Clarinase Repetabs works
Clarinase Repetabs help to reduce your allergy or common cold symptoms
by stopping the effects of a
substance called "histamine", which is produced by the body when you
are allergic to

Summary of Product characteristics

Clarinase Repetabs BE/H/0121/001
SUMMARY OF PRODUCT CHARACTERISTICS
Clarinase Repetabs BE/H/0121/001
1.
NAME OF THE MEDICINAL PRODUCT
CLARINASE®Repetabs 5 mg/120 mg prolonged-release tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release 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
Prolonged-release tablet: Round, biconvex, lustrous, white, coated
tablet
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Clarinase Repetabs is indicated for the symptomatic treatment of
seasonal allergic rhinitis when
accompanied by nasal congestion in adults and children 12 years of age
and over.
4.2
Posology and method of administration
Posology
Adults and children 12 years of age and over:
One Clarinase Repetabs prolonged-release 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).
Clarinase Repetabs BE/H/0121/001
Patients with renal or hepatic impairment
The combination product should not be used in patients w