Cirrus 5 mg/120 mg Prolonged Release Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CETIRIZINE DIHYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE

Available from:

UCB Pharma SA 60 Allee de la Recherche, B-1070 Brussels, Belgium

ATC code:

R01BA52

INN (International Name):

CETIRIZINE DIHYDROCHLORIDE 5 mg PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg

Pharmaceutical form:

PROLONGED-RELEASE TABLET

Composition:

CETIRIZINE DIHYDROCHLORIDE 5 mg PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg

Prescription type:

OTC

Therapeutic area:

NASAL PREPARATIONS

Authorization status:

Authorised

Authorization date:

2006-01-16

Patient Information leaflet

PACKAGE LEAFLET
PAGE 2 OF 8
PACKAGE LEAFLET: INFORMATION FOR THE PATIENTS
CIRRUS 5
MG/120
MG PROLONGED-RELEASE TABLETS
(5 mg cetirizine dihydrochloride - 120 mg pseudoephedrine
hydrochloride)
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
has 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 or pharmacist. 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 7 days.
WHAT IS IN THIS LEAFLET
:
1.
What Cirrus is and what it is used for
2.
What you need to know before you take Cirrus
3.
How to take Cirrus
4.
Possible side effects
5.
How to store Cirrus
6.
Contents of the pack and other information
1.
WHAT CIRRUS IS AND WHAT IT IS USED FOR
Cirrus 5mg/120mg prolonged release tablets contains two active
substances: cetirizine
dihydrochloride which is an antihistamine and pseudoephedrine
hydrochloride which is a
decongestant.
Cirrus is a medicine that is used to relieve allergic symptoms,
especially when the anti-
allergy properties of cetirizine are combined with the effects of
pseudoephedrine in reducing
swelling of the mucous membranes inside the nose.
Cirrus is indicated for the treatment of symptoms such as blocked
nose, sneezing, runny nose,
itchy nose or itchy eyes, which occur in seasonal allergic rhinitis
(hay fever) or perennial
allergic rhinitis (house-dust allergy).
Cirrus is indicated for adults and adolescents from 12 years of age
and above.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CIRRUS
DO NOT TAKE CIRRUS
-
if you are allergic to cetirizine, ephedrine or any of the other
ingredients of this medicine
PAGE 3 OF 8
(listed in section 6) or to piperazine derivative (closely related
active sustances of other
me

Summary of Product characteristics

Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
Page 2 of 12
1.
NAME OF THE MEDICINAL PRODUCT
Cirrus 5 mg/120 mg Prolonged Release Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet provides 5 mg cetirizine dihydrochloride for immediate
release, and 120 mg
pseudoephedrine hydrochloride for prolonged release.
Excipients with known effect: one tablet contains 43.23 mg lactose
monohydrate
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Prolonged release tablet.
White to off-white, round, biconvex circle-embossed, film-coated
tablet, having a circular
logo on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Cetirizine-pseudoephedrine is indicated for the treatment of symptoms
such as nasal
congestion, sneezing, rhinorrhoea, and nasal and ocular pruritus
associated with seasonal or
perennial allergic rhinitis. Cetirizine-pseudoephedrine should be
administered when the anti-
allergic properties of cetirizine dihydrochloride and the nasal
decongestant activity of
pseudoephedrine hydrochloride are desired.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults _
One tablet two times a day (morning and evening), corresponding to the
maximum
recommended dose of 10 mg of cetirizine dihydrochloride and 240 mg of
pseudoephedrine
hydrochloride daily.
_ _
Special populations
_ _
_Paediatric population _
Adolescents from 12 years of age and above: 1 tablet two times a day
(morning and evening),
with or without food.
Children under 12 years of age: the use of the product is
contraindicated (see sections 4.3 and
4.4).
Page 3 of 12
_ _
_Renal impairment _
The dose should be reduced to 1 tablet daily in patients with moderate
renal insufficiency.
_Hepatic impairment _
The dose should be reduced to 1 tablet daily in patients with moderate
hepatic insufficiency.
Duration of treatment
The duration of treatment should not exceed the period of symptoms and
should not exceed 2
to 3 weeks at the recommended dose (1 tablet, twice daily).
After disappearance of nasal symptoms, treatment s