RICAM-10 TABLET

Land: Malaysia

Sprog: engelsk

Kilde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktiv bestanddel:

CETIRIZINE HYDROCHLORIDE

Tilgængelig fra:

HOVID BERHAD

INN (International Name):

CETIRIZINE HYDROCHLORIDE

Enheder i pakken:

10x10 Tablets

Fremstillet af:

HOVID BERHAD

Indlægsseddel

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
RICAM – 10 TABLET
Cetirizine Hydrochloride (10mg)
1
WHAT IS IN THIS LEAFLET
1.
What RICAM-10 is used for
2.
How RICAM-10 works
3.
Before you use RICAM-10
4.
How to use RICAM-10
5.
While you are using RICAM-10
6.
Side effects
7.
Storage and Disposal of RICAM-
10
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial Number
WHAT RICAM-10 IS USED FOR
RICAM-10 is used for adults and
children of 2 years and above to treat
seasonal allergic rhinitis (pollen
allergic), perennial allergic rhinitis (hay
fever) and urticaria (hives) of allergic
origin.
HOW RICAM-10 WORKS
RICAM-10 contains Cetirizine
Hydrochloride which is an
antihistamine agent. Antihistamine can
help to relieve the symptoms of some
allergies and itchy skin rashes.
BEFORE YOU USE RICAM-10
_ _
_- When you must not use it _
Do not take this medicine if:
•
You have ever had an allergic
reaction to antihistamines or to any
of the other ingredients (listed in
later part of this leaflet).
•
You have severe kidney problems.
If you are not sure whether you should
start taking this medicine, talk to your
pharmacist or doctor.
_- Before you start to use it _
Tell your doctor if you are taking or
have recently taken any other
medicines, including medicines
obtained without a prescription, as they
may interact with RICAM-10.
_ _
_- Taking other medicines_
Consumption of alcohol at the same
time may reduce the alertness and
impairment of performance.
Other interactions not stated may occur.
Talk to your doctor or pharmacist if
you have any other concerns.
HOW TO USE RICAM-10
_- How much to use_
Swallow RICAM-10 with water at the
recommended dose as follows:
•
_Adult: _
10 mg (1 tablet) once daily.
A 5 mg starting dose (half of the
tablet) may be proposed if this
leads to satisfactory control of the
symptoms.
•
_Children aged from 2 to 6 years: _
2.5 mg twice daily.
•
_Children aged from 6 to 12 years: _
5 mg (half of the tablet) twice daily.
•
_Children over

Produktets egenskaber

MEDDRA SOC
ADVERSE REACTION
FREQUENCY
Blood and
lymphatic
disorders
Thrombocytopenia
Very rare
Metabolism and
nutrition
disorders
Increased appetite
Not known
Agitation
Uncommon
Aggression, confusion,
depression, hallucinations,
insomnia
Rare
Tic
Very rare
Suicidal ideation, nightmare
Not known
Psychiatric
disorders
Nervous system
disorders
Paraesthesia
Uncommon
Convulsions
Rare
Dysgeusia, syncope, tremor,
dystonia, dyskinesia
Very rare
Amnesia, memory
impairment
Unknown
Eye disorders
Accommodation disorder,
blurred v
ision, oculogyration
Very rare
Skin and
subcutaneous
tissue disorders
Pruritus, rash
Uncommon
Urticaria
Rare
Angioneurotic
oedema,
fixed drug eruption
Very rare
Acute generalized
exanthematous pustulosis
(AGEP)
Unknown
Ear and labyrinth
disorders
Vertigo
Not known
Cardiac disorders
Tachycardia
Rare
Gastro-intestinal
disorders
Diarrhoea
Uncommon
Hepatobiliary
disorders
Hepatic function abnormal
(increased transaminases,
alkaline phosphates, γ -GT
and bilirubin)
Rare
Hepatitis
Unknown
RICAM-10 TABLET
VIRIC12-reg
694
DESCRIPTION
Oblong, white to off-white film-coated tablet, bevel-edged,
shallow convex and scored on one face.
COMPOSITION
Each tablet contains Cetirizine HC
_l_
BP 10 mg.
PHARMACODYNAMICS
Cetirizine, a human metabolite of hydroxyzine, is a potent and
selective
antagonist
of
peripheral
H1-receptors.
In
vitro
receptor binding studies have shown no measurable affinity for
receptors other than H1-receptors. In addition to its anti-H1
effect, cetirizine was shown to display anti-allergic activities at
a dose of 10 mg once or twice daily, it inhibits the late phase
recruitment of eosinophils, in the skin and conjunctiva of atopic
subjects submitted to allergen challenge.
At the recommended dosage, cetirizine has demonstrated that
it improves the quality of life of patients with perennial and
seasonal allergic rhinitis.
PHARMACOKINETICS
Peak blood levels in the order of 0.3μg/ml are reached within
about one hour after the oral administration of cetirizine.
The terminal half-life is approximat