STUGERON 25MG TABLET

Land: Malaysia

Språk: engelska

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

Aktiva substanser:

CINNARIZINE

Tillgänglig från:

JOHNSON & JOHNSON SDN BHD

INN (International namn):

CINNARIZINE

Enheter i paketet:

250Tablet Tablets; 50 Tablets

Tillverkad av:

JANSSEN CILAG SPA

Bipacksedel

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
STUGERON
® TABLET
Cinnarizine
(
25mg)
1
WHAT IS IN THIS LEAFLET
1.
What STUGERON
®
is used for
2.
How STUGERON
®
works
3.
Before you use STUGERON
®
4.
How to use STUGERON
®
5.
While you are using it
6.
Side effects
7.
Storage and disposal of STUGERON
®
8.
Product description
9.
Manufacturer and product registration
holder
10.
Date of revision
11.
Serial number
WHAT STUGERON
® IS USED FOR
STUGERON
®
is used to treat the
following:
•
BALANCE DISORDERS
– STUGERON
®
relieves the dizziness and spinning
sensation (‘vertigo’) caused by problems
of the inner ear. It also relieves the
associated symptoms, like persistent
ringing in the ears (‘tinnitus’), rapid and
uncontrollable movements of the eyes,
nausea and vomiting;
STUGERON
®
also
PREVENTS MOTION
SICKNESS.
HOW STUGERON
® WORKS
The medicine in STUGERON
®
is
cinnarizine that helps symptoms caused by
balance or movement problems.
BEFORE YOU USE STUGERON
®
-
_When you must not use it _
Do not take STUGERON
®
tablets if:
•
You are allergic to cinnarizine or any
of the other ingredients in
STUGERON
®
tablets (listed in
“Product Description – Ingredients”)
•
Your child is under 5 years old
Do not take this medicine if any of the
above applies to you. If you are not sure,
talk to your doctor or pharmacist before
taking STUGERON
®
tablets.
-
_Pregnancy and breastfeeding _
If you are pregnant or plan to be
pregnant, inform your doctor, who will
decide if you can take STUGERON
®
.
STUGERON
®
should be used during
pregnancy only if the therapeutic
benefits justify the potential risks for the
fetus.
If you are taking STUGERON
®
, you
are advised not to breastfeed since
there is no data on the excretion of
STUGERON
®
in human breast milk.
-
_Before you start to use it _
_Parkinson's disease _
If you have Parkinson's disease, tell your
doctor, who will decide if you can take
STUGERON
®
.
-
_Taking other medicines _
Medicines for depression and medicines
that slow up your reactions (sleep

Produktens egenskaper

1
PRODUCT NAME
STUGERON
®
(cinnarizine)
DOSAGE FORMS AND STRENGTH
Tablets.
White, circular, halfscored tablet with the inscription “JANSSEN”
on one side and
“S/25” on the other side. Each tablet contains 25 mg cinnarizine.
For excipients, see List of Excipients.
CLINICAL INFORMATION
INDICATIONS
•
Disorders of balance - maintenance therapy for symptoms of
labyrinthine disorders,
including vertigo, dizziness, tinnitus, nystagmus, nausea and
vomiting.
•
Prophylaxis of motion sickness.
DOSAGE AND ADMINISTRATION
_DOSAGE _
_Disorders of balance_
- Adult
•
1 tablet of 25 mg three times a day
_Prophylaxis of motion sickness_
:
•
Adults and adolescents aged 13 years and above: 1 tablet of 25 mg at
least half
an hour before travelling; to be repeated every 6 hours;
•
Children aged 6 to 12 years: half of the adult dose is recommended.
_ADMINISTRATION _
STUGERON
®
should preferably be taken after meals. It is for oral administration.
CONTRAINDICATIONS
STUGERON
®
is contraindicated in patients with known hypersensitivity to the
drug.
WARNINGS AND PRECAUTIONS
As with other antihistamines STUGERON
®
may cause epigastric distress; taking it
after meals may diminish gastric irritation.
In patients with Parkinson’s disease STUGERON
®
should only be given if the
advantages outweigh the possible risk of aggravating this disease.
STUGERON
®
may cause somnolence, especially at the start of treatment. Therefore
caution should be taken when alcohol, central nervous system (CNS)
depressants or
tricyclic antidepressants are used concomitantly.
INTERACTIONS
_Alcohol/CNS Depressants and tricyclic antidepressants _
The sedative effects of STUGERON
®
and of any of the following may be potentiated
when used concomitantly: alcohol, CNS depressants, or tricyclic
antidepressants.
2
_ _
_Diagnostic interference _
Because of its antihistamine effect, STUGERON
®
may prevent otherwise positive
reactions to dermal reactivity indicators if used up to 4 days prior
to skin testing.
_ _
PREGNANCY AND BREAST-FEEDING
_Pregnancy _