Sibelium 5 mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

FLUNARIZINE DIHYDROCHLORIDE

Available from:

Janssen-Cilag Ltd

ATC code:

N07CA; N07CA03

INN (International Name):

FLUNARIZINE DIHYDROCHLORIDE

Dosage:

5 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Antivertigo preparations; flunarizine

Authorization status:

Marketed

Authorization date:

2009-01-30

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
© J-C 2017
SIBELIUM

5 MG TABLETS
flunarizine
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, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. See section 4.
IN THIS LEAFLET:
1.
What Sibelium is and what it is used for
2.
What you need to know before you take Sibelium
3.
How to take Sibelium
4.
Possible side effects
5.
How to store Sibelium
6.
Contents of the pack and other information
1.
WHAT SIBELIUM IS AND WHAT IT IS USED FOR
WHAT IS SIBELIUM?
Sibelium tablets contain flunarizine. They belong to a group of
medicines known as calcium
channel blockers, which work by preventing the narrowing of blood
vessels.
WHAT IS IT USED FOR?
Sibelium Tablets are for use in adults.
They have been prescribed for you to help your migraine-type
headaches. If you take Sibelium
Tablets regularly they can help you get fewer headaches, or less
painful headaches. They can
stop some migraine attacks starting and help make other attacks less
severe. While you are
taking Sibelium Tablets, your doctor will review your treatment at
regular intervals in order to
assess your response to the medicine.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE SIBELIUM
DO NOT TAKE SIBELIUM
-
if you are allergic (hypersensitive) to flunarizine or any of the
other ingredients of Sibelium
Tablets (listed in Section 6 below)
-
if you have a depressive illness or have a history of recurrent
depression.
-
if you have Parkinson’s Disease or a similar disease.
WARNINGS AND PRECAUTIONS
-
Talk to your doctor or pharmacist before taking Sibelium Tablets if;
-
you start to feel tired while taki

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sibelium 5 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg of flunarizine as flunarizine
dihydrochloride.
Excipients with known effect:
Each tablet also contains 57.42 mg lactose monohydrate
For the full list of excipients see section 6.1
3 PHARMACEUTICAL FORM
Tablet.
White, oblong tablet inscribed 'J-C'
on one side and 'FL 5'
on the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the prophylaxis of migraine. The limited information available for
periods longer than 12 months has shown
flunarizine to continue to be effective.
Patients should be regularly reviewed to assess their response to
treatment, and
if a sustained attack-free period is established, interrupted
flunarizine treatment should be considered.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults and elderly (18 years of age and older):
STARTING DOSE
Treatment is started at 10 mg daily (at night) for adult
patients aged 18 to 64 years and at 5 mg daily (at night) for
elderly patients aged 65 years and older. If, during this treatment,
depressive, extrapyramidal or other unacceptable
adverse experiences occur, administration should be discontinued (see
Sections 4.4 and 4.8).
If, after 2 months of this
initial treatment, no significant improvement is observed, the patient
should be considered a non-responder and
administration should be discontinued.
MAINTENANCE TREATMENT
If the patient is responding satisfactorily and a maintenance
treatment is needed, the same daily dose should be used,
but this time interrupted by two successive drug-free days every week,
eg Saturday and Sunday.
Even if the prophylactic maintenance treatment is successful and well
tolerated, it should be interrupted after 6 months
and it should be re-initiated only if the patient relapses.
Children, Infants and Neonates: Not recommended.
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