Sibelium 5 mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

FLUNARIZINE DIHYDROCHLORIDE

Available from:

Janssen Sciences Ireland UC

ATC code:

N07CA; N07CA03

INN (International Name):

FLUNARIZINE DIHYDROCHLORIDE

Dosage:

5 milligram(s)

Pharmaceutical form:

Tablet

Therapeutic area:

Antivertigo preparations; flunarizine

Authorization status:

Marketed

Authorization date:

2009-01-30

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
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 taking the table

Summary of Product characteristics

Health Products Regulatory Authority
17 August 2020
CRN009PK7
Page 1 of 6
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 57.42mg 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.
4.3 CONTRAINDICATIONS
Use in patients with current depressiv