Sandomigran

Land: Neuseeland

Sprache: Englisch

Quelle: Medsafe (Medicines Safety Authority)

Wirkstoff:

Pizotifen 1mg

Verfügbar ab:

Novartis New Zealand Ltd

INN (Internationale Bezeichnung):

Pizotifen 1 mg

Dosierung:

1 mg

Darreichungsform:

Tablet

Zusammensetzung:

Active: Pizotifen 1mg

Klasse:

Prescription

Verschreibungstyp:

Prescription

Hergestellt von:

Novartis Pharma AG

Berechtigungsdatum:

1970-02-11

Gebrauchsinformation

SANDOMIGRAN

1
SANDOMIGRAN

500 MCG TABLET
PIZOTIFEN MALATE
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Sandomigran
.
It does not contain all the available information
.
It does not take the place of talking to your doctor or pharmacist.
The information in this leaflet was last updated on the date listed on
the final page. Some more recent information on the
medicine may be available.
YOU SHOULD ENSURE THAT YOU SPEAK TO YOUR PHARMACIST OR DOCTOR TO
OBTAIN THE MOST UP TO DATE INFORMATION ON THE
MEDICINE. YOU CAN ALSO DOWNLOAD THE MOST UP TO DATE LEAFLET FROM
WWW.MEDSAFE.GOVT.NZ.
Those updates may contain important information about the medicine and
its use of which you should be aware.
All medicines have risks and benefits. Your doctor has weighed the
risks of you taking Sandomigran against the benefits this
medicine is expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT SANDOMIGRAN IS USED FOR
Sandomigran contains the active ingredient pizotifen. It is used to
prevent attacks of migraine (severe periodic headache).
Migraine attacks are thought to be caused by temporary changes in the
size of small blood vessels in the brain. These changes
to the blood vessels cause the pain and problems with vision that
often happen during a migraine. Sandomigran prevents
migraine attacks by stopping the blood vessels from changing in size.
Sandomigran can only be used to prevent migraine. It
does not work during a migraine attack.
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY SANDOMIGRAN HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it for another reason. Sandomigran is
only available with a doctor's prescription. It is not
addictive.
BEFORE YOU TAKE SANDOMIGRAN
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE SANDOMIGRAN IF YOU HAVE AN ALLERGY TO:
•
pizotifen (the active ingredient in Sandomigran)
•
any of the other ingredients listed at the end of

Fachinformation

SANDOMIGRAN
®
1. NAME OF THE MEDICINE
SANDOMIGRAN
®
pizotifen 500 micrograms coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
One coated tablet contains 725 micrograms pizotifen hydrogen malate
(corresponding to 500
micrograms pizotifen base).
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Biconvex sugar coated tablets and white colour.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
SANDOMIGRAN® is indicated in adults and children from 2 years of age
for the
prophylactic treatment of recurrent vascular headaches, such as:
•
typical or atypical migraine
•
vasomotor headache
•
cluster headache (Horton’s syndrome)
Sandomigran is less effective in tension headache and in psychogenic
and post-traumatic
headaches. It is not effective in relieving migraine attacks once in
progress.
4.2
DOSE AND METHOD OF ADMINISTRATION
General target population
Starting with 0.5 mg daily, the dosage should be progressively
increased. The average
maintenance dosage is 1.5 mg daily in divided doses or as a single
dose at night. In refractory
cases the physician may gradually raise the dosage to 3 to 4.5 mg
daily taken in 3 divided
doses.
_SPECIAL POPULATIONS _
PAEDIATRICS (CHILDREN FROM 2 YEARS OF AGE AND ADOLESCENTS)
Starting with 0.5 mg, the daily dose may be increased up to 1.5 mg in
divided doses, or 1 mg
may be given as a single dose at night.
_ _
Children below two years of age should not be given Sandomigran.
GERIATRIC PATIENTS (AGED 65 YEARS AND ABOVE)
There is no evidence to suggest that the dosage needs to be adjusted
in elderly patients.
RENAL AND HEPATIC IMPAIRMENT
Caution is required in patients with renal or hepatic impairment and
dosage adjustment may
be necessary (see
_Pharmacokinetic properties_
).
_METHOD OF ADMINISTRATION _
Tablets for oral administration.
_ _
4.3 CONTRAINDICATIONS
Hypersensitivity to pizotifen or to any of the excipients listed in
section 6.1
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Hepatic injury has been reported, ranging from transaminase elevat