Sanomigran 1.5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Pizotifen hydrogen malate

Available from:

Novartis Pharmaceuticals UK Ltd

ATC code:

N02CX01

INN (International Name):

Pizotifen hydrogen malate

Dosage:

1.5mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04070402; GTIN: 5013054190073

Patient Information leaflet

SANOMIGRAN® TABLETS 0.5 AND 1.5 MG
(PIZOTIFEN)
PATIENT INFORMATION LEAFLET
This medicine will usually be referred to just as Sanomigran Tablets
in this leaflet.
WHAT YOU NEED TO KNOW ABOUT SANOMIGRAN TABLETS
Your doctor has decided that you need this medicine to help treat your
condition.
PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START TO TAKE YOUR
MEDICINE. IT CONTAINS
IMPORTANT INFORMATION. Keep the leaflet in a safe place because you
may want to read it again.
If you have any other questions, or if there is something you don’t
understand, please ask your
doctor or pharmacist.
This medicine has been prescribed for you. Never give it to someone
else. It may not be the right
medicine for them even if their symptoms seem to be the same as yours.
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
What Sanomigran Tablets are and what they are used for
2.
Things to consider before you start to take Sanomigran Tablets
3.
How to take Sanomigran Tablets
4.
Possible side effects
5.
How to store Sanomigran Tablets
6.
Further information
1.
WHAT SANOMIGRAN TABLETS ARE AND WHAT THEY ARE USED FOR
Sanomigran Tablets are available in two different strengths containing
either 0.5 mg or 1.5 mg of the
active ingredient, pizotifen.
Sanomigran Tablets are a migraine treatment. They may help to stop the
effects of certain naturally
occuring substances in your body called “serotonin”,
“histamine” and “tryptamine” which are involved
in causing some kinds of headache, including migraine.
Sanomigran Tablets have been prescribed for you by your doctor to help
your migraine type
headaches. If they are taken regularly they can help to prevent
headaches or reduce the pain of
cluster headaches, common and classical migraine. Sanomigran Tablets
can stop some migraine
attacks starting and help make other attacks less severe. They will
not stop migraine attacks once
they have started.
2.
THINGS TO CONSIDER BEFORE YOU

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
SANOMIGRAN Tablets 1.5mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2.175mg pizotifen hydrogen malate BP
For a full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Coated tablets
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prophylactic treatment of recurrent vascular headaches, including
classical
migraine,
common
migraine
and
cluster
headaches
(periodic
migrainous
neuralgia).
The International Classification of Headache Disorders 2
nd
edition (ICHD-II)
are standard classifications of headache used by health professionals
and
describe the above-mentioned disorders as follows: prophylactic
treatment of
recurrent migraine headache with or without aura and of cluster
headache.
It is not effective in relieving migraine attacks once in progress.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS
Usually 1.5mg daily. This may be taken as a single dose at night or in
three
divided doses. Dosage should be adjusted to individual patient
requirements
up to a maximum of 4.5mg daily. Up to 3mg may be given as a single
dose.
CHILDREN AND ADOLESCENTS FROM 2 YEARS OF AGE
Use of 1.5mg SANOMIGRAN Tablets is not recommended. The appropriate
paediatric doses may be given using the 0.5mg SANOMIGRAN Tablets or
SANOMIGRAN Elixir. For children SANOMIGRAN is available in an elixir
form.
USE IN THE ELDERLY
Clinical work with SANOMIGRAN has not shown elderly patients to
require
different dosages from younger patients.
SPECIAL POPULATIONS
RENAL AND HEPATIC IMPAIRMENT
Caution is required in patients with renal or hepatic impairment and
dosage
adjustment may be necessary (see section 5.2).
METHOD OF ADMINISTRATION
Oral
4.3
CONTRAINDICATIONS
Known hypersensitivity to pizotifen or any of the excipients (see
section 6.1
List of excipients).
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Although the anticholinergic activity of SANOMIGRAN is relatively
weak,
caution is required in the presence of closed angle glaucoma and in
patients
with
a
predi