Pizotifen 500microgram tablets

Riik: Suurbritannia

keel: inglise

Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)

Toimeaine:

Pizotifen hydrogen malate

Saadav alates:

Rivopharm (UK) Ltd

ATC kood:

N02CX01

INN (Rahvusvaheline Nimetus):

Pizotifen hydrogen malate

Annus:

500microgram

Ravimvorm:

Oral tablet

Manustamisviis:

Oral

Klass:

No Controlled Drug Status

Retsepti tüüp:

Valid as a prescribable product

Toote kokkuvõte:

BNF: 04070402; GTIN: 5060388650377

Infovoldik

Pizotifen 0.5 mg & 1.5 mg tablets – PL 14682/0001-0002 Edmond Pharma
Version October 2015
PACKAPA
FLET:
PACKAGE LEAFLET: INFORMATION FOR THE USER
PIZOTIFEN 0.5 MG TABLETS
PIZOTIFEN 1.5 MG TABLETS
Pizotifen
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
• Please 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. Do not pass it on to
others. It may harm them, even if
their symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side
effects not listed in this leaflet, please
tell your doctor or pharmacist.
IN THIS LEAFLET:
1. What Pizotifen 0.5mg & 1.5mg Tablets are and what they are used for
2. Before you take Pizotifen 0.5mg & 1.5mg Tablets
3. How to take Pizotifen 0.5mg & 1.5mg Tablets
4. Possible side effects
5. How to store Pizotifen 0.5mg & 1.5mg Tablets
6. Further information
1. WHAT PIZOTIFEN 0.5MG & 1.5MG TABLETS ARE AND WHAT THEY ARE USED
FOR
The name of your medicine is Pizotifen 0.5mg or 1.5mg Tablets. The
active ingredient is pizotifen
hydrogen malate.
Pizotifen belongs to a group of medicines called anti-migraines.
Pizotifen is used to help block the
actions of certain chemicals in the blood such as serotonin, histamine
and tryptamine. These
chemicals act on the blood vessels in the brain and are involved in
causing types of headache, such
as migraine.
If Pizotifen 0.5mg or 1.5mg Tablets are taken regularly, they can help
reduce the number and severity
of headaches including the pain of cluster headaches and both common
and classical migraine.
Pizotifen can also prevent some migraine attacks starting and helps
make other attacks less severe.
Pizotifen does not help to relieve a migraine attack once it has
started
2. BEFORE YOU TAKE PIZOTIFEN 0.5MG & 1.5MG TABLETS
DO NOT TAKE THIS MEDICINE IF:
• you have ever had an allergic reaction to any of the ingredients
of Pizotifen Tablets or any other
medicines that you may

Toote omadused

OBJECT 1
PIZOTIFEN 0.5 MG TABLETS
Summary of Product Characteristics Updated 19-Apr-2017 | Rivopharm UK
Ltd
1. Name of the medicinal product
Pizotifen 0.5 mg Tablets
2. Qualitative and quantitative composition
Each tablet contains 0.725 mg pizotifen hydrogen malate BP, equivalent
to 0.5 mg of pizotifen base. Each
film-coated tablet contains lactose monohydrate 32.14 mg, as excipient
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Film coated tablet.
The tablets are white, marked P on one side and plain on the reverse.
4. Clinical particulars
4.1 Therapeutic indications
Prophylactic treatment of recurrent vascular headaches, including
classical migraine, common migraine
and cluster headache (periodic migrainous neuralgia).
It is not effective in relieving migraine attacks once in progress
4.2 Posology and method of administration
_Adults: _Usually 1.5 mg daily, This may be taken as a single dose at
night or in three divided doses.
Dosage should be adjusted according to individual patient
requirements, up to a maximum of 4.5 mg
daily. Up to 3 mg can be given as a single dose.
_Children _(aged over 2 years): Up to 1.5 mg daily, usually as a
divided dose, although up to 1 mg has been
given as a single dose at night.
_Elderly_: As for adults.
Method of administration: oral
4.3 Contraindications
Hypersensitivity to the drug or to any of the other tablet
ingredients.
Pizotifen should not be given to children under 2 years of age
4.4 Special warnings and precautions for use
Although the anticholinergic activity of Pizotifen is relatively weak,
caution is required in the presence of
closed-angle glaucoma and in patients with a predisposition to urinary
retention. Dosage adjustment may
be required in patients with renal insufficiency.
Pizotifen should be used with caution in patients with a history of
epilepsy.
Pizotifen tablets contain lactose. Patients with rare hereditary
problems of galactose intolerance, severe
lactase deficiency or glucose-glactose malabsorption should not take
Pizotifen tablet