Pizotifen 1.5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Pizotifen hydrogen malate

Available from:

Rivopharm (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: 5060388650384

Patient Information leaflet

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

Summary of Product characteristics

OBJECT 1
PIZOTIFEN 1.5 MG TABLETS
Summary of Product Characteristics Updated 19-Apr-2017 | Rivopharm UK
Ltd
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
•
Legal category
1. Name of the medicinal product
Pizotifen 1.5 mg Tablets
2. Qualitative and quantitative composition
Each tablet contains 2.175mg pizotifen hydrogen malate BP, equivalent
to 1.5mg of pizotifen base. Each
film-coated tablet contains lactose monohydrate 96.42 mg, as excipient
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Film coated tablet.
The tablets are white, marked PZ 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 1.5mg daily. This may be taken as a single dose at
night or in three