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• glaucoma
• any condition that may cause retention of
urine such as an enlarged prostate gland
• kidney problems
• a history of epilepsy

1 What Pizotifen tablets are and
what they are used for
2 Before you take
3 How to take
4 Possible side effects
5 How to store
6 Further information
1 What Pizotifen tablets are and

what they are used for

Pizotifen belongs to a group of medicines
called antihistamines or antiserotonin
agents. These work by blocking chemicals
that act on the blood vessels in the brain.
Pizotifen tablets may be used to prevent
headaches including migraine or cluster

2 Before you take
Do not take Pizotifen tablets to stop
a migraine once one has started.
Do not take Pizotifen tablets and tell
your doctor if you:

• are allergic (hypersensitive) to pizotifen or
any of the other ingredients (see section 6).
· are taking monoamine oxidase inhibitors

Check with your doctor or pharmacist
before taking Pizotifen tablets if you

Taking other medicines

Please tell your doctor or pharmacist if you
are taking or have recently taken any other
medicines, including medicines obtained
without a prescription. Especially:
• medicines to help you sleep or relax (eg
nitrazepam, diazepam or amobarbital
• antihistamines (including common cold
• medicines to lower blood pressure (eg
• medicines to treat depression, patients
taking monoamine oxidase inhibitors
(MAOIs) should not take Pizotifen tablets.


210mm +/- 0.5mm to centre line of next eye mark


Read all of this leaflet carefully before
you start taking your medicine.
• Keep this leaflet. You may need to read it
• 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.


Pizotifen 0.5mg and 1.5mg tablets

Pregnancy and breast-feeding

If you are pregnant, planning to become
pregnant or are breast-feeding ask your
doctor or pharmacist for advice before
taking this medicine.

Driving and using machines

Pizotifen tablets may make you feel drowsy,
make sure you are not affected before you
drive or operate machinery.

Sugar intolerance

If you have been told you have an
intolerance to some sugars, contact your
doctor before taking this medicine, as it
contains lactose.

Continued top of next column



3 How to take

Always take Pizotifen tablets exactly as your doctor
has told you. If you are not sure, check with your
doctor or pharmacist.
You are advised not to drink alcohol with these
Swallow the tablets with water.
• Adults and elderly: 1.5mg a day taken as a single
dose at night or in three divided doses. Dosage
should be adjusted up to a maximum of 4.5mg
a day. Up to 3mg may be given as a single daily
• Children aged 7 years and over (do not use
the 1.5mg tablet for this age group): Daily
dose up to a maximum of 1.5mg should be
taken in divided doses using the 0.5mg tablets.
A maximum single dose of 1mg can be given at

If you take more than you should

If you (or someone else) swallow a lot of tablets
at the same time, or you think a child may have
swallowed any, contact your nearest hospital
casualty department or tell your doctor immediately.
Signs of an overdose include drowsiness, dizziness,
confusion, fits or excitement (particularly in
children), difficulty in breathing or controlling
movements, fast heart beat, low blood pressure, dry
mouth, feeling or being sick, blueness of the skin,
coma or respiratory paralysis.

If you stop taking the tablets

What Pizotifen tablets look like and
contents of the pack

Pizotifen tablets are cream film-coated tablets.

Pack sizes are 28 tablets.

Marketing Authorisation Holder and manufacturer
Actavis, Barnstaple, EX32 8NS, UK

Date of revision: October 2010

Tell your doctor if you notice any of the following
side effects or notice any other effects not listed:
• Very common (more than 1 in 10 users): increased
appetite which may lead to weight gain.
• Common (less than 1 in 10 users): drowsiness,
sleepiness, dizziness, dry mouth, feeling sick,



Like all medicines, Pizotifen tablets can cause side
effects, although not everybody gets them.
Contact your doctor at once if you notice the
following signs of an allergic reaction: rash,
itching or swelling of the face, lips, throat or tongue.


4 Possible side effects

Keep out of the reach and sight of children.
Do not store above 25°C.
Do not use Pizotifen tablets after the expiry date
stated on the label/carton/bottle. The expiry date
refers to the last day of that month.
Medicines should not be disposed of via wastewater
or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These
measures will help to protect the environment.

• The active substance (the ingredient that
makes the tablet work) is pizotifen. Each tablet
contains either 0.725mg or 2.175mg of the active
ingredient pizotifen hydrogen malate which is
equivalent to 0.5mg and 1.5mg of pizotifen.
• The other ingredients are povidone, lactose, maize
starch, magnesium stearate, microcrystalline
cellulose (E460).
• The coating contains hypromellose, medium chain
triglycerides, titanium dioxide (E171), iron oxide
yellow (E172), iron oxide black (E172).

Do not take a double dose to make up for a
forgotten dose. If you forget to take a dose take it
as soon as you remember it and then take the next
dose at the right time.
Talk to your doctor before you stop taking the
tablets and follow their advice.

5 How to store

6 Further information
What Pizotifen tablets contain

If you forget to take the tablets

• Uncommon (less than 1 in 100 users):
• Rare (less than 1 in 1,000 users): pins and needles,
muscle and joint pain, depression, anxiety,
agitation, aggression, hallucinations, difficulty
sleeping, sleep disorders.
• Very rare (less than 1 in 10,000 users): fits.
Excitement in children may also occur.
If you notice any side effects, they get worse, or if
you notice any not listed, please tell your doctor or

Actavis, Barnstaple, EX32 8NS, UK

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.