Pizotifen 0.5mg Tablets
PATIENT INFORMATION LEAFLET
Pizotifen 0.5mg and 1.5mg Tablets
(Pizotifen)_
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
■ 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 only. Do not pass it on to others.
It may harm them, even if their signs of illness are the same as yours.
■ If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. (See Section 4).
What is in this leaflet:
J What Pizotifen is and what it is used for |4 Possible side effects
2 What you need to know before you take Pizotifen m How to store Pizotifen
3 How to take Pizotifen □ Contents of the pack and other
information
H What Pizotifen is and what it is used for
Pizotifen belongs to a group of medicines known as anti-migraine agents.
Pizotifen tablets are used to prevent headaches, including migraine and cluster headaches.
Cluster headaches are short lived painful headaches which usually happen at the same time of the day or night. Cluster headaches can last for several weeks.
[2 What you need to know ^ before you take Pizotifen
Do not take if:
■ you are allergic to pizotifen or any of the other ingredients in these tablets (see Section 6 "Contents of the pack and other information")
■ you are taking Monoamine oxidase inhibitors (MAOIs), used to treat depression
Warnings and precautions
Talk to your doctor before taking Pizotifen if:
■ you have kidney problems (the dose may need to be adjusted)
■ you have problems passing urine
■ you suffer from glaucoma (increased pressure in the eye which causes problems with your vision)
■ you have a history of epilepsy
Other medicines and Pizotifen
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Medicines which should not be taken with Pizotifen
■ Monoamine oxidase inhibitors (MAOIs), used to treat depression, such as iscarboxazid, moclobemide and Nardil
Other medicines which may interact with or be affect by Pizotifen, if taken together include:
■ medicines to help you sleep (hypnotics -sleeping pills), such as nitrazepam
■ medicines which help relieve anxiety and tension (sedatives), such as diazepam
■ medicines used to relieve allergic reactions
such as hay fever and itching (antihistamines), such as promethazine. Some common cold medicines include antihistamine ■ medicines for high blood pressure (adrenergic neurone blockers), such as guanethidine
Pizotifen with alcohol
You should not drink alcohol whilst taking these tablets.
Pregnancy and breast-feeding
If you are pregnant or breast feeding, think you may be pregnant or are planning to have a baby, you should not take Pizotifen unless advised to do so by your doctor.
Driving or using machinery
Some people may feel drowsy, tired or dizzy whilst taking Pizotifen. If this happens, you should not drive or operate machinery.
Pizotifen contains lactose
If you have been told by your doctor that you have intolerance to some sugars, talk to your doctor before taking this medicine.
[3 How to take Pizotifen
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
■ These tablets are for oral administration
■ The tablets should be swallowed whole with water
The recommended doses are:
Adults, including the elderly
The usual dose is 1.5mg each day.
This can be taken as a single dose (one 1.5mg tablet) at night, taken a few hours before you go to bed. Alternatively, the dose can be taken in three divided doses (three 0.5mg tablets), spread evenly throughout the day.
Your doctor may increase this dose to a maximum of 4.5mg daily. Do not take more than 3mg in a single dose.
Children
Children should only use Pizotifen 0.5mg tablets. The maximum dose for children is 1.5mg a day taken in divided doses using the 0.5mg tablets.
Continued....
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A 1mg dose may be taken at night if instructed by the doctor. Children should not take Pizotifen 1.5mg tablets.
If you take more Pizotifen than you should
Contact your nearest hospital casualty department or a doctor immediately for advice if you have swallowed too many tablets or if you think a child has accidentally swallowed any. Take this leaflet, and any tablets that you still have to show the doctor. 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 forget to take Pizotifen Take it as soon as you remember, unless it is time for your next dose. If you miss a dose do not take a double dose to make up for a forgotten dose.
If you stop taking Pizotifen Do not stop taking your tablets before talking to your doctor or pharmacist. You should take Pizotifen even when you feel well. Your headaches may come back if you stop taking the tablets.
When stopping Pizotifen, you should reduce your dose slowly. If you suddenly stop your treatment you may experience the following withdrawal effects: anxiety, shaking, difficulty sleeping, feeling sick or loss of consciousness.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
[4 Possible side effects
Like all medicines, this medicine can cause side effects although not everybody gets them.
Stop taking your tablets and tell your doctor immediately, if you notice the following:
■ Symptoms of allergy such as, swelling of the face, rash, itchy rash or hives (rare side effects)
Other possible side effects
Very common side effects (may affect more than 1 in 10 people)
■ increase in appetite, which may lead to weight gain
Common side effects (may affect up to 1 in 10 people)
■ drowsiness
■ dizziness
■ dry mouth
■ feeling sick
■ feeling tired
Uncommon side effects (may affect up to 1 in
100 people)
■ constipation
Rare side effects (may affect up to 1 in 1,000 people)
■ tingling or numbness in the hands or feet
■ children may become agitated
■ sleeping disorders, including difficulty sleeping
■ depression
■ mood changes, such as anxiety and aggression
■ seeing or hearing things that are not real (hallucinations)
■ muscle or joint pain
Very rare side effects (may affect up to 1 in
10,000 people)
■ fits
■ increased pressure in the eyes (angle closure glaucoma)
Withdrawal effects
If you suddenly stop taking Pizotifen you may experience withdrawal effects (see 'If you stop taking Pizotifen', section 3)
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the internet at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
How to store Pizotifen
Keep this medicine out of the sight and reach of children.
Store below 25°C. Keep the tablets in the original package.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
[g Contents of the pack and La other information
What Pizotifen tablets contain:
■ Each tablet contains Pizotifen malate equivalent to Pizotifen 0.5mg or 1.5mg
■ The other ingredients are lactose monohydrate, microcrystalline cellulose, magnesium stearate, hypromellose (E464), titanium dioxide (E171), iron oxides (E172), and quinoline yellow aluminium lake (E104)
What Pizotifen tablets look like and the contents of the pack:
Pizotifen 0.5mg tablets: pale cream to yellow circular biconvex film-coated tablets, with an approximate diameter of 6mm, marked 'PZT 0.5' on one face.
Pizotifen 1.5mg tablets are pale cream to yellow circular biconvex film-coated tablets, with an approximate diameter of 9.1mm, marked 'PZT 1.5' on one face
Pizotifen 0.5mg tablets come in blister packs or containers of 28 and 84 tablets.
Not all pack sizes may be marketed'
Pizotifen 1.5mg tablets come in blister packs or containers of 28 tablets.
Marketing Authorisation Holder and Manufacturer:
Tillomed Laboratories Ltd 3 Howard Road,
Eaton Socon, St Neots Cambridgeshire PE198ET UK
Product Licence Number:
Pizotifen 0.5mg tablets: PL 11311/0379 Pizotifen 1.5mg tablets: PL 11311/0380
Date of last revision : October 2013
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