Pizotifen 1.5mg Tablets
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Pizotifen 0.5mg and 1.5mg Tablets
Please read this leaflet carefully before you start to take your tablets.
• Keep this leaflet safe, as you may want to read it again
■ If you are not sure about anything or want to know more, ask your doctor or a pharmacist
■ This medicine has been prescribed for you personally and you should 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 become serious or you notice any not listed in this leaflet, please tell your doctor or pharmacist
In this leaflet:
D What this medicine is and what it is used for □ Possible side effects
□ Before you take Q How to store
El How to take □ Further information
□ What this medicine 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.
0 Before you take
Do not take if:
• you are allergic to pizotifen or any of the other ingredients (see 'Important information about some of the ingredients, end of section 2 and the list of ingredients, section 6)
Take special care 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
If any of the above applies, please consult your doctor or pharmacist.
Taking other medicines
Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Other medicines may interact with Pizotifen, in particular the following:
■ 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
Taking with alcohol
You should not drink alcohol whilst taking these tablets.
Pregnancy and breast-feeding
If you are pregnant, think you might be pregnant or you are breast-feeding, 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.
Important information about some of the ingredients of this medicine
This medicine contains lactose. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this product.
How to take
You must take your tablets as your doctor has told you to. The label will tell you how many to take and how often to take them.
Do not take more than your doctor has told you to. Read and follow the instructions on the pharmacist's label. If you are not sure about anything, please ask your doctor or pharmacist.
■ These tablets are for oral administration • The tablets should be swallowed whole with water
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.
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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. A 1 mg dose may be taken at night if instructed by the doctor. Children should not take Pizotifen 1.5mg tablets.
If you take more tablets 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.
If you forget to take a dose at the right time Take your dose as soon as you remember. Do not take two doses together. If it is almost time to take the next dose, wait until then and carry on as before.
If you stop taking your tablets
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.
Possible side effects
Like most medicines, Pizotifen can cause unwanted side effects in some people, 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 (affect more than 1 in
10 people)
■ increase in appetite, which may lead to weight gain
Common side effects (affect less than 1 in 10 people)
• drowsiness
• dizziness
■ dry mouth
• feeling sick
■ feeling tired
Uncommon side effects (affect less than 1 in 100 people)
• constipation
Rare side effects (affect less than 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 (affect less than 1 in 10,000 people)
■ fits
Withdrawal effects
If you suddenly stop taking Pizotifen you may experience withdrawal effects (see 'If you stop taking your tablets', section 3)
If any of the side effects become serious or you notice any not listed, please tell your doctor or pharmacist.
0 How to store
Keep your tablets in a safe place where children cannot see or reach them.
You should keep your tablets below 25°C
Keep them in the pack they came in. Do not put them in another container.
Do not take after the expiry date, which is stated on the carton after EXP. The expiry date refers to the last day of that month.
You should take any tablets that are out of date or which you no longer need back to your pharmacist.
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.
Further information
What Pizotifen tablets contain:
■ Active ingredient: Pizotifen malate equivalent to Pizotifen 0.5mg or 1.5mg
■ Other ingredients: lactose monohydrate, microcrystalline cellulose, magnesium stearate, hypromellose (E464), titanium dioxide (E171), iron oxides (E172), and quinoline yellow aluminium lake (E104)
This medicine contains lactose. See ‘Important information about some of the ingredients', end of section 2)
What Pizotifen tablets look like and the contents of the pack:
Pizotifen 0.5mg and 1.5mg tablets are pale cream to yellow circular biconvex film-coated tablets marked either 'PZT 0.5' or '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 Way Eaton Socon, St Neots Cambridgeshire PE19 8ET UK
Product Licence Number:
Pizotifen 0.5mg tablets:
PL 11311/0379
Pizotifen 1.5mg tablets:
PL 11311/0380
Date of approval: February 2011
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TEVA UK LIMITED
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