Pizotifen 1.5mg Tablets
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KEEP THIS LEAFLET AND READ IT BEFORE YOU TAKE YOUR MEDICINE YOUR PRESCRIPTION FOR PIZOTIFEN 0.5MG AND 1.5MG TABLETS PLEASE READ THIS CAREFULLY BEFORE YOU START TO USE YOUR TABLETS.
• This leaflet contains important information about your treatment. If you have any doubts or questions, or you are not sure about anything, ask your doctor or pharmacist.
• Keep this leaflet. You may need to read this again.
• Your 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 same as yours.
THIS LEAFLET CONTAINS INFORMATION ON:
1. What are Pizotifen 0.5mg and 1.5mg tablets and what are they used for?
2. Information to read before taking Pizotifen 0.5mg or 1.5mg tablets.
3. How to take your tablets?
4. Can your tablets have any side-effects?
5. Storing your tablets.
The name of your medicine is Pizotifen 0.5mg or 1.5mg tablets. Pizotifen Tablets come in two strengths. One strength is 0.5mg of pizotifen (present as 0.725 mg pizotifen hydrogen malate salt) and the other is 1.5mg of pizotifen (present as 2.175 mg pizotifen hydrogen malate salt). Pizotifen 0.5mg Tablets are film-coated, white coloured tablets with P05 on one side. Pizotifen 1.5mg Tablets are film-coated, white coloured tablets with P15 on one side. Pizotifen 0.5mg and 1.5mg looks as illustrated below.
Other ingredients are Lactose monohydrate, Microcrystalline cellulose (E460). Maize starch, Povidone K-30 (E1201), Magnesium stearate (E572), Colloidal silicon dioxide (E551), Hypromellose (E464), Polyethylene glycol, Talc (E553b), Titanium dioxide (E 171).
The Marketing Authorisation holder is The Co-operative Pharmacy National Distribution Centre Limited, Enterprise Way, Meir Park, Stoke on Trent, ST3 7UN, UK.
The tablets are manufactured by: Edmond Pharma s.r.l., Via Dei Giovi, N. 131-20037, Paderno, Italy.
1. WHAT ARE PIZOTIFEN TABLETS AND WHAT ARE THEY USED FOR?
What are Pizotifen 0.5mg and 1.5mg tablets?
Pizotifen belongs to a group of medicines called antiserotonin. These medicines work by blocking chemicals that act on blood vessels in the brain.
Pizotifen 0.5mg Tablets are available in blister packs of 60 tablets.
Pizotfen 1.5mg Tablets are available in blister packs of 28 tablets.
Your doctor may have given you this medicine before from another company and it may have looked slightly different. Either brand will have the same effect.
What are they used for?
Pizotifen tablets are used for the prevention of recurrent migraine headaches.
2. INFORMATION TO READ BEFORE USING PIZOTIFEN TABLETS.
Please take the time to read the following information carefully as this may stop you from being able to take Pizotifen tablets.
When should you NOT take Pizotifen tablets?
Ask yourself the following questions:
• Are you pregnant or is there a chance you may be pregnant?
• Are you breast-feeding?
• Have you ever had an allergic reaction to pizotifen or any of the ingredients in the tablet? (An allergic reaction may include a rash, itching or difficult breathing).
• Do you suffer from glaucoma?
• Do you suffer from retention of urine?
• Do you suffer from kidney problems?
• Are you taking other medicines such as medicines to make you sleep or relax e.g. nitrazepam, diazepam or amylobarbitone?
• Are you taking other medicines such as antihistamines including certain common cold preparations?
• Are you taking other medicines like medicines to lower blood pressure e.g. guanethidine?
• Are you taking any medicines to treat depression (monoamine oxidase inhibitors such as tranylcypromine) and including any that you can buy without prescription?
If the answer to any of these questions is YES and you have not already discussed this with your doctor or pharmacist you should do so as soon as possible and before taking any tablets.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
When should you take special care while taking Pizotifen tablets?
You are advised NOT to drink alcohol with this medicine.
Effects on your ability to drive and use machines
Pizotifen tablets may make you feel drowsy. Make sure you are not affected before you drive or operate machinery.
Taking Pizotifen tablets with other medicines:
It is important to check whether you are or have recently been taking other medicines before you start taking your tablets. Are you taking any of the following medicines?
Make sure that your doctor or pharmacist knows about all the medicines, you are taking including ones you have bought yourself.
Anything that makes you sleepy may make you even sleepier if you are taking pizotifen as well. This includes sleeping pills, sedatives and antihistamines such as cold and hayfever medicines. It also includes alcohol. It is best not to drink alcohol while taking pizotifen tablets.
3. HOW TO TAKE YOUR TABLETS.
It is important to take the tablets as directed by your doctor. Check the medicine label to see how many tablets to take and how often to take them. If you are not sure, ask your doctor or pharmacist. The tablets should always be taken with plenty of water.
Adults and Elderly
Usually 1.5mg once daily. This may be taken as a single dose at night or in three divided doses. Dosage should be adjusted to individual patient's requirements up to a maximum of 4.5mg daily. Up to 3mg can be given as a single daily dose.
Children
The doctor will tell you the correct dose for your child, follow their advice.
Swallow these tablets with water. It is very important that you follow your doctor's instructions as to how many Pizotifen tablets to take, how often to take them and for how long you should continue to take your tablets. It is dangerous to stop without the doctor's advice.
If you take too many tablets
It is important to stick to the dose on the label of your medicine. If you or someone else swallows several of these tablets all together, contact your doctor, pharmacist or hospital emergency department immediately. Always take any tablets left over with you and also the box, as this will allow easier identification of the tablets.
If you forget to take a dose
If you forget to take a dose, take it as soon as you remember. NEVER take two doses at the same time.
4. CAN YOUR TABLETS HAVE ANY SIDE EFFECTS?
Like all medicines, Pizotifen can have side-effects. These are usually mild.
The most commonly occurring side effects are drowsiness, this is not usually a problem as you can take the tablets in the evening. This will mean that the effect of making you drowsy will help you to sleep.
Some people may feel hungry. If you feel hungrier than usual, try to fill up on fresh low calorie foods. These are much healthier than processed high calorie foods.
Other side-effects such as dizziness, dry mouth, nausea and constipation have been reported infrequently.
If you suffer from any of the side-effects listed above and they are severe or prolonged or if you experience any other side-effects not mentioned on this leaflet, please inform your doctor or pharmacist.
5. STORING YOUR TABLETS.
Store in the original package. Do not store above 25°C, Protect from direct light.
On the label you will find 'use by' followed by some numbers. These numbers are the date when the medicine is no longer fit for use. Do not use this medicine after this date. If you have any tablets, which are out of date, return them to your pharmacist for disposal.
Store your tablets in a safe and dry place where children cannot reach them.
Remember: this treatment is for YOU. Only a doctor can prescribe it for you.
Never give it to others.
Date of preparation: March 2011