Pizotifen 0.5mg Tablets
Sanomigran® 0.5mg Tablets
(pizotifen hydrogen malate)
Patient Information Leaflet
This medicine will usually be referred to just as Sanomigran in this leaflet.
What you need to know about Sanomigran
Your doctor has decided that you need this medicine to help treat your condition.
Please read this leaflet carefully before you start to take your medicine. It contains important information.
Keep the leaflet in a safe place because you may want to read it again.
If you have any other questions, or if there is something you don’t understand, please ask your doctor or pharmacist.
This medicine has been prescribed for you. Never give it to someone else. It may not be the right medicine for them even if their symptoms seem to be the same as yours.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
The name of your medicine is Sanomigran 0.5mg Tablets but will be referred to as Sanomigran throughout this leaflet. Please note that this leaflet also contains information about the other strength: Sanomigran 1,5mg tablets.
In this leaflet:
1. What Sanomigran is and what it is used for
2. Things to consider before you start to take Sanomigran
3. How to take Sanomigran
4. Possible side effects
5. How to store Sanomigran
6. Further information
1. What Sanomigran is and what it is used for
Sanomigran is available in two different strengths containing either 0.5mg or 1,5mg of the active ingredient, pizotifen hydrogen malate.
Sanomigran is a migraine treatment.
They may help to stop the effects of certain naturally occurring substances in your body called ‘serotonin’, ‘histamine’ and ‘tryptamine’ which is involved in causing some kinds of headache, including migraine.
Sanomigran has been prescribed for you by your doctor to help your migraine type headaches. If it is taken regularly it can help to prevent headaches or reduce the pain of cluster headaches, common and classical migraine. Sanomigran can stop some migraine attacks starting and help make other attacks less severe.
They will not stop migraine attacks once they have started.
2. Things to consider before you start to take Sanomigran
Some people MUST NOT take Sanomigran.
Talk to your doctor if:
• you think you may be allergic to pizotifen hydrogen malate or to any of the other ingredients of Sanomigran. (These are listed at the end of the leaflet).
• you are breast-feeding.
Sanomigran should not be given to children aged under 2.
You should also ask yourself these questions before taking Sanomigran:
• Do you have glaucoma (raised pressure in your eyes)?
• Do you ever have problems passing urine?
• Do you have kidney problems, especially kidney failure? (The medical term for this is renal failure.)
• Do you have liver problems? Sanomigran has been associated with abnormal results of liver function tests and possibly liver problems in a few patients. You may not notice any symptoms but if you notice yellowing of your skin or the whites of your eyes, abnormal darkening of the urine or unexplained nausea, vomiting and tiredness, tell your doctor straightaway. Your doctor may request blood tests to check and to monitor your liver function and may request that you stop the treatment if your liver problem is serious.
• Do you have epilepsy?
• Are you pregnant?
• Do you have an intolerance to some sugars? (The tablets contain a small amount of lactose and sucrose.)
If the answer to any of these questions is YES, tell your doctor or pharmacist because Sanomigran might not be the right medicine for you.
Are you taking other medicines?
• Remind your doctor if you are taking drugs called alpha-or beta-blockers because Sanomigran may affect the way they work.
• Anything that makes you sleepy may make you even sleepier if you are taking Sanomigran 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 you are taking Sanomigran.
Always tell your doctor about all the medicines you are taking. This means medicines you have bought yourself as well as medicines on prescription from your doctor.
Will there be any problems with driving or using machinery?
Some people may feel drowsy and/or dizzy while they are taking Sanomigran. If this happens, you should not drive or do anything that requires you to be alert (such as operate tools or machinery) until such problems clear.
3. How to take Sanomigran
The doctor will decide what dose of Sanomigran you should take. Always take the tablets exactly as your doctor has told you to. The dose will be on the pharmacist’s label. Check the label carefully. It should tell you how many tablets to take, and how often. If you are not sure, ask your doctor or pharmacist. Keep taking the tablets for as long as you have been told unless you have any problems. In that case, check with your doctor. With Sanomigran, you do not wait for a migraine and then treat the pain. You take it regularly to stop your migraines even beginning or to make them less severe.
Adults
• The usual dose is 1,5mg of pizotifen each day. This is one 1,5mg tablet or three 0.5mg tablets. You may have been told to take your tablets once a day or as three smaller doses.
• Do not take more than 3mg in a single dose (two 1,5mg tablets or six 0.5mg tablets). Do not take more than 4.5mg (three 1,5mg tablets or nine 0.5mg tablets) in a day.
Children (aged over 2 years)
• Children can take up to 1,5mg of pizotifen each day. This is three 0.5mg tablets. This is usually best given in two or three smaller doses.
• Do not use the 1,5mg tablets for children. Do not give them more than 1 mg in a single dose. This is two 0.5mg tablets.
For children over 2 who find it difficult to take tablets Sanomigran is also available as an elixir (syrup).
Sanomigran and Elixir should not be given to children under 2 years of age.
Taking Sanomigran
• Swallow the tablets whole. Have a drink with them if this helps you to swallow.
• If you take Sanomigran once a day, take them in the evening a few hours before you go to bed as any drowsiness will help you to sleep.
• If you take your tablets in two or three doses, spread them evenly through the day.
Carry on taking your Sanomigran even when you feel well. Your headaches may come back if you stop taking them. Do not stop taking them suddenly, or you may experience withdrawal symptoms, such as feeling anxious, shaking, insomnia, feeling sick and blackouts. Talk to your doctor if you want to stop taking your tablets.
What if you forget to take a dose?
If you forget to take your tablets, do not worry. If you normally take Sanomigran several times a day you should take the last dose you missed as soon as you remember. Do not take it if there is less than 4 hours before your next dose, but go back to your regular dosing schedule. Do not double doses or take more than your maximum daily dose.
If you normally take one tablet each day take the dose as soon as you remember. Take your next dose as usual. Do not take more than your maximum daily dose.
Tell your doctor if you keep forgetting to take your tablets.
What if you take too many tablets?
All tablets can be risky if you take too many. If you take too many Sanomigran at once, tell your doctor or hospital casualty department as soon as possible. Take your medicine pack with you so that people can see what you have taken.
If you stop taking Sanomigran
Do not change or stop the treatment without first asking your doctor. Your doctor may want you to reduce the dosage gradually before stopping completely. This is to prevent any worsening of your condition and reduce the risk of withdrawal symptoms such as depression, trembling, nausea, anxiety, generally feeling unwell, dizziness, sleep disorder and weight loss.
4. Possible side effects
Sanomigran is suitable for most people, but, like all medicines, they can sometimes cause side effects.
Some side effects can be serious Stop taking the tablets and tell your doctor immediately if you notice any of the following rare symptoms:
• Symptoms of allergy such as a rash, itching or hives on the skin or swelling of the face.
The side effects listed below have also been reported:
More than 1 in 10 people have experienced:
Increase in appetite and weight gain. An increase in appetite may lead to an increase in bodyweight. If you feel hungrier than usual, try to fill up on fresh low calorie foods. These are much healthier than processed high calorie foods. Your doctor can give you advice about diet as some kinds of foods are known to trigger migraine.
Up to 1 in 10 people have experienced:
Drowsiness, tiredness, dizziness, dry mouth, nausea. Feeling drowsy is not usually a problem as you can take the tablets in the evening. The effect of making you drowsy will help you to sleep. You are less likely to feel drowsy after a few weeks, as you get used to the tablets.
Up to 1 in 100 people have experienced:
Constipation.
Up to 1 in 1,000 people have experienced:
Depression, excitability or restlessness, hallucinations (seeing, hearing or feeling things that are not there), sleep disturbances, insomnia, anxiety, tingling or numbness of the hands or feet, muscle or joint pain.
Very rarely (less than 1 in 10,000) people have experienced:
Convulsions (fits). Tell your doctor immediately if you have a fit.
Frequency: not known:
If you have signs of yellowing of your skin or the whites of your eyes, abnormal darkening of the urine or unexplained nausea, vomiting and tiredness (signs of jaundice or hepatitis).
Muscle cramps.
If any of the symptoms become trou blesome, or if you notice anything else not mentioned here, please go and see your doctor. He/she may want to give you a different medicine.
Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.aov.uk/vellowcard By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Sanomigran
• Keep out of the sight and reach of children.
• Do not use after the expiry date which is stated on the carton after ‘Exp’. The expiry date refers to the last day of that month.
• Keep the blister strips in the outer carton in order to protect from light. Only remove them when it is time to take your medicine.
• 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.
6. Further information
What Sanomigran contains
• Each tablet contains 0.725mg pizotifen hydrogen malate equivalent to 0.5mg pizotifen.
• The other ingredients are:
tablet core - lactose monohydrate, maize starch, povidone, magnesium stearate, talc
tablet coating - acacia gum, talc, sucrose, colloidal anhydrous silica, carnauba wax, printing ink and colouring agents titanium dioxide (E171) and yellow iron oxide (E172).
What Sanomigran looks like and contents of the pack
• Sanomigran is small ivory to yellow tablets marked ‘SMG’ on one face.
• Sanomigran comes in blister packs containing 60 tablets.
Manufactured by:
Novartis Pharmaceuticals UK Limited Wimblehurst Road, Horsham, West Sussex, RH12 5AB, England
Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 ONU, UK.
Sanomigran® 0.5mg Tablets IpoM I PL No: 18799/2390 1-1
Leaflet date: 26.06.2015
Sanomigran is a registered trademark of Novartis.
Patient Information Leaflet
This medicine will usually be referred to just as Pizotifen in this leaflet.
What you need to know about Pizotifen
Your doctor has decided that you need this medicine to help treat your condition.
Please read this leaflet carefully before you start to take your medicine. It contains important information.
Keep the leaflet in a safe place because you may want to read it again.
If you have any other questions, or if there is something you don’t understand, please ask your doctor or pharmacist.
This medicine has been prescribed for you. Never give it to someone else. It may not be the right medicine for them even if their symptoms seem to be the same as yours.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
The name of your medicine is Pizotifen 0.5mg Tablets but will be referred to as Pizotifen throughout this leaflet. Please note that this leaflet also contains information about the other strength: Pizotifen 1,5mg tablets.
In this leaflet:
1. What Pizotifen is and what it is used for
2. Things to consider before you start to take Pizotifen
3. How to take Pizotifen
4. Possible side effects
5. How to store Pizotifen
6. Further information
1. What Pizotifen is and what it is used for
Pizotifen is available in two different strengths containing either 0.5mg or 1,5mg of the active ingredient, Pizotifen hydrogen malate.
Pizotifen is a migraine treatment.
They may help to stop the effects of certain naturally occurring substances in your body called ‘serotonin’, ‘histamine’ and ‘tryptamine’ which is involved in causing some kinds of headache, including migraine.
Pizotifen have been prescribed for you by your doctor to help your migraine type headaches.
If it is taken regularly it can help to prevent headaches or reduce the pain of cluster headaches, common and classical migraine. Pizotifen can stop some migraine attacks starting and help make other attacks less severe.
They will not stop migraine attacks once they have started.
2. Things to consider before you start to take Pizotifen
Some people MUST NOT take Pizotifen. Talk to your doctor if:
• you think you may be allergic to Pizotifen hydrogen malate or to any of the other ingredients of Pizotifen. (These are listed at the end of the leaflet).
• you are breast-feeding.
Pizotifen should not be given to children aged under 2.
You should also ask yourself these questions before taking Pizotifen:
• Do you have glaucoma (raised pressure in your eyes)?
• Do you ever have problems passing urine?
• Do you have kidney problems, especially kidney failure? (The medical term for this is renal failure.)
• Do you have liver problems? Pizotifen has been associated with abnormal results of liver function tests and possibly liver problems in a few patients. You may not notice any symptoms but if you notice yellowing of your skin or the whites of your eyes, abnormal darkening of the urine or unexplained nausea, vomiting and tiredness, tell your doctor straightaway. Your doctor may request blood tests to check and to monitor your liver function and may request that you stop the treatment if your liver problem is serious.
• Do you have epilepsy?
• Are you pregnant?
• Do you have an intolerance to some sugars? (The tablets contain a small amount of lactose and sucrose.)
If the answer to any of these questions is YES, tell your doctor or pharmacist because Pizotifen might not be the right medicine for you.
Are you taking other medicines?
• Remind your doctor if you are taking drugs called alpha-or beta-blockers because Pizotifen may affect the way they work.
• 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 you are taking Pizotifen.
Always tell your doctor about all the medicines you are taking. This means medicines you have bought yourself as well as medicines on prescription from your doctor.
Will there be any problems with driving or using machinery?
Some people may feel drowsy and/or dizzy while they are taking Pizotifen. If this happens, you should not drive or do anything that requires you to be alert (such as operate tools or machinery) until such problems clear.
3. How to take Pizotifen
The doctor will decide what dose of Pizotifen you should take. Always take the tablets exactly as your doctor has told you to. The dose will be on the pharmacist’s label. Check the label carefully. It should tell you how many tablets to take, and how often. If you are not sure, ask your doctor or pharmacist. Keep taking the tablets for as long as you have been told unless you have any problems. In that case, check with your doctor. With Pizotifen, you do not wait for a migraine and then treat the pain. You take it regularly to stop your migraines even beginning or to make them less severe.
Adults
• The usual dose is 1,5mg of Pizotifen each day. This is one 1,5mg tablet or three 0.5mg tablets. You may have been told to take your tablets once a day or as three smaller doses.
• Do not take more than 3mg in a single dose (two 1,5mg tablets or six 0.5mg tablets). Do not take more than 4.5mg (three 1.5mg tablets or nine 0.5mg tablets) in a day.
Children (aged over 2 years)
• Children can take up to 1,5mg of Pizotifen each day. This is three 0.5mg tablets. This is usually best given in two or three smaller doses.
• Do not use the 1,5mg tablets for children. Do not give them more than 1 mg in a single dose. This is two 0.5mg tablets.
For children over 2 who find it difficult to take tablets Pizotifen is also available as an elixir (syrup).
Pizotifen and Elixir should not be given to children under 2 years of age.
Taking Pizotifen
• Swallow the tablets whole. Have a drink with them if this helps you to swallow.
• If you take Pizotifen once a day, take them in the evening a few hours before you go to bed as any drowsiness will help you to sleep.
• If you take your tablets in two or three doses, spread them evenly through the day.
Carry on taking your Pizotifen even when you feel well. Your headaches may come back if you stop taking them. Do not stop taking them suddenly, or you may experience withdrawal symptoms, such as feeling anxious, shaking, insomnia, feeling sick and blackouts. Talk to your doctor if you want to stop taking your tablets.
What if you forget to take a dose?
If you forget to take your tablets, do not worry. If you normally take Pizotifen several times a day you should take the last dose you missed as soon as you remember. Do not take it if there is less than 4 hours before your next dose, but go back to your regular dosing schedule. Do not double doses or take more than your maximum daily dose.
If you normally take one tablet each day take the dose as soon as you remember. Take your next dose as usual. Do not take more than your maximum daily dose.
Tell your doctor if you keep forgetting to take your tablets.
What if you take too many tablets?
All tablets can be risky if you take too many. If you take too many Pizotifen at once, tell your doctor or hospital casualty department as soon as possible. Take your medicine pack with you so that people can see what you have taken.
If you stop taking Pizotifen
Do not change or stop the treatment without first asking your doctor. Your doctor may want you to reduce the dosage gradually before stopping completely. This is to prevent any worsening of your condition and reduce the risk of withdrawal symptoms such as depression, trembling, nausea, anxiety, generally feeling unwell, dizziness, sleep disorder and weight loss.
4. Possible side effects
Pizotifen are suitable for most people, but, like all medicines, they can sometimes cause side effects.
Some side effects can be serious Stop taking the tablets and tell your doctor immediately if you notice any of the following rare symptoms:
• Symptoms of allergy such as a rash, itching
or hives on the skin or swelling of the face.
The side effects listed below have also been reported:
More than 1 in 10 people have experienced:
Increase in appetite and weight gain. An increase in appetite may lead to an increase in bodyweight. If you feel hungrier than usual, try to fill up on fresh low calorie foods. These are much healthier than processed high calorie foods. Your doctor can give you advice about diet as some kinds of foods are known to trigger migraine.
Up to 1 in 10 people have experienced:
Drowsiness, tiredness, dizziness, dry mouth, nausea. Feeling drowsy is not usually a problem as you can take the tablets in the evening. The effect of making you drowsy will help you to sleep. You are less likely to feel drowsy after a few weeks, as you get used to the tablets.
Up to 1 in 100 people have experienced:
Constipation.
Up to 1 in 1,000 people have experienced:
Depression, excitability or restlessness, hallucinations (seeing, hearing or feeling things that are not there), sleep disturbances, insomnia, anxiety, tingling or numbness of the hands or feet, muscle or joint pain.
Very rarely (less than 1 in 10,000) people have experienced:
Convulsions (fits). Tell your doctor immediately if you have a fit.
Frequency: not known:
If you have signs of yellowing of your skin or the whites of your eyes, abnormal darkening of the urine or unexplained nausea, vomiting and tiredness (signs of jaundice or hepatitis).
Muscle cramps.
If any of the symptoms become trou blesome, or if you notice anything else not mentioned here, please go and see your doctor. He/she may want to give you a different medicine.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.aov.uk/vellowcard By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Pizotifen
• Keep out of the sight and reach of children.
• Do not use after the expiry date which is stated on the carton after ‘Exp’. The expiry date refers to the last day of that month.
• Keep the blister strips in the outer carton in order to protect from light. Only remove them when it is time to take your medicine.
• 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.
6. Further information
What Pizotifen contains
• Each tablet contains 0.725mg Pizotifen hydrogen malate equivalent to 0.5mg Pizotifen.
• The other ingredients are:
tablet core - lactose monohydrate, maize starch, povidone, magnesium stearate, talc
tablet coating - acacia gum, talc, sucrose, colloidal anhydrous silica, carnauba wax, printing ink and colouring agents titanium dioxide (E171) and yellow iron oxide (E172).
What Pizotifen looks like and contents of the pack
• Pizotifen is small ivory to yellow tablets marked ‘SMG’ on one face.
• Pizotifen comes in blister packs containing 60 tablets
Manufactured by:
Novartis Pharmaceuticals UK Limited Wimblehurst Road, Horsham, West Sussex, RH12 5AB, England.
Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 ONU, UK
Pizotifen 0.5mg Tablets |POM|
PL No: 18799/2390
Leaflet date: 26.06.2015