Sanomigran Elixir 0.25mg/5ml
SANOMIGRAN® Elixir (pizotifen)
Patient Information Leaflet
What you need to know about Sanomigran Elixir
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.
In this leaflet:
1. What Sanomigran Elixir is and what it’s used for
2. Things to consider before you start to take Sanomigran Elixir
3. How to take Sanomigran Elixir
4. Possible side effects
5. How to store Sanomigran Elixir
6. Further information
1. What Sanomigran Elixir is and what it’s used for
Sanomigran Elixir is a syrup containing 0.25 mg of the active ingredient, pizotifen, in each 5 ml.
Sanomigran Elixir is a migraine treatment. It may help to stop the effects of certain naturally occurring substances in your body called “serotonin”, “histamine” and “tryptamine” which are involved in causing some kinds of headache, including migraine.
Sanomigran Elixir 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 Elixir can stop some migraine attacks starting and help make other attacks less severe. It will not stop migraine attacks once they have started.
2. Things to consider before you start to take Sanomigran Elixir
Some people MUST NOT take Sanomigran Elixir. Talk to your doctor if:
• you think you may be allergic to pizotifen or to any of the other ingredients of the elixir. (These are listed at the end of the leaflet.)
• you are breast-feeding.
Sanomigran Elixir should not be given to children aged under 2.
You should also ask yourself these questions before taking Sanomigran Elixir:
• 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 such as fructose? (The elixir contains maltitol (hydrogenated glucose syrup).)
• Are you an alcoholic?
If the answer to any of these questions is YES, tell your doctor or pharmacist because Sanomigran Elixir 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 Elixir may affect the way they work.
• Anything that makes you sleepy may make you even sleepier if you are taking Sanomigran Elixir 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 Elixir.
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 Elixir. 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.
Sanomigran Elixir contains ethanol (alcohol). 5 ml of the elixir contains nearly 0.1 g of ethanol. The usual daily dose of 30 ml (1.5 mg pizotifen), will contain nearly 0.6 g of ethanol. This is less than a glass of wine or a pint of beer, but will affect your blood alcohol levels so you should take care not to go over the limit if you are driving.
Other special warnings
• Sanomigran Elixir contains small amounts of the preservatives methyl and propyl
hydroxybenzoate. These can sometimes cause allergic reactions which might appear some time after first taking the elixir.
3. How to take Sanomigran Elixir
The doctor will decide what dose of Sanomigran Elixir you should take. Always take the medicine 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 much to take, and how often. If you are not sure, ask your doctor or pharmacist. Keep taking Sanomigran Elixir for as long as you have been told unless you have any problems. In that case, check with your doctor.
With Sanomigran Elixir, 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 for adults is 1.5 mg of pizotifen each day. This is six 5ml spoonfuls.
• You may have been told to take your medicine once a day, or you may have it split into three smaller doses.
• Do not take more than 3 mg (twelve 5ml spoonfuls) in a single dose. Do not take more than 4.5 mg (eighteen 5ml spoonfuls) in a day.
Children (aged over 2 years)
• Children can take up to 1.5 mg of pizotifen each day. This is six 5ml spoonfuls.
• This is usually best given in two or three smaller doses.
• Do not give them more than 1 mg in a single dose. This is four 5ml spoonfuls.
Sanomigran Elixir should not be given to children under 2 years of age.
Taking Sanomigran Elixir
• Have a drink with your elixir if this helps you to swallow.
• If you take Sanomigran Elixir once a day, take it in the evening a few hours before you go to bed as any drowsiness will help you to sleep.
• If you take your elixir in two or three doses, spread them evenly through the day.
Carry on taking your Sanomigran Elixir even when you feel well. Your headaches may come back if you stop taking it. Do not stop taking it 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 the medicine.
What if you forget to take a dose?
If you forget to take your medicine, do not worry. If you normally take Sanomigran Elixir 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 Sanomigran Elixir once a 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 medicine.
What if you take too much?
All medicines can be risky if you take too much. If you take too much Sanomigran Elixir at one go, 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 Elixir is suitable for most people, but, like all medicines, it can sometimes cause side effects.
Some side effects can be serious
Stop taking the medicine 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 medicine 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 medicine.
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 troublesome, 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 or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine. United Kingdom: Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard
5. How to store Sanomigran Elixir
Keep all medicines out of the reach and sight of children.
Do not take the elixir after the expiry date which is printed on the outside of the pack.
If your doctor tells you to stop taking Sanomigran Elixir, please take any which is left back to your pharmacist to be destroyed. Only keep it if the doctor tells you to. Do not throw it away with your normal household water or waste. This will help to protect the environment.
6. Further information
Sanomigran Elixir is a clear, colourless liquid with a pleasant fruity flavour containing 0.25 mg of the active ingredient pizotifen (as 0.365 mg of pizotifen hydrogen malate) in each 5 ml of syrup. It comes in a bottle containing 300 ml.
The syrup also contains the inactive ingredients citric acid anhydrous, methyl and propyl hydroxybenzoate, raspberry flavour, maraschino flavour, disodium phosphate anhydrous, ethanol 96% w/v, maltitol liquid and purified water. It does not contain tartrazine.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Phoenix Labs, Suite 12, Bunkilla Plaza, Bracetown Business Park, Clonee, County Meath, Ireland. Manufacturer
Novartis Pharmaceuticals UK Ltd, Wimblehurst Road, Horsham, West Sussex, RH12 5AB, England, United Kingdom and Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, England, United Kingdom.