Flunarizine to prevent complex migraine in children

This leaflet should be read in conjunction with the product characteristic leaflet that can be found inside all boxes of medication. The use of any medicine is based on considerations of how benefits outweigh potential side effects. Your prescribing doctor will discuss the risks and benefits of the medication as it relates to you and answer any further questions you may have.

This information sheet describes flunarizine, how it can be used and some of the possible side effects. Each person reacts differently to medicines so your child will not necessarily suffer every side effect mentioned. If you have any questions or concerns, please ask your doctor, nurse or pharmacist or telephone one of the numbers on this information sheet.

What is flunarizine?

Flunarizine has been used in medical practice for over 25 years. It was initially introduced as a medicine to improve blood flow and is a medicine known as a calcium channel blocker. It has been mainly used in the treatment of dizziness, vertigo and prevention of migraine.

Although this medicine is widely used by headache specialists in the world and is licensed in many countries for the prevention of migraine, it should be noted that flunarizine is not marketed nor licensed in the UK. The medicine has to be imported from abroad by a licensed pharmaceutical import company under the brand name Sibelium®.

Medicines are often used ‘off licence’ in children for a number of reasons for example limited data available for a specific use in children. This is not necessarily hazardous but should be explained and agreed before use. Your doctor will explain this further to you.

How is it given?

Flunarizine should be taken at night time starting with a low dose of 5mg. This may then be increased as recommended by your doctor.

You should encourage your child to continue with the medicine as it may not take full effect for about eight to 12 weeks. If beneficial, the medicine will usually be used for at least six months but you will be advised further about this by your doctor.

Who should not take flunarizine?

People with the following conditions should discuss taking flunarizine with their doctor:

• Hypersensitivity to flunarizine or any of its ingredients
• Depression or previous episodes of serious depression
• Parkinson’s disease or a family history of Parkinson’s disease
• Liver damage

What are the side effects of flunarizine?

The main side effects of flunarizine are tiredness, drowsiness, weight gain and low mood.

• Tiredness and drowsiness can be reduced by starting with a low dose and taking it at night. The dose will then be increased gradually once your child becomes tolerant to these effects.
• Possible weight gain is caused by an increase in appetite and can be avoided by your child following his or her usual diet without any increase in portion size.
• If your child develops low mood or depressive symptoms, please tell your doctor as flunarizine may need to be discontinued. You should take advice from your family doctor (GP) whether specific treatment may be necessary for the treatment of depression if the symptoms do not disappear within one month.

There have also been reported cases of flunarizine causing symptoms as seen in Parkinsons’s Disease (such as slowing of movements, rigidity and tremor) which usually disappear when flunarizine is stopped.

As this medication has a long half-life it will usually take a few weeks for the side-effects to subside after stopping the drug.

Other side effects that have been reported include: sickness and upset stomach, insomnia, dry mouth, weakness and muscles aches, and a skin rash. If you are concerned about any of these, please tell your doctor.

Flunarizine and other medicines

Please ensure you tell any doctor or pharmacist involved in your care that you take flunarizine. Flunarizine can interact with other medication, including herbal or complementary medicines, possibly leading to further side effects.

Getting supplies of flunarizine

As this drug is not licensed for use in UK, you can only obtain the prescription and medication through our hospital out-patient pharmacy (Rowlands Pharmacy). You must make contact with our pharmacy with a minimum of three weeks before you run out of supply to enable us to arrange another prescription for you which you may need to pick up from Addenbrooke’s hospital.

Important information

• Keep medicines in a safe place where children cannot reach them.
• The tablets should be kept in a cool, dry place out of direct sunlight and heat.
• If you forget to give your child a dose and it is within a few hours of when the dose was due, give it as soon as you remember. Otherwise, do not give this dose but give the next dose when it is due. Do not give a double dose.
• If your doctor decides to stop treatment or the tablets pass their expiry date, return any unused tablets to the pharmacist. Do not flush them down the toilet or throw them away.

Useful numbers

Addenbrookes switchboard: 01223 245 151

Pharmacy medicines information: 01223 217 502

Neurology department: 01223 216662