Frisium 10mg Tablets
S60 frisium LEAFLET 20140227
PACKAGE LEAFLET: INFORMATION FOR USER FRISIUM 10mg TABLETS (clobazam)
Your medicine is marketed using the above names but will be referred to as Frisium throughout the following patient information leaflet.
Read all of this leaflet carefully before you start taking this
medicine
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do 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 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 Frisium is and what it is used for
2. Before you take Frisium
3. How to take Frisium
4. Possible side effects
5. How to store Frisium
6. Further information
1. WHAT FRISIUM IS AND WHAT IT IS USED FOR
Frisium contains a medicine called Clobazam. This belongs to a group of medicines called benzodiazepines. It works by having a calming effect on the brain.
Frisium can be used for:
• Severe anxiety over a short time
• Epilepsy (fits) over a longer time
• Mental illness such as schizophrenia (in combination with other treatments)
2. BEFORE YOU TAKE FRISIUM
Do not take Frisium if:
• You are allergic (hypersensitive) to clozabam, other benzodiazepine medicines or any of the other ingredients of Frisium (see section 6: Further Information)
Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue
• You are in the first three months of pregnancy or think you might be pregnant (see below under ‘Pregnancy and breastfeeding' for more information)
• You are breast-feeding
• You have ever had problems with drugs or alcohol dependence in the past
• You suffer from an illness that causes muscle weakness (called ‘myasthenia gravis')
• You have liver problems
• You have breathing problems
• You stop breathing for short periods during sleep (called ‘sleep apnoea syndrome')
• The patient is under 6 years old
Do not take if any of the above apply to you. If you are not sure, talk
to your doctor or pharmacist before taking Frisium.
Take special care with Frisium
Check with your doctor or pharmacist before taking your medicine if:
• You have problems with controlling your movements (called ‘spinal or cerebellar ataxia')
• You have depression, irrational fears and obsessions
• You have delusions (believing things which are not true) or hallucinations (sensing things which are not there)
• You have kidney problems
• You have ever become dependent upon another drug or alcohol
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Frisium.
A small number of people being treated with anti-epileptics such as frisium have had thoughts if harming or killing themselves. If at any time you have theses thoughts, immediately contact your doctor.
Taking Frisium with other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Frisium can affect the way some other medicines work. Also some medicines can affect the way Frisium works. In particular, tell your doctor if you are taking any of the following:
• Medicines for epilepsy (such as phenytoin, carbamazepine or valproic acid)
• Medicines for depression (such as MAOIs or tricyclic antidepressants - such as trazodone)
• Medicines for severe mental illness called ‘neuroleptics' (such as chlorpromazine, haloperidol and clozapine)
• Painkillers (such as medicines containing codeine, dihydrocodeine or morphine)
• Sleeping tablets (such as zolpidem)
• Tranquilisers (such as diazepam, temazepam or lorazepam)
• Muscle relaxants (such as baclofen)
• Antihistamines that make you sleepy (such as chlorphenamine, promethazine or diphenenhydramine)
• Lithium - used for a mental illness called ‘manic-depressive illness' (mood changes between a state of high excitability or exaggerated emotions and depression)
• Cimetidine - used to treat ulcers and heartburn
If you are not sure if any of the above apply to you talk to your
doctor or pharmacist
Anaesthetics
If you are going to have an anaesthetic, tell your doctor or anaesthetist you are taking Frisium. This is because your doctor may need to change the amount of anaesthetic or muscle relaxants to give you.
Taking Frisium with food and drink
• Do not drink alcohol while taking Frisium. This is because alcohol can change the way Frisium works
• Take your tablets with at least half a glass of water
• Do not chew the tablets Pregnancy and breast-feeding:
Do not take Frisium if you are:
• In the first three months of pregnancy
• Breast-feeding. This is because it may pass into the mother's milk
Talk to your doctor before taking this medicine if you are pregnant, plan to get pregnant, or think you may be pregnant. This is because Frisium is not recommended for use in pregnant women.
However, your doctor may give you this medicine during late pregnancy or during labour
• If this happens, there is a risk of having a baby with a low body temperature, floppiness, breathing or feeding problems
• If this medicine is taken regularly in late pregnancy, your baby may get withdrawal symptoms
Driving and using machines
You may feel sleepy or have concentration or memory problems after taking this medicine. You may also experience double vision or you may react more slowly to things. If this happens, do not drive or use any tools or machines.
Important information about some of the ingredients of Frisium
If you have been told by your doctor that you cannot tolerate some sugars, talk to your doctor before taking this medicine. This is because Frisium contains lactose.
3. HOW TO TAKE FRISIUM
Always take Frisium exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Taking this medicine
Swallow the tablets whole with half a glass of water. Do not chew the tablets.
• If you feel the effect of your medicine is too weak or too strong, do not change the dose yourself, but ask your doctor
• Keep taking Frisium until your doctor tells you to stop
• Frisium is usually given for 2 to 4 weeks. After that, your doctor will decide whether you should keep taking this medicine
Adults
• The usual dose is 20 mg to 30 mg each day. This can be taken as two separate doses or as a single dose at night
• Your doctor may increase your dose to up to 60 mg each day
• Your doctor may lower the dose to suit you Children (6 years and above)
• The usual dose is 5 mg each day Elderly
• The usual dose for anxiety is 10 mg to 20 mg each day If you take more Frisium than you should
If you take more Frisium than you should, tell your doctor or go to your nearest hospital casualty department straight away. Do not drive yourself, because you may start to feel sleepy. Remember to take with you any tablets that are left and the pack. This is so the doctor knows what you have taken.
If you forget to take Frisium
• If you forget a dose, take it as soon as you remember it
• However, if it is nearly time for the next dose, skip the missed dose
• Do not take a double dose to make up for a forgotten tablet If you stop taking Frisium
Keep taking this medicine until your doctor tells you to stop. Do not stop taking Frisium just because you feel better
• When your doctor says that you can stop taking Frisium, you need to do this gradually. Your doctor will help you to do this.
• Stopping the tablets can make you feel stressed (anxiety), confused or depressed. You may also lose your appetite and have difficulty sleeping. Tell your doctor if this happens.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Frisium can cause side effects, although not everybody gets them.
You may feel ill after taking the tablets, or notice unusual or unexpected symptoms. If this happens, tell your doctor.
Tell your doctor straight away if you have any of the following side effects:
• Feeling restless, have difficulty sleeping or nightmares
• Feeling irritable or anxious
• Believing things which are not true (delusions)
• Sensing things which are not there (hallucinations)
• Feeling suicidal
If you get any of the above side effects, your doctor may decide that your treatment needs to be stopped. These side-effects are more likely to happen in elderly people and children.
Tell your doctor or pharmacist if any of the following side effects get serious or lasts longer than a few days, or if you notice any side effects not listed in this leaflet.
The following side effects are more likely to happen at the start of treatment. They usually last for a short time.
• Feeling sleepy or dizzy
• Dry mouth, constipation
• Loss of appetite, feeling sick
• Shaking fingers Other side-effects include:
• Headache
• Breathing problems
• Loss of memory, confusion
• Skin rash
• Muscle weakness
• Problems walking or other movement problems
• Being aggressive
• Reacting to things more slowly than usual
• Eye problems such as double vision
• Difficulty in staying awake or alert
• Becoming dependent on Frisium (also called ‘physical or mental dependence')
• Weight gain
• Loss of sexual drive
If you take this medicine for a long time, you are more likely to get the following side effects: anxiety, confusion, depression, loss of appetite and difficulty sleeping.
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.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on the safety of this medicine.
5. HOW TO STORE FRISIUM
• KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
• Do not store your tablet above 25°C.
• Store in the original package.
• Do not use Frisium after the expiry date printed on the carton label or blister strip. The expiry date refers to last day of that month.
• If your doctor tells you to stop using the medicine or the medicine goes out of date, please take it back to the pharmacist for safe disposal. Only keep the medicine if your doctor tells you to.
• If the medicine becomes discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.
• 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 Frisium contains
• Each tablet contains 10mg of the active ingredient, clobazam.
• Frisium Tablets also contain the following inactive ingredients: lactose, maize starch, talc, colloidal silicon dioxide and magnesium stearate.
What Frisium looks like and contents of the pack
Frisium tablets are round, white tablets marked on one side with ‘B' and ‘GL' on either side of a scoreline, and the company logo on the other side.
Frisium Tablets are available as blister packs of 20 and 30 tablets. Product Licence holder
Procured from within the EU and repackaged by the Parallel Import Product Licence holder: S&M Medical Ltd, Chemilines House, Alperton Lane, Wembley, HA0 1 DX.
Manufacturer
These products are manufactured by Usiphar SA, 56 Route de Choisy au Bac, 60200 Compiegne, France.
| POM | PL No: 19488/0060 Leaflet revision date: 27 February 2014
Frisium is a registered trademark of IPR Pharmaceuticals Puerto Rico.
S60 frisium LEAFLET 20140227