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The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 04425/0214.
Frisium 10mg Tablets
Frisium® 10mg Tablets
Clobazam
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1. What Frisium is and what it is used for
2. What you need to know before you take Frisium
3. How to take Frisium
4. Possible side effects
5. How to store Frisium
6. Contents of the pack and other information
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:
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.
Talk to your doctor or pharmacist before taking Frisium if:
Drowsiness, difficulties breathing, coma and death may occur if Frisium is taken together with opioids. Frisium and opioids should only be used concomitantly, when other treatment options are inadequate. Please tell your doctor about all opioid medicines you are taking and follow your doctor’s dosage recommendations closely.
Some studies have shown an increased risk of suicidal ideation, suicide attempt and suicide in patients taking certain sedatives and hypnotics, including this medicine. However, it has not been established whether this is caused by the medicine or if there may be other reasons. If you have suicidal thoughts, contact your doctor as soon as possible for further medical advice (see section 4).
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Frisium.
Tell your doctor or pharmacist if you are taking, have recently taken or might take 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:
Concomitant use of Frisium and opioids increases the risk of drowsiness, difficulties breathing, coma and death. Follow your doctor’s dosage recommendations closely.
If you are not sure if any of the above apply to you talk to your doctor or pharmacist.
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.
Do not drink alcohol while taking Frisium. This is because there is increased risk of sleepiness and other side effects.
Use of this medicine is not recommended during pregnancy and in women of childbearing potential not using contraception.
If you discover that you are pregnant or are planning to have a baby, consult your doctor right away to reassess the need for treatment. Do not stop taking Frisium without talking to your doctor.
A large amount of data has not shown evidence for malformations associated with the use of benzodiazepines. However, some studies have shown a potentially increased risk of cleft lip and palate in newborn babies compared to that in the general population.
Cleft lip and palate (sometimes called ‘harelip’) is a deformation at birth caused by incomplete fusion of the palate and upper lip.
Reduced fetal movement and fetal heart rate variability may occur after taking clobazam during the second and/or third trimester of pregnancy.
If Frisium is taken at the end of pregnancy or during childbirth, your baby may show drowsiness (sedation), muscle weakness (hypotonia or floppy infant syndrome), a drop in body temperature (hypothermia), difficulty feeding (problems suckling causing poor weight gain) and breathing problems (respiratory depression, sometimes severe).
If taken regularly in late pregnancy, your baby may get withdrawal symptoms such as agitation or shaking. In this case the newborn should be closely monitored during the postnatal period.
Do not take Frisium if you are breast-feeding or are planning to breast-feed. This is because it may pass into the mothers’ milk.
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.
The medicine can affect your ability to drive as it may make you sleepy or dizzy.
Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.
If you have been told by your doctor that you cannot tolerate some sugars, talk to your doctor before taking this medicine.
Always take Frisium exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Swallow the tablets whole or crushed and mixed with apple sauce. The tablets can be divided into equal halves of 5mg. Frisium can be taken with or without food.
Adults
Children (6 years and above)
Elderly
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.
Keep taking this medicine until your doctor tells you to stop. Do not stop taking Frisium just because you feel better.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
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.
Common side effects (may affect up to 1 in 10 people):
Uncommon side effects (may affect up to 1 in 100 people):
Not known (frequency cannot be estimated from available data):
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.
Very common side effects (may affect more than 1 in 10 people):
Common side effects (may affect up to 1 in 10 people):
Uncommon side effects (may affect up to 1 in 100 people):
Not known (frequency cannot be estimated from available data):
The following side effects are more likely to happen at the start of treatment. They usually last for a short time: feeling tired, dry mouth, constipation, loss of appetite, feeling sick, shaking fingers.
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.
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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
Keep out of the sight and reach of children.
Do not use Frisium after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month.
Store below 25°C.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
The tablets are white and round. Frisium is presented in a blister pack of 30 tablets.
Marketing Authorisation Holder
Manufacturer
This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.
This leaflet was last revised in July 2021
© Sanofi, 1997 - 2021
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