Perizam 2mg/ml Oral Suspension

• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4
• This medicine contains clobazam, which can cause dependence, tolerance and addiction. You can get withdrawal symptoms if you stop taking it or reduce the dose suddenly. If this medicine is being used for the treatment of epilepsy you must continue to take this medicine as instructed by your doctor.

1. What Perizam Oral Suspension is and what it is used for
2. What you need to know before you take Perizam Oral Suspension
3. How to take Perizam Oral Suspension
4. Possible side effects
5. How to store Perizam Oral Suspension
6. Contents of the pack and other information

• you are allergic to clobazam or any of the other ingredients of this medicine (listed in section 6).
  The signs of an allergic reaction may include swelling of your face, lips, tongue or throat, difficulty breathing or swallowing, severe itching of your skin with raised lumps
• you have ever been addicted to drugs or alcohol
• you have an illness that causes muscle weakness (‘myasthenia gravis’)
• you have breathing problems
• you stop breathing for short periods while you sleep (‘sleep apnoea syndrome’)
• you have severe liver problems
• you are in the first 3 months of pregnancy, think you might be pregnant or are breast-feeding (see section 2 ‘Pregnancy, breast-feeding and fertility’)
• the patient is under 2 years old, except if the doctor decides this is necessary.

Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Perizam.

Note: Make sure that you receive the same clobazam medicine every time you collect your prescription unless your doctor has agreed to change to a different clobazam medicine. If the appearance of this medicine is not the same as usual or if the dosage instructions have changed, speak to your doctor or pharmacist as soon as possible to make sure you have the right medicine.

There have been very rare reports of potentially life-threatening skin rashes (Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis) with the use of Perizam. Symptoms of which may include: flu-like symptoms followed by a painful red or purplish rash that spreads and blisters. If you develop any of the above you must stop taking this medicine and inform your doctor straight away (see Section 4).

Talk to your doctor or pharmacist before taking Perizam if:

• you have problems with controlling your movements (‘spinal or cerebellar ataxia’)
• you have depression, irrational fears or obsessions
• you have kidney problems
• you sometimes believe things which are not true (delusions) or see things which are not there (hallucinations)
• you have ever been addicted to opioids, alcohol, prescription medicines, or illegal drugs, or if you have ever had a history of struggling to control your alcohol or drug intake. Alcohol should not be taken during treatment with Perizam as there is an increased risk of experiencing side effects
• you have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating, when you have stopped taking alcohol or drugs
• you are over 65. This is due to increased sensitivity to adverse reactions in elderly such as drowsiness, dizziness and muscle weakness. There is also an increased risk of fall that might result in serious injury
• you have difficulty digesting medicines. In some patients the liver may not metabolise (break down) medicines adequately. In these patients the medicine may remain in the body for a longer period of time. This may result in side effects. If you are known to poorly metabolise certain medicines please speak to your doctor.
• you are taking any medicinal or non-medicinal products containing cannabidiol, as it may increase the side effects of clobazam.
• you feel you need to take more of Perizam to get the same level of symptom control, this may mean you are developing tolerance to the effects of this medicine or are becoming addicted to it. Speak to your prescriber who will discuss your treatment and may change your dose or switch you to an alternative medication.

Taking this medicine regularly, particularly for a long time, can lead to physical dependence and addiction. Your prescriber should have explained how long you will be taking it for and, when it is appropriate to stop, how to do this safely. When your treatment is stopped, it is usually done gradually over a period which is specific to you and may occur over a period of weeks to months.

Drowsiness, difficulties breathing, coma and death may occur if Perizam is taken together with opioids. Perizam 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.

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Perizam.

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 Perizam.

You may become dependent on Perizam if you take it for a long period of time, especially if you regularly drink a lot of alcohol or use drugs. This means that you may feel that you need to continue the treatment with Perizam in order to feel well (‘psychological dependence’).

Physical dependence and addiction can cause withdrawal symptoms when you stop taking this medicine. Withdrawal symptoms can include:

• headaches, muscle pain, anxiety, tension, depression, restlessness, sweating, confusion or irritability. Do not stop taking your tablets suddenly. This could lead to more serious symptoms such as loss of the sense of reality, feeling unreal or detached from life, and unable to feel emotion. Some patients have also experienced numbness or tingling of the arms or legs, tinnitus (ringing sounds in the ears), oversensitivity to light, sound and touch, uncontrolled or overactive movements, twitching, shaking, feeling sick, being sick, stomach upsets or stomach pain, loss of appetite, agitation, abnormally fast heartbeats, panic attacks, dizziness or feeling that you are about to fall, memory loss, hallucinations, feeling stiff and unable to move easily, feeling very warm, convulsions (sudden uncontrolled shaking or jerking of the body).
  Your prescriber will discuss with you how to gradually reduce your dose before stopping the medicine. It is important that you do not stop taking the medicine suddenly as you will be more likely to experience withdrawal symptoms. Your prescriber will ensure that your plan for stopping treatment is tailored to you and can be adapted according to your needs and experience of any withdrawal symptoms.

If you take Perizam for epilepsy for a long period of time then it is possible that you may become ‘tolerant’ to it. This means that it will not work as well as it did when you first started taking it. Talk to your doctor if you feel that Perizam is no longer helping to control your symptoms- they may suggest that you take a short break from this medicine.

Benzodiazepines should only be used by those they are prescribed for. Do not give your medicine to anyone else. Taking higher doses or more frequent doses of benzodiazepines may increase the risk of addiction. Overuse and misuse can lead to overdose and/or death.

Epilepsy (fits): Perizam should only be taken by children under 2 years if the doctor decides this is necessary.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription and herbal medicines. This is because Perizam can affect the way some other medicines work.

Also, some other medicines can affect the way Perizam works.

In particular tell your doctor or pharmacist if you are taking any of the following:

• medicines for epilepsy such as phenytoin, carbamazepine or valproic acid
• medicines for depression such as trazodone, ‘SSRI’s’ (such as fluoxetine or citalopram), ‘tricyclic anti-depressants’ (such as amitriptyline or nortriptyline) or ‘MAOIs’ (such as phenelzine or moclobemide)
• medicines for serious mental health problems called ‘neuroleptics’ such as chlorpromazine, haloperidol, clozapine and pimazide
• painkillers such as medicines containing codeine, dihydrocodeine or morphine
• sleeping tablets such as zolpidem or temazepam
• medicines for anxiety such as diazepam or lorazepam
• muscle relaxants such as baclofen
• antihistamines that make you feel sleepy such as chlorphenamine, promethazine or diphenhydramine
• lithium, used for a serious mental health problem called ‘bipolar disorder’ (mood changes between a state of high excitability or exaggerated emotions and depression)
• cimetidine, used to treat stomach ulcers and heartburn
• omeprazole, used to treat symptoms of acid reflux such as heartburn or acid regurgitation
• ticlopidine, an antiplatelet medication used in patients with an increased risk of stroke
• fluconazole, used in the treatment of fungal conditions
• dextromethorphan, used to relieve dry irritating coughs
• nebivolol, medicines used to treat high blood pressure.
• Cannabidiol-containing products (medicinal or non-medicinal products)

When taking Perizam you should not start taking any different medicines containing clobazam unless your doctor tells you to. If you do, it may cause breathing difficulties and sleepiness.

Concomitant use of Perizam and opioids increases the risk of drowsiness, difficulties breathing, coma and death. Because of this, concomitant use should only be considered when other treatment options are not possible.

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 operation or dental work, tell your doctor or dentist that you are taking Perizam. This is because they may need to change the amount of medicine (anaesthetic or muscle relaxant) they give to you.

Do not drink alcohol while taking Perizam. This is because alcohol can change the way Perizam works.

Do not take Perizam if:

• you are in the first 3 months of pregnancy or think you may be pregnant
• you are breast-feeding. This is because Perizam may pass into the mother’s breast milk.

Talk to your doctor before taking this medicine if you are more than 3 months pregnant or plan to become pregnant.

• Your doctor may give you this medicine during later pregnancy or during labour. If this happens, there is a risk of having a baby with low body temperature, floppiness, breathing or feeding problems.
• If this medicine is taken regularly in late pregnancy, your baby may get withdrawal symptoms. In this case the newborn should be closely monitored during the postnatal period.

In fertility studies, no effects on fertility were observed in animals.

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 feel sleepy or dizzy.

• Do not drive while taking this medicine until you know how it affects you.
• It is an offence to drive if this medicine affects your ability to drive.
• However, you would not be committing an offence if:
  • The medicine has been prescribed to treat a medical or dental problem
  • You have taken it according to the instructions given by the prescriber or in the information provided with the medicine
  • It was not affecting your ability to drive safely.

Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.

• Liquid maltitol (0.3g/ml) - a type of sugar. If your doctor has told you that you cannot tolerate some sugars, talk to your doctor before taking this medicine.
• Sodium methyl parahydroxybenzoate and sodium propyl parahydroxybenzoate. These may cause an allergic reaction. This allergy may happen some time after starting the medicine.
• Sodium: This medicine contains 2.3mg sodium (main component of cooking/table salt) in each ml. This is equivalent to 0.12% of the recommended maximum daily dietary intake of sodium for an adult. This should be taken into account by patients on a low salt diet.
• This medicine contains 6.21mg propylene glycol in each ml. If your baby is less than 4 weeks old, talk to your doctor or pharmacist before giving them this medicine, in particular if the baby is given other medicines that contain propylene glycol or alcohol.

• This medicine contains 2 milligrams (mg) of clobazam in each 1 millilitre (ml) of suspension.
• Take this medicine by mouth.
• This product must not be mixed with other medicinal products or beverages.
• Always shake the bottle before using it.
• Always use the syringe supplied with the pack.
• Perizam can be taken with or without food.

Instructions for use of the syringe.

If you are taking a large dose, you may have to measure the dose with the syringe more than one time. It may be helpful to write on a piece of paper the amount of times you have to use the syringe.

Each time you take the dose, tick off a dose on the paper.

• Open the bottle: press the cap and turn it anticlockwise (Figure 1).
• Insert the syringe adaptor into the bottle neck (Figure 2).
• Take the syringe and put it in the adaptor opening (Figure 3).
• Turn the bottle upside down (Figure 4).
• Fill the syringe with a small amount of solution by pulling the piston down (Figure 4A). Then push the piston upward in order to remove any possible bubbles (Figure 4B). Finally, pull the piston down to the graduation mark corresponding to the quantity in millilitres (ml) prescribed by your doctor (Figure 4C).
• Turn the bottle the right way up (Figure 5A).
• Remove the syringe from the adaptor (Figure 5B). Put the end of the syringe into your mouth and push the plunger slowly back in to take the medicine.
• Wash the syringe with water and let it dry before you use it again (Figure 6).
• Close the bottle with the plastic screw cap- leave the syringe adaptor in the bottle.

If low doses are required, the 1mg/ml strength product is the most suitable presentation.

If high doses are required, the 2mg/ml strength product is the most suitable presentation.

Adults

• The usual dose is 20mg (10ml) to 30mg (15ml) each day. This can be taken as 2 separate doses or as a single dose at night.
• Your doctor may increase your dose to up to 60mg (30ml) each day.
• Your doctor may lower the dose to suit you.

Children (2 years and over)

• The usual starting dose is 0.1mg/kg each day.
• Your doctor will then change the dose according to your child’s weight.

Elderly

• The usual dose for anxiety is 10mg (5ml) to 20mg (10ml) each day.

• If you take more Perizam than you should, talk to your doctor or go to the nearest hospital straight away. Take the medicine pack with you. Do not drive yourself because you may start to feel sleepy.

• If you forget a dose, skip the missed dose. Then wait until the next dose is due.
• Do not take a double dose to make up for a forgotten dose.

Do not suddenly stop taking this medicine. If you want to stop taking this medicine, discuss this with your prescriber first. They will tell you how to do this, usually by reducing the dose gradually so that any unpleasant withdrawal effects are kept to a minimum. This may occur over a period of weeks to months. Your prescriber will ensure that your plan for stopping treatment is tailored to you and can be adapted according to your needs and experience of any withdrawal symptoms.

Withdrawal symptoms such as:

• headaches, muscle pain, anxiety, tension, depression, restlessness, sweating, confusion or irritability. Do not stop taking your tablets suddenly. This could lead to more serious symptoms such as loss of the sense of reality, feeling unreal or detached from life, and unable to feel emotion. Some patients have also experienced numbness or tingling of the arms or legs, tinnitus (ringing sounds in the ears), oversensitivity to light, sound and touch, uncontrolled or overactive movements, twitching, shaking, feeling sick, being sick, stomach upsets or stomach pain, loss of appetite, agitation, abnormally fast heartbeats, panic attacks, dizziness or feeling that you are about to fall, memory loss, hallucinations, feeling stiff and unable to move easily, feeling very warm, convulsions (sudden uncontrolled shaking or jerking of the body).

• allergic reaction- the signs may include swelling of your face, lips, tongue or throat, difficulty breathing or swallowing, severe itching of your skin with raised lumps.

Stop taking Perizam and see a doctor or go to a hospital straight away if you notice the symptoms listed above.

Common side effects (may affect up to 1 in 10 people:

• Feeling irritable or restless.

Uncommon side effects (may affect up to 1 in 100 people):

• Poor memory while taking Perizam (amnesia) or showing unusual behaviour.
• Nightmares.
• Feeling anxious.
• Believing things which are not true (delusions).
• Increased possibility of tripping or falling, especially in elderly patients.

Not known (frequency cannot be estimated from available data):

• Sleeping problems that get worse after taking this medicine.
• Sensing things which are not there (hallucinations).
• Being less aware of your environment, especially in the elderly.
• Feeling suicidal.
• Blistering or bleeding of the skin around the lips, eyes, mouth, nose and genitals. Also flu-like symptoms and fever. This may be something called ‘Stevens-Johnson Syndrome’.
• A severe blistering rash where layers of the skin may peel off to leave large areas of raw exposed skin over the body. Also a feeling of being generally unwell, fever, chills and aching muscles. This is something called ‘Toxic Epidermal Necrolysis’ (TEN). Both Stevens Johnson Syndrome and TEN can be fatal.
• dependence and addiction (see section “How do I know if I am tolerant or addicted?”).

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.

Very common side effects (may affect more than 1 in 10 people):

• Difficulty in staying awake or alert

Common side effects (may affect up to 1 in 10 people):

• Feeling sleepy or dizzy.
• Feeling agitated or being aggressive.
• Depression.
• Headache.
• Short attention span.
• Difficulty in speaking.
• Shaking fingers (tremor).
• Problems with walking or other movement problems.
• Perizam having less effect than normal (especially in long term use).
• Dry mouth, constipation.
• Loss of appetite, feeling sick (nausea).

Uncommon side effects (may affect up to 1 in 100 people):

• Loss of sexual drive.
• Memory difficulties, confusion.
• Double vision.
• Skin rash.
• Weight gain.

Not known (frequency cannot be estimated from available data):

• Becoming dependent on Perizam (‘physical or mental dependence’) (especially in long term use).
• A feeling of being out of touch with reality and being unable to think or judge clearly (psychosis).
• Feeling angry.
• Changes in the way you walk.
• Breathing problems.
• Sensitivity to sunlight.
• Itchy, lumpy rash (urticaria).
• Muscle spasms or muscle weakness.
• Reacting to things more slowly than usual.
• Rapid uncontrollable movement of the eyes.
• Learning problems.
• Abnormally low body temperature.

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.

Use of Perizam may lead to a physical addiction. Stopping Perizam suddenly may lead to side effects. Dependence on Perizam may occur. Talk to your doctor if you feel you have developed a dependence on Perizam.

When you stop taking Perizam, you may experience drug withdrawal symptoms, which include:

• headaches, muscle pain, anxiety, tension, depression, restlessness, sweating, confusion or irritability. Do not stop taking your tablets suddenly. This could lead to more serious symptoms such as loss of the sense of reality, feeling unreal or detached from life, and unable to feel emotion. Some patients have also experienced numbness or tingling of the arms or legs, tinnitus (ringing sounds in the ears), oversensitivity to light, sound and touch, uncontrolled or overactive movements, twitching, shaking, feeling sick, being sick, stomach upsets or stomach pain, loss of appetite, agitation, abnormally fast heartbeats, panic attacks, dizziness or feeling that you are about to fall, memory loss, hallucinations, feeling stiff and unable to move easily, feeling very warm, convulsions (sudden uncontrolled shaking or jerking of the body).

If you notice any of the following signs whilst taking Perizam, it could be a sign that you have become addicted.

• You may feel the need to keep taking the medication for longer than your doctor recommended
• You feel you need to use more than the recommended dose
• You are using the medicine for reasons other than prescribed
• When you stop taking the medicine you feel unwell, and you feel better once taking the medicine again

If you notice any of these signs, it is important you talk to your prescriber.

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

or search for MHRA Yellow Card in the Google Play or Apple App Store.

• The active substance is clobazam. Each ml of oral suspension contains 2mg of clobazam.
• The other ingredients are aluminium magnesium silicate, citric acid monohydrate (E330), di-sodium hydrogen phosphate dihydrate, simethicone emulsion, sucralose (E955), polysorbate 80 (E433), masking flavour (contains propylene glycol (E1520)), raspberry flavour (contains propylene glycol (E1520)), xanthan gum (E415), sodium propyl hydroxybenzoate (E217), sodium methyl hydroxybenzoate (E219), liquid maltitol (E965) and purified water.

Perizam is an off-white suspension. It comes in a brown glass bottle holding 150ml of suspension with a 5ml syringe and bottle adaptor. The bottle adaptor is not pre-fitted.