Skip to Content

CLOBAZAM ATNAHS 10MG/5ML ORAL SUSPENSION

Active substance(s): CLOBAZAM / CLOBAZAM / CLOBAZAM

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

Package leaflet: Information for the user

Clobazam Atnahs
5mg/5ml and 10mg/5ml
Oral Suspension
Clobazam
Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.
• 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.
What is in this leaflet
1. What Clobazam Oral Suspension is and what it is used for
2. What you need to know before you take Clobazam Oral
Suspension
3. How to take Clobazam Oral Suspension
4. Possible side effects
5. How to store Clobazam Oral Suspension
6. Contents of the pack and other information

1.

What Clobazam Oral Suspension is and what
it is used for

Clobazam Oral Suspension contains a medicine called
clobazam. This belongs to a group of medicines called
benzodiazepines. Clobazam Oral Suspension works by
having a calming effect on the brain.
Clobazam Oral Suspension can be used to treat:
• Severe anxiety over a short time
• Epilepsy (fits) over a longer time
• Mental illness such as schizophrenia (in combination with
other treatments)

2.

What you need to know before you take
Clobazam Oral Suspension

• Antihistamines that make you sleepy (such as chlorphenamine, promethazine or diphenhydramine)
• 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)
• Omeprazole – used to treat the 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 treatment of fungal conditions
• Dextromethorphan – used to relieve dry, irritating coughs
• Nebivolol – medicine used to treat high blood pressure
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 Clobazam Oral Suspension. This
is because your doctor may need to change the amount of
anaesthetic or muscle relaxants given to you.
Clobazam Oral Suspension with food, drink and alcohol
Do not drink alcohol while you are taking Clobazam Oral
Suspension. This is because there is increased risk of
sleepiness and other side effects.
Pregnancy and breast-feeding
Do not take Clobazam Oral Suspension:
• If you are in the first three months of pregnancy
• If you are 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 Clobazam Oral Suspension 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. In this case the
newborn should be closely monitored during the postnatal
period.
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.

Do not take Clobazam Oral Suspension
• If you are allergic (hypersensitive) to clobazam, other
benzodiazepine medicines or any of the other ingredients
of this medicine (see section 6: contents of the pack and
other information).
Signs of an allergic reaction include: a rash, swallowing or
breathing problems, swelling of your lips, face, throat or
tongue
• If you are in the first three months of pregnancy or think
you might be pregnant (see below under 'Pregnancy and
breast-feeding' for more information).
• If you are breast-feeding.
• If you have ever had problems with drugs or alcohol
dependence in the past.
• If you suffer from an illness that causes muscle weakness
(called 'myasthenia gravis').
• If you have liver problems.
• If you have breathing problems.
• If you stop breathing for short periods during sleep (called
'sleep apnoea syndrome').
• If the patient is under 6 years old.

Important information about some of the ingredients of
Clobazam Oral Suspension

Do not take if any of the above apply to you. If you are not
sure, talk to your doctor or pharmacist before taking
Clobazam Oral Suspension.

Clobazam Oral Suspension contains sorbitol (E420), sodium
methyl parahydroxybenzoate (E219), sodium propyl parahydroxybenzoate (E217) and Sodium

3. How to take Clobazam Oral Suspension
Always take this medicine exactly as your doctor has told
you. Clobazam Oral Suspension is usually given for 2 to 4
weeks. After that, your doctor will decide whether you
should keep taking this medicine. Check with your doctor or
pharmacist if you are not sure.
Method of administration:
The box containing this medicine will contain a 5ml dosing
syringe, a dosing adapter and a 30ml dosing cup. Instructions are provided below for using the dosing syringe.

5 mL

In particular, tell your doctor if you are taking any of the
following:
• Medicines for epilepsy (such as phenytoin, carbamazepine,
stiripentol or valproic acid)
• Medicines for depression (such as Monoamine Oxidase
Inhibitors (MAOIs), or tricyclic anti-depressants such as
trazodone or Selective Serotonin Re-uptake Inhibitors
(SSRIs) such as fluvoxamine or paroxetine)
• Medicines for severe mental illness called 'antipsychotics'
(such as chlorpromazine, haloperidol, clozapine and
pimozide)
• 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)

Sodium
Each ml of Clobazam Oral Suspension contains 3.05 mg of
sodium. The sodium content of the maximum daily dose is
therefore 183 mg for Clobazam 5mg/5ml Oral Suspension
and 91.5 mg for Clobazam 10mg/5ml Oral Suspension. You
must take this into account if you are on a controlled
sodium diet.

4

Please tell your doctor, pharmacist or nurse if you are
taking, have recently taken any other medicines. This
includes medicines you buy without a prescription, including
herbal medicines. This is because clobazam can affect the
way some other medicines work. Also some medicines can
affect the way Clobazam Oral Suspension works.

Sodium methyl parahydroxybenzoate (E219) and sodium
propyl parahydroxybenzoate (E217)
These may cause allergic reactions in some people that could
occur some time after taking this medicine. The signs may
include a rash, swallowing or breathing problems and
swelling of your lips, face, throat or tongue. If you have any
concerns over whether this medicine is suitable for you, talk
to your doctor, pharmacist or nurse.

2

Other medicines and Clobazam Oral Suspension

Sorbitol (E420)
If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before
taking this medicinal product.

3

If you are not sure if any of the above apply to you, talk to
your doctor or pharmacist before taking Clobazam Oral
Suspension.

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

1

Warnings and precautions
Talk to your doctor before taking Clobazam Oral Suspension:
• If you have problems with controlling your movements
(called 'spinal or cerebellar ataxia').
• If you have depression, irrational fears and obsessions.
• If you have delusions (believing things which are not true)
or hallucinations (sensing things which are not there).
• If you have kidney problems.
• If you have ever become dependent upon another drug or
alcohol. Alcohol should not be taken during treatment
with clobazam as there is an increased risk of experiencing
side effects.
• If you are over 65. This is due to the increased sensitivity to
adverse reactions in the elderly such as drowsiness,
dizziness and muscle weakness. There is also an increased
risk of fall that may result in serious injury.
• You have difficulty digesting medicines. Some patient’s
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.

The medicine can affect your ability to drive as it may make
you 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:
1. The medicine has been prescribed for you to treat a
medical or dental problem
2. You have taken it according to the instructions given by
the prescriber or in the information provided with the
medicine
3. It was not affecting your ability to drive safely.

If you have any questions about how to use the syringe, you
should ask your pharmacist.
This product may settle during storage.
Please shake the bottle well before use.

Continued overleaf >

Instructions for use:
- Open the bottle: press the cap and turn it anticlockwise.
(see figure 1)
- Holding the bottle, take the plastic syringe adapter from
the box and insert the adapter firmly into the bottle neck.
(see figure 2)
- Take the syringe and put it in the adapter opening
(see figure 3)

1

2

3

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
• Increased possibility of tripping or falling especially in
elderly patients
• 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' which is 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'.
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.

- Turn the bottle upside down and fill the syringe with a
small amount of suspension by pulling the piston down
(see figure 4), then push the piston upward in order to
remove any possible bubbles. Pull the piston down to the
graduation mark corresponding to the quantity in
milliliters (ml) prescribed by your doctor.
- Turn the bottle the right way up. Remove the syringe from
the adapter. (see figure 5)
- Administer the contents of the syringe into the mouth by
pushing the piston to the bottom of the syringe
(see figure 6) and ensure the medicine is swallowed.

4

5

6

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 occur at the
start of treatment. They usually last for a short time:
• Feeling sleepy or dizzy
• Dry mouth or 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 and rapid
uncontrollable movement of eyes
• Difficulty in staying awake or alert
• Becoming dependent on Clobazam Oral Suspension (also
called 'physical or mental dependence')
• Weight gain
• Loss of sexual drive.

This medicine comes in two strengths. Make sure you follow
the dosage instructions for the strength of medicine you
have been prescribed.

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.

5mg/5ml: Doses
Adults
• The usual dose is 20 mg (20 ml) to 30 mg (30 ml) 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 (60 ml) each day.
• Your doctor may lower the dose to suit you.

If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor,
pharmacist or nurse.

Children (6 years and over)
• The usual starting dose is 5 mg (5 ml) each day.
Elderly
• The usual dose for anxiety is 10 mg (10 ml) to 20 mg (20 ml) each
day.
10mg/5ml: Doses
Adults
• The usual dose is 20 mg (10 ml) to 30 mg (15 ml) 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 (30 ml) each day.
• Your doctor may lower the dose to suit you.
Children (6 years and over)
• The usual starting dose is 5 mg (2.5 ml) each day.
Elderly
• The usual dose for anxiety is 10 mg (5 ml) to 20 mg (10 ml)
each day.
After use:
Remove the adapter from the bottle and close the bottle
with the plastic screw cap. Wash the adapter and syringe or
cup with warm water. Dry and replace them into the box
with your medicine.
When you are taking Clobazam Oral Suspension you should
not change to any different clobazam containing medicines
except under your doctor's supervision.
If you take more Clobazam Oral Suspension than you should
If you take more Clobazam Oral Suspension 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 Clobazam Oral Suspension that is left and the pack.
This is so the doctor knows what you have taken.
If you forget to take Clobazam Oral Suspension
• If you have missed a dose take it as soon as you remember.
• 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
dose.
If you stop taking Clobazam Oral Suspension
Keep taking this medicine until your doctor tells you to stop.
Do not stop taking Clobazam Oral Suspension just because
you feel better.
• When your doctor says that you can stop taking clobazam,
you need to do this gradually. Your doctor will help you to
do this.
• Stopping the suspension 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, this medicine can cause side effects,
although not everybody gets them. You may feel ill after
taking the medicine, or notice unusual or unexpected
symptoms. If this happens, tell your doctor.

Reporting of side effects
If you get any side effects, talk to your doctor or 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 Clobazam Oral Suspension
Keep this medicine out of the sight and reach of children.
Do not use Clobazam Oral Suspension after the expiry date
stated on the bottle label and carton after EXP.
The expiry date refers to the last day of that month.
Do not store above 25ºC. Use within 28 days of opening.
Keep the bottle in the outer carton in order to protect from
light.
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. Contents of the pack and other information
What Clobazam Oral Suspension contains

The active substance (the ingredient that makes the oral
suspension work) is clobazam.
Each 5 ml of Clobazam 5mg/5ml Oral Suspension contains
5 mg of clobazam.
Each 5 ml of Clobazam 10mg/5ml Oral Suspension contains
10mg of clobazam.
The other ingredients are sorbitol (E420), xanthan gum
(E415), acesulfame potassium (E950), raspberry flavour,
sodium propyl parahydroxybenzoate (E217), sodium methyl
parahydroxybenzoate (E219), disodium hydrogen phosphate
dihydrate, sodium dihydrogen phosphate dihydrate and
purified water.
What Clobazam Oral Suspension looks like and contents of
the pack
Clobazam Oral Suspension is an off-white viscous suspension
with an odour of raspberry supplied in an amber glass
bottle. The contents may settle during storage and should
be shaken before use.
Each pack also contains a 5 ml oral syringe, syringe adapter
and 30 ml measuring cup. Pack size is 150ml.
Marketing Authorisation Holder
Atnahs Pharma UK Limited, Sovereign House,
Miles Gray Road, Basildon, Essex, SS14 3FR,
United Kingdom
Manufacturer
Dales Pharmaceuticals Limited
Snaygill Industrial Estate, Keighley Road, Skipton,
North Yorkshire, BD23 2RW, United Kingdom
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 November 2016
If you would like any more information or would like the
leaflet in a different format, please contact medical
information at the above address.

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide