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TAPCLOB 5MG/5ML ORAL SUSPENSION

Active substance(s): CLOBAZAM

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Transcript
If you have any concerns over whether this medicine is
suitable for you talk to your doctor, pharmacist or nurse.

5 mL

4

3

1.0 mL

5ml syringe each numbered increment is 1ml equivalent
to 1mg of Tapclob 5mg/5ml Oral Suspension and 2mg
of Tapclob 10mg/5ml Oral Suspension . The smaller
increments are 0.2ml or 0.2mg of Tapclob 5mg/5ml
Oral Suspension and 0.4mg of Tapclob 10mg/5ml Oral
Suspension.
0.9

Do not take Tapclob® Oral Suspension:
• If you are allergic (hypersensitive) to clobazam,
other benzodiazepine medicines or any of the other
ingredients of this medicine (listed in section 6).
• If you are in the first three months of pregnancy or think
you might be pregnant (see ‘Pregnancy and breastfeeding’ 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 severe liver problems.
• If you have breathing problems.
• I f you stop breathing for short periods during sleep
(called ‘sleep apnoea syndrome’).
Warnings and precautions
Talk to your doctor before taking Tapclob® 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 your liver or kidneys do not work as well as they should.

0.8

2. What you need to know before you
take Tapclob® 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.
Tapclob® Oral Suspension contains:
• 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
• Sodium methyl hydroxybenzoate (E219) and sodium
propyl hydroxybenzoate (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

0.7

Tapclob® Oral Suspension is used to treat:
• Severe anxiety over a short time
• Epilepsy (fits) over a longer time (in combination with
other treatments)
• Mental illness such as schizophrenia (in combination
with other treatments)

2

Clobazam works by having a calming effect on the brain.

0.6

Tapclob® Oral Suspension contains clobazam which
belongs to a group of medicines called benzodiazepines.

If you take Tapclob® Oral Suspension for long periods
of time for treatment of epilepsy it is possible that you
may become tolerant to it, meaning that it will not be as
effective as it was when you first started taking it. If you
feel that Tapclob® Oral Suspension is no longer helping
to control your symptoms please talk to your doctor, they
may suggest you take a short break from this medicine.
Other medicines and Tapclob® Oral Suspension
Please tell your doctor, pharmacist or nurse if you
are taking, have recently taken or might use any other
medicines, including medicines obtained without a
prescription. Especially:
• medicines for epilepsy (such as phenytoin,
carbamazepine or valproic acid)
• medicines for depression (such as MAOIs, SSRI’s or
tricyclic anti-depressants - 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 diphenhydramine)
• lithium - used for a mental illness called ‘bipolar disorder’
(mood changes between a state of high excitability or
exaggerated emotions and depression)
• cimetidine (used to treat ulcers and heartburn)
Anaesthetics
If you are going to have an anaesthetic, tell your doctor or
anaesthetist you are taking Tapclob® Oral Suspension. This
is because your doctor may need to change the amount of
anaesthetic or muscle relaxants given to you.
Tapclob® Oral Suspension with food, drink and alcohol
Do not drink alcohol while you are taking Tapclob® Oral
Suspension. This is because alcohol can change the way
Tapclob® Oral Suspension works.

0.5

1. What Tapclob® Oral Suspension is and
what it is used for

If you take Tapclob® Oral Suspension late in pregnancy
or during labour your baby might have a low body
temperature, floppiness, breathing or feeding difficulties.
If taken regularly during late pregnancy, your baby may
develop 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. Do not drive or use any tools or
machines if you are affected in this way.
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:
• The medicine has been prescribed to treat a medical or
dental problem and
• You have taken it according to the instructions given by
the prescriber or in the information provided with the
medicine and
• It was not affecting your ability to drive safely

1

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

If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor
for advice before taking this medicine. Tapclob® Oral
Suspension should be avoided during pregnancy.

0.4

What is in this leaflet

• If you have ever become dependent upon another drug
or alcohol.
Suicidal thoughts
Some patients have experienced suicidal thoughts while
taking medicines containing clobazam, particularly if they
are already depressed. If you start experiencing thoughts
of suicide or harm towards yourself please tell your doctor
immediately.
Dependence, tolerance and withdrawal
It is possible for you to become dependent on Tapclob®
Oral Suspension if you take it for long periods of time,
particularly if you have a history of heavy alcohol or
drug use. This means that you may feel that you need
to continue treatment with Tapclob® Oral Suspension in
order to feel well (known as psychological dependence).
If you suddenly stop taking Tapclob® Oral Suspension you
may experience worsening of the symptoms you were
originally being treated for, as well as mood changes,
anxiety, sleep disturbance or restlessness. This is known as
withdrawal and can be avoided by slowly reducing your
dose. If you are worried about dependence or withdrawal
please talk to your doctor.

0.3

D03044

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,
nurse or pharmacist.
• This medicine has been prescribed for you.
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,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet.

0.2

Tapclob® 5mg/5ml and 10mg/5ml Oral Suspension
Clobazam

5mg/5ml: Doses
Adults and adolescents (over 15 years)
• The usual dose is 20mg (20ml) to 30mg (30ml) 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 60mg
(60ml) each day.
• Your doctor may lower the dose to suit you.
Children (over 6 years)
• The usual starting dose is 5mg (5ml) each day.
• Your doctor will then adjust the dose according to your
child’s need.
Elderly
• The usual dose for anxiety is 10mg (10ml) to 20mg
(20ml) each day.
10mg/5ml: Doses
Adults and adolescents (over 15 years)
• The usual dose is 20mg (10ml) to 30mg (15ml) 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 60mg
(30ml) each day.
• Your doctor may lower the dose to suit you.
Children (over 6 years)
• The usual starting dose is 5mg (2.5ml) each day.
• Your doctor will then adjust the dose according to your
child’s need.
Elderly
• The usual dose for anxiety is 10mg (5ml) to 20mg (10ml)
each day.
Method of administration:
This product may settle during storage, please shake well
before use.
Your doctor, pharmacist or nurse will show you how
to administer this medicine. The box containing this
medicine will contain a 5ml dosing syringe, a dosing
adaptor and a 30ml dosing cup.

0.1

Pregnancy and breast-feeding
Do not take Tapclob® Oral Suspension if you
• are in the first three months of pregnancy
• are breast-feeding

PACKAGE LEAFLET: INFORMATION FOR THE USER

3. How to take Tapclob® Oral Suspension
Always take this medicine exactly as your doctor has told
you. Tapclob® 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.
When you are taking Tapclob Oral Suspension you
should not change to any different clobazam containing
medicines except under your doctor’s supervision.

30ml dosing cup. Each numbered increment is 5ml equivalent to 5mg of Tapclob 5mg/5ml Oral Suspension
and 10mg of Tapclob 10mg/5ml Oral Suspension.
Instructions are provided overleaf for using the dosing
syringe. If you have any questions about the dose you
should use or how to use the syringe, you should ask your
pharmacist.
Continued overleaf

3044-H

100mm Measurement Verification Bar

Instructions for use:
• Open the bottle: press the cap and
turn it anticlockwise (figure 1)

5
1

• Turn the bottle the right way up.
Remove the syringe from the adaptor
(figure 5).

6
• Holding the bottle, take the plastic
syringe adaptor from the box and
insert the adaptor into the bottle
neck (figure 2).

2

• Administer the contents of
the syringe into the mouth
by pushing the piston to the
bottom of the syringe
(figure 6) and ensure the
medicine is swallowed.
Remove the adaptor from the bottle and close the
bottle with the plastic screw cap.

Ensure it is well fixed.

Wash the adaptor and the syringe with warm water. Dry
them with a clean paper towel and replace them into
the box with your medicine.
• Take the syringe and put it in the
adaptor opening (figure 3).

3

• Turn the bottle upside down.

• Fill the syringe with a small amount of suspension
by pulling the piston down (figure 4a), then push the
piston upward in order to remove any possible bubble
(figure 4b). Pull the piston down to the graduation
mark corresponding to the quantity in milliliters (ml)
prescribed by your doctor (figure 4C).

4a

4b

4c

If you take more Tapclob® Oral Suspension than you
should
If you take more Tapclob® Oral Suspension than you should,
tell your doctor or go to your nearest hospital casualty
department immediately. Do not drive yourself because
you may start to feel sleepy.
If you forget to take Tapclob® Oral Suspension
If you have missed a dose take it as soon as you remember
unless it is almost time for the next one then carry on
as before. Do not take a double dose to make up for a
forgotten dose.
If you stop taking Tapclob® Oral Suspension
Do not stop taking your medicine without telling your
doctor as he may gradually reduce your dose before
stopping it completely. If stopped suddenly, you may
have unpleasant side effects including stress (anxiety),
confusion, or depression. You may also lose your appetite
and have difficulty sleeping (see Section 2 ‘Dependence,
tolerance and withdrawal’).
If you have any further questions on the use of this
medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Tell your doctor immediately if you have any of the
following side effects. These effects are more likely to
occur in children and the elderly:
• 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 (see Section 2 ‘Suicidal thoughts’)
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, constipation
• loss of appetite, feeling sick
• shaking fingers
Other side-effects include:
• headache
• breathing problems
• loss of memory, confusion or inappropriate behaviour
• skin rash
• muscle weakness
• problems walking or other movement problems
• being aggressive
• reacting to things more slowly than usual
• problems with your vision such as double vision
• difficulty in staying awake or alert
• becoming dependent on Tapclob® Oral Suspension (also
called ‘physical or mental dependence’) (see Section 2
‘Dependence, tolerance and withdrawal’)
• weight gain
• loss of sexual drive
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.

6. Contents of the pack and other
information
What Tapclob® Oral Suspension contains
• The active substance (the ingredient that makes the oral
suspension work) is Clobazam.
Each 5ml of Tapclob® 5mg/5ml Oral Suspension
contains 5mg of clobazam.
Each 5ml of Tapclob® 10mg/5ml Oral Suspension
contains 10mg of clobazam.
• The other ingredients are sorbitol (E420), xanthan gum
(E415), acesulfame potassium (E950), raspberry flavour,
sodium propyl hydroxybenzoate (E217), sodium methyl
hydroxybenzoate (E219), disodium hydrogen phosphate
dihydrate, sodium dihydrogen phosphate dihydrate and
purified water.
What Tapclob® Oral Suspension looks like and
contents of the pack
Tapclob® 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.
Pack sizes are 100ml, 150ml and 250ml.
Manufacturer and Marketing Authorisation Holder
Martindale Pharmaceuticals Ltd
Trading as Martindale Pharma
Bampton Road, Harold Hill, Romford, Essex,
RM3 8UG, United Kingdom
If you would like any more information, or would like
the leaflet in a different format, please contact medical
information at the above address.
Product licence numbers: PL 00156/0322

PL 00156/0323
This leaflet was last revised in July 2015

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 Website: http://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 Tapclob® Oral Suspension
Keep this medicine out of the sight and reach of children.
Do not use Tapclob® 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.
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.

D03044

3044-H

100mm Measurement Verification Bar

If you have any concerns over whether this medicine is
suitable for you talk to your doctor, pharmacist or nurse.

5 mL

4

3

1.0 mL

5ml syringe each numbered increment is 1ml equivalent
to 1mg of Tapclob 5mg/5ml Oral Suspension and 2mg
of Tapclob 10mg/5ml Oral Suspension . The smaller
increments are 0.2ml or 0.2mg of Tapclob 5mg/5ml
Oral Suspension and 0.4mg of Tapclob 10mg/5ml Oral
Suspension.
0.9

Do not take Tapclob® Oral Suspension:
• If you are allergic (hypersensitive) to clobazam,
other benzodiazepine medicines or any of the other
ingredients of this medicine (listed in section 6).
• If you are in the first three months of pregnancy or think
you might be pregnant (see ‘Pregnancy and breastfeeding’ 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 severe liver problems.
• If you have breathing problems.
• I f you stop breathing for short periods during sleep
(called ‘sleep apnoea syndrome’).
Warnings and precautions
Talk to your doctor before taking Tapclob® 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 your liver or kidneys do not work as well as they should.

0.8

2. What you need to know before you
take Tapclob® 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.
Tapclob® Oral Suspension contains:
• 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
• Sodium methyl hydroxybenzoate (E219) and sodium
propyl hydroxybenzoate (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

0.7

Tapclob® Oral Suspension is used to treat:
• Severe anxiety over a short time
• Epilepsy (fits) over a longer time (in combination with
other treatments)
• Mental illness such as schizophrenia (in combination
with other treatments)

2

Clobazam works by having a calming effect on the brain.

0.6

Tapclob® Oral Suspension contains clobazam which
belongs to a group of medicines called benzodiazepines.

If you take Tapclob® Oral Suspension for long periods
of time for treatment of epilepsy it is possible that you
may become tolerant to it, meaning that it will not be as
effective as it was when you first started taking it. If you
feel that Tapclob® Oral Suspension is no longer helping
to control your symptoms please talk to your doctor, they
may suggest you take a short break from this medicine.
Other medicines and Tapclob® Oral Suspension
Please tell your doctor, pharmacist or nurse if you
are taking, have recently taken or might use any other
medicines, including medicines obtained without a
prescription. Especially:
• medicines for epilepsy (such as phenytoin,
carbamazepine or valproic acid)
• medicines for depression (such as MAOIs, SSRI’s or
tricyclic anti-depressants - 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 diphenhydramine)
• lithium - used for a mental illness called ‘bipolar disorder’
(mood changes between a state of high excitability or
exaggerated emotions and depression)
• cimetidine (used to treat ulcers and heartburn)
Anaesthetics
If you are going to have an anaesthetic, tell your doctor or
anaesthetist you are taking Tapclob® Oral Suspension. This
is because your doctor may need to change the amount of
anaesthetic or muscle relaxants given to you.
Tapclob® Oral Suspension with food, drink and alcohol
Do not drink alcohol while you are taking Tapclob® Oral
Suspension. This is because alcohol can change the way
Tapclob® Oral Suspension works.

0.5

1. What Tapclob® Oral Suspension is and
what it is used for

If you take Tapclob® Oral Suspension late in pregnancy
or during labour your baby might have a low body
temperature, floppiness, breathing or feeding difficulties.
If taken regularly during late pregnancy, your baby may
develop 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. Do not drive or use any tools or
machines if you are affected in this way.
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:
• The medicine has been prescribed to treat a medical or
dental problem and
• You have taken it according to the instructions given by
the prescriber or in the information provided with the
medicine and
• It was not affecting your ability to drive safely

1

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

If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor
for advice before taking this medicine. Tapclob® Oral
Suspension should be avoided during pregnancy.

0.4

What is in this leaflet

• If you have ever become dependent upon another drug
or alcohol.
Suicidal thoughts
Some patients have experienced suicidal thoughts while
taking medicines containing clobazam, particularly if they
are already depressed. If you start experiencing thoughts
of suicide or harm towards yourself please tell your doctor
immediately.
Dependence, tolerance and withdrawal
It is possible for you to become dependent on Tapclob®
Oral Suspension if you take it for long periods of time,
particularly if you have a history of heavy alcohol or
drug use. This means that you may feel that you need
to continue treatment with Tapclob® Oral Suspension in
order to feel well (known as psychological dependence).
If you suddenly stop taking Tapclob® Oral Suspension you
may experience worsening of the symptoms you were
originally being treated for, as well as mood changes,
anxiety, sleep disturbance or restlessness. This is known as
withdrawal and can be avoided by slowly reducing your
dose. If you are worried about dependence or withdrawal
please talk to your doctor.

0.3

D03047

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,
nurse or pharmacist.
• This medicine has been prescribed for you.
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,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet.

0.2

Tapclob® 5mg/5ml and 10mg/5ml Oral Suspension
Clobazam

5mg/5ml: Doses
Adults and adolescents (over 15 years)
• The usual dose is 20mg (20ml) to 30mg (30ml) 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 60mg
(60ml) each day.
• Your doctor may lower the dose to suit you.
Children (over 6 years)
• The usual starting dose is 5mg (5ml) each day.
• Your doctor will then adjust the dose according to your
child’s need.
Elderly
• The usual dose for anxiety is 10mg (10ml) to 20mg
(20ml) each day.
10mg/5ml: Doses
Adults and adolescents (over 15 years)
• The usual dose is 20mg (10ml) to 30mg (15ml) 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 60mg
(30ml) each day.
• Your doctor may lower the dose to suit you.
Children (over 6 years)
• The usual starting dose is 5mg (2.5ml) each day.
• Your doctor will then adjust the dose according to your
child’s need.
Elderly
• The usual dose for anxiety is 10mg (5ml) to 20mg (10ml)
each day.
Method of administration:
This product may settle during storage, please shake well
before use.
Your doctor, pharmacist or nurse will show you how
to administer this medicine. The box containing this
medicine will contain a 5ml dosing syringe, a dosing
adaptor and a 30ml dosing cup.

0.1

Pregnancy and breast-feeding
Do not take Tapclob® Oral Suspension if you
• are in the first three months of pregnancy
• are breast-feeding

PACKAGE LEAFLET: INFORMATION FOR THE USER

3. How to take Tapclob® Oral Suspension
Always take this medicine exactly as your doctor has told
you. Tapclob® 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.
When you are taking Tapclob Oral Suspension you
should not change to any different clobazam containing
medicines except under your doctor’s supervision.

30ml dosing cup. Each numbered increment is 5ml equivalent to 5mg of Tapclob 5mg/5ml Oral Suspension
and 10mg of Tapclob 10mg/5ml Oral Suspension.
Instructions are provided overleaf for using the dosing
syringe. If you have any questions about the dose you
should use or how to use the syringe, you should ask your
pharmacist.
Continued overleaf

3047-D

100mm Measurement Verification Bar

Instructions for use:
• Open the bottle: press the cap and
turn it anticlockwise (figure 1)

5
1

• Turn the bottle the right way up.
Remove the syringe from the adaptor
(figure 5).

6
• Holding the bottle, take the plastic
syringe adaptor from the box and
insert the adaptor into the bottle
neck (figure 2).

2

• Administer the contents of
the syringe into the mouth
by pushing the piston to the
bottom of the syringe
(figure 6) and ensure the
medicine is swallowed.
Remove the adaptor from the bottle and close the
bottle with the plastic screw cap.

Ensure it is well fixed.

Wash the adaptor and the syringe with warm water. Dry
them with a clean paper towel and replace them into
the box with your medicine.
• Take the syringe and put it in the
adaptor opening (figure 3).

3

• Turn the bottle upside down.

• Fill the syringe with a small amount of suspension
by pulling the piston down (figure 4a), then push the
piston upward in order to remove any possible bubble
(figure 4b). Pull the piston down to the graduation
mark corresponding to the quantity in milliliters (ml)
prescribed by your doctor (figure 4C).

4a

4b

4c

If you take more Tapclob® Oral Suspension than you
should
If you take more Tapclob® Oral Suspension than you should,
tell your doctor or go to your nearest hospital casualty
department immediately. Do not drive yourself because
you may start to feel sleepy.
If you forget to take Tapclob® Oral Suspension
If you have missed a dose take it as soon as you remember
unless it is almost time for the next one then carry on
as before. Do not take a double dose to make up for a
forgotten dose.
If you stop taking Tapclob® Oral Suspension
Do not stop taking your medicine without telling your
doctor as he may gradually reduce your dose before
stopping it completely. If stopped suddenly, you may
have unpleasant side effects including stress (anxiety),
confusion, or depression. You may also lose your appetite
and have difficulty sleeping (see Section 2 ‘Dependence,
tolerance and withdrawal’).
If you have any further questions on the use of this
medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Tell your doctor immediately if you have any of the
following side effects. These effects are more likely to
occur in children and the elderly:
• 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 (see Section 2 ‘Suicidal thoughts’)

6. Contents of the pack and other
information
What Tapclob® Oral Suspension contains
• The active substance (the ingredient that makes the oral
suspension work) is Clobazam.
Each 5ml of Tapclob® 5mg/5ml Oral Suspension
contains 5mg of clobazam.
Each 5ml of Tapclob® 10mg/5ml Oral Suspension
contains 10mg of clobazam.

Other side-effects include:
• headache
• breathing problems
• loss of memory, confusion or inappropriate behaviour
• skin rash
• muscle weakness
• problems walking or other movement problems
• being aggressive
• reacting to things more slowly than usual
• problems with your vision such as double vision
• difficulty in staying awake or alert
• becoming dependent on Tapclob® Oral Suspension (also
called ‘physical or mental dependence’) (see Section 2
‘Dependence, tolerance and withdrawal’)
• weight gain
• loss of sexual drive

• The other ingredients are sorbitol (E420), xanthan gum
(E415), acesulfame potassium (E950), raspberry flavour,
sodium propyl hydroxybenzoate (E217), sodium methyl
hydroxybenzoate (E219), disodium hydrogen phosphate
dihydrate, sodium dihydrogen phosphate dihydrate and
purified water.
What Tapclob® Oral Suspension looks like and
contents of the pack
Tapclob® 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.
Pack sizes are 100ml, 150ml and 250ml.
Marketing Authorisation Holder
Martindale Pharmaceuticals Ltd
Trading as Martindale Pharma
Bampton Road, Harold Hill, Romford, Essex,
RM3 8UG, United Kingdom
Manufacturer
Nupharm Laboratories Limited
2 Newtech Square, Deeside Industrial Park,
Deeside, Flintshire, CH5 2NT
United Kingdom

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.

If you would like any more information, or would like
the leaflet in a different format, please contact medical
information at the above address.

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, constipation
• loss of appetite, feeling sick
• shaking fingers

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 Website: http://www.
mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more
information on the safety of this medicine.

Product licence numbers: PL 00156/0322

PL 00156/0323
This leaflet was last revised in July 2015

5. How to store Tapclob® Oral Suspension
Keep this medicine out of the sight and reach of children.
Do not use Tapclob® 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.
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.

D03047

3047-D

100mm Measurement Verification Bar

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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.

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