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Diazepam Syrup 2 mg/5 ml and
Diazepam Forte Syrup 5 mg/5 ml

Read all of this leaflet carefully before you start taking your 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

In this leaflet:
1. What Diazepam is and what is it used for
2. Before you take Diazepam
3. How to take Diazepam
4. Possible side effects
5. How to store Diazepam
6. Further Information


What Diazepam is and what it is used for

Diazepam belongs to a group of medicines known as
benzodiazepines, which have sedative and muscle relaxing

Diazepam Syrup and Diazepam Forte Syrup are used to
treat a number of conditions including:

In Adults
• The short-term treatment of anxiety that is severe,
disabling or associated with unacceptable distress.
• To treat sleeplessness (insomnia) that is severe, disabling
or associated with unacceptable distress.
• To relieve the symptoms of acute alcohol withdrawal.
• In the control of muscle spasm in tetanus.
• In selected cases of cerebral palsy and in the treatment of
other forms of muscle spasm.
• In the treatment of some forms of epilepsy.
• In the treatment of muscle spasm due to poisoning.
In Children
• To treat night terrors or sleep walking in children.
• In the control of muscle spasm in tetanus.
• To control tension and irritability in selected cases of
cerebral palsy.

Both adults and children can take a small dose of Diazepam
before an operation to help with relaxation and to cause


Before you take Diazepam

Do not take Diazepam
If you:
• Are allergic or sensitive to benzodiazepines, diazepam or
any of the ingredients in this medicine (see section 6
Further information).
• Have breathing difficulties.
• Are or might be pregnant, planning to become pregnant or
are breast-feeding, (see Pregnancy and breast-feeding
• Have or have ever had any mental illness including
depression, phobia, obsession or anxiety.
• Have myasthenia gravis (a condition which causes
muscles to weaken and tire easily).
Take special care with Diazepam
Tell your doctor if any of the following applies to you
• You have a personality disorder.
• You have kidney or liver disease.
• You are elderly or you are weakened by illness.
• You have any disorder of the brain (hardening of the
arteries in the brain).
• You have problems with your circulation.
• You have porphyria (an inherited condition causing skin
blisters, abdominal pain and brain or nervous system
• Someone close to you has recently died.
• You are or have been a user/abuser of alcohol and/or
drugs or have a personality disorder (In these
circumstances your doctor should monitor you regularly
whilst you are taking diazepam and not prescribe further
solution unless there are very particular reasons to do so).

You should take the lowest dose possible and you should not
continue the treatment beyond 4 weeks.

Taking other medicines
Please tell your doctor or pharmacist if you are taking or
have recently taken any other medicines, including
medicines obtained without a prescription.
• Antidepressants, sedatives (to calm you down), hypnotics
(for mental conditions), neuroleptics (for mental illness)
and other medicines for mental illness such as zotepine or
fluvoxamine, tranquilisers (sleeping tablets) or analgesics
(strong pain killers).

These medicines act in the same way as diazepam and
could make you very sleepy.
• Medicines for alcohol dependence such as disulfiram.
• Medicines for epilepsy e.g. phenobarbitone, sodium
valporate. These can make the side effects of diazepam
• Cimetidine (for ulcers) as these can cause diazepam to
be removed from the body more slowly than usual.
• ACE inhibitors (for high blood pressure e.g. Captopril,
Enalapril or Lisinopril).
• Medicines for hypertension e.g.hydralazine, methyldopa,
minoxidil or clonidine.
• Medicines to treat tuberculosis (e.g. rifampicin, isoniazid).
• Beta-blockers (e.g. propanolol or atenolol for heart
• Baclofen (for cerebral palsy).
• Levodopa (for Parkinsonʼs disease).
• Antihistamines (for allergies).
• Anaesthetics (used during surgery or dental treatment).
• Antivirals such as ritonavir (anti-infection medicines).
If you are going to have an operation involving an
anaesthetic, the hospital will need to know in advance that
you are taking Diazepam.
Taking Diazepam with food and drink
Do not drink alcohol while you are taking diazepam.
Alcohol may increase the sedative effects of Diazepam and
make you very sleepy. If you regularly drink alcohol please
tell your doctor before using this medicine.

Pregnancy and breast-feeding
You should not take Diazepam if you are pregnant, planning
to become pregnant or if you are breast-feeding. If you take
Diazepam late in your pregnancy or during labour your baby
might have a low body temperature, floppiness, breathing
and feeding difficulties. If you take this medicine regularly
during late pregnancy, your baby may develop withdrawal
Driving and using machines
Diazepam may make you feel sleepy, affect your
concentration or you may have problems with the way your
muscles work.
Do not:
• drive or use any tools or machines if you are affected in
this way.
• take part in other activities where this would put you or
others at risk.
• drink alcohol, as this will make these effects worse.

You should make sure that you get enough sleep, otherwise
you may experience difficulty staying alert. If this happens do
not drive, use tools or operate machines.
Important information about some of the ingredients of
Diazepam contains sucrose (a type of sugar). If you have
been told by your doctor that you have an intolerance to
some sugars, contact your doctor before taking this

Diazepam contains potassium sorbate and colouring
ponceau 4R red. Potassium sorbate is an irritant which may
cause dermatitis (skin inflammations). Ponceau 4R red
(E124) may cause allergic reactions.
Diazepam contains methyl and propyl hydroxybenzoate
(E219 and E217). These may cause allergic reactions
(possibly delayed).


How to take Diazepam

Always take Diazepam exactly as your doctor has told you.
You should check with your doctor or pharmacist if you are
not sure.
Diazepam Syrup and Diazepam Forte Syrup should be taken
by mouth.

Continued on the next page >>

Daily doses should be divided and taken on two or three
separate occasions during the day, for example in the
morning, at midday and at night or as instructed.

You should not take Diazepam for longer than 4 weeks
and you should take the lowest dose possible in order to
control the illness.
Important: These syrups should be shaken well before
The dose of Diazepam Syrup or Diazepam Forte Syrup may
vary according to the condition being treated and the
following is a guide to the doses often used:
For anxiety: the usual dose is 2 mg three times a day, this
may be increased up to 30 mg daily in divided doses if
For sleeping difficulties associated with anxiety: 5 mg to
15 mg before going to bed.

For cerebral palsy and muscle spasms, associated with
upper motor neurone disease or muscle spasms associated
with epilepsy, fibrositis, cervical spondylosis: your doctor
may tell you to take 2 mg to 15 mg daily in divided doses, up
to 60 mg in severe cases.
For muscle spasms associated with conditions such as
epilepsy, fibrositis, cervical spondylosis: 2 mg to 15 mg daily
in divided doses.
To help with control of muscle spasms as in tetanus: the
dose you are given will depend upon your bodyweight and
will be based upon 3 to 10 mg for every kg of your weight,

Before a dental operation: the usual does is 5 mg the night
before, 5 mg on waking and another 5 mg two hours before
the appointment.

To help with alcohol withdrawal symptoms: your doctor may
tell you to take 5 mg to 20 mg, which may be repeated after
2 to 4 hours if necessary.

For night terrors and sleep walking: the usual dose is 1 mg to
5 mg daily before going to bed.
Before an operation: 2 mg to 10 mg is usual.

To control muscle spasms, as in tetanus: this dose is based
on your childʼs bodyweight and will be between 3 to 10 mg
for each kg of weight, daily.
For cerebral palsy: 2 mg to 40 mg daily in divided doses is
The dosage should be half that recommended for adults

If you take more Diazepam than you should:
If you accidentally take too much syrup, you may feel
drowsy, experience shaky movements and slurred speech.
In very severe cases you may lose consciousness. It is
important to seek medical help from your doctor or local
casualty department.

If you forget to take Diazepam
Do not double the dose in order to make up for a forgotten
dose. If you are at all concerned, you should consult your
doctor or pharmacist, for advice.
• If you remember within one hour of the missed dose take
your medicine now and continue with your next dose at
the usual time.
• If your next dose is less than 2 hours away, skip the
missed dose and take the next dose now.

If you stop taking Diazepam
Do not stop taking your medicine without telling your doctor
as he may wish to gradually reduce the amount you take
before stopping it completely. If you stop taking Diazepam
suddenly you may experience unpleasant side effects
including confusion, serious mood or behavioural changes,
tremors or convulsions. Nervousness, insomnia, irritability,
sweating, diarrhoea and depression may also occasionally if
your treatment has only been for a short period of time.
As with other benzodiazepine drugs, there is the possibility
of dependence on treatment occurring, but this normally
does not happen with low doses and short courses of

If you have any further questions on the use of this medicine,
ask your doctor or pharmacist.


Possible side effects

Like all medicines, Diazepam can cause side effects,
although not everybody gets them.
If you experience the following, stop taking Diazepam Syrup
and tell your doctor immediately or go to the casualty
department of your nearest hospital.

The following rare side effects have been reported. If
you experience any of these see your doctor at once:
• Depression with suicidal tendencies
• Jaundice (yellowing of skin and whites of the eyes)
• Breathing problems such as breathlessness
• Abnormal behaviour changes such as aggression,
excitement and confusion
• Low blood pressure (symptoms such as dizziness,
fainting, blurred vision, or irregular heart beat)
• Blood disorders (increased risk of infections particularly
frequent throat infections, mouth ulcers, pale skin,
bruising, prolonged bleeding from gums or elsewhere)
• Muscle weakness
• Amnesia (forgetfulness).
Other side effects include:
• Drowsiness
• Sedation (feeling sleepy)
• Unsteadiness when walking
• Blurring of vision
• Difficulties performing skilled tasks and reduced
Drinking alcohol may exaggerate these effects.

You could notice the above side effects even after a single
dose and they may continue for more than 24 hours. If you
are elderly you are more likely to suffer from side effects,
especially confusion.

Less common effects include:
If you experience any of these side-effects you should
reduce your dose and seek advice from your doctor.
• Vertigo, fainting or giddiness
• Confusion
• Visual problems (including seeing things which are not
• Changes in sex drive
• Stomach upsets
• Headaches
• Slurred speech
• Tremor
• Skin rashes
• Loss of co-ordination
• Incontinence
• Urinary retention (inability to pass urine).
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.


How to store Diazepam

• Keep your medicines out of the reach and sight of
• Do not use Diazepam after the expiry date marked on the
container or package. The expiry date refers to the last
day of that month.
• Diazepam Syrup should be stored below 25°C. Please
keep in the original carton to protect the medicine from
• If you notice any defects with this product such as a
non-pink colour you should take this medicine to your
pharmacist for advice before taking it.
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.


Further information

What Diazepam contains
• Each 5 ml of your medicine will contain the active
substance diazepam. (Either 2 mg diazepam in Diazepam
Syrup or 5 mg diazepam in Diazepam Forte Syrup).
• The other ingredients present include sucrose,
microcrystalline cellulose, glycerin, methyl hydroxybenzoate
(E219), propyl hydroxybenzoate (E217), ethanol, sodium
carboxymethylcellulose, framboise flavour, ponceau 4R
red (E124), potassium sorbate and water.
What Diazepam looks like and the content of the pack
Diazepam Syrup and Diazepam Forte Syrup are pink,
raspberry flavoured suspensions.
Diazepam is available in bottles supplied in volumes of
50 ml, 100 ml, 150 ml, 250 ml, 300 ml or 500 ml (both
strengths) or 200 ml (Diazepam Syrup 5 mg/5 ml only).
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:
Sandoz Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.
This leaflet was last revised in 07/2012.

A severe allergic reaction (rash, itching, swelling of the face,
lips, mouth or throat that may cause difficulty in swallowing
or breathing).


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.