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DIAZEPAM 2MG

Active substance(s): DIAZEPAM

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Diazepam

2 mg/5 ml

To help with control of muscle spasms as in tetanus: the dose you are given will depend upon your body weight and will be
based upon 3 to 10 mg for every kg of your weight, daily.

Oral use. Use as directed by your doctor.
Read the package leaflet before use.

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.

Store below 25°C. Protect from light.
Shake well before use.

Syrup

500 ml

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.

Keep all medicines out of the reach
of children.
Each 5 ml contains diazepam BP 2 mg.
Other ingredients include glycerin, sucrose,
methyl hydroxybenzoate, propyl
hydroxybenzoate, alcohol 96% v/v, E124
and potassium sorbate.

Children:
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 child’s body weight 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 usual.

PL 04416/0026
POM
Sandoz Ltd, Frimley Business Park,
Frimley, Camberley, Surrey, GU16 7SR.

Elderly
The dosage should be half that recommended for adults above.

PACKAGE LEAFLET: INFORMATION FOR THE USER

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

Diazepam

2 mg/5 ml

1. What Diazepam is and what is it used for
Diazepam belongs to a group of medicines known as benzodiazepines, which have sedative and muscle relaxing properties.

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 pharmacist.

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

SZ00000LL000

Diazepam Syrup 2 mg/5 ml

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.

Diazepam Syrup is 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.

Oral use. Use as directed by your doctor.
Read the package leaflet before use.
Store below 25°C. Protect from light.
Shake well before use.

Syrup

Keep all medicines out of the reach
of children.

500 ml

Each 5 ml contains diazepam BP 2 mg.
Other ingredients include glycerin, sucrose,
methyl hydroxybenzoate, propyl
hydroxybenzoate, alcohol 96% v/v, E124
and potassium sorbate.

EXP:

POM

Lot:

PL 04416/0026
Sandoz Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR.

SZ00000LL000

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

2. 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
below).
• 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.

4. 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.
A severe allergic reaction (rash, itching, swelling of the face, lips, mouth or throat that may cause difficulty in swallowing
or breathing).
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).

• 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 disorders).
• 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 syrup 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 worse.

Other side effects include:
• Drowsiness
• Sedation (feeling sleepy)
• Unsteadiness when walking
• Blurring of vision
• Difficulties performing skilled tasks and reduced alertness.
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 there)
• Changes in sex drive
• Stomach upsets
• Headaches

• 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. propranolol or atenolol for heart problems).
• Baclofen (for cerebral palsy).
• Levodopa (for Parkinson’s 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

• 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.

5. How to store Diazepam
• Keep your medicines out of the reach and sight of children.
• 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. Protect the medicine from light.
• 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

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 symptoms.
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
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 medicine.
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).

no longer required. These measures will help to protect the environment.

6. Further information
What Diazepam contains
• Each 5 ml of your medicine will contain 2 mg of the active substance diazepam.
• The other ingredients present include sucrose, microcrystalline cellulose, glycerin, methyl hydroxybenzoate (E219), propyl
hydroxybenzoate (E217), ethanol, sodium carboxymethyl cellulose, framboise flavour, ponceau 4R red (E124),
potassium sorbate and water.
What Diazepam looks like and contents of the pack
Diazepam Syrup is a pink, raspberry flavoured suspension.
Diazepam is available in bottles supplied in volumes of 50 ml, 100 ml, 150 ml, 250 ml, 300 ml or 500 ml.
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.

Larger text version of
the leaflet can be made
available upon request.

3. 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 should be taken by mouth.
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: The syrup should be shaken well before using.
The dose of Diazepam Syrup may vary according to the condition being treated and the following is a guide to the doses often used:
Adults
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 necessary.
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.

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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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