Active substance: DIAZEPAM

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Diazepam oral solution 2mg/5ml
Read all of this leaflet carefully before you start taking this
• 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.

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

1 What Diazepam oral solution is and what it is used for

Diazepam belongs to a group of medicines called benzodiazepines. Diazepam
helps in the treatment of anxiety, muscle spasms and convulsions (fits). It is
used to treat:
In adults
• short term relief (14 days) of severe anxiety and may occur alone or with
insomnia (trouble sleeping) or mental health problems
• cerebral palsy
• muscle spasm caused by tetanus (when taken with other medicines)
• epilepsy (when taken with other medicines)
• patients with the symptoms of alcohol withdrawal
• helping to relax nervous dental patients.
In children
• tension and irritability caused by cerebral spasticity
• helping to relax and cause sleepiness before an operation.

2 Before you take

Do not take Diazepam oral solution and tell your doctor if you

• are allergic (hypersensitive) to diazepam, benzodiazepine medicines, or to
any of the other ingredients in Diazepam oral solution (see section 6)
• have a phobia or other mental illness or are hyperactive
• are breathless or have difficulty breathing
• have myasthenia gravis (a condition which causes muscles to weaken and
tire easily)
• suffer from sleep apnoea ( a condition where you stop breathing whilst
• have severe liver disorders
• have porphyria (an inherited condition causing skin blisters, abdominal
pain and brain or nervous system disorders)
• planning pregnancy or are pregnant (see below ‘Pregnancy and breastfeeding’).

Check with your doctor or pharmacist before taking Diazepam
oral solution if you have

• a history of alcoholism or drug abuse
• problems with your heart and lungs or have kidney or liver disease
• someone close to you who has recently died
• low blood levels of a protein called albumin
• a personality disorder
• a poor blood supply to the brain (arteriosclerosis)
• depression (with or without anxiety)
• smoke.
Continued top of next column

Other considerations

• Dependence – there is a risk of dependence, which increases with the dose
and duration of treatment and if you have a history of alcoholism and drug
• Tolerance – if after a few weeks you notice that the tablets are not working
as well as they did when first starting treatment, you should go and see
your doctor.

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, antipsychotics (to treat mental problems),
antihistamines (to treat allergies), general anaesthetics, lofexidine (to
help relieve symptoms when you stop taking opioids), nabilone (to treat
nausea and vomiting), hypnotics (to help you sleep), alpha blockers
or moxonidine (to lower high blood pressure), muscle relaxants (eg
baclofen, tizanidine). Taking these medicines with diazepam could make
you very sleepy.
• some strong pain killers may give you a heightened sense of well being
when taken with diazepam, which can increase your desire to continue
taking these medicines (dependency) or can make you very sleepy.
• disulfiram (to treat alcohol addiction). Taking this medicine with diazepam
could make you very sleepy and can cause diazepam to be removed from
the body more slowly than usual.
• medicines for epilepsy e.g. Phenobarbital, phenytoin, carbamazepine,
or sodium valproate, (diazepam can affect the blood levels of these
• cimetidine or omeprazole (for ulcers), oestrogen-containing
contraceptives, erythromycin (an antibiotic), antifungals (fluconazole,
voriconazole) or isoniazid (to treat tuberculosis) as these can cause
diazepam to be removed from the body more slowly than usual.
• rifampicin (to treat infections) or theophylline (to treat asthma) as this can
cause diazepam to be removed from the body more quickly than usual.
• amprenavir or ritonavir (antivirals) as these can make you feel sleepy for
longer or cause difficulty breathing.
• medicines to lower high blood pressure, diuretics (water tablets),
nitrates (for heart conditions) as these could lower your blood pressure too
• levodopa (to treat Parkinson’s Disease) as diazepam may cause levodopa to
not work so well.
• antacids (reduces stomach acid) may slow down absorption of diazepam in
the body.

Taking Diazepam oral solution with food and drink

Do not drink alcohol while you are taking Diazepam oral solution. Alcohol
may increase the sedative effects of Diazepam oral solution and make you
very sleepy.
Grapefruit juice may increase the amount of diazepam in your blood. If you
are elderly, suffer from cirrhosis or any of the conditions listed in section 2, this
could possibly increase the sedative effects of Diazepam oral solution and you
should speak to your doctor or pharmacist.
Drinks containing caffeine may reduce the effects of diazepam.

Pregnancy and breast-feeding

You should not take Diazepam oral solution if you are pregnant, planning to
become pregnant or are breast feeding. If you take Diazepam oral solution late
in pregnancy or during labour your baby might have a low body temperature,
floppiness, and breathing difficulties. If taken regularly during late pregnancy,
your baby may develop withdrawal symptoms. Ask your doctor or pharmacist
for advice before taking any medicine.

Driving and using machines

Diazepam oral solution can make you sleepy, forgetful, have poor
co-ordination along with other side effects that can affect everyday activities
(see Possible side effects). You should not drive, operate machinery or take
part in such activities where, if affected, you could put yourself or others at risk.
Continued over page

Important information about some of the ingredients of
Diazepam oral solution

Diazepam oral solution contains 1.91g to 2.58g of sorbitol per 5ml solution.
This may have a mild laxative effect. If you have been told that you have an
intolerance to some sugars, contact your doctor before taking this medicine.
This medicine also contains propylene glycol which may cause alcohol-like
symptoms and glycerol, which may cause headache, stomach upset and

3 How to take

Always take Diazepam oral solution exactly as your doctor has told you. You
should not take Diazepam oral solution for longer than 4 weeks. You
should check with your doctor or pharmacist if you are not sure.
You should make sure you are able to have 7-8 hours of uninterrupted sleep.
• Anxiety or mental health problems: 2mg-30mg each day, in divided doses
• Insomnia: 5mg-30mg at bedtime
• Cerebral palsy: 2mg-60mg each day, in divided doses
• Other spasticities: 5mg-60mg each day, in divided doses
• To control muscle spasm: 2mg-15mg each day, in divided doses
• Epilepsy as a premedication: 2mg-60mg per day, in divided doses
• Epilepsy: 5mg-20mg daily
• Alcohol withdrawal symptoms: 5mg-20mg, which may be repeated after 2
to 4 hours if necessary
• Before dental treatment: 5mg the night before treatment, 5mg on waking
and 5mg two hours before the appointment
• Cerebral spasticity: 2mg-40mg each day, in divided doses
• For muscle spasm associated with tetanus, the adult dose is usually given
• Epilepsy: 2mg-10mg daily
Specific patient groups
• Elderly or frail: you are likely to be more sensitive to the effects of
Diazepam oral solution, especially sedation, drowsiness and confusion.
Your doctor will give you much lower doses, this should not be more than
half the adult dose.
• Breathing difficulties: you may be given you a lower dose.

If you take more Diazepam oral solution than you should

If you (or someone else) swallow a lot of Diazepam Oral Solution, or you
think a child may have swallowed any, contact your nearest hospital
casualty department or tell your doctor immediately. Signs of an overdose
include clumsiness and loss of coordination, feeling sleepy or deep sleep,
speech problems, irregular or slow heartbeat, uncontrolled eye movement,
muscle weakness or excitement. An extreme overdose may lead to coma
(unrousable unconsciousness), reflex problems and breathing difficulties.

If you forget to take Diazepam oral solution

Do not take a double dose to make up for a forgotten dose. If you forget to
take a dose take it as soon as you remember it and then take the next dose
at the right time.

If you stop taking Diazepam oral solution

• 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 headaches,
muscle pain, extreme anxiety, tension, restlessness, confusion and
irritability. In severe cases you may experience depersonalisation (feeling
that your mind is becoming separated from your body), derealisation
(feeling that the world around you is not real), abnormally acute hearing or
painful sensitivity to sound, numbness and tingling in arms and legs, over
sensitivity to light, noise and physical contact, seeing, hearing or feeling
things that are not there (hallucinations) or fits.
• Withdrawal symptoms include depression. Withdrawal symptoms may
occur between normal and high doses or if your doctor is switching you to
another benzodiazepine.
Continued top of next column

• Treatment should be gradually withdrawn otherwise the symptoms being
treated may return more intense than before (rebound insomnia and
anxiety). Mood changes, anxiety, restlessness or changes in sleep patterns
may also occur.

4 Possible Side Effects

Like all medicines, Diazepam oral solution can cause side-effects, although
not everybody gets them.
Stop treatment and contact a doctor at once if you have the following
symptoms of an allergic reaction e.g. itchy skin, rash, swelling of the face,
lips, tongue or throat, or difficulty breathing or swallowing.
Tell your doctor if you notice any of the following side effects or notice any
other effects not listed:
• drowsiness, sedation, tiredness, slurred speech, light-headedness,
unsteadiness or clumsiness and loss of co-ordination (you may notice
these even after a single dose and this may continue into the following
• confusion, memory loss (which may be experienced several hours
after taking diazepam. If possible, to reduce the risk allow 7 to 8 hours
of uninterrupted sleep after taking), seeing or sensing things that are
not there, inappropriate behaviour, difficulty concentrating, agitation/
irritability, restlessness, experiencing rage, excitement, numbed emotions,
depression with suicidal tendencies, headache, ‘spinning’ sensation
• blood disorders (you may develop sore throats, nose bleeds or infections)
changes in sex drive, visual disturbances, low blood pressure, stomach
upsets, yellowing of the skin or whites of the eyes (jaundice)
• muscle spasms/shaking or weakness, breathing difficulties
• difficulty passing urine, increase in amount of saliva
• you feel you are abusing or becoming dependant on this product
• Withdrawal symptoms: see Section 3, ‘If you stop taking Diazepam oral
• Dependence: see Section 2, ‘Other Considerations’
If you notice any side effects, they get worse, or if you notice any not listed,
please tell your doctor or pharmacist.

5 How to store

Keep out of the reach and sight of children.
Do not store above 25°C. Keep container in the outer carton and keep the
container tightly closed.
Do not use Diazepam oral solution after the expiry date stated on the label/
carton/bottle. The expiry date refers to the last day of that month.
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 Further Information

What Diazepam oral solution contains

• The active substance (the ingredient that makes the oral solution work) is
diazepam. Each 5ml spoonful contains 2mg of the active ingredient.
• The other ingredients are docusate sodium, magnesium aluminium
silicate, propylene glycol, raspberry flavour, saccharin sodium, percol
erythrosine (E127), sorbic acid (E200), propyl hydroxybenzoate (E216),
methyl hydroxybenzoate (E218), sorbitol (E420), glycerol (E422).

What Diazepam oral solution looks like and contents of the
Diazepam oral solution is a pink syrup with an odour of raspberries.
Pack sizes are 100ml.
Marketing Authorisation Holder:
Actavis, Barnstaple, EX32 8NS, UK
Pinewood Laboratories Ltd, Ballymacarbry,
Clonmel, Ireland
Date of Revision: July 2011

Actavis, Barnstaple, EX32 8NS, UK

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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.