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DIAZEPAM 5MG TABLETS

Active substance(s): DIAZEPAM

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PACKAGE LEAFLET: INFORMATION FOR THE USER

DIAZEPAM 2 mg, 5 mg
& 10 mg TABLETS
Read all of this leaflet carefully before you start
taking this 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 become serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

THIS LEAFLET CONTAINS
1. What Diazepam is for
2. Before you take Diazepam
3. How to take Diazepam
4. Possible side effects
5. How to store Diazepam
6. Further information

1. WHAT DIAZEPAM IS FOR
Diazepam belongs to a group of medicines called
benzodiazepines. It can be used to treat a number of
conditions, including:
In adults:
 the short-term relief of severe anxiety
 insomnia (difficulty in sleeping) due to anxiety
 muscle spasms and cerebral spasticity
(a condition associated with a disease or trauma
affecting the brain or spinal cord which causes
weakness, un-coordinated movements, rigidity and
stiffness)
 some forms of epilepsy (when taken with other
medicines)
 the symptoms of alcohol withdrawal
 before dental or surgical procedures to help with
relaxation and to cause sleepiness
In children:
 nightmares and sleepwalking
 tension and irritability caused by cerebral spasticity
If you are not sure why you have been prescribed
these tablets then please ask your doctor.

2. BEFORE YOU TAKE DIAZEPAM
Do not take Diazepam and tell your doctor if you:
 are allergic to Diazepam, any of the other
ingredients in the tablets (listed in section 6 of this
leaflet) or to other benzodiazepines
 have severe liver, lung or breathing problems
 have muscle weakness sometimes causing
difficulty breathing (myasthenia gravis)
 suffer from breathing problems whilst asleep (sleep
apnoea)
 suffer from depression, mental health problems,
irrational fears (phobias) or obsessions
Take special care with Diazepam
Tell your doctor before you take this medicine if you:
 have a history of alcohol or drug abuse
 suffer from a personality disorder
 have recently suffered a loss or bereavement
 are elderly or have problems with your liver,
kidneys or lungs
 have weak or tired muscles
 suffer from an inherited iron disorder (porphyria)
Medicines such as Diazepam may lead to
addiction. Any risk is more likely with high doses,
prolonged treatment or if you have a history of alcohol
or drug abuse or you suffer from a personality disorder.
Taking other medicines
Tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, even medicines
bought without a prescription.
In particular, tell your doctor or pharmacist if you are
taking any of the following medicines, as they may

affect how Diazepam tablets work:
 Medicines to treat depression such as Fluvoxamine
or Mirtazapine
 Medicines to treat mental health problems such as
Olanzapine, Prochlorperazine or Zotepine
 Medicines to calm you down or to help you sleep
 Sodium oxybate to reduce daytime sleepiness or
sudden loss of muscle strength
 Disulfiram or Lofexidine for drug dependence
 Strong pain killers or general anaesthetics
 Nabilone to treat sickness caused by
chemotherapy
 Medicines to treat epilepsy such as Phenytoin,
Valproate or barbiturates
 Levodopa to treat Parkinson's disease
 Medicines to treat high blood pressure or heart
failure such as Moxonidone, Diazoxide,
Hydralazine or Minoxidil
 Medicines to increase urine production such as
Diuretics
 Muscle relaxants such as Baclofen or Tizanidine
 Isoniazid or Rifampicin to treat bacterial infections
 Fosamprenavir or Ritonavir to treat viral infections
 Medicines to treat ulcers such as Cimetidine,
Omeprazole or Esomeprazole
 Antihistamines for allergies
 Theophylline for asthma
If you go into hospital or have treatment for other
conditions, tell the doctor that you are taking
Diazepam.
Taking Diazepam with food and drink
Alcohol may increase the sedative effects of Diazepam
and make you feel very sleepy. Do not drink alcohol
whilst taking Diazepam.
Pregnancy and breast-feeding
Do not take Diazepam if you are pregnant, planning to
become pregnant or you are breast-feeding, unless
your doctor has told you to.
If you take this medicine late in your pregnancy or
during labour your baby might have an irregular heart
rate, a low body temperature, floppiness, and breathing
and feeding difficulties.
If you take this medicine regularly during late
pregnancy, your baby may become dependent on
Diazepam and develop withdrawal symptoms after
birth.
Make sure you follow your doctor's advice.
Driving and using machines
Diazepam can affect your ability to drive and use
machines as it may make you sleepy or dizzy. Do not
drink alcohol as it can make these effects worse.
Do not drive or use machinery while taking Diazepam
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:
- Diazepam 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
Talk to your doctor or pharmacist if you are not sure
whether it is safe for you to drive while taking this
medicine.
Important information about some of the
ingredients of Diazepam
Diazepam 2 mg, 5 mg and 10 mg tablets contain
lactose (a type of sugar). If you know you have an
intolerance to some sugars contact your doctor before
taking this medicine.

3. HOW TO TAKE DIAZEPAM
Always take Diazepam tablets exactly as your
doctor has told you. Take this medicine by mouth.
When taking Diazepam tablets try to make sure you
sleep well for 7-8 hours per night.
Dosage
You will be prescribed the lowest effective dose for the
shortest time necessary to treat your symptoms. This
will reduce the risk of addiction.

Typically Diazepam will not be prescribed for more
than 4 weeks.
Adults:
Anxiety: Typical dose is 2 mg three times a day. This
can be increased to 15-30 mg daily in divided doses.
Insomnia in association with anxiety: Typical dose
is 5-15 mg at bedtime.
Muscle spasms: Typical dose is 2-15 mg daily in
divided doses.
Cerebral spasticity or epilepsy: Typical dose is 2-60
mg daily depending on your response to the medicine.
Alcohol withdrawal symptoms: Typical dose is 5-20
mg, which may be repeated after two to four hours if
necessary.
Before dental or surgical procedures: Typical dose
is 5 mg the night before the operation then 5 mg two
hours before the operation.
Elderly or debilitated (those that are weak or feeble):
Typically require half the adult dose, as you are more
likely to be sensitive to the effects of Diazepam. Follow
your doctor's advice.
If you have liver or kidney problems or breathing
difficulties you may also require lower doses.
Children:
Nightmares and sleepwalking: Typical dose is 1-5
mg at bedtime.
Tension and irritability in cerebral spasticity:
Typical dose is 2-40 mg daily in divided doses.
If you take more Diazepam than you should
Contact your doctor or go to a hospital immediately.
Show them the package or container. Symptoms of an
overdose may include drowsiness, confusion,
tiredness, breathing problems, difficulty in swallowing,
difficulty in controlling movements, low blood pressure
or falling into a coma.
If you forget to take Diazepam
Don't worry, just take your next scheduled dose at the
correct time. Do not take a double dose to make up for
the one you have missed.
If you suddenly stop taking Diazepam
The risk of withdrawal symptoms is greater. Your doctor
will gradually reduce your dose.
Withdrawal symptoms may include headache,
sweating, diarrhoea, muscle pain, tension, extreme
anxiety, depression or irritability and occasionally
hallucinations, fits, unusual behaviour, numbness and
tingling of the hands and feet or sensitivity to light,
noise or touch.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Diazepam can cause side effects,
although not everybody gets them.
If you get any of the following side effects, STOP
TAKING this medicine and tell your doctor at once:
 feeling restless, agitated or irritated
 nightmares or hallucinations (hearing or seeing
things that are not there)
 aggressive outbursts or rages
 unusual behaviour or false beliefs (delusions)
Other side effects include:
The most common side effects are:
 feeling sleepy, light-headed
 unsteadiness
 clumsiness and loss of co-ordination
You could notice the above common 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 and loss
of co-ordination.
Other side effects that occur less often are:
 loss of memory
 numbed emotions
 headache
 dizziness or a feeling of spinning (vertigo)

reduced alertness and tiredness
low blood pressure
stomach upsets
skin rashes
muscle weakness, shaking (tremor)
problems with your vision
difficulty in speaking
making more saliva than usual
changes in your sex drive
difficulty passing urine.
loss of control of your bladder or bowels
(incontinence)
A few cases of unusual bleeding or bruising of the skin,
feeling feverish or yellowing of the skin and whites of
the eyes (jaundice) have been known to occur. If this
happens contact your doctor immediately.












Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet.
You can also report side effects directly via 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 DIAZEPAM
Keep out of the sight and reach of children.
Do not store above 25°C. Store in the original package
to protect from light or store in the original container
and keep the container tightly closed.
Do not use these tablets after the expiry date, which is
stated on the package or container. 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 tablets contain
The active ingredient in Diazepam 2 mg, 5 mg and 10
mg tablets is diazepam.
The other ingredients in the 2 mg tablets are lactose,
maize starch, pregelatinised starch and magnesium
stearate.
The other ingredients in the 5 mg tablets are lactose,
maize starch, pregelatinised starch, magnesium
stearate, dried aluminium oxide and quinoline yellow
(E104).
The other ingredients in the 10 mg tablets are lactose,
maize starch, magnesium stearate and indigo carmine
(E132).
What Diazepam tablets look like and contents of
the pack
Diazepam 2 mg tablets are round white tablets with the
marking MP57 on one side.
Diazepam 5 mg tablets are round pale yellow tablets
with the marking MP58 on one side.
Diazepam 10 mg tablets are round pale blue tablets
with the marking MP59 on one side and a break line
engraved on the other.
The tablets come in containers of 14, 15, 21, 28, 30,
50, 56, 60, 84, 100, 250, 500 and 1000 tablets and in
blister packs of 14 and 28 tablets. Not all pack sizes
may be marketed.
Marketing Authorisation Holder
Metwest Pharmaceuticals Limited,
15 Runnelfield, Harrow on the Hill,
Middlesex HA1 3NY
Manufacturer
DDSA Pharmaceuticals Limited,
310 Old Brompton Road,
London SW5 9JQ
For more information about this product, please
contact the Marketing Authorisation Holder.
This leaflet was last revised in 06/2014
M0057-0058-0059/O/PIL/M1

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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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