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DIAZEPAM BP 5MG TABLETS

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PACKAGE LEAFLET

PACKAGE LEAFLET: INFORMATION FOR THE USER DIAZEPAM
2 mg, 5 mg and 10 mg
TABLETS BP
(Diazepam)

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 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 is and what it is used 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 AND WHAT IT IS USED FOR
Diazepam belongs to a group of medicines called benzodiazepines. It is not clear exactly how this
medicine works but it is thought that diazepam increases the actions of a naturally occurring substance
called GABA, in the brain.
Diazepam is used to treat a number of conditions, including:
In adults:






severe anxiety, which is an emotional state where you may sweat, tremble, feel anxious and
have a fast heart beat
tension headaches; migraine attacks and insomnia (trouble sleeping) all of which could be
brought on by anxiety
helping muscles relax and for muscle spasm and cerebral spasticity (a condition associated
with adisease or trauma affecting the brain or spinal cord which causes weakness, uncoordinated movements, rigidity and stiffness)
epilepsy (when taken with other medicines)
patients with the symptoms of alcohol withdrawal.

In children:


to help treat nightmares and sleepwalking and for tension and irritability caused by cerebral
spasticity

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 (hypersensitive) to Diazepam or any of the other ingredients in your tablets
are breathless or have difficulty breathing
suffer from depression
have a phobia (a fear of a particular object or situation)
are being treated for mental illness.

Take special care with Diazepam
Tell your doctor if any of the following applies to you:




problems with your liver, kidneys or lungs
Myasthenia Gravis (a condition which causes muscles to weaken and tire easily)
someone close to you has recently died.

Taking other medicines
Tell your doctor if you are taking any of the following medicines:





antidepressants, sedatives (to calm you down), hypnotics (to help you sleep) or strong pain
killers. These medicines act in the same way as Diazepam and could make you very sleepy
medicines for epilepsy eg. barbiturates or Phenytoin. These can make the side effects of
Diazepam worse
Cimetidine or Omeprazole (for ulcers) as these can cause Diazepam to be removed from the
body more slowly than usual
Rifampicin (an antibiotic) as this can cause Diazepam to be removed from the body more
quickly than usual.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including medicines bought without a prescription.
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.
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, and breathing and feeding difficulties. If you take this medicine
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 may make you feel sleepy or affect your concentration. Do not drive or use any tools or
machines if you are affected in this way and do not drink alcohol, as this will make these effects
worse.
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

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
This product contains lactose (a type of sugar). If you have been told that you have intolerance to
some sugars contact your doctor before taking this medicine.

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. The number of tablets you take will depend on what you are taking the
tablets for. You should not take Diazepam for longer than 4 weeks. Swallow the tablets whole.

Adults
If you are taking the tablets for anxiety the usual dose is 2 mg three times a day. This amount can be
increased up to 10 mg three times a day.
If you are taking Diazepam to help you sleep, the usual dose is 5 mg to 15 mg at bedtime. If possible
you should not take Diazepam every night.
If you are taking Diazepam to help with alcohol withdrawal symptoms your doctor may tell you to
take single dose of 5 mg to 20 mg, which may be repeated after 2 to 4 hours if necessary.
If you are taking Diazepam to help control muscle spasm your doctor may tell you to take 2 mg to 15
mg of diazepam each day. This dose should be divided up into 2 or 3 doses throughout the day.
If you are taking Diazepam to help cerebral spasticity or epilepsy your doctor may tell you to take 2
mg to 60 mg of Diazepam each day, divided up into 2 or 3 doses throughout the day.
If you are given Diazepam before an operation a single dose of between 5 mg and 20 mg of Diazepam
is usual.
Children
If your doctor has given your child Diazepam for nightmares or sleepwalking the usual dose is 1 mg
to 5 mg at bedtime.

For tension and irritability in cerebral spasticity the dose is usually between 2 mg and 40 mg each day
divided up into 2 or 3 doses throughout the day.
If your doctor has given your child Diazepam to take before an operation a single dose of between 2
mg and 10 mg of Diazepam is usual.

Elderly
If you are elderly or frail you are likely to be more sensitive to the effects of Diazepam and your
doctor will give you much lower doses than those mentioned above.
If you have liver or kidney problems or breathing difficulties you may also be given a lower dose.
If you take more Diazepam than you should
If you take more Diazepam than you should contact your doctor or nearest hospital emergency
department immediately. Take the container and any remaining tablets with you.
If you forget to take Diazepam
If you forget to take a dose of Diazepam take it as soon as you remember, unless it is almost time for
your next dose, in which case miss out the forgotten dose completely and carry on as normal. Do not
take a double dose to make up for a forgotten dose.
If you stop taking Diazepam
Do not stop taking your medicine without telling your doctor as he may wish to gradually reduce the
number of tablets you take before stopping them completely. If you stop taking Diazepam suddenly,
you may experience unpleasant side effects including depression, nervousness, sleeplessness,
irritability, sweating or diarrhoea and occasionally confusion, convulsions or unusual behaviour.
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.
The following unexplainable side-effects have been reported. If you experience any of these see
your doctor at once, as you should not take this medicine:





feeling over excited or nervous
feeling or seeing things that are not there
experiencing rage
changes in sleep pattern and having tight stiff muscles.

Other side-effects include:
The most common side effects are:


feeling sleepy




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.
Other side-effects that occur less often are:










loss of memory
headache
dizziness
low blood pressure
stomach upsets
skin rashes
changes to eye sight
lack of sexual drive
difficulty passing urine.

A few cases of unusual bleeding or bruising of the skin, feeling feverish or yellowing of the skin or
whites of the eyes have been known to occur.
If any side-effect 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 tablets out of the reach and sight of children. Do not use Diazepam after the expiry date,
which is stated on the carton after EXP. The expiry date refers to the last day of that month. • Store
your medicine in a dry place, below 25°C and away from light.
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 contains:
The active substance is diazepam . The other ingredients are lactose, maize starch and magnesium
stearate. The 5 mg tablets contain the colour quinoline yellow (E104) and the 10 mg tablets contain
the colour indigo carmine (E132).
What Diazepam looks like and contents of the pack:
The Diazepam 2 mg tablet is white and marked 'DM 2' on one side and 'G' on the other. The 5 mg
tablet is yellow and marked 'DM 5' on one side and 'G' on the other. The 10 mg tablet is blue and
marked 'DM 10' on one side and 'G' on the other.
Diazepam is available in amber glass bottles containing
100, 250, 500 or 1,000 tablets; in plastic pots with white caps or blisters containing 5, 7, 10, 14, 15,
20,21, 25, 28, 30, 50, 56, 60, 84, 90, 100, 112, 120,168, 180, 250, 500 or 10,000 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:
Generics [UK] Limited, Station Close, Potters Bar, Hertfordshire, EN6 1TL.
Date of revision: January 2014

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.

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