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Active substance(s): DIAZEPAM

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GB 726-7511-APIL

Diazepam 2 mg, 5 mg and 10 mg Tablets

Patient Information Leaflet
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
- 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 becomes severe, or if you notice
any side effects not listed in this leaflet, please tell your
doctor or pharmacist.
In this leaflet:
1. What Diazepam 2 mg, 5 mg and 10 mg Tablets are and
what they are used for.
2. Before you take Diazepam 2 mg, 5 mg and 10 mg Tablets.
3. How to take Diazepam 2 mg, 5 mg and 10 mg Tablets.
4. Possible side effects.
5. How to store Diazepam 2 mg, 5 mg and 10 mg Tablets.
6. Further information.
The name of your medicine is Diazepam 2 mg, 5 mg or 10 mg
The active ingredient is diazepam.
Diazepam is one of a group of medicines called
Benzodiazepines can be used for many different reasons; for
the short-term (2-4 weeks) relief of anxiety occurring alone or
associated with sleeping problems, to help control certain
forms of epilepsy, to relieve muscle spasms, to help relieve
symptoms of acute alcohol withdrawal, or as an oral
pre-medication before surgery.
Do not take this medicine if:
• you have ever had an allergic reaction to diazepam or any
of the other ingredients of this medicine (allergic reactions
include mild symptoms such as itching and / or rash. More
severe symptoms include swelling of the face, lips, tongue
and / or throat with difficulty in swallowing or breathing);
• you suffer from acute breathing problems;
• you have severe liver disease;
• you suffer from muscle weakness (myasthenia gravis);
• you suffer from a condition where you stop breathing whilst
asleep (sleep apnoea);
• you have a phobia (a fear of a particular object or
situation) or other mental illness;
• you have porphyria (an inherited condition causing skin
blisters, abdominal pain and brain or nervous system
• you suffer from depression or anxiety associated with
• you suffer from restlessness or hyperactivity.
Take special care and tell your doctor or pharmacist if:
• you have long term kidney, liver, heart or respiratory
• you suffer from a personality disorder;
• you have a history of alcoholism or drug abuse;
• you have a history of seizures (fits);
• someone close to you has recently died;
• you have low blood levels of a protein called albumin;
• you are elderly (risk of confusion or clumsiness, causing fall
or injury).
If you have trouble sleeping, make sure you discuss this fully
with your doctor before taking this medicine.
Other considerations
• Dependence - when taking this medicine there is a risk of
dependence, which increases with the dose and duration of
treatment and also in patients with a history of alcoholism
and drug abuse.
• 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 speak to your doctor.
• Withdrawal - treatment should be gradually withdrawn.
Withdrawal symptoms occur with Diazepam Tablets even
when normal doses are given for short periods of time. See
Section 3, ‘If you stop taking Diazepam Tablets’.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines
obtained without prescription, especially the following:
• antidepressants, antipsychotics (to treat mental problems,
e.g. zotepine), antihistamines (to treat allergies), general
anaesthetics, alcohol, lofexidine (to help relieve symptoms
when you stop taking opioids), nabilone (to treat nausea and
vomiting), cisapride (to treat reflux), hypnotics (to help you
sleep), alpha-blockers or moxonidine (to lower high blood
pressure), muscle relaxants (e.g. baclofen, tizanidine). Taking
these medicines with diazepam could make you very tired.
• 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 feel very tired;
• disulfiram (to treat alcohol addiction). Taking this medicine
with diazepam could make you very tired and can cause
diazepam to be removed from the body more slowly than
• medicines for epilepsy, e.g. phenobarbital, phenytoin,
carbamazepine, or sodium valproate (diazepam can affect
the blood levels of these medicines);
• cimetidine, omeprazole or esomeprazole (for ulcers),
oestrogen-containing contraceptives, erythromycin (an
antibiotic), antifungals (fluconazole, voriconazole,
itraconazole, ketoconazole) or isoniazid (to treat
tuberculosis) as these can cause diazepam to be removed
from the body more slowly than usual;
• sodium oxybate (to treat narcolepsy/excessive sleepiness) as
the effects of this drug can be increased if used with
• rifampicin (to treat infections) or theophylline (to treat
asthma) as these can cause diazepam to be removed from
the body more quickly than usual;
• amrenavir or ritonavir (antivirals) as these can make you
feel tired for longer or cause difficulty breathing;
• zidovudine (to treat HIV/AIDS infections) as when used with
diazepam zidovudine can be removed from the body more
quickly than usual;

• medicines to lower high blood pressure, diuretics (water
tablets), nitrates (for heart conditions) as these could lower
your blood pressure too much;
• levodopa (to treat Parkinson’s Disease) as diazepam may
cause levodopa not to work so well;
• antacids (reduces stomach acid) may slow down absorption
of diazepam in the body.
Taking Diazepam Tablets with food and drink
Do not drink alcohol while you are taking Diazepam Tablets.
Alcohol may increase the sedative effects of Diazepam Tablets
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 Tablets and you should speak to
your doctor or pharmacist.
Drinks containing caffeine may reduce the effects of diazepam.
Other special warnings
- If you see another doctor or visit a hospital, remember to
tell them what medicines you are already taking.
- If you are going to have an operation please tell the
anaesthetist that you are taking Diazepam Tablets as this
may affect some of the drugs he/she may use.
Pregnancy and breast-feeding
Tell your doctor if you become pregnant, or if you are
breast-feeding. You should not take Diazepam Tablets if you
are pregnant, planning to become pregnant or are
breast-feeding. If this medicine is taken regularly in late
pregnancy, your baby may develop withdrawal symptoms.
Diazepam can pass into breast milk. Ask your doctor or
pharmacist for advice before taking any medicine.
Driving and using machines
Individual patients vary in their response to the medicines used
to treat anxiety so you should always talk to your doctor before
driving and/or operating machinery. In addition, if you
experience symptoms such as drowsiness or loss of
concentration, it is advisable not to drive or operate machinery.
Important information about some of the ingredients
of Diazepam Tablets
Diazepam Tablets contain lactose (a type of sugar). If you have
been told that you have an intolerance to some sugars contact
your doctor before taking this medicine.
The tablets should be swallowed whole with a glass of water.
Always take your medicine exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not sure. He
or she will tell you how many to take and how often to take them.
The usual doses are:
Anxiety states: The lowest dose which can control symptoms
should be used. The usual dose is 2 mg, but you may be given 5
mg or 10 mg, three times a day. The maximum dose should not
exceed 30 mg daily in divided doses. Treatment should always
be reduced gradually.
Insomnia: Treatment should be intermittent if possible. Refer
to dosing for anxiety states.
Insomnia associated with anxiety: 5-15 mg before bedtime.
If your doctor advises you to take a different amount of this
medicine, you should always follow your doctor’s instructions
about when, how much and how often you should take your
medicine. If you do not understand or are in any doubt, ask
your doctor or pharmacist.
Relief of alcohol withdrawal symptoms: 5-20 mg
repeated if necessary every 2-4 hours.
Children do not need to take as many tablets as adults. Your
doctor will suggest the correct number of tablets for them to take.
For night terror and sleepwalking: 1-5 mg at bedtime.
In elderly patients the recommended dose should not exceed
half of the normal recommended adult dose.
Diazepam 2 mg, 5 mg or 10 mg Tablets should be used for a
short period only, normally not longer than four weeks. After
this your doctor will probably review your treatment.
If your doctor tells you that you no longer need to take your
tablets, you should carefully follow your doctor’s advice about
how to stop your course of treatment. If you stop taking this
medicine suddenly, it may cause you to experience some
withdrawal symptoms such as feeling unwell, depressed or
anxious or have problems sleeping again. Your doctor may wish
to see you more regularly when he starts to reduce your tablets.
If you take more Diazepam Tablets than you should
If you accidentally took too many tablets you will find yourself
feeling very drowsy and very weak. Other signs include slurred
speech or confusion and slow pulse which may lead to
unconsciousness in some cases. You MUST NOT drive. Contact
your doctor or hospital casualty department immediately as
you will need further treatment.
If you forget to take your Diazepam Tablets
If you forget to take a dose, just take the next dose at the usual
time. DO NOT take a double dose.
If you stop taking Diazepam Tablets
• Do not stop taking your medicine without telling your
doctor as s/he may wish to gradually reduce the number of
tablets you take before stopping them completely. If you
stop taking Diazepam Tablets suddenly, you may
experience unpleasant side effects including depression,
nervousness, irritability, sweating , quick or irregular
heartbeat, muscle spasms, shaking, loss of appetite, feeling
or being sick, stomach cramps or diarrhoea. If you have
been taking a high dose, you may occasionally experience
confusion or unusual behaviour. Patients at risk of
convulsions may be more susceptible to suffering fits on
• Treatment should be gradually withdrawn otherwise the
symptoms you are being treated for may return more
intensely than before (rebound insomnia and anxiety). The
risk of this happening is greater when you stop taking
diazepam suddenly. You may also experience mood
changes, anxiety, restlessness or changes in sleep patterns.


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


Like all medicines Diazepam Tablets can cause side effects in
some people, 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.

Do not store above 25°C. Keep the container tightly closed and
store in the original container in order to protect from light. Do
not use Diazepam Tablets after the expiry date that is stated
on the carton.

You are unlikely to get any of the following, but if you do, tell
your doctor immediately:
• drowsiness, sedation, tiredness, slurred speech,
light-headedness, unsteadiness or clumsiness and loss of
coordination (you may notice these even after a single dose
and this may continue into the following day);
• 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, trouble sleeping;
• blood disorders (you may develop sore throats, nose bleeds
or infections), changes in sex drive, development of breasts
in male patients, visual disturbances (including involuntary
eye movement), 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;
• hip fracture (increased risk in the elderly);
• you feel you are abusing or becoming dependant on this
Withdrawal symptoms: see Section 3, ‘If you stop taking
Diazepam Tablets’.
If you think you are suffering from any of these side effects, do
not take any more of your medicine and go back to see your
If any of the side effects becomes severe, or if you notice any
side effects not listed in this leaflet, please tell your doctor
or pharmacist immediately.

10 877 0 602291

Return any unused medicine to your pharmacist.
What Diazepam 2 mg, 5 mg and 10 mg Tablets
Each tablet contains 2 mg, 5 mg or 10 mg of an active
ingredient called diazepam.
The tablets also contain colloidal silicon dioxide, maize starch,
lactose, yellow iron oxide (E172), quinoline yellow lake (E104),
dextrin, indigo carmine lake (E132) and magnesium stearate.
What Diazepam 2 mg, 5 mg and 10 mg Tablets look
like and contents of the pack
Diazepam 2 mg: Flat white tablets with beveled edges, 8 mm
diameter. One face embossed with “DZ” and “2” separated by
a breakline. The reverse face is plain.
Diazepam 5 mg: Flat, pale yellow tablets with beveled edges,
8 mm diameter. One face is embossed with “DZ” and “5”
separated by a breakline. The reverse is plain.
Diazepam 10 mg: Flat, blue tablets with beveled edges, 8 mm
diameter. One face is embossed with “DZ” and “10” separated
by a breakline. The reverse is plain.
Diazepam 2 mg, 5 mg and 10 mg Tablets are available in
blister packs of 28 tablets and pots of 21, 100, 250, 500 and
1000 tablets.
Marketing Authorisation Holder and Manufacturer:
Waymade Plc trading as Sovereign Medical, Sovereign House,
Miles Gray Road, Basildon, Essex. SS14 3FR.
The information in this leaflet applies only to Diazepam 2 mg,
5 mg and 10 mg Tablets.
Date of preparation of the leaflet: June 2013

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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.