Patient leaflet - Diazepam 10 mg tablets
1. What Diazepam tablet is and what it is used for
Diazepam helps in the treatment of anxiety, muscle spasms and convulsions (fits).
This medicine has been prescribed for you for:
In Adults
•short term relief (2-4 weeks only) of severe anxiety, which is an
emotional state where you may sweat, tremble, feel anxious and have a fast heartbeat and may occur alone or with insomnia (trouble sleeping) or mental health problems
helping muscles relax and for muscle spasm and cerebral palsy
(a condition affecting the brain which causes movement problems and rigidity or stiffness)
- epilepsy (when taken with other medicines)
- patients with the symptoms of alcohol withdrawal
- helping to relax nervous dental patients.
In Children
- To treat night terrors or sleepwalking in children
In the control of muscle spasm in tetanus (when taken with
other medicines).
To control tension and irritability in selected cases spasticity in
cerebral palsy (a condition associated with a disease or trauma affecting the brain or spinal cord which causes weakness, un-coordinated movements, rigidity and stiffness).
Both adults and children can take a small dose of Diazepam before an operation to help with relaxation and to cause sleepiness.
It contains diazepam which belongs to a class of medicines called benzodiazepines.
This medicine has been prescribed to you and should not be given to anyone else.
This medicine should be used for as short a time as possible and should not be used for more than four weeks.
Benzodiazepines can cause dependence, tolerance and addiction, and you may get withdrawal symptoms if you stop taking it or reduce the dose suddenly. Your prescriber should have explained how long you will be taking it for and, when it is appropriate to stop, how to do this safely. When your treatment is stopped, it is usually done gradually over a period which is specific to you and may occur over a period of weeks to months. If this medicine is being used for the treatment of epilepsy you must continue to take it as prescribed by your doctor.
When taking this medicine there is a risk of dependence (a need to keep taking the medicine).
The risk increases with the dose and length of treatment period. The risk is greater if you have ever had a history of alcohol or drug abuse.
2. What you need to know before you take Diazepam tablets
Do not take Diazepam if you:
are allergic to diazepam, benzodiazepine medicines, or to any
of the other ingredients of this medicine (listed in section 6)
- have a phobia or other mental illness or are hyperactive
breathing problems, which may be severe, including slow and/
or shallow breathing
have myasthenia gravis (a condition which causes muscles to
weaken and tire easily)
suffer from sleep apnoea (a sleep disorder where you have
abnormal pauses in breathing during sleep)
- have severe liver disorders
planning a pregnancy or are pregnant (see below ‘Pregnancy
and breast-feeding’)
- suffer from depression (with or without anxiety) or hyperactivity
have porphyria (an inherited condition causing skin blisters,
abdominal pain and brain or nervous system disorders)
Warnings and precautions
Talk to your prescriber before taking this medicine if you:
- have a history of alcoholism or drug abuse
have problems with your heart and lungs or have severe kidney
failure
- have had someone close to you recently die
are elderly. Diazepam can cause confusion and have effects
on muscles causing falls and injuries.
- have breathing difficulties
- have suicidal thoughts
- have epilepsy or a history of seizures
- have low blood levels of a protein called albumin
- have a personality disorder
- have a poor blood supply to the brain (arteriosclerosis)
are or have ever been addicted to opioids, alcohol, prescription
medicines, or illegal drugs, or if you
have ever had a history of struggling to control your alcohol or
drug intake.
- smoke
- suffer from depression
have previously suffered from withdrawal symptoms such as
agitation, anxiety, shaking or sweating, when you have stopped taking alcohol or drugs.
feel you need to take more of Diazepam to get the same level of
symptom control, this may mean you are developing tolerance to the effects of this medicine or are becoming addicted to it. Speak to your prescriber who will discuss your treatment and may change your dose or switch you to an alternative medication.
Taking this medicine regularly, particularly for a long time, can lead to physical dependence and addiction. Your prescriber should have explained how long you will be taking it for and, when it is appropriate to stop, how to do this safely. When your treatment is stopped, it is usually done gradually over a period which is specific to you and may occur over a period of weeks to months.
Physical dependence and addiction can cause withdrawal symptoms when you stop taking this medicine. Withdrawal symptoms can include: headaches, muscle pain, anxiety, tension, depression, restlessness, sweating, confusion or irritability. Do not stop taking your tablets suddenly. This could lead to more serious symptoms such as loss of the sense of reality, feeling unreal or detached from life, and unable to feel emotion. Some patients have also experienced numbness or tingling of the arms or legs, tinnitus (ringing sounds in the ears), oversensitivity to light, sound and touch, uncontrolled or overactive movements, twitching, shaking, feeling sick, being sick, stomach upsets or stomach pain, loss of appetite, agitation, abnormally fast heartbeats, panic attacks, dizziness or feeling that you are about to fall, memory loss, hallucinations, feeling stiff and unable to move easily, feeling very warm, convulsions (sudden uncontrolled shaking or jerking of the body).
Your prescriber will discuss with you how to gradually reduce your dose before stopping the medicine. It is important that you do not stop taking the medicine suddenly as you will be more likely to experience withdrawal symptoms. Your prescriber will ensure that your plan for stopping treatment is tailored to you and can be adapted according to your needs and experience of any withdrawal symptoms.
Benzodiazepines should only be used by those they are prescribed for. Do not give your medicine to anyone else. Taking higher doses or more frequent doses of benzodiazepines, may increase the risk of addiction. Overuse and misuse can lead to overdose and/or death.
Other considerations
- Mental side effects – contact your doctor if you experience side effects such as agitation, hyperactivity, restlessness, aggressiveness, nightmares or hallucinations. These side effects are more likely to occur in children or the elderly.
- Amnesia (total or partial memory loss) – you could experience amnesia when taking this medicine. Amnesia is more likely to occur when taking high doses of diazepam.
- 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. Therefore, you should take Diazepam for as short period of time as possible.
- Tolerance – if after a few weeks you notice that the Diazepam is not working as well as it did when first starting treatment, you should go and see your doctor.
Withdrawal – treatment should be gradually withdrawn.
Withdrawal symptoms occur with Diazepam even when normal doses are given for short periods of time. Anxiety and insomnia may reoccur on stopping treatment (Rebound phenomena). See Section 3, ‘If you stop taking Diazepam’.
Children and adolescents
Use in children below 6 months is not recommended. Paradoxical side effects are more likely to occur in children (see section 4).
Other medicines and Diazepam
Do not take diazepam and tell your doctor or pharmacist if you are taking:
- amrenavir, atazanavir, ritonavir, delavirdine, efavirenz, indinavir, nelfinavir, saquinavir or zidovudine (antivirals). These can cause diazepam to be removed from the body more slowly than usual and therefore increase the risk of side effects, such as making you feel sleepy for longer or cause difficulty breathing.
- sodium oxybate (for narcolepsy). Enhanced effect of sodium oxybate when taken with Diazepam.
Concomitant use of diazepam and opioids (strong pain killers, medicines for substitution therapy and some cough medicines) increases the risk of drowsiness, difficulties in breathing (respiratory depression) and coma which may be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible.
However, if your doctor does prescribe diazepam together with opioids, the dose and duration of concomitant treatment should be limited by your doctor.
Please tell your doctor about all opioid medicines you are taking, and follow your doctor’s dose recommendation closely. It could be helpful to inform friends or relatives to be aware of the signs and symptoms stated above. Contact your doctor when experiencing such symptoms.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. Especially:
- sodium oxybate (used to prevent episodes of sudden onset of sleep (narcolepsy) with muscle weakness)
- antidepressants (e.g. fluvoxamine, fluoxetine)
- antipsychotics such as clozapine (to treat mental problems)
- antihistamines (to treat allergies)
- general anaesthetics
- sedatives (used to give calming effects)
- hypnotics (to help you sleep)
- erythromycin (an antibiotic)
- muscle relaxants (e.g. suxamethonium, tubocurarin)
- some strong pain killers such as morphine (opioids) may give you a heightened sense of wellbeing when taken with diazepam, which can increase your desire to continue taking these medicines (dependency) or can make you very sleepy.
- barbiturates such as phenobarbital (to treat epilepsy and mental disorders)
- medicines to lower high blood pressure, diuretics (water tablets) or nitrates (for heart conditions) as these could lower your blood pressure too much
- antacids (reduces stomach acid) may slow down absorption of diazepam in the body
fluconazole, itraconazole, ketoconazole or voriconazole
(anti-fungal medicines). These can cause diazepam to be removed from the body more slowly than usual and therefore increase the risk of side effects, such as making you feel sleepy for longer or cause difficulty breathing.
Taking these medicines with diazepam could affect your mental status, make you very sleepy and suppress your breathing and blood pressure.
- 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 and carbamazepine, sodium valproate (diazepam can affect the blood levels of these medicines). Diazepam can furthermore affect how phenytoin works.
- theophylline (to treat asthma and other breathing disorders), as it can weaken the effect of diazepam. This can cause diazepam to be removed from the body more quickly than usual.
- cimetidine, omeprazole or esomeprazole (stomach acid reducing medicines), as these can cause diazepam to be removed from the body more slowly than usual.
- rifampicin, to treat infections (an antibiotic) as this can cause diazepam to be removed from the body more quickly than usual. The effect of diazepam can be weakened.
- isoniazid (used to treat tuberculosis), as it can cause diazepam to be removed from the body more slowly than usual.
- oral contraceptives, as they can slow down the removal of diazepam from the body and increase its effect. Breakthrough bleeding can occur when taking diazepam and oral contraceptives together, but the contraceptive protection is not reduced.
- cisapride (used to treat stomach problems), as it can cause diazepam to be removed from the body more slowly than usual.
- corticosteroids (medicines used to treat inflammation in the body) as they can weaken the effect of diazepam.
- levodopa (used to treat Parkinson’s disease). Diazepam can reduce the effect of levodopa.
- valproic acid (used to treat epilepsy and mental disorders) as it can slow down the removal of diazepam from the body and increase its effect.
- ketamine (an anaesthetic) as diazepam increases the effect of ketamine.
- lofexidine (to help relieve symptoms when you stop taking opioids)
- nabilone (to treat nausea and vomiting)
- alpha blockers or moxonidine (to lower high blood pressure)
Diazepam with food, drink and alcohol
Do not drink alcohol while you are taking Diazepam. Alcohol may increase the sedative effects of Diazepam 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 and you should speak to your doctor or pharmacist.
Drinks containing caffeine may reduce the effects of diazepam. Pregnancy and breast-feeding
Do not take Diazepam if you are pregnant, planning to have a baby or are breast feeding. If you take Diazepam late in pregnancy or during labour this may harm your baby. Your baby might have a low body temperature, be listless, and breathing difficulties. If taken regularly during late pregnancy, your baby may develop withdrawal symptoms.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Diazepam can make you sleepy, forgetful, have poor co-ordination along with other side effects that can affect everyday activities (see section 4). You should not drive, operate machinery or take part in such activities where, if affected, you could put yourself or others at risk.
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.
Diazepam contains lactose monohydrate
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. How to take Diazepam tablets
Always take this medicine exactly as your doctor has told you. You should not take Diazepam for longer than 4 weeks. 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.
Your prescriber should have discussed with you how long the course of tablets will last. They will arrange a plan for stopping treatment. This will outline how to gradually reduce the dose and stop taking the medicine. Your prescriber will ensure that your plan for stopping treatment is tailored to you and can be adapted according to your needs and experience of any withdrawal symptoms.
The recommended dose is:
Adults
Anxiety or mental health problems: 5mg-30mg each day, in
divided doses
- Insomnia associated with anxiety: 5mg-15mg at bedtime
To help cerebral palsy or other spasticities: 5mg-60mg each
day, in divided doses
- To control muscle spasm: 5mg-15mg each day, in divided doses
To help with control of muscle spasms as in tetanus: the dose
you are given will depend upon your bodyweight and will be based upon 3 to 10mg for every kg of your weight, daily.
- Epilepsy: 2mg-60mg per day, in divided doses
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.
- Before operation: 5mg-20mg
Children and adolescents
For night terrors and sleepwalking: 1mg-5mg before going to
bed
For muscle spasm associated with tetanus, dose depends upon
bodyweight - and will usually be 3 to 10mg for every kg of bodyweight, daily
Spasticity in cerebral palsy:2mg-40mg each day, in divided
doses
- Before operation: 2mg-10mg
Specific patient groups
Elderly or frail: you are likely to be more sensitive to the
effects of Diazepam, especially sedation, drowsiness and confusion.
Your doctor will give you much lower doses; this should not be
more than half the adult dose.
Breathing, liver or kidney problems: you may be given a
lower dose.
Method of administration
The tablet can be divided into equal doses.
If you take more diazepam than you should
if you have taken too many tablets (more than prescribed), or you think a child may have swallowed any, contact your nearest hospital casualty department or tell your doctor or pharmacist immediately. Signs of an overdose include drowsiness, clumsiness, and loss of coordination, feeling sleepy or deep sleep, speech problems, irregular or slow heartbeat, uncontrolled eye movement, muscle weakness. An extreme overdose may lead to coma (unrousable unconsciousness), reflex problems and breathing difficulties.
If you forget to take diazepam
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
Do not suddenly stop taking this medicine. If you want to stop taking this medicine, discuss this with your prescriber first. They will tell you how to do this, usually by reducing the dose gradually so that any unpleasant withdrawal effects are kept to a minimum. This may occur over a period of weeks to months. Your prescriber will ensure that your plan for stopping treatment is tailored to you and can be adapted according to your needs and experience of any withdrawal symptoms.
Withdrawal symptoms such as: headaches, muscle pain, anxiety, tension, depression, restlessness, sweating, confusion or irritability. Do not stop taking your tablets suddenly. This could lead to more serious symptoms such as loss of the sense of reality, feeling unreal or detached from life, and unable to feel emotion. Some patients have also experienced numbness or tingling of the arms or legs, tinnitus (ringing sounds in the ears), oversensitivity to light, sound and touch, uncontrolled or overactive movements, twitching, shaking, feeling sick, being sick, stomach upsets or stomach pain, loss of appetite, agitation, abnormally fast heartbeats, panic attacks, dizziness or feeling that you are about to fall, memory loss, hallucinations, feeling stiff and unable to move easily, feeling very warm, convulsions (sudden uncontrolled shaking or jerking of the body).
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor if you notice any of the following side effects or notice any other effects not listed:
Some side effects can be serious and may require immediate medical treatment:
Uncommon (may affect up to 1 in 100 people)
- Respiratory depression (very slow and/or shallow breathing).
Rare (may affect up to 1 in 1,000 people)
- Respiratory arrest (cessation of breathing)
- Unconsciousness
Jaundice (yellowing of your skin or the white of your eyes).
Very rare (may affect up to 1 in 10,000 people)
Anaphylaxis (severe allergic reaction) with symptoms such as
sudden wheezing, swelling of your lips, tongue and throat or body, rash, fainting or difficulties to swallow.
Tell your doctor if you notice any of the following side effects or notice any other effects not listed:
Very common: may affect more than 1 in 10 people
Drowsiness
Common: may affect up to 1 in 10 people
- Fatigue
- Withdrawal symptoms (for possible symptoms please see ‘If you stop taking Diazepam in Section 3)
- Confusion
- Loss of coordination of muscle movements (ataxia) and other movement disorders, tremor
Uncommon: may affect up to 1 in 100 people
- Muscle weakness
- Memory loss, difficulty in concentrating, balance disorders, dizziness, headache, slurred speech
- Stomach and intestinal problems such as nausea,vomiting, constipation, diarrhoea
- Increased salivation (particularly in children)
Rare: may affect up to 1 in 1,000 people
- Mental side effects such as excitation, agitation, restlessness, irritability, aggressiveness, delusion, rages, psychoses, nightmares or hallucinations. May be or become serious. These side effects are more likely to occur in children or the elderly. Talk to your doctor.
- Decreased alertness
- Depression, emotional withdrawal, insomnia (problems sleeping)
- Heart problems such as slow heartbeat (bradycardia), heart failure and cessation of heartbeat (cardiac arrest).
- Low blood pressure, fainting (syncope)
- Increased mucus in the lungs (particularly in children)
- Dry mouth, increased appetite
- Changes in certain liver enzymes as seen in blood tests
- Lack of ability to urinate, loss of bladder control (leakage of urine)
- Breast enlargement in men
- Impotence, changes in sexual drive (libido)
- Blood disorders (you may develop sore throats, nose bleeds or infections)
- Unconsciousness
- Jaundice (yellowing of your skin or the white of your eyes)
Very rare: may affect up to 1 in 10,000 people
- Low levels of white blood cells (leukopenia)
- Higher level of a certain enzyme in the blood (transaminase)
Not known: frequency cannot be estimated from the available data
Blurred vision, double vision and involuntary eye movements
(these side effects disappear after you have stopped taking diazepam)
- Temporary pause in breathing
- Dependence and addiction (see section “How do I know if I am tolerant or addicted?”).
Drug Withdrawal
When you stop taking Diazepam, you may experience drug withdrawal symptoms, which include: headaches, muscle pain, anxiety, tension, depression, restlessness, sweating, confusion or irritability. Do not stop taking your tablets suddenly. This could lead to more serious symptoms such as loss of the sense of reality, feeling unreal or detached from life, and unable to feel emotion. Some patients have also experienced numbness or tingling of the arms or legs, tinnitus (ringing sounds in the ears), oversensitivity to light, sound and touch, uncontrolled or overactive movements, twitching, shaking, feeling sick, being sick, stomach upsets or stomach pain, loss of appetite, agitation, abnormally fast heartbeats, panic attacks, dizziness or feeling that you are about to fall, memory loss, hallucinations, feeling stiff and unable to move easily, feeling very warm, convulsions (sudden uncontrolled shaking or jerking of the body).
How do I know if I am tolerant or addicted?
If you notice any of the following signs whilst taking <product name>, it could be a sign that you have become addicted.
- You may feel the need to keep taking the medication for longer than your doctor recommended
- You feel you need to use more than the recommended dose
- You are using the medicine for reasons other than prescribed
- When you stop taking the medicine you feel unwell, and you feel better once taking the medicine again
If you notice any of these signs, it is important you talk to your prescriber.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Diazepam tablets
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Diazepam tablet contains
The active substance is diazepam. Each tablet contains 2 mg,
5mg, 10mg of diazepam.
- The other ingredients are Lactose monohydrate, maize starch, starch, pregelatinised (maize starch), magnesium stearate, iron oxide yellow (E172) (5 mg only), FD&C blue No.1 (Brilliant Blue FCF Aluminum Lake) (E133) (10 mg only).
What Diazepam Tablets looks like and contents of the pack
Tablet
Diazepam 2 mg Tablets:
White to off-white, circular, flat face bevelled edge approximately 8.8mm, uncoated tablet debossed with “D” and “2” separated by break line on one side and plain on the other side.
The tablet can be divided into equal halves.
Diazepam 5 mg Tablets:
Pale yellow colored, circular, flat face bevelled edge approximately 8.8mm, uncoated tablet debossed with “D” and “5” separated by break line on one side and plain on the other side.
The tablet can be divided into equal halves.
Diazepam 10 mg Tablets:
Pale blue colored, circular, flat face bevelled edge approximately 8.8mm, uncoated tablet debossed with “D” and “10” separated by break line on one side and plain on the other side.
The tablet can be divided into equal halves.
Diazepam tablets are available in blister and HDPE packs.
Pack sizes:
Blister packs: 10, 20, 28, 30, 40 and 60 tablets.
HDPE pack:
1000 tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Milpharm Limited
1 Roundwood Avenue,
Stockley Park, Uxbridge,
UB11 1AF,United Kingdo
Manufacturer
APL Swift Services (Malta) Ltd
HF26, Hal Far Industrial Estate, Hal Far,
Birzebbugia, BBG 3000, Malta.
Generis Farmaceutica, S.A.,
Rua Joao De Deus, N 19, Venda Nova,
Amadora, 2700-487, Portugal.
Milpharm Limited
1 Roundwood Avenue,
Stockley Park, Uxbridge,
UB11 1AF,United Kingdom
This leaflet was last revised in 07/2026.
Ref Ver: 1.0