DIAZEPAM 2mg/5ml ORAL SUSPENSION – patient leaflet, side effects, dosage

1 What Diazepam is and what it is used for

• 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.

Diazepam belongs to a group of medicines known as benzodiazepines, which have sedative and muscle relaxing properties. This medicine has been prescribed for:

• Dependence – there is a risk of dependence, which increases with the dose and duration of treatment if you have a history of alcoholism and drug abuse. Therefore, you should take Diazepam tablet for as short period of time as possible.

In Adults

• short term relief (14 days) of severe anxiety and may occur alone or with insomnia (trouble sleeping) or mental health problems

  • 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.
• To relieve the symptoms of acute alcohol withdrawal.
• In the control of muscle spasm in tetanus.

• In selected cases of cerebral palsy and in the treatment of other forms of muscle spasm.

  • Withdrawal – treatment should be gradually withdrawn.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’.
• In the treatment of some forms of epilepsy.
• In the treatment of muscle spasm due to poisoning.

• As a sedative and premedicant.

  You should take the lowest dose possible and you should not continue the treatment beyond 4 weeks

In Children

• To treat night terrors or sleep walking in children.

  If any of the above apply to you or you are unsure, please talk to your doctor before taking the medicine.

• In the control of muscle spasm in tetanus.

• To control tension and irritability in selected cases of cerebral palsy. Both adults and children can take a small dose of Diazepam before an operation to help with relaxation and to cause sleepiness. It contains the active substance, diazepam, which belongs to a class of medicines called benzodiazepines.

  Other medicines and Diazepam Oral Suspension

  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:

  • antidepressants (e.g. fluvoxamine, fluoxetine),

This medicine has been prescribed to you and should not be given to anyone else.

• sedatives (to calm you down),
• antipsychotics such as clozapine (to treat mental problems),

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.

• antihistamines (to treat allergies),
• general anaesthetics (used during surgery or dental treatment),
• hypnotics (to help you sleep),
• erythromycin (an antibiotic),
• muscle relaxants (eg baclofen, tizanidine, suxamethonium, tubocurarin),
• 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.

2 What you need to know before you take

• barbiturates such as phenobarbital (to treat epilepsy and mental disorders)

Diazepam

• medicines to lower high blood pressure e.g. captopril, enalapril or Lisinopril; diuretics (water tablets); nitrates (for heart conditions) as these could lower your blood pressure too much.

Do not take Diazepam if you:

• are allergic or sensitive to the active substance, benzodiazepines or any of the ingredients in this medicine (see section 6 Further information).

  • antacids (reduces stomach acid) may slow down absorption of diazepam in the body.

• are breathless or have difficulty breathing including slow and/or shallow breathing.

  Taking these medicines with diazepam could affect your mental status, make you very sleepy and suppress your breathing and blood pressure.

• planning a pregnancy or are pregnant (see below ‘Pregnancy and breast-feeding’)

  • 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.

• have or have ever had any mental illness including depression, phobia, obsession, anxiety, hyperactivity and inability to concentrate.

  • medicines for epilepsy e.g. Phenobarbital, phenytoin, carbamazepine, or sodium valproate, (diazepam can affect the blood levels of these medicines). Diazepam can furthermore affect how phenytoin works.
• have myasthenia gravis (a condition which causes muscles to weaken and tire easily)

• suffer from sleep apnoea (a condition where you stop breathing whilst asleep)

  • theophylline (to treat asthma and other breathing disorders), as it can weaken the effect of diazepam. As this can cause diazepam to be removed from the body more quickly than usual.
• have severe liver disorders

• have porphyria (an inherited condition causing skin blisters, abdominal pain and brain or nervous system disorders) Warnings and precautions

  • cimetidine, omeprazole or esomeprazole (stomach acid reducing medicines), as these can cause diazepam to be removed from the body more slowly than usual.

Talk to your doctor or pharmacist before taking Diazepam if you:

Talk to your prescriber before taking this medicine if you:

• 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.
• 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.
• amprenavir, atazanavir, ritonavir, delavirdine, efavirenz, indinavir, nelfinavir or saquinavir (antivirals) as these can make you feel sleepy for longer or cause difficulty breathing.
• have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating, when you have stopped taking alcohol or drugs.
• fluconazole, voriconazole, itraconazole or ketoconazole (antifungal medicines) as these can cause diazepam to be removed from the body more slowly than usual and therefore increase the risk of side effects.
• 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.
• isoniazid (used to treat tuberculosis), as it can cause diazepam to be removed from the body more slowly than usual.
• oestrogen-containing 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.

Physical dependence and addiction can cause withdrawal symptoms when you stop taking this medicine. Withdrawal symptoms can include:

• corticosteroids (medicines used to treat inflammation in the body) as they can weaken the effect of diazepam.
• Benzodiazepines: 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).
• levodopa (to treat Parkinson’s disease) as diazepam may cause levodopa to not work so well.
• 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),
• neuroleptics (for mental illness) and other medicines for mental illness such as zotepine, tranquilisers (sleeping tablets).
• beta-blockers (e.g. propanolol or atenolol for heart problems)
• HIV-protease inhibitors: (e.g. zidovudine)

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 drugs, may increase the risk of addiction. Overuse and misuse can lead to overdose and/or death.

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), coma and 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. If you are going to have an operation involving an anaesthetic, the hospital will need to know in advance that you are taking Diazepam. Diazepam with food and drink

• have problems with your heart and lungs or have kidney or liver disease
• are elderly or you are weakened by illness.
• have breathing problems
• have suicidal thoughts
• have epilepsy of a history of seizures

• have any disorder of the brain (hardening of the arteries in the brain).

  Do not drink alcohol while you are taking diazepam. Alcohol may increase the sedative effects of Diazepam and make you very sleepy. If you regularly drink alcohol please tell your doctor before using this medicine.

• have problems with your circulation.
• have low blood levels of a protein called albumin
• have depression (with or without anxiety)

• have a personality disorder

  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

• someone close to you has recently died.
• are or have been a user/abuser of alcohol and/or drugs or have a personality disorder (in these circumstances your doctor should monitor you regularly whilst you are taking diazepam and not prescribe further solution unless there are very particular reasons to do so).

Other considerations

• Mental side effects – contact your doctor if you experience side effects such as agitation, hyperactivity, restlessness,

Ask your doctor or pharmacist for advice before taking this medicine. Driving and Using machines:

Diazepam may make you feel sleepy, affect your concentration or you may have problems with the way your muscles work. Do not:

• drive or use any tools or machines if you are affected in this way
• take part in other activities where this would put you or others at risk
• drink alcohol, as this will make these effects worse. You should make sure that you get enough sleep, otherwise you may experience difficulty staying alert. If this happens do not drive, use tools or operate machines.

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 sucrose, Ponceau 4R red (E124), methyl and propyl hydroxybenzoate (E218 and E216) and ethanol

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. Also, sucrose may be harmful to the teeth.

Diazepam contains the colouring Ponceau 4R red (E124) which may cause allergic reactions.

Diazepam contains methyl and propyl hydroxybenzoate (E218 and E216). These may cause allergic reactions (possibly delayed). This medicine contains 3.6 mg of alcohol (ethanol) in each 5 ml, which is equivalent to 0.72 mg/ml. The amount in 1 ml of this medicine is equivalent to less than 1 ml beer or 1 ml wine. The small amount of alcohol in this medicine will not have any noticeable effects. This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.

3 How to take Diazepam

Your prescriber should have discussed with you how long the course of Diazepam 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.

You should not take Diazepam for longer than 4 weeks and you should take the lowest dose possible in order to control the illness.

Diazepam Oral Suspension should be taken by mouth. Daily doses should be divided and taken on two or three separate occasions during the day, for example in the morning, at midday and at night or as instructed.

You should make sure you are able to have 7-8 hours of uninterrupted sleep.

Important: These suspensions should be shaken well before using.

The dose of Diazepam Oral suspension may vary according to the condition being treated and the following is a guide to the doses often used:

Adults

For anxiety: the usual dose is 2mg three times a day, this may be increased up to 30mg daily in divided doses if necessary. For sleeping difficulties associated with anxiety: 5mg to 15mg before going to bed.

For cerebral palsy and muscle spasms, associated with upper motor neurone disease or muscle spasms associated with epilepsy, fibrositis, cervical spondylosis: your doctor may tell you to take 2mg to 15mg daily in divided doses, up to 60mg in severe cases. For muscle spasms associated with conditions such as epilepsy, fibrositis, cervical spondylosis: 2mg to 15mg daily 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.

Before a dental operation: the usual does is 5mg the night before, 5mg on waking and another 5mg two hours before the appointment. To help with alcohol withdrawal symptoms: your doctor may tell you to take 5mg to 20mg, which may be repeated after 2 to 4 hours if necessary.

Use in children and adolescents:

For night terrors and sleep walking: the usual dose is 1mg to 5mg daily before going to bed.

Before an operation: 2mg to 10mg is usual.

To control muscle spasms, as in tetanus: this dose is based on your child’s bodyweight and will be between 3 to 10mg for each kg of weight, daily.

For cerebral palsy: 2mg to 40mg daily in divided doses is usual. Older people

The dosage should be half that recommended for adults above. If you take more Diazepam than you should:

If you accidentally take too much suspension or you think a child may have swallowed any, immediately seek medical help from your doctor or local casualty department.

Signs of overdose include clumsiness, loss of coordination, feeling sleepy or deep sleep, drowsiness, irregular or slow heartbeat, uncontrolled eye movement muscle weakness, shaky movements, excitement or slurred speech. In very severe cases you may lose consciousness, have breathing difficulties or experience reflex problems..

If you forget to take Diazepam

Do not double the dose in order to make up for a forgotten dose. If you are at all concerned, you should consult your doctor or pharmacist, for advice.

• If you remember within one hour of the missed dose take your medicine now and continue with your next dose at the usual time.
• If your next dose is less than 2 hours away, skip the missed dose and take the next dose now.

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:

• Benzodiazepines: 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).

4 Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience the following, stop taking Diazepam Suspension and tell your doctor immediately or go to your nearest hospital.

Stop treatment and contact your doctor immediately if you have the following symptoms of an allergic reaction: rash, itching, swelling of the face, lips, mouth or throat that may cause difficulty in swallowing or breathing.

The following side effects have been reported. If you experience any of these see your doctor at once:

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) Other side effects:

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 tablets’ 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, memory loss, 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 with suicidal tendencies
• Emotional withdrawal
• Insomnia (problems sleeping)
• Difficulty speaking
• 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)

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

Drinking alcohol may exaggerate these effects.

Drug Withdrawal

Unknown frequency: dependence and addiction (see section “How do I know if I am tolerant or addicted?”).

When you stop taking Diazepam you may experience drug withdrawal symptoms, which include:

• Benzodiazepines: 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).

You could notice the above 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 How do I know if I am tolerant or addicted?

If you notice any of the following signs whilst taking Diazepam 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.

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 the Yellow Card Scheme (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

• 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 bottle or carton. The expiry date refers to the last day of that month.
• Diazepam Suspension should be stored below 25°C. Please keep in the original carton to protect the medicine from light.
• If you notice any defects with this product such as a non-pink colour you should take this medicine to your pharmacist for advice before taking it.

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 contains

• The active substance is Diazepam. Each 5ml of your medicine contains 2mg diazepam in Diazepam 2mg/5ml Oral Suspension.
• The other ingredients are sucrose, microcrystalline cellulose, glycerin, methyl hydroxybenzoate (E218), propyl hydroxybenzoate (E216), ethanol, croscarmellose sodium, framboise (raspberry) flavour, Ponceau 4R red (E124), potassium sorbate and purified water.

What Diazepam looks like and the content of the pack

Diazepam Oral Suspension is a pink, raspberry flavoured suspension. Diazepam is available in bottles supplied in volumes of 50ml, 100ml, 150ml, 250ml, 300ml or 500ml.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Sandoz Limited, Park View, Riverside Way, Watchmoor Park, Camberley, Surrey, GU15 3YL, United Kingdom

Manufacturer:

Sandoz Limited, Park View, Riverside Way, Watchmoor Park, Camberley, Surrey, GU15 3YL, United Kingdom and/or

PURNA PHARMACEUTICALS NV/SA, Rijksweg 17, B 2870 Puurs This leaflet was last revised in November 2025