Patient leaflet - Diazepam injection BP 10 mg / 2 ml
1. What Diazepam Injection 10mg/2ml is and what it is used for
This medicine has been prescribed for you:
- in the short-term treatment of anxiety and agitation that is severe, disabling or associated with unacceptable distress
- for the control of muscle spasms including tetanus
- for the treatment of convulsions with fever (e.g febrile conditions) and as a result of poisoning • in the treatment of some forms of epilepsy (e.g status epilepticus)
- as premedication prior to and as sedative cover during surgery and minor surgical procedures • in the short term treatment of anxiety and agitation due to alcohol withdrawal (delirium tremens) that is severe.
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.
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.
2. What you need to know before you are given Diazepam Injection 10mg/2ml
You should not be given Diazepam Injection 10mg/2ml if you:
are allergic to diazepam, other benzodiazepines or any of the other ingredients in this medicine
(listed in section 6)
- have a phobia (a fear of a particular object or situation), obsessions, a personality disorder or other mental illness
- have difficulty in breathing, are short of breath or have weakness of your chest muscles that help you breathe (including a condition called Myasthenia Gravis)
- have 'sleep apnoea syndrome' a condition where your breathing stops for short spells when you are asleep
- have severe liver problems (severe hepatic impairment).
- have Porphyria, a disorder of the blood
- are planning a pregnancy or are pregnant (see section pregnancy and breast-feeding).
Warnings and precautions
This medicine will be given under the supervision of a doctor or nurse.
Talk to your doctor before you are given Diazepam Injection 10mg/2ml:
- if you suffer from depression (with or without anxiety)
- if you are over 60 years of age
- if you have liver or kidney disease, do not take this medicine unless recommended by your doctor. Your doctor may carry out extra checks while you are taking this medicine. • if you have breathing problems
- if you have a heart or lung condition
- if you have epilepsy or a history of seizures
- if you have a history of alcohol or drug abuse or dependence
- if someone close to you has recently died
- if you have suicidal thoughts
- if you have had changes in your brain, particularly arteriosclerosis (a narrowing of the blood vessels).
- if your child has been given this medicine. Your child’s doctor may carry out extra checks depending on the amount given.
When given intravenously, Diazepam Injection 10mg/2ml can slow down your breathing and heart rate. On rare occasions this has caused breathing or the heart to stop. To avoid this, doses are given slowly and are as low as possible.
Talk to your prescriber before taking this medicine if you:
- 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. • 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 Injection 10mg/2ml 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 injection 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 medicines and Diazepam Injection 10mg/2ml
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.
Tell your doctor or nurse if you are using or have recently used or might use any other medicines, including medicines obtained without a prescription.
Amnesia - you could experience amnesia when taking this medicine.
Amnesia is more likely to occur when taking high doses of medicines, including medicines obtained without a prescription, especially:
- antidepressants (e.g. fluvoxamine, fluoxetine)
- antipsychotics such as clozapine (to treat mental problems)
- antihistamines (for the treatment of allergies)
- general anaesthetics
- sedatives (used to give calming effects)
- erythromycin (an antibiotic)
- muscle relaxants (e.g. suxamethonium, tubocurarine)
- some strong pain killers such as morphine (opioids) may give you a heightened sense of well-being when taken with diazepam which can increase your desire to continue taking these medications (dependency) or can make you very sleepy
- barbiturates such as phenobarbital (used to treat epilepsy and mental disorders) • medicines to lower high blood pressure, diuretics (water tablets), nitrates (for heart conditions) as these could lower your blood pressure too much
- antacids (to reduce stomach acid) may slow down absorption of diazepam in the body.
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
- 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 • amprenavir, atazanavir, ritonavir, delavirdine, efavirenz, indinavir, nelfinavir or saquinavir (antivirals), fluconazole, itraconazole, ketoconazole or voriconazole (anti-fungal medicines) as these can cause diazepam to be removed from the body more slowly than usual and therefore increase the risk of side effects. As these can make you feel sleepy for longer or cause difficulty breathing
- 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 Injection 10mg/2ml with food, drink and alcohol
Do not drink alcohol if you are being given Diazepam Injection 10mg/2ml. Alcohol may increase the sedative effects of Diazepam Injection 10mg/2ml 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 Injection 10mg/2ml and you should speak to your doctor, pharmacist or nurse.
Drinks containing caffeine may reduce the effects of diazepam.
Pregnancy and breast-feeding:
Do not take this medicine if you are pregnant, might become pregnant, or are breast-feeding. If your doctor has decided that you should receive this medicine during late pregnancy or during labour, your baby might have a low body temperature, floppiness, breathing and feeding difficulties. Your doctor may carry out extra checks while you are receiving this medicine. Infants born to mothers who receive this medicine for a prolonged period during late pregnancy may develop dependence and be at risk of withdrawal symptoms after birth.
Infants born to mothers who receive this medicine during the first three months of pregnancy may be at increased risk of deformities being present at birth.
Please tell your doctor or nurse before being given this injection if you are breast-feeding – if possible this injection should be avoided during breast- feeding.
Driving and using machines:
This medicine may make you sleepy, forgetful or affect your concentration and coordination. This may affect your performance at skilled tasks, e.g. driving or operating machinery. Your doctor should advise you when you can start these again. You should always be accompanied home by a responsible adult after your treatment
Details regarding a new driving offence concerning driving after drugs have been taken in the UK may be found here: https://www.gov.uk/drug-driving-law
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
The amount of alcohol in this medicine can affect your ability to drive or use machines. This is because it may affect your judgement and how fast you react.
Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.
Diazepam Injection BP contains propylene glycol
This medicine contains 550 mg propylene glycol in each 1 ml of solution (i.e. each 2 ml ampoule of Diazepam Injection BP contains 1100 mg propylene glycol).
Propylene glycol in this medicine can have the same effects as drinking alcohol and increase the likelihood of side effects.
If this medicine is given to your child, your child’s doctor may carry out extra checks depending on the amount of the medicine given.
Diazepam Injection 10mg/2ml contains benzyl alcohol, benzoic acid, sodium benzoate and dehydrated alcohol
This medicine contains 15mg/ml of benzyl alcohol. This medicine must not be given to premature babies or neonates. It may cause toxic reactions and allergic reactions in infants and in children up to 3 years old.
This medicine also contains 1mg/ml of benzoic acid and 49mg/ml of sodium benzoate. This may increase the risk of jaundice in newborn babies.
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially 'sodium-free'.
This medicinal product contains 12.5 vol % ethanol (alcohol) i.e. 100mg per ml, equivalent to 10ml beer, 4ml wine per dose. It is therefore harmful to those suffering from alcoholism. This should also be taken into account in pregnant or breast-feeding women, children and high risk groups such as patients with liver disease or epilepsy.
3. How to use Diazepam Injection 10mg/2ml
Your prescriber should have discussed with you how long the course 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.
This medicine will be given to you by a doctor or nurse.
The dose of Diazepam Injection 10mg/2ml may vary according to the condition being treated and the following is a guide to the doses usually given:
Adults:
Severe acute anxiety or agitation:
10mg by intramuscular injection (i.m.) or intravenous injection (i.v.) which may be repeated after a minimum period of 4 hours.
Alcohol withdrawal symptoms (delirium tremens): 10mg to 20mg by i.v. or i.m. injection. If the symptoms are very severe a higher dose may be given.
Acute muscle spasms: 10mg by i.m. or i.v. injection which may be repeated after a minimum period of 4 hours.
Tetanus: In this case the dose will depend on body weight and is usually based on 0.1-0.3mg/kg weight and the dose is repeated at intervals of 1 to 4 hours. In very severe cases, your doctor may decide a higher dose is appropriate.
Epilepsy and for convulsions due to poisoning: 10mg to 20mg by i.v. or i.m. injection and repeated if necessary 30-60 minutes later.
As premedication: The dose will depend on body weight and is based on 0.2mg/kg body weight. The usual adult dose will be 10-20mg but higher doses may sometimes be given.
Elderly or debilitated patients:
The dose is usually not more than half that recommended for a healthy adult.
Children:
Epilepsy, convulsions due to poisoning and feverish conditions: 0.2mg to 0.3mg/kg body weight by i.v. or i.m. injection. Alternatively, the dose may be based on 1mg per year of life. Tetanus: The dose is the same as that recommended for adults.
As premedication: The dose is based on 0.2mg/kg body weight.
Your doctor may decide to change your dose according to your condition. Ask your doctor if you want more information. In usual circumstances, your course of treatment with diazepam should not be longer than four weeks.
If you are given more Diazepam Injection 10mg/2ml than you should: Overdose by this medicine is unlikely since treatment is carefully monitored.
Stopping treatment with Diazepam Injection 10mg/2ml:
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 injection 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.
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.
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 'Long term treatment' below) - 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
- Allergic skin reactions in the form of itching, skin redness and swelling and skin rash.
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 - Decreased alertness
- Depression
- Numbing of your emotions (emotional poverty)
- 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
- 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) - Enlargement of mammary glands in men
- Impotence, changes in sexual drive (libido)
- Blood disorders (you may develop sore throats, nose bleeds or infections) - Difficulty speaking.
Very rare: may affect up to 1 in 10,000 people
- Low levels of white blood cells (leukopenia)
- Reduction in the number of certain types of blood cells (Thrombocytopenia) - 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)
- Sensation that you, or the environment around you, is moving or spinning (vertigo) - Breathing difficulties (apnoea)
- Injection site pain or redness
- Swelling and redness of veins
- Blood clots
- Worsening of lung disease
- Metabolic disorders
- Dependence and addiction (see section “How do I know if I am tolerant or addicted?”).
Drug Withdrawal
When you stop taking Diazepam Injection, you may experience drug withdrawal symptoms, which include:
- headaches, muscle pain, anxiety, tension, depression, restlessness, sweating, confusion or irritability. Do not stop taking your injection 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 Diazepam Injection, 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, 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: 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 Injection 10mg/2ml
Keep this medicine out of the sight and reach of children.
This medicine will be given by a doctor or nurse.
Do not use this medicine after the expiry date which is stated on the label and carton. The expiry date refers to the last day of that month. Store below 25°C and protect from light.
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 Injection 10mg/2ml contains:
This medicine contains the active substance diazepam.
Each ampoule contains 10mg of diazepam in 2ml of solution.
The other ingredients are: benzoic acid, dehydrated alcohol, propylene glycol, sodium benzoate, benzyl alcohol and water.
What Diazepam Injection 10mg/2ml looks like and contents of the pack:
Diazepam Injection 10mg/2ml is a colourless to light yellow solution for injection. Diazepam Injection 10mg/2ml are packed into boxes of 10 ampoules.
Marketing Authorisation Holder:
Ennogen IP Ltd
Unit G4, Riverside Industrial Estate, Riverside Way, Dartford, DA1 5BS, UK
Manufacturer:
Human Serum Production & Medicine Manufacturing Co Limited
H-2100 Godollo, Tancsics Milhaly UT 82 Budapest, Hungary
This leaflet was last revised in April 2026.
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