Diazepam Injection BP

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Diazepam Injection BP is and what it is used for
2. What you need to know before you are given Diazepam Injection BP
3. How Diazepam Injection BP is given
4. Possible side effects
5. How to store Diazepam Injection BP
6. Contents of the pack and other information

• if you are allergic to diazepam, the group of medicines known as benzodiazepines or any of the other ingredients (listed in section 6) in this injection.
• if you have a phobia (a fear of a particular object or situation), obsessions, a personality disorder or other mental illness.
• if you have difficulty in breathing, are short of breath or have weakness of your chest muscles that help you breath (including a condition called Myasthenia Gravis).
• if you have “Sleep Apnoea Syndrome” - a condition where your breathing stops for short spells when you are asleep.
• if you have Porphyria - a disorder of the blood.
• if you have a liver condition (severe hepatic impairment).
• if you are planning a pregnancy or are pregnant (see Pregnancy and breast-feeding below).

Talk to your doctor, pharmacist or nurse before receiving Diazepam Injection BP if:

• your child has been given this medicine. Your child’s doctor may carry out extra checks depending on the amount given.
• you suffer from a 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.
• you suffer from depression (with or without anxiety).
• you are over 60 years of age.
• you have a heart or lung condition.
• you have breathing problems.
• you have epilepsy or a history of seizures.
• you have a history of alcohol or drug abuse or dependence.
• someone close to you has recently died.
• you have suicidal thoughts.
• you have had changes in your brain, particularly arteriosclerosis (a narrowing of the blood vessels).

When given intravenously, Diazepam Injection BP 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.

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 pharmacist 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 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. 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).

Do not drink alcohol if you are being given Diazepam Injection BP. Alcohol may increase the sedative effects of Diazepam Injection BP 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 BP and you should speak to your doctor, nurse or pharmacist.

Drinks containing caffeine may reduce the effects of diazepam.

You should not be given Diazepam Injection BP if you are pregnant, planning to become pregnant or are breast feeding.

If your doctor decides you should be given this medicine during late pregnancy, labour or caesarean section, your baby might have an irregular heart beat, a low body temperature, floppiness and 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.

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.

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.

This medicine contains 250 mg of alcohol (ethanol) in each 1 ml of solution (i.e. each 2 ml ampoule of Diazepam Injection BP contains 500 mg ethanol). The amount in each 2 ml ampoule of this medicine is equivalent to 13 ml beer or 5 ml wine.

The alcohol in this preparation is likely to affect children. These effects may include feeling sleepy and changes in behaviour. It may also affect their ability to concentrate and take part in physical activities.

If you have epilepsy or liver problems, talk to your doctor or pharmacist before taking this medicine.

The amount of alcohol in this medicine may alter the effects of other medicines. Talk to your doctor or pharmacist if you are taking other medicines.

If you are pregnant or breast-feeding, talk to your doctor or pharmacist before being given this medicine.

If you are addicted to alcohol, talk to your doctor or pharmacist before being given this medicine.

This medicine contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially ‘sodium-free‘.

Since the injection will be given to you by a doctor, nurse or dentist, it is unlikely that you will be given too much. If you think you have been given too much you must tell the person giving you the injection.

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

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
• 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)

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)

Patients who receive long term treatment with diazepam may become tolerant (their medicine becomes less effective) or dependent upon their medicine.

After treatment for a long time (such as in an intensive care unit) the following withdrawal symptoms may occur: headaches, muscle pain, anxiety, restlessness, confusion, irritability, inability to sleep, hallucinations and convulsions. Your doctor will reduce your dose gradually to avoid these effects happening to you.

If you think this injection is causing you any problems, or you are at all worried, talk to your doctor, nurse or pharmacist.

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.

The active substance is diazepam. In Diazepam Injection BP each 1 ml of solution contains 5 mg of diazepam.

The other ingredients are ethanol, propylene glycol, sodium hydroxide and water for injections.

Diazepam Injection BP is a clear, colourless to greenish yellow, sterile solution contained in clear glass ampoules.

The injection is available in packs of 10 ampoules containing 2 ml of solution.

For any information about this medicine, please contact the Marketing Authorisation Holder.