Diazemuls Emulsion for injection 5mg/ml
(diazepam)
Read all of this leaflet carefully before you start taking this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1 What Diazemuls is and what it is used for
2 Before you use
3 How to use
4 Possible side effects
5 How to store
6 Further information
What Diazemuls is and what it is used for
Diazemuls contains diazepam which belongs to a group of medicines called benzodiazepines.
Diazemuls is used to treat a number of conditions, including:
- severe anxiety (which is an emotional state where you may sweat, tremble, feel anxious and have a fast heart beat ) or agitation
- muscle spasm due to tetanus or poisoning
- epilepsy
- patients with the symptoms of alcohol withdrawal
- helping relax patients before minor operations or procedures
- as a premedication before a general anaesthetic.
Before you take
Do not use Diazemuls and tell your doctor if you
- are allergic (hypersensitive) to diazepam or to other benzodiazepine medicines or to any of the other ingredients in the injection (see section 6). This includes eggs or soya beans as egg phospholipid and soya bean oil are included in the injection
- have a phobia (a fear of a particular object or situation), obsessions or other mental illness
- have porphyria (an inherited condition causing skin blisters, abdominal pain and brain or nervous system disorders).
Check with your doctor or pharmacist before using Diazemuls if you
- have myasthenia gravis (a condition which causes muscles to weaken and tire easily)
- suffer from depression (with or without anxiety)
- have problems with your liver, kidney or lungs
- have someone close to you who has recently died
- have a personality disorder
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Especially:
antidepressants, antipsychotics (to treat mental problems), antihistamines (to treat allergies), general anaesthetics, hypnotics (to help you sleep) and some strong pain killers - if these medicines, including by injection, are given together with Diazemuls, breathing difficulties and blood circulation problems may occur
medicines for epilepsy such as phenobarbitone
cimetidine or omeprazole (for ulcers)
isoniazid (for tuberculosis)
zidovudine (used in the treatment of AIDS)
Using Diazemuls with food and drink
Do not drink alcohol while you are using Diazemuls.
Alcohol may increase the sedative effects of Diazemuls and make you very sleepy.
Pregnancy and breast-feeding
You should not use Diazemuls if you are pregnant, planning to become pregnant or are breast feeding.
If you use Diazemuls late in your pregnancy or during labour your baby might have a low body temperature, floppiness, and breathing difficulties. If used regularly during late pregnancy, your baby may develop withdrawal symptoms. Ask your doctor or pharmacist for advice before using any medicine.
Driving and using machines
Diazemuls may affect your concentration or how your muscles work or may make you feel sleepy or forgetful. It may also affect alertness (especially if you don’t have enough sleep). Do not drive or use any tools or machines if you are affected in this way.
Important information about some of the ingredients of Diazemuls
Diazemuls contains egg phospholipid and soya bean oil. If you are allergic to eggs or soya beans contact your doctor before using this medicine.
How to use
Diazemuls will be given by a doctor or a nurse as a slow intravenous injection (into a vein), or as a continuous infusion (into a vein).
Doses:
anxiety, agitation, muscle spasm, symptoms of alcohol withdrawal: 10mg repeated at intervals of 4 hours, as required
tetanus: 0.1-0.3mg per kg of body weight by intravenous injection repeated every 1-4 hours as required, or a continuous infusion of 3-10mg per kg of body weight every 24 hours
epilepsy: initial dose of 0.15-0.25mg per kg of body weight by intravenous injection repeated in 30 to 60 minutes if required, and followed if needed by infusion up to 3mg per kg of body weight over 24 hours.
before a general anaesthetic: 0.1-0.2mg per kg of body weight by intravenous injection, should be adjusted to the patient’s response.
sedation before a minor operation or procedure: 0.1-0.2mg per kg of body weight by intravenous injection. The normal adult dose is 10-20mg, but should be adjusted to the patient’s response.
If you are elderly or debilitated you are likely to be more sensitive to diazepam. Therefore, your dose may be reduced to one half the normal dose at the start of treatment.
If you use more Diazemuls than you should
If you think you have had too much Diazemuls, contact your nearest hospital casualty department or tell your doctor immediately. Signs of an overdose include feeling sleepy or deep sleep, muscle weakness or excitement. In more severe cases symptoms may include loss of co-ordination of movements, low blood pressureand breathing difficulties.
If you forget to use Diazemuls
If you think you have missed a dose, let your nurse or doctor know.
If you stop using Diazemuls
Do not stop using your medicine without telling your doctor as he may wish to gradually reduce the number of injections you use before stopping them completely.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Diazemuls Side Effects
Like all medicines, Diazemuls 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:
Common (less than 1 in 10 users): sedation, drowsiness, unsteadiness, and loss of co-ordination. The severity of these side effects usually depends on the size of the dose of diazepam and may continue into the following day.
Uncommon (less than 1 in 100 users): headache, ‘spinning’ sensation, low blood pressure, stomach upsets, visual disturbances, changes in sexual desire, problems passing water.
Rare (less than 1 in 1000 users): a sudden, allergic reaction with low blood pressure, swelling of the tissues of the face, lips, tongue or throat, difficulty in breathing or nettle rash
Isolated cases: jaundice (yellow skin), blood disorders.
Local pain or inflammation of the vein used for the injection and sometimes a skin rash may occur at the site of the injection, which usually clears up in 1 or 2 days. Abnormal psychological reactions such as numbing of the emotions may occur in children and the elderly. Confusion is also more common in the elderly.
If you notice any side effects, they get worse, or if you notice any not listed, please tell your doctor or pharmacist.
How to store
Keep out of the reach and sight of children.
Store below 25°C. Do not freeze.
Do not use Diazemuls after the expiry date stated on the label/carton/bottle. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Further Information
What Diazemuls contains:
- The active substance (the ingredient that makes the tablet work) is diazepam.
- The other ingredients are soya bean oil, monoglycerides, egg phospholipids, glycerol, sodium hydroxide, and water for injections.
What Diazemuls looks like and contents of the pack
Diazemuls is a white, milky fluid.
Pack sizes are in boxes of 10x2ml ampoules.
Marketing Authorisation Holder:
Manufacturer:
Distributor:
Date of Revision: July 2009
L1438-33
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