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Format: 180 x 210 mm – Laetus-Code: 261 – Schrift: 7 p PACKAGE LEAFLET: INFORMATION FOR THE USER
Diazepam 5mg / 10mg rectal solution
The name of your medicine is Diazepam rectal solution,
• have a poor blood supply to the brain or any
Driving and using machines
which will be referred to as ‘Diazepam’ or ‘Diazepam brain damage
You should not drive or use machines until 24 hours after solution’ throughout this leaflet.
• have a history of alcohol or drug abuse
the last dose. After 24 hours, if you still feel sleepy or find Read all of this leaflet carefully before you start
• are suffering from mental illness
it hard to concentrate, if you notice muscle weakness or taking this medicine.
Diazepam should only be given to children if a doctor episodes of memory loss you should not drive or operate • Keep this leaflet. You may need to read it again.
thinks this is necessary and any treatment should be • If you have any further questions, ask your doctor or Important information about some of the
Withdrawal symptoms
ingredients of Diazepam solution
• This medicine has been prescribed for you. Do not The dependence potential of diazepam is low when Diazepam solution contains Benzoic acid (E210) and
pass it on to others. It may harm them, even if their limited to short-term use. However, withdrawal symptoms sodium benzoate (E211). These may irritate the skin,
might be experienced including headaches, muscle pain, eyes, nose and throat and may also increase the risk of • If any of the side effects gets serious, or if you notice extreme anxiety, tension, restlessness, confusion and jaundice (yellow skin) in newborn babies.
any side effects not listed in this leaflet, please tell irritability. In severe cases, the following symptoms may occur: derealization (the world feels unreal), 3. HOW YOU USE
In this leaflet:
depersonalization (feeling detached from your body), DIAZEPAM RECTAL SOLUTION
1. What Diazepam is and what it is used for hyperacusis (sensitivity to sound), numbness and tingling, sensitivity to light, voices or physical contact, hallucinations, epileptic fits, mood changes, an xiety or Always use Diazepam solution exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. The usual dose is 0.25 – Reducing the dose gradually can help prevent any 0.5mg/kg (body weight). The dose also depends on the withdrawal effects. Diazepam solution may not be as patient's age and health. Diazepam is for use in adults effective after repeated use for a few weeks.
1. WHAT DIAZEPAM IS AND WHAT IT IS USED FOR
Taking other medicines
The recommended dose would be normally:
Diazepam belongs to a group of medicines known as Please tell your doctor or pharmacist if you are taking, or • for children between 1 and 3 years (10 – 15kg): benzodiazepines, which are used as sedatives and have recently taken, any other medicines, including anticonvulsants (to control fits), or to relax tense muscles.
medicines obtained without a prescription. This is especially important of the following medicines as they • for children over 3 years (more than 15kg): • to control epileptic or febrile convulsions (fits) • antipsychotics (treatments for mental illness) • for sedation before minor surgical or dental • anxiolytics (treatments for anxiety) Diazepam solution is for use in emergency cases.
• sedatives or hypnotics (e.g. sleeping pills) They are not intended for long-term use. If it becomes • antidepressants (treatments for depression) necessary, the dose may be repeated every 12 hours. If • for severe, disabling, or extremely distressing anxiety • narcotic analgesics (strong painkillers) convulsions (fits) are still not controlled the doctor should Diazepam solution may be used as above when an • antiepileptics (treatments for epilepsy, e.g. phenytoin) The tubes containing Diazepam solution are for
injection is not practical or not wanted. • sedative antihistamines (treatments for allergies that rectal (into the anus) and single use only. Treatment
Diazepam solution may be useful for the immediate should be as short as possible. The lowest dose that can control the symptoms should be used. If used • disulfiram (for treatment of alcoholism) continuously for too long, there is a risk of becoming 2. BEFORE YOU USE DIAZEPAM
• cimetidine, omeprazole (drugs for heartburn and ulcers)• oral contraceptives (e.g. ‘The Pill’) dependent on diazepam or of having problems when Do not use Diazepam solution if:
• you are allergic (hypersensitive) to diazepam or
If no effect is seen after 10 minutes, the dose can be
any of the other ingredients of Diazepam solution (see repeated in children or an additional 10mg tube given to list of ingredients in Section 6). An allergic reaction may include rash, itching, difficulty of breathing or Nicotine (e.g. smoking) may reduce the efficacy Elderly and debilitated patients or those with liver
swelling of the face, lips, throat or tongue.
or kidney dysfunction may need a reduced dose.
• you have myasthenia gravis (very weak muscles)
• you suffer from sleep apnoe (temporary stopping
It may still be all right for you to be given Diazepam and your doctor will be able to decide what is suitable for you.
• you have a severe liver disorder
Using Diazepam solution with food and drink
• you have a severe breathing disorder
Using alcohol may interact also with Diazepam solution • Diazepam should not used for premature babies
by increasing the sedative (calming) effects of diazepam.
Take special care with Diazepam solution
Pregnancy and breast-feeding
(and talk to your doctor) if you:
You should not use Diazepam if you are pregnant, think • have a kidney or liver disorder
you may be pregnant or if you are breast-feeding an • have a breathing disorder
infant unless your doctor tells you to. Ask your doctor or • have glaucoma (high pressure in the eye)
Format: 180 x 210 mm – Laetus-Code: 261 – Schrift: 7 p How to use Diazepam solution
If you take more Diazepam solution than you
indigestion), obstipation (severe constipation), diarrhoea, jaundice (yel ow skin), problems in passing water, If you have taken more Diazepam solution than you changes in sexual desire, problems with periods, spasm should, talk to a doctor or pharmacist immediately.
of the airway, difficulty with breathing, apnoea (temporary Symptoms of overdose include drowsiness, mental stopping of breathing), increased appetite.
confusion and lethargy (a drowsy dullness). Very rare (less than 1 patient out of 10000): In serious cases, symptoms include low blood pressure, shallow breathing, co-ordination problems, floppiness, Diazepam solution may cause dependence, even at therapeutic dosages. Stopping treatment may cause 1. If possible, turn patient on side, or front for a child.
If you stop taking Diazepam solution
withdrawal effects. In some patients, depression may Since the risk of withdrawal phenomena/rebound phenomena is greater after abrupt discontinuation of If any of the side effects gets serious, or if you
treatment, it is recommended that the dosage is notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
Withdrawal symptoms include headaches, muscle pain, extreme anxiety, tension, restlessness, confusion and 5. HOW TO STORE
irritability. In severe cases, the following symptoms may DIAZEPAM RECTAL SOLUTION
occur: derealization (the world feels unreal), Diazepam solution should be kept out of the reach and depersonalization (feeling detached from your body), hyperacusis (sensitivity to sound), numbness and tingling, sensitivity to light, voices or physical contact, Store below 25°C. Do not use after the expiry date stated 4. Insert the nozzle completely into the anus, pointing it hallucinations, epileptic fits, mood changes, anxiety or sleep disturbances and restlessness.
Medicines should not be disposed of via wastewater or Note: In children under 15kg insert the nozzle only half If you have any further questions about the use of this household waste. Ask your pharmacist how to dispose of product, ask your doctor or pharmacist.
medicine no longer required. These measures will help to protect the environment.

4. POSSIBLE SIDE EFFECTS

6. FURTHER INFORMATION
Like all medicines, Diazepam solution can cause side effects, although not everybody gets them. What Diazepam solution contains:
The active substance is diazepam. The other ingredients All medicines can cause allergic reactions, although are: benzyl alcohol, ethanol 96%, propylene glycol, serious allergic reactions are very rare. Tell your doctor
benzoic acid, sodium benzoate and purified water straight away if you get any sudden difficulty in
breathing, swelling of the eyelids, face or lips, rash
What Diazepam solution looks like and contents
5. Empty the tube by pressing firmly between the or itching (especially affecting your whole body).
of the pack
Diazepam Rectal Solution is a clear, colourless or slightly The following side effects have been reported:
yellowish solution in a white polythene tube.
Common (between 1 and 10 patients out of 100): Sedation, drowsiness, headaches, dizziness (with risk of Pack of 5 rectal tubes. Each tube contains 2.5ml solution fal s in the elderly), unsteadiness, slurred speech, trembling hands, tiredness, hangover effect, seeing Marketing Authorisation Holder and Manufacturer
double, muscle weakness, reduced alertness, numbed emotions, confusion, and forgetfulness.
Also common are paradoxical reactions – instead of feeling sleepy, some patients (particularly children or the elderly) may feel agitated with a change in their 6. Keep the tube completely pressed to gether until
personality. Other symptoms are restlessness, changing mood, rage, delusions (irrational ideas), nightmares or Note: A small amount of the solution is intended to be hallucinations (sensing things that are not real).
left in the tube after the dose has been given.
Rare (between 1 and 10 patients out of 10000): Low blood pressure, slow pulse, chest pain, blood cell 7. Keep the patient’s position and hold the buttocks changes, eye changes, Dry mouth, Nausea (feeling sick), This leaflet was last revised in
together for a few minutes to prevent leakage.
vomiting (being sick), epigastric pain (heartburn/

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