Online Article Directory New Zealand: Diazepam Oral Solution

Diazepam oral solution 2mg/5ml

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 Diazepam oral solution is and what it is used for

2 Before you take

3 How to take

4 Possible side effects

5 How to store

6 Further information

What Diazepam oral solution is and what it is used for

Diazepam belongs to a group of medicines called benzodiazepines.

Diazepam helps in the treatment of anxiety, muscle spasms and convulsions (fits). It is used to treat:

In adults

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

cerebral palsy

muscle spasm caused by tetanus (when taken with other medicines)

epilepsy (when taken with other medicines)

patients with the symptoms of alcohol withdrawal

helping to relax nervous dental patients.

In children

tension and irritability caused by cerebral spasticity

helping to relax and cause sleepiness before an operation.

Before you take

Do not take Diazepam oral solution and tell your doctor if you

are allergic (hypersensitive) to diazepam, benzodiazepine medicines, or to any of the other ingredients in Diazepam oral solution (see section 6)

have a phobia or other mental illness or are hyperactive

are breathless or have difficulty breathing

have glaucoma (increased pressure in the eye)

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)

have severe liver disorders

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

Check with your doctor or pharmacist before taking Diazepam oral solution if you have

a history of alcoholism or drug abuse

problems with your heart and lungs or have kidney or liver disease

someone close to you who has recently died

low blood levels of a protein called albumin

a personality disorder

a poor blood supply to the brain (arteriosclerosis)

depression (with or without anxiety).

Other considerations

Dependence – there is a risk of dependence, which increases with the dose and duration of treatment and if you have a history of alcoholism and drug abuse.

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.

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), hypnotics (to help you sleep), lofexidine (to help relieve symptoms when you stop taking opioids), some strong pain killers, anaesthetics, sedative antihistamines eg chlorphenamine (to treat allergies), nabilone (to treat nausea and vomiting), disulfiram (to treat alcohol addiction)

zidovudine, ritonavir (antivirals), rifampicin, erythromycin (antibiotics), isoniazid (to treat tuberculosis)

cimetidine or omeprazole (for ulcers), antacids

medicines for epilepsy such as phenytoin (hydantoins), barbiturates

medicines to lower high blood pressure such as alpha blockers or moxonidine

baclofen (a muscle relaxant)

levodopa (to treat Parkinson’s Disease)

caffeine or theophylline

oestrogen-containing contraceptives.

Taking Diazepam oral solution with food and drink

Do not drink alcohol while you are taking Diazepam oral solution. Alcohol may increase the sedative effects of Diazepam oral solution and make you very sleepy.

Pregnancy and breast-feeding

You should not take Diazepam oral solution if you are pregnant, planning to become pregnant or are breast feeding. If you take Diazepam oral solution late in pregnancy or during labour your baby might have a low body temperature, floppiness, and breathing difficulties. If taken regularly during late pregnancy, your baby may develop withdrawal symptoms. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Diazepam oral solution may affect your concentration, make you feel sleepy or forgetful (especially if you don’t have enough uninterrupted sleep). It may also affect how your muscles work. Do not drive or use any tools or machines if you are affected in this way. Do not drink alcohol as this can make you feel even more sleepy.

Important information about some of the ingredients of Diazepam oral solution

Diazepam oral solution contains 1.91g to 2.58g of sorbitol per 5ml solution. This may have a mild laxative effect. If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.

This medicine also contains propylene glycol which may cause alcohol-like symptoms and glycerol, which may cause headache, stomach upset and diarrhoea.

How to take

Always take Diazepam oral solution exactly as your doctor has told you. You should not take Diazepam oral solution for longer than 4 weeks. You should check with your doctor or pharmacist if you are not sure.

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

Doses

Adults

Anxiety or mental health problems: 2mg-30mg each day, in divided doses

Insomnia: 5mg-30mg at bedtime

Cerebral palsy: 2mg-60mg each day, in divided doses

Other spasticities: 5mg-60mg each day, in divided doses

To control muscle spasm: 2mg-15mg each day, in divided doses

Epilepsy as a premedication: 2mg-60mg per day, in divided doses

Epilepsy: 5mg-20mg daily

Alcohol withdrawal symptoms: 5mg-20mg, which may be repeated after 2 to 4 hours if necessary

Before dental treatment: 5mg the night before treatment, 5mg on waking and 5mg two hours before the appointment

Children

Cerebral spasticity: 2mg-40mg each day, in divided doses

For muscle spasm associated with tetanus, the adult dose is usually given

Epilepsy: 2mg-10mg daily

Specific patient groups

Elderly or frail: you are likely to be more sensitive to the effects of Diazepam oral solution, especially sedation, drowsiness and confusion. Your doctor will give you much lower doses, this should not be more than half the adult dose.

Breathing difficulties: you may be given you a lower dose.

If you take more Diazepam oral solution than you should

If you (or someone else) swallow a lot of Diazepam Oral Solution, or you think a child may have swallowed any, contact your nearest hospital casualty department or tell your doctor immediately. Signs of an overdose include clumsiness and loss of coordination, feeling sleepy or deep sleep, speech problems, muscle weakness or excitement. An extreme overdose may lead to coma (unrousable unconsciousness), reflex problems and breathing difficulties.

If you forget to take Diazepam oral solution

Do not take a double dose to make up for a forgotten dose. If you forget to take a dose take it as soon as you remember it and then take the next dose at the right time.

If you stop taking Diazepam oral solution

Do not stop taking your medicine without telling your doctor as he may gradually reduce your dose before stopping it completely. If stopped suddenly, you may have unpleasant side effects including headaches, muscle pain, extreme anxiety, tension, restlessness, confusion and irritability. In severe cases you may experience depersonalisation (feeling that your mind is becoming separated from your body), derealisation (feeling that the world around you is not real), abnormally acute hearing or painful sensitivity to sound, numbness and tingling in arms and legs, over sensitivity to light, noise and physical contact, seeing, hearing or feeling things that are not there (hallucinations) or fits.

Withdrawal symptoms include depression. Withdrawal symptoms may occur between normal and high doses or if your doctor is switching you to another benzodiazepine.

Treatment should be gradually withdrawn otherwise the symptoms being treated may return more intense than before (rebound insomnia and anxiety). Mood changes, anxiety, restlessness or changes in sleep patterns may also occur.

Possible Side Effects

Like all medicines, Diazepam oral solution can cause side-effects, although not everybody gets them.

Contact your doctor at once if you notice any of the following side effects.

These effects may be quite severe and are more likely to occur in children and the elderly:

confusion, experiencing rage, excitement, depression with suicidal tendencies, restlessness, agitation, irritability, delusion, nightmares, hallucinations (seeing or hearing things that are not there), psychoses (loss of contact with reality), unusual behaviour

Tell your doctor if you notice any of the following side effects or notice any other effects not listed:

mild drowsiness and lightheadedness may occur during the first few days of treatment.

drowsiness, sedation, clumsiness and loss of coordination, headache, ‘spinning’ sensation, forgetfulness, numbed emotions

blood disorders (changes in numbers and types of blood cells), changes in sex drive, visual disturbances, low blood pressure, stomach upsets, yellowing of the skin or whites of the eyes (jaundice), muscle spasms, difficulty passing urine, muscle weakness

Withdrawal symptoms: see Section 3, ‘If you stop taking Diazepam oral solution’

Dependence: see Section 2, ‘Other Considerations’

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.

Do not store above 25°C. Keep container in the outer carton and keep the container tightly closed.

Do not use Diazepam oral solution 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 Diazepam oral solution contains

The active substance (the ingredient that makes the oral solution work) is diazepam. Each 5ml spoonful contains 2mg of the active ingredient.

The other ingredients are docusate sodium, magnesium aluminium silicate, propylene glycol, raspberry flavour, saccharin sodium, percol erythrosine (E127), sorbic acid (E200), propyl hydroxybenzoate (E216), methyl hydroxybenzoate (E218), sorbital (E420), glycerol (E422).

What Diazepam oral solution looks like and contents of the pack

Diazepam oral solution is a pink syrup with an odour of raspberries.

Pack sizes are 100ml.

Marketing Authorisation Holder:

Actavis

Barnstaple

EX32 8NS

Manufacturer:

Pinewood Laboratories Ltd

Ballymacarbry

Clonmel

Ireland

Date of Revision: June 2009