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The product code for this leaflet is: PL 00142/0103

 

Diazepam Oral Solution

Company Details

Actavis UK Ltd


Whiddon ValleyBarnstapleDevonEX32 8NS
Telephone:
Fax:
Medical Information Direct Line:
Medical Information e-mail:medinfo@actavis.co.uk
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PATIENT INFORMATION LEAFLET

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

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1 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.
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2 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 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)
  • planning pregnancy or are pregnant (see below ‘Pregnancy and breast-feeding’).

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)
  • smoke.

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), antihistamines (to treat allergies), general anaesthetics, lofexidine (to help relieve symptoms when you stop taking opioids), nabilone (to treat nausea and vomiting), hypnotics (to help you sleep), alpha blockers or moxonidine (to lower high blood pressure), muscle relaxants (eg baclofen, tizanidine). Taking these medicines with diazepam could make you very sleepy.
  • some strong pain killers may give you a heightened sense of well being when taken with diazepam, which can increase your desire to continue taking these medicines (dependency) or can make you very sleepy.
  • 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, carbamazepine, or sodium valproate, (diazepam can affect the blood levels of these medicines).
  • cimetidine or omeprazole (for ulcers), oestrogen-containing contraceptives, erythromycin (an antibiotic), antifungals (fluconazole, voriconazole) or isoniazid (to treat tuberculosis) as these can cause diazepam to be removed from the body more slowly than usual.
  • rifampicin (to treat infections) or theophylline (to treat asthma) as this can cause diazepam to be removed from the body more quickly than usual.
  • amprenavir or ritonavir (antivirals) as these can make you feel sleepy for longer or cause difficulty breathing.
  • medicines to lower high blood pressure, diuretics (water tablets), nitrates (for heart conditions) as these could lower your blood pressure too much.
  • levodopa (to treat Parkinson’s Disease) as diazepam may cause levodopa to not work so well.
  • antacids (reduces stomach acid) may slow down absorption of diazepam in the body.

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.

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 oral solution and you should speak to your doctor or pharmacist.

Drinks containing caffeine may reduce the effects of diazepam.

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 can make you sleepy, forgetful, have poor co-ordination along with other side effects that can affect everyday activities (see Possible side effects). You should not drive, operate machinery or take part in such activities where, if affected, you could put yourself or others at risk.

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.

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3 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, irregular or slow heartbeat, uncontrolled eye movement, 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.
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4 Possible Side Effects

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

Stop treatment and contact a doctor at once if you have the following symptoms of an allergic reaction e.g. itchy skin, rash, swelling of the face, lips, tongue or throat, or difficulty breathing or swallowing.

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

  • drowsiness, sedation, tiredness, slurred speech, light-headedness, unsteadiness or clumsiness and loss of co-ordination (you may notice these even after a single dose and this may continue into the following day)
  • confusion, memory loss (which may be experienced several hours after taking diazepam. If possible, to reduce the risk allow 7 to 8 hours of uninterrupted sleep after taking), seeing or sensing things that are not there, inappropriate behaviour, difficulty concentrating, agitation/irritability, restlessness, experiencing rage, excitement, numbed emotions, depression with suicidal tendencies, headache, ‘spinning’ sensation
  • blood disorders (you may develop sore throats, nose bleeds or infections) changes in sex drive, visual disturbances, low blood pressure, stomach upsets, yellowing of the skin or whites of the eyes (jaundice)
  • muscle spasms/shaking or weakness, breathing difficulties
  • difficulty passing urine, increase in amount of saliva
  • you feel you are abusing or becoming dependant on this product
  • 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.

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5 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.

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6 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), sorbitol (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
UK

Manufacturer:

Pinewood Laboratories Ltd
Ballymacarbry
Clonmel
Ireland
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Date of Revision: July 2011

Actavis
Barnstaple
EX32 8NS
UK

L19710PIN-30


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