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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
  • breathing problems, which may be severe, including slow and/or shallow breathing
  • have myasthenia gravis (a condition which causes muscles to weaken and tire easily)
  • suffer from sleep apnoea (a sleep disorder where you have abnormal pauses in breathing during sleep)
  • have severe liver disorders
  • have porphyria (an inherited condition causing skin blisters, abdominal pain and brain or nervous system disorders)
  • planning a 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 that has recently died
  • are elderly Diazepam tablets can cause confusion and have effects on muscles causing falls and injuries.
  • have breathing problems
  • have suicidal thoughts
  • have epilepsy or a history of seizures
  • 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

  • Mental side effects – contact your doctor if you experience side effects such as agitation, hyperactivity, restlessness, aggressiveness, nightmares or hallucinations. These side effects are more likely to occur in children or the elderly.
  • Amnesia (total or partial memory loss) – you could experience amnesia when taking this medicine. Amnesia is more likely to occur when taking high doses of diazepam.
  • Dependence – when taking this medicine there is a risk of dependence, which increases with the dose and duration of treatment and also in patients with a history of alcoholism and drug abuse. Therefore, you should take Diazepam tablets for as short period of time as possible.
  • 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.
  • Withdrawal – treatment should be gradually withdrawn. Withdrawal symptoms occur with Diazepam tablets even when normal doses are given for short periods of time. See Section 3, ‘If you stop taking Diazepam’.

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 (e.g. fluvoxamine, fluoxetine)
  • antipsychotics such as clozapine (to treat mental problems)
  • antihistamines (to treat allergies)
  • general anaesthetics
  • sedatives (used to give calming effects)
  • hypnotics (to help you sleep)
  • erythromycin (an antibiotic)
  • muscle relaxants (e.g. suxamethonium, tubocurarin)
  • 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 medicines (dependency) or can make you very sleepy.
  • barbiturates such as phenobarbital (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 (reduces 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 furthermore affect how phenytoin works.
  • theophylline (to treat asthma and other breathing disorders), as it can weaken the effect of diazepam. As this can cause diazepam to be removed from the body more quickly than usual.
  • 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.
  • amrenavir, 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. As 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)

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.

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

Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.

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 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, sudden wheezing, swelling of the face, lips, tongue or throat, or body, rash, fainting or difficulty breathing or swallowing.

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

Some side effects can be serious and may require immediate medical treatment:

Uncommon: affects 1 to 10 users in 1,000

  • Respiratory depression (very slow and/or shallow breathing)

Rare: affects 1 to 10 users in 10,000

  • Respiratory arrest (cessation of breathing)
  • Unconsciousness
  • Jaundice (yellowing of your skin or the white of your eyes)

Other side effects:

Very common: affects more than 1 user in 10

  • Drowsiness

Common: affects 1 to 10 users in 100

  • Fatigue
  • Withdrawal symptoms (for possible symptoms please see ‘If you stop taking Diazepam tablets’ in Section 3)
  • Confusion
  • Loss of coordination of muscle movements (ataxia) and other movement disorders, tremor

Uncommon: affects 1 to 10 users in 1,000

  • 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 (particularly in children)
  • Allergic skin reactions in the form of itching, skin redness and swelling and skin rash.

Rare: affects 1 to 10 users in 10,000

  • 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. Talk to your doctor.
  • Decreased alertness
  • Depression
  • Emotional withdrawal
  • 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 (particularly in children)
  • 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)
  • Breast enlargement in men
  • Impotence, changes in sexual drive (libido)
  • Blood disorders (you may develop sore throats, nose bleeds or infections)

Very rare: affects less than 1 user in 10,000

  • 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)
  • Temporary pause in breathing

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.

Reporting of side effects

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

By reporting side effects you can help provide more information on the safety of this medicine.

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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 and Manufacturer:

Actavis
Barnstaple
EX32 8NS
UK
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Date of Revision: November 2014

Actavis
Barnstaple
EX32 8NS
UK

AAAG6980


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