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The product codes for this leaflet are: PL 00142/0089, PL 00142/0088, PL 00142/0087

 

Diazepam tablets 2mg, 5mg, 10mg

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 2mg, 5mg and 10mg tablets

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 tablets are and what they are 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 tablets are and what they are used for

Diazepam belongs to a group of medicines called benzodiazepines. Diazepam helps in the treatment of anxiety, muscle spasms and convulsions (fits).

Diazepam tablets are used to treat a number of conditions, including:

In adults

  • short term relief (2-4 weeks only) of severe anxiety, which is an emotional state where you may sweat, tremble, feel anxious and have a fast heart beat and may occur alone or with insomnia (trouble sleeping) or mental health problems
  • helping muscles relax and for muscle spasm and cerebral palsy (a condition affecting the brain which causes movement problems and rigidity or stiffness)
  • epilepsy (when taken with other medicines)
  • patients with the symptoms of alcohol withdrawal
  • helping to relax nervous dental patients.

In children

  • helping to treat tension and irritability caused by cerebral spasticity (a condition associated with a disease or trauma affecting the brain or spinal cord which causes weakness, un-coordinated movements, rigidity and stiffness)
  • helping to treat muscle spasm caused by tetanus (when taken with other medicines).

Both adults and children can take Diazepam tablets before an operation to help with relaxation and to cause sleepiness.

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2 Before you take

Do not take Diazepam tablets and tell your doctor if you

  • are allergic (hypersensitive) to diazepam or to other benzodiazepine medicines or to any of the other ingredients in your tablets (see section 6)
  • are breathless or have difficulty breathing
  • suffer from depression (with or without anxiety) or hyperactivity
  • have a phobia (a fear of a particular object or situation) or other mental illness
  • 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 a pregnancy or are pregnant (see below Pregnancy and breast-feeding).

Check with your doctor or pharmacist before taking Diazepam tablets if you

  • have a history of alcoholism or drug abuse
  • have problems with your heart and lungs or have severe kidney failure
  • someone close to you has recently died
  • have low blood levels of a protein called albumin
  • have a personality disorder
  • have a poor blood supply to the brain (arteriosclerosis)
  • are elderly (risk of confusion or clumsiness causing you to fall or injure yourself).
  • smoke

Other considerations

  • 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.
  • 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 speak to 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 tablets’.

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 eg zotepine), 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 eg 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.
  • amrenavir 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 tablets with food and drink

Do not drink alcohol while you are taking Diazepam tablets. Alcohol may increase the sedative effects of Diazepam tablets 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 tablets 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 tablets if you are pregnant, planning to become pregnant or are breast feeding. If you take Diazepam tablets 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 tablets 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 tablets

Diazepam tablets contain lactose (a type of sugar). If you have been told that you have intolerance to some sugars contact your doctor before taking this medicine.

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3 How to take

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

Swallow the tablets whole, with a glass of water.

Doses

Adults

  • Anxiety or mental health problems: 5mg-30mg each day, in divided doses.
  • To help you sleep: 5mg-15mg at bedtime.
  • To help cerebral palsy or other spasticities: 5mg-60mg each day, in divided doses.
  • To help control muscle spasm: 5mg-15mg each day, in divided doses.
  • To help epilepsy: 2mg-60mg each day, in divided doses.
  • To help with 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.
  • Before an operation: 5mg-20mg.

Children

For tension and irritability in cerebral spasticity: 5mg-40mg each day, in divided doses.

If your doctor has given your child Diazepam tablets to take before an operation, the usual dose is 2mg-10mg.

Elderly or Frail

If you are elderly or frail you are likely to be more sensitive to the effects of Diazepam tablets, such as confusion, and your doctor will give you much lower doses. The dose should not be more than half the adult dose.

If you have liver or kidney problems you may also be given a lower dose.

If you take more Diazepam tablets than you should

If you (or someone else) swallow a lot of tablets at the same time, 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 tablets

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 tablets

  • Do not stop taking your medicine without telling your doctor as he may wish to gradually reduce the number of tablets you take before stopping them completely. If you stop taking Diazepam tablets suddenly, you may experience unpleasant side effects including depression, nervousness, irritability, sweating , quick or irregular heartbeat, muscle spasms, shaking, loss of appetite, feeling or being sick, stomach cramps or diarrhoea. If you have been taking a high dose, you may occasionally experience confusion or unusual behaviour. Patients at risk of convulsions may be more susceptible to suffering fits on withdrawal
  • Treatment should be gradually withdrawn otherwise the symptoms you are being treated for may return more intensely than before (rebound insomnia and anxiety). The risk of this happening is greater when you stop taking Diazepam suddenly. You may also experience mood changes, anxiety, restlessness or changes in sleep patterns.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

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4 Possible Side Effects

Like all medicines, Diazepam tablets 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 tablets’.

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.

Do not use Diazepam tablets 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 tablets contain

  • The active substance (the ingredient that makes the tablet work) is diazepam. Each tablet contains either 2mg, 5mg or 10mg of the active ingredient.
  • The other ingredients are lactose, magnesium stearate, maize starch and stearic acid.
  • The 5mg tablets also contain quinoline yellow (E104).
  • The 10mg tablets also contain HT Lake (E132).

What Diazepam tablets look like and contents of the pack

Diazepam tablets are uncoated tablets in the following colours:

2mg-white, 5mg-yellow, 10mg-blue

Pack sizes are 28 tablets.

Marketing Authorisation Holder and Manufacturer:

Actavis
Barnstaple
EX32 8NS
UK
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Date of Revision: March 2011

Actavis
Barnstaple
EX32 8NS
UK

50493202


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