WebSite Malta: Diazepam tablets 2mg, 5mg, 10mg (Actavis UK Ltd)

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

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.

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)

have a phobia (a fear of a particular object or situation) or other mental illness

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 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).

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), 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 zotepine (diazepam can affect the blood levels of these medicines).

cimetidine or omeprazole (for ulcers), oestrogen-containing contraceptives, erythromycin (an antibiotic) or isoniazid (to treat tuberculosis) as these can cause diazepam to be removed from the body more slowly than usual.

rifampicin (to treat infections) 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.

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 may affect your concentration or may make you feel sleepy or forgetful (especially if you don’t have 7-8 hours 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.

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.

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, 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 or diarrhoea. If you have been taking a high dose, you may occasionally experience confusion, convulsions or unusual behaviour.

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.

Possible Side Effects

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

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

allergic reaction: skin rashes, itching

drowsiness, sedation, 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, experiencing rage, excitement, 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, difficulty passing urine

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.

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.

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

Date of Revision: September 2008