DIAZEPAM

02 Details

DIAZEPAM 5MG AND 10MG TABLETS

Read this entire 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
2. 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.

2. 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)
• breathing problems, which may be severe, including slow and/or shallow 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 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 tablets if you

• have a history of alcoholism or drug abuse
• have problems with your heart and lungs or have severe kidney failure
• have someone close to you that 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 Diazepam tablets can cause confusion and have effects on muscles causing falls and injuries.
• have breathing difficulties
• smoke
• suffer from depression
• have suicidal thoughts
• have epilepsy or a history of seizures

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 a short a 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 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 (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 epilepsye.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 reduct 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 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 your 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.

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 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.

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 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.

4. 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:

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)

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

• Anaphylaxis (severe allergic reaction) with symptoms such as sudden wheezing, swelling of your lips, tongue and throat or body, rash, fainting or difficulties to swallow

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
• 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
• 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 dissappear after you have stopped taking diazepam)

Withdrawal symptoms: see Section 3, ‘If you stop taking Diazepam tablets.’

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.pokupharmagh.com

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

5. How to store

Keep out of the reach and sight of children.

Do not store above 30°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.

6. 6. Further Information

What Diazepam tablets contain:

• The active substance (the ingredient that makes the tablet work) is diazepam. Each tablet contains either 5mg or 10mg of the active ingredient.
• The other ingredients are magnesium stearate, maize starch, sodium lauryl sulphate, purified talc, sodium starch glycolate, aerosol, povidone, dicalcium phosphate, sodium methyl paraben, brilliant blue.

What Diazepam tablets looks like and contents of the pack

Diazepam tablets are uncoated brilliant blue tablets.

Pack sizes are 20x1x10 tablets

Date of Publication: August, 2016

Date of Review: August, 2018

 

MANUFACTURED BY: POKUPHARMA LTD

P.O.BOX 3009, KUMASI

LOCATION: PLT 12 TOTTOE STREET, FUMESUA-KUMASI

DISTRIBUTED BY: POKUPHARMA LTD

P.O.BOX 3009, KUMASI

LOCATION: PLT 12 TOTTOE STREET, FUMESUA-KUMASI