TEMAZEPAM TABLETS 20 MG - patient leaflet, side effects, dosage

4. possible side effects

Like all medicines, this medicine can cause unwanted side effects, although not everybody gets them.

Stop treatment and contact a doctor immediately if you have the following symptoms of an allergic reaction:

• itchy skin, rash, swelling of the face, lips, tongue or throat, or difficulty breathing or swallowing.

Contact your doctor if you develop:

• sore throats, infections, bruising or nose bleeds as these may be signs of changes in the number and types of blood cells. Your doctor may wish to give you a blood test.
• jaundice (yellowing of the skin or whites of the eyes caused by liver or blood problems).
• incontinence
• inability to urinate
• behavioural mood changes such as aggressiveness, delusions (false beliefs), rage, depression and psychoses.

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

• Common – drowsiness the following day numbed emotions reduced alertness dizziness confusion fatigue tiredness shaky movements double vision co-ordination disturbances muscle weakness lightheadedness memory loss.
• Rare – vivid dreams restless sleep awareness of abnormal heartbeat skin reactions changes in sex drive sedation impaired muscular functions dry mouth stomach upsets (indigestion, diarrhoea, constipation) changes in the blood (identified by blood tests) reduced urine output visual disturbances headache ‘spinning’ sensation low blood pressure salivation changes difficulty in speaking shaking.

Other behavioural mood changes such as restlessness, agitation, irritability, nightmares, hallucinations, sleepwalking have also been

reported mainly in elderly patients. When these reactions occur, you should tell your doctor and stop taking Temazepam tablets.

Psychological dependence may occur, meaning you think that you cannot ever sleep without taking Temazepam tablets.

Use (even at therapeutic dosages) may lead to physical dependence, sudden discontinuation of treatment may result in withdrawal effects and recurrence of problems.

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

5. How to store Temazepam tablets

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the product packaging. The expiry date refers to the last day of that month.

Store at or below 25°C in a dry place. Protect from light.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Temazepam Tablets contains

• The active substance (the ingredient that makes the medicine work) is temazepam. Each tablet contains either 10mg or 20mg of the active ingredient.
• The other ingredients are lactose monohydrate, maize starch, pregelled starch, sodium starch glycollate, microcrystalline cellulose and magnesium stearate.

What Temazepam Tablets looks like and contents of the pack

Temazepam 10 mg tablets are round, white to pale yellow tablets with

TEM 10 on one side and plain on the other.

Temazepam 20 mg tablets are round, white to pale yellow tablets with

TEM 20 on one side and plain on the other.

They are supplied in plastic containers of 28, 30, 56, 60, 84, 100, 168, 200, 250 and 500 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and Manufacturer

Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK.

This leaflet was last revised in 05/2016.

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2. What you need to know before you take

Temazepam tablets

Do not take Temazepam tablets if you:

• are allergic to active substance, to other benzodiazepines or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may include a rash, itching, difficulty breathing or swallowing or swelling of the face, lips, throat or tongue.
• are 18 years of age or under.
• have severe liver problems.
• suffer from breathing problems whilst sleeping (sleep apnoea).
• suffer from severe muscle weakness (myasthenia gravis).
• suffer from sudden or severe breathing problems.
• have any long term mental illness including obsessions or phobias (irrational fears).
• suffer from anxiety with or without depression or psychotic illness. Temazepam tablets may unmask or worsen symptoms
• are breast-feeding.
• suffer from glaucoma (increased pressure in the eye).

Warnings and precautions

Talk to your doctor or pharmacist before taking Temazepam tablets if you:

• are elderly or frail. If you get up at night, take care as there is an increased risk of falling and consequently of hip fractures due to the muscle relaxant effect of the tablets.
• have suffered a loss or bereavement (temazepam can affect the way in which you react to this).
• have any long-term kidney or liver problems.
• have a history of breathing problems. Whilst taking Temazepam tablets your breathing may become less forceful.
• suffer from or have a history of depression.
• have or have ever had a history of or tendency to alcohol or drug

abuse (see “Dependence” below).

• are or suspect that you are pregnant.
• suffer from a personality disorder.
• suffer from muscle weakness.

Please tell your doctor if you have any of the conditions listed above.

Other considerations

• 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 as an adjustment to your dosage may be required.
• Dependence – when taking this type of medicine there is a risk of dependence, which increases with dose and length of treatment. There is a greater risk in patients with a history of alcohol or drug abuse.

• Withdrawal – treatment should be gradually withdrawn. Withdrawal symptoms occur with Temazepam tablets even when normal doses are given for short periods of time. See Section 3, “If you stop taking Temazepam tablets”.
• Memory loss may be experienced several hours after taking temazepam. If possible, to reduce the risk allow 7–8 hours of uninterrupted sleep after taking Temazepam tablets.
• Psychiatric and “paradoxical” reactions – Temazepam tablets can cause behavioural side effects such as restlessness, agitation, irritability, aggressiveness, delusions (false beliefs), rages, nightmares, hallucinations, psychoses, sleepwalking, inappropriate behaviour, increased insomnia and other adverse behavioural effects.
• Minor surgery – it you have been given Temazepam tablets as a sedative prior to minor surgery you should make arrangements to be

accompanied home.

• Sleep behaviour – complex sleep behaviour-related events such as “sleep driving” (driving while not tully awake with no memory ot the event) have been reported in patients taking temazepam. The risk ot these behaviours increases when alcohol is consumed. Tell your doctor immediately it you sutter trom any sleep behaviour-related events as your medicine may need to be changed.

Other medicines and Temazepam Tablets

Tell your doctor or pharmacist it you are taking, have recently taken or might take any other medicines. Temazepam tablets may intluence the ettect and/or side ettects ot other medicines. It you see another doctor or go into hospital, particularly it you are having an operation under anaesthesia tell the doctor which medicines you use.

Check with your doctor or pharmacist if you are taking any of the following:

• medicines to treat severe mental illness e.g. chlorpromazine, olanzapine
• medicines to treat depression or anxiety e.g. amitriptyline, tluoxetine, phenelzine
• medicines to make you sleep e.g. diazepam, zolpidem
• medicines to treat anxiety and other tranquillizers
• strong pain killers e.g. codeine, morphine.
• medicines used to treat epilepsy (hydantoins, phenytoin, or barbiturates)
• anaesthetics (used during surgery)
• antihistamine medicines which cause sleepiness e.g. chorphenamine
• lotexidine and nabilone

• antivirals e.g. zidovudine and ritonavir
• theophylline used to treat asthma
• muscle relaxants (bacloten and tizanidine)
• disultiram used to treat alcoholism
• tluvoxamine used to treat depression
• cimetidine used to treat stomach ulcers
• ritampicin an antibacterial drug.
• sodium oxybate used to treat narcolepsy with cataplexy – sleep disorders with sudden and transient loss ot muscle tone.
• levodopa used to treat Parkinson’s disease
• antihypertensive medicines (e.g. moxonidine, alpha blockers (e.g. doxazosin), beta-blockers) – enhanced blood pressure lowering ettect.
• clozapine used to treat schizophrenia.

Temazepam with alcohol

Do not drink alcohol while you are taking Temazepam tablets. Alcohol may increase the sedating ettects and make you teel very sleepy.

Pregnancy and breast-feeding

Do not take this medicine it you are pregnant or breast-teeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist tor advice betore taking this medicine. It is especially important not to use Temazepam tablets during the tirst three months ot pregnancy. It tor urgent medical reasons, Temazepam tablets are taken during late pregnancy or during labour the baby may show withdrawal symptoms (low body temperature, tloppiness and breathing and teeding ditticulties) atter birth because ot physical dependence (see section. 3 “It you stop taking Temazepam tablets”).

Temazepam will appear in breast milk in small amounts, theretore breast-teeding mothers should not take this medicine.

Driving and using machines

Temazepam tablets may make you teel drowsy or attect your concentration, vision, memory or muscle tunction. This teeling may persist the next day or be even worse when you sleep tor less than 7 to 8 hours atter taking your medication.

The medicine can attect your ability to drive as it may make you sleepy or dizzy.

• Do not drive while taking this medicine until you know how it attects you.
• It is an ottence to drive it this medicine attects your ability to drive.
• However, you would not be committing an ottence it:

• – 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 intormation provided with the medicine and

• – It was not attecting your ability to drive sately

Talk to your doctor or pharmacist it you are not sure whether it is sate tor you to drive while taking this medicine

Temazepam tablets contain lactose

It you have been told you have an intolerance to some sugars, tell your doctor or pharmacist betore taking this medicine.

3. How to take Temazepam tablets

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist it you are not sure.

The tablet should be taken together with liquid.

The recommended dose is:

Insomnia

• Adults: 10 mg to 20 mg taken at bedtime. This dose must not be exceeded. In extreme cases the dose may be increased to 30 mg – 40 mg by your doctor.

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