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The product code for this leaflet is: PL 00427/0089

 

Temazepam 10mg/5ml Oral Solution

Company Details

Rosemont Pharmaceuticals Limited


Rosemont HouseYorkdale Industrial ParkBraithwaite StreetLeedsYorkshireLS11 9XE
Telephone:
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Patient Information Leaflet

Temazepam 10mg/5ml Oral Solution

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 your pharmacist.
  • This medicine has been prescribed only 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 is Temazepam Oral Solution and what is it used for
2. Before you take Temazepam Oral Solution
3. How to take Temazepam Oral Solution
4. Possible side effects
5. How to store Temazepam Oral Solution
6. Further information

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1. What is Temazepam Oral Solution and what is it used for

The name of your medicine is Temazepam Oral Solution. This belongs to a group of medicines called benzodiazepines.

Temazepam can be used:

  • to help you sleep and re-set your sleep patterns when you have been having difficulty sleeping
  • as a medicine that you should take before you have an operation or a test.
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2. Before you take Temazepam Oral Solution

Do not take temazepam and tell your doctor if:

  • you are allergic (hypersensitive) to temazepam or any other ingredients in this liquid (listed in section 6). The signs of an allergic reaction can include a rash, itching or shortness of breath
  • you have severe breathing problems
  • you have severe liver problems
  • you have ‘myasthenia gravis’. The signs of this may be long term tiredness (fatigue) and muscle weakness
  • you suffer from a condition where you stop breathing whilst asleep (sleep apnoea)
  • you have an eye problem called “glaucoma”
  • you have a severe mental health problem called “chronic psychosis” or a “phobic or obsessional state”
  • you have anxiety problems with or without depression. Temazepam may cause you to think about killing yourself (suicide) more often.

Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor before taking temazepam.

Take special care with temazepam

Before you take this medicine, tell your doctor if:

  • you have kidney problems
  • you have a history of alcohol or drug abuse
  • you have a personality disorder such as schizophrenia
  • you are having a general anaesthetic. Tell the doctor you are taking temazepam
  • you have recently suffered a loss or bereavement as the medicine may affect the way you react and adjust to this.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking temazepam.

Note: Temazepam can be habit forming. This medicine should only be used for the shortest time possible.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines bought without a prescription, including herbal medicines. This is because Temazepam Oral Solution can affect the way some other medicines work. Also, some medicines can affect the way Temazepam Oral Solution works.

In particular tell your doctor if you are taking any of the following medicines:

  • medicines used for depression including Monoamine Oxidase Inhibitors (MAOIs) such as phenelzine
  • narcotic painkillers such as codeine and morphine
  • medicines used to treat epilepsy such as phenytoin, barbiturates, carbamazepine or sodium valproate
  • medicines that calm your emotions or help you sleep
  • antihistamines used to treat allergies that make you drowsy
  • medicines used to treat high blood pressure such as moxonidine or doxazosin
  • medicines used to treat HIV infection such as zidovudine and ritonavir
  • medicines used to treat Parkinsons disease such as levodopa
  • medicines that help the muscles relax in multiple sclerosis or spine injuries such as baclofen or tizanidine
  • lofexidine, used to treat drug problems (dependence)
  • nabilone, used to treat sickness caused by chemotherapy
  • clozapine, used for schizophrenia
  • disulfiram, used for alcohol problems (alcoholism).

Taking Temazepam Oral Solution with food and drink

Do not drink alcohol whilst taking this medicine. This medicine can make you sleepy and drinking alcohol when you are taking this medicine can make you even more sleepy.

Pregnancy and Breast-feeding

  • do not take this medicine if you are pregnant, likely to become pregnant or are breast-feeding.
  • if your doctor has decided that you should take this medicine during late pregnancy or during labour, your baby may have a low body temperature, floppiness (hypotonia) and breathing or feeding difficulties.
  • if this medicine is taken regularly in late pregnancy, your baby may develop withdrawal symptoms.

Driving and using machines

Temazepam may make you sleepy or affect your concentration. If this happens to you, take extra care when driving or using tools or machinery.

Important information about what is in Temazepam Oral Solution:

This medicine contains:

  • liquid sorbitol (a type of sugar). If your doctor has told you that you cannot tolerate some sugars, talk to your doctor before taking this medicine.
  • ethanol (alcohol). Each 5ml spoonful contains 10%v/v ethanol which is equal to 10ml of beer or 4ml of wine. Speak to your doctor before taking this medicine if you have an addiction to alcohol, liver disease, epilepsy, brain injury or disease, you are pregnant or if this medicine has been prescribed for a child.
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3. How to take Temazepam Oral Solution

Take this medicine as your doctor or pharmacist has told you. Look on the label and ask the doctor or pharmacist if you are not sure.

Taking this medicine

  • this medicine contains 10mg of temazepam in each 5ml
  • take this medicine by mouth
  • long term use of this medicine is not recommended.

Adults

For sleeping problems:

  • the usual dose is 5ml to 20ml each day before going to bed
  • this should only be taken for up to 4 weeks at a time
  • your doctor may advise you to take this only when necessary.

As a pre-medication:

  • the usual dose is 10 to 20ml, half to one hour before your surgery or test
  • make sure that you have someone to take you home after the procedure.

Older people and people with disease of the blood vessels

  • the usual dose is 2.5ml to 7.5ml
  • take this each day before going to bed.

Children

For sleeping problems:

  • this medicine should not be used to help children sleep.

As a pre-medication:

  • the usual dose is 0.5ml per kilogram of body weight before surgery or test
  • the doctor will work out the correct dose for your child.

If you take more Temazepam Oral Solution than you should

If you take more of this medicine than you should, talk to a doctor or go to your nearest hospital straight away. Take the medicine pack with you.

If you take too much the following effects may happen:

  • having trouble with your co-ordination
  • slurred speech
  • feeling confused
  • feeling tired, light-headed and possibly fainting (all due to low blood pressure)
  • breathing problems
  • falling into a coma

If you forget to take Temazepam Oral Solution

  • if you forget a dose, take it as soon as you remember it. However, if it is nearly time for the next dose, skip the missed dose
  • do not take a double dose (two doses at the same time) to make up for a forgotten dose.

If you stop taking Temazepam Oral Solution

Do not stop taking this medicine unless your doctor tells you to. Do not stop it abruptly.

If the medicine is stopped quickly, the following effects may happen:

  • feeling nervous, irritable, confused, being unable to sleep, finding it hard to concentrate
  • feeling depressed, loss of appetite, having a headache, ringing in your ears (tinnitus), feeling dizzy, feeling detached from yourself or your surroundings (toxic psychosis)
  • tingling hands or feet, sweating, being more sensitive to light, noise or touch than usual, fits and shaking
  • diarrhoea

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, Temazepam Oral Solution can cause side effects although not everybody gets them.

Stop taking this medicine and see a doctor straight away if you have any of the following:

  • an allergic reaction.
    The signs of an allergic reaction may include:
    • swelling of your face, lips, tongue or throat or difficulty breathing or swallowing
    • severe itching of your skin with raised lumps.
  • A rare reaction that affects behaviour (affects more than 1 in 10,000 people)
    The signs of this may include:
    • feeling depressed and suicidal
    • feeling excited, restless, agitated, irritable and confused
    • aggressive outbursts or rages
    • nightmares
    • hallucinations (seeing or hearing things that are not there)
    • delusions (thinking things are true that are not really true)
    • feeling detached from yourself or your surroundings (psychosis)
    • inappropriate behaviour.

Tell your doctor if you get any of these side effects:

Common (affects more than 1 in 100 people):

  • feeling drowsy, sleepy, extremely tired or unable to sleep
  • blurring of vision
  • feeling unsteady or dizzy
  • feeling less alert to your surroundings
  • numbed emotions
  • lack of co-ordination or muscle weakness
  • slurred speech
  • shallow breathing

These side effects are more likely to occur at the start of treatment, if alcohol is taken with this medicine or if you are an older person.

Rare (affects more than 1 in 10,000 people):

  • low blood pressure
  • stomach upset
  • change in sexual desire
  • headache
  • jaundice (yellowing of the skin and whites of the eyes)
  • difficulty passing water
  • skin rashes
  • sight problems
  • memory loss
  • hangover
  • shaking
  • feeling dizzy or like you are spinning (vertigo)
  • difficulty pronouncing your words, dry mouth or making more saliva than usual
  • loss of control of your bladder or bowels (incontinence).

You may have changes to your blood cells. The signs you may notice of this are feeling weak, sore throat, unexplained bruises or bleeding, getting more infections and sores or ulcers in your mouth.

You may develop tolerance to the effects of temazepam. This means you may notice that your medicine is not working as well to relieve your symptoms. If this happens, speak to your doctor.

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.

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5. How to store Temazepam Oral Solution

  • keep out of the reach and sight of children
  • store between 4°C and 25°C
  • take back to the pharmacy 3 months after you first open it
  • do not use after the expiry date (month, year) stated on the label and carton
  • if it is out of date or you no longer want it, take it back to the pharmacy
  • do not use Temazepam Oral Solution if you notice anything wrong with the medicine. Talk to your pharmacist
  • medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicine no longer required. These measures will help to protect the environment.
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6. Further information

What Temazepam Oral Solution contains

  • the active ingredient is temazepam
  • the other ingredients are ethanol, propylene glycol (E1520), peppermint oil, caramel E150, trometamol, citric acid, colour E131, glycerol (E422), sorbitol solution 70% (E420) and purified water.

What Temazepam Oral Solution looks like and contents of the pack

A clear green liquid with an odour of peppermint.

It comes in a brown glass bottle holding 100ml or 300ml of solution.

Marketing Authorisation Holder and Manufacturer

Rosemont Pharmaceuticals Ltd
Yorkdale Industrial Park
Braithwaite Street
Leeds
LS11 9XE
UK
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This leaflet was last approved in January 2010

P0496


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