TEMAZEPAM 10MG/5ML ORAL SOLUTION

Active substance: TEMAZEPAM

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Page 2
52mm x 97mm

Package leaflet: Information for the user
Temazepam 10mg/5ml Oral Solution
Read all of this leaflet carefully before you start taking this medicine because it contains important
information for you.
I Keep this leaflet. You may need to read it again.
I If you have any further questions, ask your doctor or pharmacist.
I This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if
their signs of illness are the same as yours.
I If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.
What is in this leaflet
1. What Temazepam Oral Solution is and what it is used for
2. What you need to know 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. Contents of the pack and other information

Temazepam 10mg/5ml Oral Solution

Page 3

52mm x 98mm
1. What Temazepam Oral Solution is and what it is used for
The name of your medicine is Temazepam Oral Solution. This belongs to a group of medicines called
benzodiazepines.
Temazepam can be used:
I to help you sleep and re-set your sleep patterns when you have been having difficulty sleeping
I as a medicine that you should take before you have an operation or a test.
2. What you need to know before you take Temazepam Oral Solution
Do not take Temazepam and tell your doctor if:
I 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
I you have severe breathing problems
I you have severe liver problems
I you have ‘myasthenia gravis’. The signs of this may be long term tiredness (fatigue) and muscle weakness
I you suffer from a condition where you stop breathing whilst asleep (sleep apnoea)
I you have an eye problem called “glaucoma”
I you have a severe mental health problem called “chronic psychosis” or a “phobic or obsessional state”
I you have anxiety problems with or without depression. Temazepam may cause you to think about killing
yourself (suicide) more often.

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
I 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
I 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:
I feeling nervous, irritable, confused, being unable to sleep, finding it hard to concentrate
I feeling depressed, loss of appetite, having a headache, ringing in your ears (tinnitus), feeling dizzy,
feeling detached from yourself or your surroundings (toxic psychosis)
I tingling hands or feet, sweating, being more sensitive to light, noise or touch than usual, fits and shaking
I diarrhoea.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
I
I
I

NEW ADVICE FOR DRIVERS
Sugar Free
– see leaflet
Each 5ml contains 10mg Temazepam.
The product also includes ethanol, propylene glycol (E1520), glycerol (E422) and
sorbitol solution (E420). See leaflet for further information.
Administration: For oral use. Read the package leaflet before use.
This medicine can make you feel sleepy. Do not drive while taking this medicine
until you know how it makes you feel. See the leaflet inside for more information.
Storage: Store between 4°C and 25°C and protect from light. Use within 3 months of
opening. Keep out of the sight and reach of children.
Manufactured by the MA holder:
Rosemont Pharmaceuticals Ltd., Leeds, LS11 9XE, UK.
Distributed by: Focus Pharmaceuticals Ltd.,
POM CD
Burton upon Trent, DE14 2WX, UK. PL 0427/0089             

300ml

Page 9

52mm x 100mm

52mm x 98mm

NEW ADVICE FOR DRIVERS
Sugar Free
– see leaflet
Each 5ml contains 10mg Temazepam.
The product also includes ethanol, propylene glycol (E1520), glycerol (E422) and
sorbitol solution (E420). See leaflet for further information.
Administration: For oral use. Read the package leaflet before use.
This medicine can make you feel sleepy. Do not drive while taking this medicine
until you know how it makes you feel. See the leaflet inside for more information.
Storage: Store between 4°C and 25°C and protect from light. Use within 3 months of
opening. Keep out of the sight and reach of children.
Manufactured by the MA holder:
Rosemont Pharmaceuticals Ltd., Leeds, LS11 9XE, UK.
Distributed by: Focus Pharmaceuticals Ltd.,
Burton upon Trent, DE14 2WX, UK. PL 0427/0089     
POM CD

300ml

Base Page

52mm x 144mm

5 060064 791080 >

Temazepam 10mg/5ml Oral Solution

L1444

Page 5

52mm x 96mm
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.
Warnings and precautions
Talk to your doctor or pharmacist before taking Temazepam if:
I you have kidney problems
I you have a history of alcohol or drug abuse
I you have a personality disorder such as schizophrenia
I you are having a general anaesthetic. Tell the doctor you are taking temazepam
I 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.
Other medicines and Temazepam
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.

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:
I 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.
I 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.

L1444

Page 1

Peel Here But Do Not Remove

Page 4

Page 10

52mm x 98mm

Page 6

52mm x 96mm
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
I narcotic painkillers such as codeine and morphine
I medicines used to treat epilepsy such as phenytoin, barbiturates, carbamazepine or sodium valproate
I medicines that calm your emotions or help you sleep
I antihistamines used to treat allergies that make you drowsy
I medicines used to treat high blood pressure such as moxonidine or doxazosin
I medicines used to treat HIV infection such as zidovudine and ritonavir
I medicines used to treat Parkinsons disease such as levodopa
I medicines that help the muscles relax in multiple sclerosis or spine injuries such as baclofen or tizanidine
I lofexidine, used to treat drug problems (dependence)
I nabilone, used to treat sickness caused by chemotherapy
I clozapine, used for schizophrenia
I disulfiram, used for alcohol problems (alcoholism)
I fluvoxamine, used to treat depression
I cimetidine, used to treat stomach ulcers
I rifampicin, used to treat bacterial infections
I theophylline, used to treat asthma.
I

Tell your doctor if you get any of these side effects:
Common (affects more than 1 in 100 people):
I feeling drowsy, sleepy, extremely tired or unable to sleep
I blurring of vision
I feeling unsteady or dizzy
I feeling less alert to your surroundings
I numbed emotions
I lack of co-ordination or muscle weakness
I slurred speech
I 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):
I low blood pressure
I stomach upset
I change in sexual desire
I headache
I jaundice (yellowing of the skin and whites of the eyes)
I difficulty passing water
I skin rashes

Page 11

52mm x 96mm

Page 7

52mm x 98mm
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
I do not take this medicine if you are pregnant, likely to become pregnant or are breast-feeding.
I 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.
I if this medicine is taken regularly in late pregnancy, your baby may develop withdrawal symptoms.
Driving and using machines
This medicine can affect your ability to drive as it may make you sleepy or dizzy.
I Do not drive while taking this medicine until you know how it affects you.
I It is an offence to drive if this medicine affects your ability to drive.
I 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.

sight problems
memory loss
hangover
I shaking
I feeling dizzy or like you are spinning (vertigo)
I difficulty pronouncing your words, dry mouth or making more saliva than usual
I 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.
I
I
I

52mm x 98mm
Temazepam Oral Solution contains liquid sorbitol and ethanol:
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.
I 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.
I

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
I this medicine contains 10mg of temazepam in each 5ml
I take this medicine by mouth
I 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.

5. How to store Temazepam Oral Solution
Keep this medicine out of the sight and reach of children.
I Store between 4°C and 25°C.
I Take back to the pharmacy 3 months after you first open it.
I Do not use after the expiry date (month, year) stated on the label and carton. The expiry date refers to
the last day of that month.
I If it is out of date or you no longer want it, take it back to the pharmacy.
I Do not use Temazepam Oral Solution if you notice anything wrong with the medicine. Talk to your
pharmacist.
I 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.
I

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly to the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the
safety of this medicine.

Page 12

52mm x 96mm

Page 13

52mm x 98mm

Page 8

52mm x 100mm
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:
I having trouble with your co-ordination
I slurred speech
I feeling confused

6. Contents of the pack and other information
What Temazepam Oral Solution contains
I The active substance is temazepam. This medicine contains 10mg of temazepam in each 5ml of
solution.
I The other ingredients are ethanol, propylene glycol (E1520), peppermint oil, caramel E150,
trometamol, citric acid, colour E131, glycerol (E422), sorbitol solution 70% non-crystallising (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 300ml of
solution.
Marketing Authorisation Holder and Manufacturer
Rosemont Pharmaceuticals Ltd, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK.
Distributed by: Focus Pharmaceuticals Ltd., Burton upon Trent, DE14 2WX, UK.
This leaflet was last approved in 06/2014.

Page 14

52mm x 97mm

Page 2
52mm x 97mm

Package leaflet: Information for the user
Temazepam 10mg/5ml Oral Solution
Read all of this leaflet carefully before you start taking this medicine because it contains important
information for you.
I Keep this leaflet. You may need to read it again.
I If you have any further questions, ask your doctor or pharmacist.
I This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if
their signs of illness are the same as yours.
I If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.
What is in this leaflet
1. What Temazepam Oral Solution is and what it is used for
2. What you need to know 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. Contents of the pack and other information

Temazepam 10mg/5ml Oral Solution

Temazepam
#10 mg/#5 ml
Oral Solution

NEW ADVICE FOR DRIVERS
Sugar Free
– see leaflet
Each 5ml contains 10mg Temazepam.
The product also includes ethanol, propylene glycol (E1520), glycerol (E422) and
sorbitol solution (E420). See leaflet for further information.
Administration: For oral use. Read the package leaflet before use.
This medicine can make you feel sleepy. Do not drive while taking this medicine
until you know how it makes you feel. See the leaflet inside for more information.
Storage: Store between 4°C and 25°C and protect from light. Use within 3 months of
opening. Keep out of the sight and reach of children.
Manufactured by the MA holder:
Rosemont Pharmaceuticals Ltd., Leeds, LS11 9XE, UK.
Distributed by: Focus Pharmaceuticals Ltd.,
POM CD
Burton upon Trent, DE14 2WX, UK. PL 0427/0089             

300ml

Page 3

52mm x 98mm
1. What Temazepam Oral Solution is and what it is used for
The name of your medicine is Temazepam Oral Solution. This belongs to a group of medicines called
benzodiazepines.
Temazepam can be used:
I to help you sleep and re-set your sleep patterns when you have been having difficulty sleeping
I as a medicine that you should take before you have an operation or a test.
2. What you need to know before you take Temazepam Oral Solution
Do not take Temazepam and tell your doctor if:
I 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
I you have severe breathing problems
I you have severe liver problems
I you have ‘myasthenia gravis’. The signs of this may be long term tiredness (fatigue) and muscle weakness
I you suffer from a condition where you stop breathing whilst asleep (sleep apnoea)
I you have an eye problem called “glaucoma”
I you have a severe mental health problem called “chronic psychosis” or a “phobic or obsessional state”
I you have anxiety problems with or without depression. Temazepam may cause you to think about killing
yourself (suicide) more often.

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
I 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
I 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:
I feeling nervous, irritable, confused, being unable to sleep, finding it hard to concentrate
I feeling depressed, loss of appetite, having a headache, ringing in your ears (tinnitus), feeling dizzy,
feeling detached from yourself or your surroundings (toxic psychosis)
I tingling hands or feet, sweating, being more sensitive to light, noise or touch than usual, fits and shaking
I diarrhoea.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
I
I
I

Page 9

52mm x 100mm

52mm x 98mm

NEW ADVICE FOR DRIVERS
Sugar Free
– see leaflet
Each 5ml contains 10mg Temazepam.
The product also includes ethanol, propylene glycol (E1520), glycerol (E422) and
sorbitol solution (E420). See leaflet for further information.
Administration: For oral use. Read the package leaflet before use.
This medicine can make you feel sleepy. Do not drive while taking this medicine
until you know how it makes you feel. See the leaflet inside for more information.
Storage: Store between 4°C and 25°C and protect from light. Use within 3 months of
opening. Keep out of the sight and reach of children.
Manufactured by the MA holder:
Rosemont Pharmaceuticals Ltd., Leeds, LS11 9XE, UK.
Distributed by: Focus Pharmaceuticals Ltd.,
Burton upon Trent, DE14 2WX, UK. PL 0427/0089     
POM CD

300ml

Base Page

52mm x 144mm

Temazepam
#10 mg/#5 ml
Oral Solution
Only Braille Check text, will not be printed

5 060064 791080 >

Temazepam 10mg/5ml Oral Solution

L1444

Page 5

52mm x 96mm
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.
Warnings and precautions
Talk to your doctor or pharmacist before taking Temazepam if:
I you have kidney problems
I you have a history of alcohol or drug abuse
I you have a personality disorder such as schizophrenia
I you are having a general anaesthetic. Tell the doctor you are taking temazepam
I 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.
Other medicines and Temazepam
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.

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:
I 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.
I 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.

L1444

Page 1

Peel Here But Do Not Remove

Page 4

Page 10

52mm x 98mm

Page 6

52mm x 96mm
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
I narcotic painkillers such as codeine and morphine
I medicines used to treat epilepsy such as phenytoin, barbiturates, carbamazepine or sodium valproate
I medicines that calm your emotions or help you sleep
I antihistamines used to treat allergies that make you drowsy
I medicines used to treat high blood pressure such as moxonidine or doxazosin
I medicines used to treat HIV infection such as zidovudine and ritonavir
I medicines used to treat Parkinsons disease such as levodopa
I medicines that help the muscles relax in multiple sclerosis or spine injuries such as baclofen or tizanidine
I lofexidine, used to treat drug problems (dependence)
I nabilone, used to treat sickness caused by chemotherapy
I clozapine, used for schizophrenia
I disulfiram, used for alcohol problems (alcoholism)
I fluvoxamine, used to treat depression
I cimetidine, used to treat stomach ulcers
I rifampicin, used to treat bacterial infections
I theophylline, used to treat asthma.
I

Tell your doctor if you get any of these side effects:
Common (affects more than 1 in 100 people):
I feeling drowsy, sleepy, extremely tired or unable to sleep
I blurring of vision
I feeling unsteady or dizzy
I feeling less alert to your surroundings
I numbed emotions
I lack of co-ordination or muscle weakness
I slurred speech
I 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):
I low blood pressure
I stomach upset
I change in sexual desire
I headache
I jaundice (yellowing of the skin and whites of the eyes)
I difficulty passing water
I skin rashes

Page 11

52mm x 96mm

Page 7

52mm x 98mm
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
I do not take this medicine if you are pregnant, likely to become pregnant or are breast-feeding.
I 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.
I if this medicine is taken regularly in late pregnancy, your baby may develop withdrawal symptoms.
Driving and using machines
This medicine can affect your ability to drive as it may make you sleepy or dizzy.
I Do not drive while taking this medicine until you know how it affects you.
I It is an offence to drive if this medicine affects your ability to drive.
I 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.

sight problems
memory loss
hangover
I shaking
I feeling dizzy or like you are spinning (vertigo)
I difficulty pronouncing your words, dry mouth or making more saliva than usual
I 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.
I
I
I

52mm x 98mm
Temazepam Oral Solution contains liquid sorbitol and ethanol:
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.
I 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.
I

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
I this medicine contains 10mg of temazepam in each 5ml
I take this medicine by mouth
I 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.

5. How to store Temazepam Oral Solution
Keep this medicine out of the sight and reach of children.
I Store between 4°C and 25°C.
I Take back to the pharmacy 3 months after you first open it.
I Do not use after the expiry date (month, year) stated on the label and carton. The expiry date refers to
the last day of that month.
I If it is out of date or you no longer want it, take it back to the pharmacy.
I Do not use Temazepam Oral Solution if you notice anything wrong with the medicine. Talk to your
pharmacist.
I 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.
I

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly to the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the
safety of this medicine.

Page 12

52mm x 96mm

Page 13

52mm x 98mm

Page 8

52mm x 100mm
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:
I having trouble with your co-ordination
I slurred speech
I feeling confused

6. Contents of the pack and other information
What Temazepam Oral Solution contains
I The active substance is temazepam. This medicine contains 10mg of temazepam in each 5ml of
solution.
I The other ingredients are ethanol, propylene glycol (E1520), peppermint oil, caramel E150,
trometamol, citric acid, colour E131, glycerol (E422), sorbitol solution 70% non-crystallising (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 300ml of
solution.
Marketing Authorisation Holder and Manufacturer
Rosemont Pharmaceuticals Ltd, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK.
Distributed by: Focus Pharmaceuticals Ltd., Burton upon Trent, DE14 2WX, UK.
This leaflet was last approved in 06/2014.

Page 14

52mm x 97mm

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52mm x 97mm

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52mm x 98mm

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52mm x 96mm

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52mm x 96mm

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52mm x 98mm

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52mm x 98mm

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52mm x 100mm

Temazepam
#10 mg/#5 ml
Oral Solution
Page 1

52mm x 100mm

Base Page

52mm x 144mm

Temazepam
#10 mg/#5 ml
Oral Solution
Only Braille Check text, will not be printed

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52mm x 98mm

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52mm x 98mm

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52mm x 96mm

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52mm x 96mm

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52mm x 98mm

Page 14

52mm x 97mm

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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