Temazepam 10mg/5ml oral solution sugar free

Nazione: Regno Unito

Lingua: inglese

Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)

Principio attivo:

Temazepam

Commercializzato da:

Rosemont Pharmaceuticals Ltd

Codice ATC:

N05CD07

INN (Nome Internazionale):

Temazepam

Dosaggio:

2mg/1ml

Forma farmaceutica:

Oral solution

Via di somministrazione:

Oral

Classe:

Schedule 3 (CD No Register)

Tipo di ricetta:

Valid as a prescribable product

Dettagli prodotto:

BNF: 04010100; GTIN: 5016119124495 5016119124099

Foglio illustrativo

TEMAZEPAM 10MG/5ML ORAL SOLUTION
24.05.16
FOUR
TBC
1 of 2
10MG/5ML
TMG Drug Driving
-
YES
-
210 x 300mm (folded 150 x 30mm)
1
Black
Keyline
300ML
SPC UPDATES
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
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Keep this leaflet. You may need to read it again.
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If you have any further questions, ask your doctor or pharmacist.
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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.
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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
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:
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to help you sleep and re-set your sleep patterns when you have been
having difficulty sleeping
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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 IF:
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you are allergic to temazepam, to other benzodiazapines or any other
ingredients of this medicine (listed in
section 6). The signs of an allergic reaction can include a rash,
itching, difficulty breathing or swallowing or
swelling of the face, lips, throat or tongue
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you have sudden or severe breathing problems
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you have severe liver problems
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you have ‘myasthenia gravis’. The signs of this may be long term
tiredness (fatigue) and muscle weakness
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you suffer from a condition where you stop breathing whilst asleep
(sleep apnoea)
n
you have an eye problem called “glauco

Scheda tecnica

OBJECT 1
TEMAZEPAM 10MG/5ML ORAL SOLUTION
Summary of Product Characteristics Updated 21-Sep-2016 | Rosemont
Pharmaceuticals Limited
1. Name of the medicinal product
Temazepam 10mg/5ml Oral Solution
2. Qualitative and quantitative composition
Temazepam BP 10mg/5ml
Excipients with known effect: sorbitol and 10%v/v ethanol
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
An elixir containing 10mg Temazepam BP per 5ml for oral
administration.
4. Clinical particulars
4.1 Therapeutic indications
Temazepam is indicated for the short term treatment of sleep
disturbances, considered severe or disabling
or where insomnia is subjecting the individual to extreme distress.
This product is especially useful in
those patients for whom particularly rapid onset of hypnotic action is
required and for whom the
persistence of hypnotic effect after rising would be undesirable.
Temazepam is particularly suitable for patients with transient sleep
disorders in whom re-establishment of
normal sleep patterns is expected following the resolution of
precipitating factors.
It is also indicated for pre-medication for minor surgical and
investigative procedures, especially in the
case of outpatients.
4.2 Posology and method of administration
Posology
Insomnia:
_Adults_:
Each 5ml dose of Temazepam Elixir is equivalent to 10mg Temazepam. The
usual dose is 5 - 15ml orally
on retiring; a dose of 10ml will be found to be satisfactory for most
patients. This may be increased to 15
- 20ml (30 - 40mg Temazepam) in patients who do not respond to the
lower dose. Lower doses may be
adequate for some patients, as for the elderly.
Pre- medication
10 - 20ml from half an hour to one hour prior to surgery or
investigative procedures.
_Elderly_:
Elderly patients or those suffering from cerebral vascular changes
such as arteriosclerosis are likely to
respond to smaller doses. Half the normal dose, 2.5 to 7.5ml (5 -
15mg) may be sufficient for a
therapeutic response.
_Paediatric population _
Insomnia: Not recommended
Pre-medication:
1mg (