Nitrazepam 5mg tablets

Země: Velká Británie

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivní složka:

Nitrazepam

Dostupné s:

Wockhardt UK Ltd

ATC kód:

N05CD02

INN (Mezinárodní Name):

Nitrazepam

Dávkování:

5mg

Léková forma:

Oral tablet

Podání:

Oral

Třída:

Schedule 4 (CD Benz)

Druh předpisu:

Valid as a prescribable product

Přehled produktů:

BNF: 04010100; GTIN: 5012727903064

Informace pro uživatele

MEASURE BAR SHOULD BE 150MM AT 100% SCALE
Customer
Description
Item Code
Profile
Size
Min. Point Size
Market
Language
Proof By
Proof No.
Date
Artwork No.
Pharma
Code
Colours Used
Wockhardt UK Limited
Nitrazepam leaflet
105232/4
n-a
128 x 420mm
matt.pirie-scott
1
26/08/2015
591904
n-a
Process Black
Keylines (non-printing)
[e-mail]
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WARNING! We cannot accept responsibility for any errors
in this proof after approval. Whilst we take extreme care
at all times to ensure accuracy to our clientʼs brief,
the final responsibility must be taken by our client.
IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING
FULL APPROVAL OF DESIGN AND TEXT.
UK
English
8pt (main body) / 8pt (variables)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
START TO TAKE THIS MEDICINE.
- Keep this leaflet. You may need to read it
again.
- If you have any further questions, please 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 get serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
1. What Nitrazepam Tablets are and what they
are used for
2. Before you take Nitrazepam Tablets
3. How to take Nitrazepam Tablets
4. Possible side effects
5. How to store Nitrazepam Tablets
6. Further information
1. What Nitrazepam Tablets are and what
they are used for
The name of your medicine is Nitrazepam
Tablets. The active ingredient in your medicine
is nitrazepam. Nitrazepam Tablets belong to
a group of medicines called benzodiazepines
which are used as sedatives.
Nitrazepam Tablets are used to treat severe
sleeplessness problems (insomnia) and the
worry such sleeping problems may cause.
2. Before you take Nitrazepam Tablets
DO NOT TAKE NITRAZEPAM TABLETS IF YOU
• are allergic (hypersensitive) to nitrazepam,
or other benzodiazepines, or to any of the
other ingredients in

Charakteristika produktu

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Nitrazepam 5mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Nitrazepam 5mg
For excipients, see 6.1.
3
PHARMACEUTICAL FORM
Oral tablet
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Tablets containing nitrazepam (a benzodiazepine) should be used to
treat insomnia
only when it is severe, disabling or subjecting the individual to
extreme distress.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Adults:
5 - 10mg before retiring.
Elderly or debilitated:
2.5 - 5mg before retiring
Hepatic/renal impairment:
A reduction in dose may be required in patients with hepatic or renal
impairment.
Children:
Nitrazepam Tablets are not recommended for use in children
Note:
The lowest dose which can control symptoms should be used. It should
not be
continued beyond four weeks.
Treatment if possible should be intermittent. Long term chronic use is
not
recommended.
Treatment should always be tapered off gradually.
Patients who have taken benzodiazepines for a long time may require a
longer period
during which doses are reduced.
4.3
CONTRAINDICATIONS
•
Hypersensitivity to benzodiazepines or to any of the other ingredients
•
Acute pulmonary insufficiency: respiratory depression: sleep apnoea
(risk of
further respiratory depression)
•
Porphyria
•
Phobic or Obsessional states (inadequate evidence of safety and
efficacy).
•
Chronic psychoses (inadequate evidence of safety and efficacy).
•
Severe hepatic insufficiency (may precipitate encephalopathy)
•
Planning a pregnancy (see section 4.6)
•
Pregnancy (unless there are compelling reasons – see section 4.6)
•
Myasthenia gravis (increased risk of respiratory depression)
•
Head injuries (reduced cerebral perfusion: risk of irreversible
neurological
damage)
Nitrazepam should not be used alone in depression or anxiety with
depression (may
precipitate suicide).
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Nitrazepam should be used with caution in patients with renal or
hepatic dysfunction,
coma, muscle we