Nitrazepam Tablets

Krajina: Malta

Jazyk: angličtina

Zdroj: Malta Medicines Authority

Aktívna zložka:

NITRAZEPAM

Dostupné z:

Wockhardt UK Limited Ash Road North, Wrexham, LL13 9UF, United Kingdom

ATC kód:

N05CD02

INN (Medzinárodný Name):

NITRAZEPAM 5 mg

Forma lieku:

TABLET

Zloženie:

NITRAZEPAM 5 mg

Typ predpisu:

POM

Terapeutické oblasti:

PSYCHOLEPTICS

Stav Autorizácia:

Withdrawn

Dátum Autorizácia:

2006-12-20

Príbalový leták

PACKAGE LEAFLET: INFORMATION FOR THE USER
NITRAZEPAM 5MG TABLETS
Nitrazepam
(Referred to as Nitrazepam Tablets in the remainder of the leaflet)
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
this medicine (see section 6. Further information)
• suffer from breathing problems (respiratory depression)
• suffer from a condition known as acute pulmonary insufficiency (a
severe heart condition causing shortness
of breath and fatigue)
• suffer from a condition known as porphyria (an inherited condition
causing skin blisters, abdominal pain,
and brain or nervous system disorder)
• have severe liver problems
• suffer from a condition known as myasthenia gravis (a muscle
disorder causing extreme weakness)
• suffer from a condition known as sleep apnoea syndrome (where you
stop breathing whil

Súhrn charakteristických

Page 1 of 10
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.
Page 2 of 10
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
hepati