Nortem 20mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Temazepam

Available from:

Teva B.V.

ATC code:

N05CD; N05CD07

INN (International Name):

Temazepam

Dosage:

20 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Benzodiazepine derivatives; temazepam

Authorization status:

Marketed

Authorization date:

1993-12-13

Patient Information leaflet

NORTEM 10 MG TABLETS
NORTEM 20 MG TABLETS
temazepam
PACKAGE LEAFLET: INFORMATION FOR THE USER
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE
BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, 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 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 NORTEM TABLETS ARE AND WHAT THEY ARE USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NORTEM TABLETS
3. HOW TO TAKE NORTEM TABLETS
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE NORTEM TABLETS
6. CONTENTS OF THE PACK AND FURTHER INFORMATION
1. WHAT NORTEM TABLETS ARE AND WHAT THEY ARE USED FOR
Nortem Tablets contain temazepam as the active ingredient. Temazepam
is an anti-anxiety drug which is
used in the short-term to help people sleep. It belongs to a group of
drugs called benzodiazepines.
Nortem Tablets are used for:
•
short-term treatment of insomnia (difficulty in sleeping) which is
severe, disabling or causing
extreme distress
•
pre-medication before minor surgery or other procedures.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NORTEM TABLETS
DO NOT TAKE NORTEM TABLETS IF YOU:
•
are allergic to temazepam or other benzodiazepines (e.g. diazepam) or
any of the other ingredients
of this medicine
•
have difficulty in breathing or lung problems
•
have a condition called sleep apnoea syndrome (where breathing stops
during sleep)
•
have myasthenia gravis (a condition where the muscles become weak and
tire easily)
•
have severe liver problems
WARNINGS AND PRECAUTIONSTALK TO YOUR DOCTOR BEFORE YOU START TO TAKE
THIS MEDICINE IF YOU:
•
have long-term lung problems (taking Nortem Tablets may cause fatal
breathing problems)
•
have kidney problems
•
have li

Summary of Product characteristics

Health Products Regulatory Authority
26 January 2022
CRN00CQPM
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nortem 20mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 20 mg of temazepam.
Excipient(s) with known effect
Each tablet contains 280.0 mg lactose.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablet
White to pale yellow, flat bevel-edged tablets with a breakline on one
side, 5K2 on reverse.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As a hypnotic for the short-term management of insomnia only when it
is severe, disabling or subjecting the individual to
extreme distress.
For pre-medication prior to minor surgery or other related procedures.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Oral.
The treatment period should be of the shortest duration possible. This
may vary from a few days to two weeks with a maximum
(including tapering off) of four weeks. The dose reduction process
should be tailored to the individual. In certain cases
extension beyond the maximum treatment period may be necessary; if
this is the case it should not take place without
re-evaluation of the patient's status. The product should be taken on
retiring or up to 30 minutes before going to bed.
DOSAGE
Insomnia
Adults: 10 ‑ 20 mg. In exceptional circumstances, the dose may be
increased to 30 ‑ 40 mg.
Elderly: 10 mg. In exceptional circumstances, the dose may be
increased to 20 mg.
Pre-medication: The usual dose is 20 ‑ 40 mg 30 to 60 minutes before
the procedure.
Children: Not recommended for use in children.
Treatment should be started with the lowest, recommended dose. The
maximum dose should not be exceeded. Patients
suffering from renal or hepatic impairment should receive a reduced
dose.
4.3 CONTRAINDICATIONS
Myasthenia Gravis.
Severe respiratory insufficiency.
Health Products Regulatory Authority
26 January 2022
CRN00CQPM
Page 2 of 7
Sleep apnoea syndrome.
Severe hepatic insufficiency.
Nortem Tablets are contraindicated in patients with hy