Pethidine (Noumed)

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Pethidine hydrochloride 50mg;  

Available from:

Noumed Pharmaceuticals Limited

INN (International Name):

Pethidine hydrochloride 50 mg

Dosage:

50 mg

Pharmaceutical form:

Tablet

Composition:

Active: Pethidine hydrochloride 50mg   Excipient: Acacia Lactose monohydrate Magnesium stearate Maize starch

Units in package:

Bottle, glass, 10 tablets

Class:

Class B3 Controlled Drug

Prescription type:

Class B3 Controlled Drug

Manufactured by:

Saneca Pharmaceuticals AS

Therapeutic indications:

For the relief of most types of moderate to severe pain. As it has some antispasmodic activity it may be the analgesic of choice in renal colic, bilary colic and acute pancreatitis.

Product summary:

Package - Contents - Shelf Life: Bottle, glass, - 10 tablets - 36 months from date of manufacture stored at or below 25°C protect from light

Authorization date:

1969-12-30

Patient Information leaflet

New Zealand Consumer Medicine Information
1
PETHIDINE TABLETS (NOUMED)
_Pethidine Hydrochloride BP _
_ _
Tablet, uncoated 50 mg
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully before you start using Pethidine
Tablets (Noumed).
This leaflet answers some common questions about Pethidine Tablets
(Noumed).
It does not contain all the available information. It does not take
the place of talking to
your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
risks of you using
WARNINGS
LIMITATIONS OF USE
Pethidine Tablets (Noumed) should only be used when your doctor
decides that
other treatment options are not able to effectively manage your pain,
or you cannot
tolerate them.
HAZARDOUS AND HARMFUL USE
Pethidine Tablets (Noumed) poses risks of abuse, misuse and addiction
which
can lead to overdose and death. Your doctor will monitor you regularly
during
treatment.
LIFE THREATENING RESPIRATORY DEPRESSION
Pethidine Tablets (Noumed) can cause life-threatening or fatal
breathing
problems (slow, shallow, unusual or no breathing), even when used as
recommended. These problems can occur at any time during use, but the
risk is
higher when first starting Pethidine Tablets (Noumed) and after a dose
increase,
if you are older, or have an existing problem with your lungs. Your
doctor will
monitor you and change the dose as appropriate.
USE OF OTHER MEDICINES WHILE USING PETHIDINE TABLETS (NOUMED)
Pethidine Tablets (Noumed) with other medicines that can make you feel
drowsy
such as sleeping tablets (e.g., benzodiazepines), other pain
relievers,
antihistamines, antidepressants, antipsychotics, gabapentinoids (e.g.,
gabapentin and pregabalin), cannabis and alcohol may result in severe
drowsiness, decreased awareness, breathing problems, coma and death.
Your
doctor will minimise the dose and duration of use; and monitor you for
signs and
symptoms of breathing difficulties and sedation. You must not drink
alcohol
while using Pethidine Tablets (Noumed).
New Zealand Consumer Medicine Informatio

Summary of Product characteristics

NEW ZEALAND DATA SHEET
Page 1 of 14
1.
PRODUCT NAME (strength pharmaceutical form)
Pethidine, Tablet, 50 mg (NOUMED) Pethidine, Tablet, 100 mg (NOUMED)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Name and strength of the active substance
Pethidine Hydrochloride 50 mg
Pethidine Hydrochloride 100 mg
Excipient(s) with known effect
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral – tablet
Presentation
Pethidine Hydrochloride 50 mg tablets are: round, white, normal
biconvex tablets, 8.0
mm diameter.
Pethidine Hydrochloride 100 mg Tablets are: round, white, normal
biconvex tablets,
9.5 mm diameter.
_Note: Not all product strengths may be marketed. _
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Pethidine Tablets given orally are indicated for the relief of most
types of moderate to
severe pain. As it has some antispasmodic activity, it may be the
analgesic of choice in
renal colic, biliary colic and acute pancreatitis.
4.2
Dose and method of administration
_Adults: _
For the relief of pain, Pethidine Tablets given in oral doses of 50 to
150 mg by mouth
every 4 hours if necessary.
_Children_:
For the relief of pain, 1.1 to 1.76 mg per kg of body weight, not to
exceed 100 mg
every 3 to 4 hours as needed. (See Section 4.4 Special Warnings and
Precautions for
use).
Opioid agonist analgesics may suppress respiration, especially in the
very young,
NEW ZEALAND DATA SHEET
Page 2 of 14
elderly, very ill or debilitated patients and those with respiratory
problems. Lower
doses may be required for these patients.
Neonates (see also Pharmacology section 5 and Use in Pregnancy section
4.6)
Excretion and metabolism of Pethidine in the neonate is reduced
compared with
adults. Safety has not been established in neonates and due to lack of
data, no dosage
regimen can be recommended.
Geriatric patients
Dose reduction to half normal adult dose is recommended in geriatric
patients (over
70 years).
Liver impairment
Dosage reduction and/or increased dosage intervals are recommended.
Renal impairment
Due t