Pentazocine 50mg capsules

国家: 英国

语言: 英文

来源: MHRA (Medicines & Healthcare Products Regulatory Agency)

有效成分:

Pentazocine hydrochloride

可用日期:

Accord-UK Ltd

ATC代码:

N02AD01

INN（国际名称）:

Pentazocine hydrochloride

剂量:

50mg

药物剂型:

Oral capsule

给药途径:

Oral

类:

Schedule 3 (CD No Register Exempt Safe Custody)

处方类型:

Valid as a prescribable product

產品總結:

BNF: 04070200; GTIN: 5012617010483

资料单张

260x210 Leaflet Reel Fed Bi Fold Profile (BST)
Dimensions:
Component:
Date Sent:
Technologist: TECHNICALLY APPROVED
Pharmacode:
JDE No.:
Pentazocine BP Capsules
50mg x 28 (UK)
260x210 (Reel Fed)
50995350
Leaflet for Bottle
2142
T. Hull
16/11/20
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PENTAZOCINE 50MG X 28 CAPSULES PIL - UK
Black
Profile
BBBA9717
NM
23/11/2020
17/12/2020
NM
260x210mm
7 pts
Accord Barnstaple
N/A
04
Version 7
12.02.2020
Cartons and label leaflets only
(labels only when specified)
page 1
page 4
50995350 BBBA9717
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PENTAZOCINE 50MG CAPSULES
(Pentazocine Hydrochloride)
THIS MEDICINE CONTAINS PENTAZOCINE
HYDROCHLORIDE WHICH IS AN OPIOID,
WHICH CAN CAUSE ADDICTION. YOU CAN
GET WITHDRAWAL SYMPTOMS IF YOU STOP
TAKING IT SUDDENLY.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE
YOU START TAKING 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 only. Do not pass it on to others. It
may harm them, even if their signs of
illness 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 PENTAZOCINE CAPSULES ARE
AND WHAT THEY ARE USED FOR
2
WHAT YOU NEED TO KNOW BEFORE
YOU TAKE PENTAZOCINE CAPSULES
3
HOW TO TAKE PENTAZOCINE
CAPSULES
4
POSSIBLE SIDE EFFECTS
5
HOW TO STORE PENTAZOCINE
CAPSULES
6
CONTENTS OF THE PACK AND

产品特点

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Pentazocine Capsules BP 50mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 50mg Pentazocine Hydrochloride BP.
Excipient(s) with known effect: Each capsule contains 83.50mg lactose
monohydrate
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Orange and grey, hard gelatin capsules printed “C” and the
identifying letters
“NT” in white.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the relief of moderate to severe pain
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Prior to starting treatment with opioids, a discussion should be held
with
patients to put in place a strategy for ending treatment with
pentazocine
hydrochloride in order to minimise the risk of addiction and drug
withdrawal
syndrome (see section 4.4).
Posology
The dosage is usually tailored to the individual patient and to the
severity of
the pain.
_Adults_
The usual recommended dosage is one to two 50mg capsules every three
to
four hours after meals. The maximum daily dose is 600mg.
_ _
_Elderly_
Since impaired renal or hepatic function is often associated with
ageing,
elderly patients may require smaller doses of pentazocine.
_ _
_Paediatric population _
Not recommended for children under 12 years of age.
Method of administration
For oral use
4.3
CONTRAINDICATIONS
- Hypersensitivity to the active substance or to any of the excipients
listed in section
6.1.
- Pentazocine should not be administered to patients with established
respiratory
depression, especially in the presence of cyanosis and excessive
bronchial secretion
- Acute alcoholism
- Acute bronchial asthma
- Heart failure secondary to chronic lung disease
- Porphyria
- Raised intracranial pressure, head injuries or pathological brain
conditions where
clouding of the sensorium is undesirable
4.4.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Pentozocine can both depress as well as elevate blood pressure
possibly through the
release of endogenous catecholamines. Particular caution sh