Pentazocine 25mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Pentazocine hydrochloride

Available from:

Accord-UK Ltd

ATC code:

N02AD01

INN (International Name):

Pentazocine hydrochloride

Dosage:

25mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

Schedule 3 (CD No Register Exempt Safe Custody)

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04070200; GTIN: 5012617010476

Patient Information leaflet

260x210 Leaflet Reel Fed Bi Fold Profile (BST)
Dimensions:
Component:
Date Sent:
Technologist: TECHNICALLY APPROVED
Pharmacode:
JDE No.:
Pentazocine BP Tablets
25mg x 28 (UK)
260x210 (Reel Fed)
50995317
Leaflet for Bottle
2229
T. Hull
16/11/20
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PENTAZOCINE 25MG X 28 TABLETS PIL - UK
Black
Profile
BBBA9716
NM
20/11/2020
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
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 TABLETS ARE
AND WHAT THEY ARE USED FOR
2
WHAT YOU NEED TO KNOW BEFORE
YOU TAKE PENTAZOCINE TABLETS
3
HOW TO TAKE PENTAZOCINE TABLETS
4
POSSIBLE SIDE EFFECTS
5
HOW TO STORE PENTAZOCINE
TABLETS
6
CONTENTS OF THE PACK AND OTHER
INFORMATION
1
WHAT PENTAZOCINE TABLETS ARE
AND WHAT THEY ARE USED FOR
This medicine has been prescribed for you
for r

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
PENTAZOCINE TABLETS BP 25mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 25mg Pentazocine Hydrochloride BP.
Excipient(s) with known effect:
Each tablet contains
200.00mg
lactose
monohydrate
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
White uncoated tablets.
White, circular, biconvex uncoated tablets impressed “C” and the
identifying
letters “PZ” on one face.
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 initial dosage is two 25 mg tablets (50mg) every four hours
after
meals followed by 25mg to 100mg of pentozocine every three to four
hours.
_ _
_Elderly _
Since impaired renal or hepatic function is often associated with
ageing,
elderly patients may require smaller doses of pentazocine.
_ _
_Paediatric population _
_6-12 years:_ One 25mg tablet every three to four hours as necessary.
Pentazocine tablets are not recommended for children under 6 years of
age. No data are available.
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.
SPECIA