Pentazocine 50mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Pentazocine hydrochloride

Available from:

DE Pharmaceuticals

ATC code:

N02AD01

INN (International Name):

Pentazocine hydrochloride

Dosage:

50mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

Schedule 3 (CD No Register Exempt Safe Custody)

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04070200

Patient Information leaflet

130x210 Leaflet Reel Fed Profile (BST)
Dimensions:
Component:
Date Sent:
Technologist: TECHNICALLY APPROVED
Pharmacode:
JDE No.:
Pentazocine, Capsules, 50 mg,
28s - UK
130x210 (Reel Fed)
50985581
Leaflet for Bottles
1951
RH
16-12-19
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GTIN 13
(Belgium & Slovenia):
[e-mail]
PENTAZOCINE HYDROCHLORIDE 50MG 28 CAPSULES PIL - UK
Black
Profile
BBBA7196
S.Anson
06.01.20
15.01.20
S.Anson
130 x 210
7pt
Accord Barnstaple
n/a
n/a
3
Version 6
12.12.2019
German GTIN 14
(incorporating PZN):
Cartons and label leaflets only
(labels only when specified)
PENTAZOCINE CAPSULES 50MG
(Pentazocine Hydrochloride)
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
_Continued over page_
_Continued top of next column_
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 CA

Summary of Product characteristics

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