Tramadol 50mg capsules

Страна: Велика Британія

мова: англійська

Джерело: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активний інгредієнт:

Tramadol hydrochloride

Доступна з:

Genus Pharmaceuticals Ltd

Код атс:

N02AX02

ІПН (Міжнародна Ім'я):

Tramadol hydrochloride

Дозування:

50mg

Фармацевтична форма:

Oral capsule

Адміністрація маршрут:

Oral

Клас:

Schedule 3 (CD No Register Exempt Safe Custody)

Тип рецепту:

Valid as a prescribable product

Огляд продуктів:

BNF: 04070200

інформаційний буклет

350x210 Leaflet Reel Fed Profile Landscape (BST)
Dimensions:
Component:
Date Sent:
Technologist: TECHNICALLY APPROVED
Pharmacode:
JDE No.:
Tramadol Hydrochloride Capsules
50mg x 30, 100 (UK)
350x210 (Reel Fed)
50988803
Leaflet for Blisters
3737
T. Hull
28/02/20
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TRAMADOL 50MG CAPSULES BLISTER PACK PIL - UK
Black
Profile
BBBA7635
NM
02/03/2020
22/04/2020
NM
350 x 210 (Reel Fed)
9 pts
Accord Barnstaple
NA
05
Version 7
12.02.2020
German GTIN 14
(incorporating PZN):
NA
Cartons and label leaflets only
(labels only when specified)
page 1
page 4
50988803 BBBA7635
THIS MEDICINE CONTAINS TRAMADOL 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,
pharmacist or nurse.
•
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,
pharmacist or nurse. This includes any possible side
effects not listed in the leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1 WHAT TRAMADOL CAPSULES ARE AND WHAT THEY
ARE USED FOR
2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE
TRAMADOL CAPSULES
3 HOW TO TAKE TRAMADOL CAPSULES
4 POSSIBLE SIDE EFFECTS
5 HOW TO STORE TRAMADOL CAPSULES
6 CONTENTS OF THE PACK AND OTHER INFORMATION
1 WHAT TRAMA

Характеристики продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Tramadol Hydrochloride Capsules 50mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains Tramadol hydrochloride 50mg.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Capsule, hard.
Olive/Yellow capsule shell, imprinted‘TRM’ on the cap and ‘50’
on the body
containing white powder.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Management (treatment and prevention) of moderate to severe pain.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dose should be adjusted to the intensity of the pain and the
sensitivity of
the individual patient. The lowest effective dose for analgesia should
generally
be selected. The total daily dose of 400mg active substance should not
be
exceeded, except in special circumstances.
Unless otherwise prescribed Tramadol Capsules should be administered
as
follows:
Adults and adolescents aged 12 years and over:
Acute pain: An initial dose of 100mg is usually necessary. This can be
followed by doses of 50 mg or 100 mg at 4- 6 hourly intervals, and
duration of
therapy should be matched to clinical need.
Pain associated with chronic conditions:
Use an initial dose of 50mg and then titrate dose according to pain
severity.
The need for continued treatment should be assessed at regular
intervals as
withdrawal symptoms and dependence have been reported, although rarely
(_See section 4.4_).
Geriatric patients
A dose adjustment is not usually necessary in patients up to 75 years
without
clinically manifest hepatic or renal insufficiency. In elderly
patients over 75
years elimination may be prolonged. Therefore, if necessary the dosage
interval is to be extended according to the patient's requirements.
Renal insufficiency/dialysis and hepatic impairment
In patients with renal and/or hepatic insufficiency the elimination of
tramadol
is delayed. In these patients prolongation of the dosage intervals
should be
carefully considered according to the patient's requirements.
Children:
Tra