Tramadol 50mg capsules

Ország: Egyesült Királyság

Nyelv: angol

Forrás: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktív összetevők:

Tramadol hydrochloride

Beszerezhető a:

NorthStar Healthcare Unlimited Company

ATC-kód:

N02AX02

INN (nemzetközi neve):

Tramadol hydrochloride

Adagolás:

50mg

Gyógyszerészeti forma:

Oral capsule

Az alkalmazás módja:

Oral

Osztály:

Schedule 3 (CD No Register Exempt Safe Custody)

Recept típusa:

Valid as a prescribable product

Termék összefoglaló:

BNF: 04070200; GTIN: 5051089990657 5051089990664

Betegtájékoztató

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

Termékjellemzők

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Tramadol Hydrochloride 50mg Capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 50 mg tramadol hydrochloride (equivalent to 43.9
mg of
tramadol base)
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Capsule
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Tramadol capsules are indicated for the management (treatment and
prevention) of
moderate to severe pain.
_4.2 _
_POSOLOGY AND METHOD OF ADMINISTRATION _
Posology
As with all analgesic drugs, 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. A total daily oral dose of 400 mg should not be exceeded,
except in special
circumstances.
Unless otherwise prescribed, tramadol should be administered as
follows:
Adults and children aged 12 years and over
_Acute pain: _
An initial dose of 100 mg is usually necessary. This can be followed
by doses of 50 or 100
mg at 4 – 6 hourly, intervals, and the duration of treatment should
be matched to clinical
need (see section 5.1).
_Pain associated with Chronic Conditions: _
An initial dose of 50 mg is advised 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 (see section 4.4).
Paediatric population
Tramadol capsules are not suitable for children below the age of 12
years.
Older people
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 requirement.
_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 int