Zamadol SR 50mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Tramadol hydrochloride

Available from:

Mawdsley-Brooks & Company Ltd

ATC code:

N02AX02

INN (International Name):

Tramadol hydrochloride

Dosage:

50mg

Pharmaceutical form:

Modified-release 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

PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER
ZAMADOL
® SR 50MG PROLONGED-RELEASE HARD CAPSULES
(TRAMADOL HYDROCHLORIDE)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.

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. Do not pass it on to
others.
It may harm them, even if their symptoms are the same as yours.

If any of the side effects get serious, or if you notice any side
effects
not listed in this leaflet, please tell your doctor or pharmacist.

Zamadol
®
SR 50mg prolonged-release hard capsules are also
available in other strengths.

The name of this medicine is Zamadol
®
SR 50mg prolonged-release
hard capsules but will be referred to as Zamadol SR prolonged-release
hard capsules throughout the remainder of this leaflet.
IN THIS LEAFLET:
1) What Zamadol SR prolonged-release hard capsules is and what it
is used for
2) Before you take Zamadol SR prolonged-release hard capsules
3) How to take Zamadol SR prolonged-release hard capsules
4) Possible side effects
5) How to store Zamadol SR prolonged-release hard capsules
6) Further information
1) WHAT ZAMADOL SR PROLONGED-RELEASE HARD
CAPSULES IS AND WHAT IT IS USED FOR
Zamadol SR prolonged-release hard capsules belongs to a group of
medicines called analgesics, commonly known as pain killers or pain
relievers. The active substance, tramadol hydrochloride, interrupts
the
pain messages being sent to your brain, and it also acts in your brain
to
stop pain messages from being felt. This means that Zamadol SR
prolonged-release hard capsules does not stop the pain from happening,
but you will not be able to feel the pain as much.
Zamadol SR prolonged-release hard capsules is used to relieve
moderate to severe pain. (for example pain after an operation, or
after an
injury).
2) BEFORE YOU TAKE ZAMADOL SR PROLONGED-RELEASE
HARD CAPSULES
DO NOT TAKE ZAMADOL SR PROLONGED-RELEASE HARD CAPSULES:

if you are al

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Zamadol SR 50 mg prolonged-release hard capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
One capsule contains 50 mg of tramadol hydrochloride
This product contains the excipients sucrose (9.375 mg/capsule).
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Prolonged release hard capsule
The 50 mg capsules are dark green of about 14 – 14.5 mm, marked
T50SR.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of moderate to severe pain.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The capsules are intended for twice daily oral administration and can
be taken
independently of meal times, swallowed whole with water.
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.
_Adults:_
The usual initial dose is 50-100 mg twice daily, morning and evening.
This
dose may be titrated up to 150-200 mg twice daily according to pain
severity.
If long-term pain treatment with tramadol is necessary in view of the
nature and
severity of the illness, then careful and regular monitoring should be
carried out (if
necessary with breaks in treatment) to establish whether and to what
extent further
treatment is necessary.
A total oral daily dose of 400 mg should not be exceeded except in
special
clinical circumstances.
_Elderly 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
Zamadol
SR prolonged-release capsules is delayed. In these patients
prolongation of
the dosage intervals should be carefully considered according to the
patient’s
requirem