Zamadol SR 200mg capsules

Riik: Suurbritannia

keel: inglise

Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)

Toimeaine:

Tramadol hydrochloride

Saadav alates:

CST Pharma Ltd

ATC kood:

N02AX02

INN (Rahvusvaheline Nimetus):

Tramadol hydrochloride

Annus:

200mg

Ravimvorm:

Modified-release capsule

Manustamisviis:

Oral

Klass:

Schedule 3 (CD No Register Exempt Safe Custody)

Retsepti tüüp:

Valid as a prescribable product

Toote kokkuvõte:

BNF: 04070200; GTIN: 5055946801506

Infovoldik

ZAMADOL SR 200MG PROLONGED-RELEASE HARD CAPSULES
(tramadol hydrochloride)
PATIENT INFORMATION LEAFLET
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE,
BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
*
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.
*
Keep this leaflet. You may need to read it again.
*
If you have any further questions, ask your doctor or pharmacist.
*
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.
Your medicine is called Zamadol SR 200mg prolonged-release hard
capsules and will be referred to as Zamadol SR prolonged-release hard
capsules throughout the rest of this leaflet. Please note that the
leaflet also
contains information about other strengths of the medicine, Zamadol SR
50mg prolonged-release hard capsules, Zamadol SR 100mg
prolonged-release hard capsules and Zamadol SR 150mg prolonged-release
hard capsules.
WHAT IS IN THIS LEAFLET:
What Zamadol SR prolonged-release hard capsules is and what it is
used for
What you need to know before you take Zamadol SR
prolonged-release hard capsules
How to take Zamadol SR prolonged-release hard capsules
Possible side effects
How to store Zamadol SR prolonged-release hard capsules
Contents of the pack and other information
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

Toote omadused

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Zamadol SR 200 mg prolonged-release hard capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
One capsule contains 200mg of tramadol hydrochloride
Excipients with known effect
This product contains sucrose (37.5 mg/capsule).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Prolonged release hard capsule
The 200 mg capsules are yellow of about 19 – 19.5 mm, marked T200SR
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment 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.
_Dosage for adults and adolescents from 12 years of age: _
The usual initial dose is 50-100 mg twice daily, in the morning and in
the evening.
This dose may be titrated up to 150-200 mg twice daily according to
pain severity.
If long-term pain treatment with tramadol hydrochloride 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.
_Paediatric population: _
Zamadol SR prolonged-release hard capsules should not be used in
children under 12
years of age since safety and efficacy have not been established.
_Elderly patients:_
A dose adjustment is usually not necessary in patients up to 75 years
of age without
clinically manifest hepatic or renal insufficiency. In elderly
patients over 75 years of
age 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-