Zamadol SR 50mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Tramadol hydrochloride

Available from:

Viatris UK Healthcare 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; GTIN: 5060035240173

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
Zamadol
®
Capsules 50mg
active substance: tramadol hydrochloride
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 as 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 Zamadol is and what it is used for
2. What you need to know before you take Zamadol
3. How to take Zamadol
4. Possible side effects
5. How to store Zamadol
6. Contents of the pack and other information
1. What Zamadol is and what it is used for
The name of your medicine is Zamadol
®
Capsules 50 mg
(referred to as a Zamadol throughout this leaflet).
Zamadol 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 does not stop the pain from happening, but
you will not be able to feel the pain as much.
Zamadol is used to relieve moderate to severe, a sudden or
a long-standing pain (for example pain after an operation,
or after an injury) in adults and adolescents aged 12 years
and older.
2. What you need to know before you take Zamadol
Do not take Zamadol if:
•
you are allergic to tramadol hydrochloride or to any of
the other ingredients of this medicine (listed in section 6),
resulting in a skin rash, swelling of face or difficulty in
breathing.
•
you are taking, or you have taken in the last two weeks,
monoamine oxidase inhibitors (MAOIs) to treat your
de
pression (see section 2, “Other me

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Zamadol® Capsules 50 mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Zamadol capsule contains 50 mg of tramadol hydrochloride.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Hard gelatin capsules.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment and prevention of moderate to severe pain.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dose of Zamadol Capsules 50 mg 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 aged 12 years and older is_:
For acute pain - an initial dose of 100 mg is usually necessary. This
can be followed
by doses of 50 mg or 100 mg not more frequently than 4 hourly, and
duration of
therapy should be matched to clinical need.
For pain associated with chronic conditions -use in an initial dose of
50 mg 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)
A total oral daily dose of 400 mg should not be exceeded except in
special clinical
circumstances.
_Paediatric population _
Zamadol Capsules 50 mg should not be taken by children under 12 years
of
age, since safety and efficacy have not been established.
_Elderly patients_:
A dose adjustment is usually 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.
_Patients with renal or hepatic impairment_:
In patients with renal and/or hepatic insufficiency the elimination of
Zamadol
50 mg capsules is delayed. In these patients prolongation of the
dosage
intervals should be carefully considered accord