Anadol Capsule 50mg

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

TRAMADOL HYDROCHLORIDE

Available from:

MEDISPEC (M) SDN.BHD

INN (International Name):

TRAMADOL HYDROCHLORIDE

Units in package:

30 Capsule Capsules; 100 Capsule Capsules

Manufactured by:

SQUARE PHARMACEUTICALS LTD

Patient Information leaflet

ANADOL CAPSULE
Tramadol hydrochloride (50mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What Anadol is used for
2.
How Anadol works
3.
Before you use Anadol
4.
How to use Anadol
5.
While you are using it
6.
Side effects
7.
Storage and Disposal Anadol
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT ANADOL IS USED FOR
Anadol is used for the management of
moderate to severe pain.
HOW ANADOL WORKS
Anadol relieves pain by acting on
specific nerve cells of the spinal cord and
brain.
BEFORE YOU USE ANADOL
-
_When you must not use it _
Do not use Anadol:
-
if you are known hypersensitivity
towards tramadol or any of the
excipients.
-
if you are in acute poisoning with
alcohol, sleeping pills, pain
relievers, opioids or other
psychotropic medicines (medicines
that affect mood and emotions).
-
if you are also taking Monoamine
oxidase inhibitors (MAOIs) (certain
medicines used for treatment of
depression) or have taken them in
the last 14 days before treatment
with Anadol.
-
Anadol must not be used for narcotic
withdrawal treatment.
-
You are less than 12 years old
-
You have slow or shallow breathing,
or other breathing problem
-
You are pregnant
-
You are breastfeeding
_ _
_Pregnancy and lactation _
_ _
Do not take Anadol if you are pregnant,
trying to get pregnant or think you may
be pregnant.
Do not take Anadol if you are breast-
feeding. Ask your doctor or pharmacist
for advice before taking any medicine.
_ _
_ _
-
_Before you start to use it _
Tell your doctor or pharmacist:
-
if you think that you are addicted to
other pain relievers (opioids).
_ _
-
if you suffer from consciousness
disorders.
-
if you are in a state of shock;
-
if you suffer from increased pressure
in the brain (possibly after a head
injury or brain disease).
-
if you have a tendency towards
epilepsy.
-
if you are experiencing minor pain.
-
_Taking other medicines _
Tell your doctor if you are taking any
other medicines, including any that you
buy
without
a
prescrip

Summary of Product characteristics

1. NAME OF THE MEDICINAL PRODUCT
ANADOL
®
CAPSULE.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains Tramadol hydrochloride 50 mg.
3. PHARMACEUTICAL FORM
Hard gelatin capsule filled with white granular powder having a green
(Pantone 331C) color cap and white
color body imprinted 'Square' on both parts.
4. CLINICAL PARTICULARS
_4.1 THERAPEUTIC INDICATIONS_
Treatment of moderate to severe pain
_4.2 POSOLOGY AND METHOD OF ADMINISTRATION_
The basis of dose adjustment is the intensity of the pain and the
sensitivity of the individual patient.
Unless otherwise prescribed, Anadol should be administered as follows:
Adults and adolescents (12 years and older)
Oral administration
Anadol is not approved for use in patients below 12 years old.
Acute Pain: An initial dose of 100mg is usually necessary. This can be
followed by doses of 50 or 100mg not
more frequently than 4 hourly, 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.
The lowest analgesically effective dose should generally be selected.
Daily doses of 400 mg active
substance should not be exceeded, except in special clinical
circumstances.
The capsules are to be taken whole, not divided or chewed, with
sufficient liquid, independent of meals.
Anadol should under no circumstances be administered for longer than
absolutely necessary. If long-term
pain treatment with Anadol 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.
Paediatric population
The safety and efficacy of Anadol has not been studied in the
paediatric population. Therefore, use of Anadol
is not recommended in patients under 12 years of age.
Geriatric