Bidol (Tramadol Hydrochloride 37.5mg and Paracetamol 325 mg tablets)

Šalis: Malaizija

kalba: anglų

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

Veiklioji medžiaga:

Paracetamol; TRAMADOL HYDROCHLORIDE

Prieinama:

HEALOL PHARMACEUTICALS SDN. BHD.

INN (Tarptautinis Pavadinimas):

Paracetamol; TRAMADOL HYDROCHLORIDE

Vienetai pakuotėje:

3 x 10 Tablets; 10tablet Tablets; 10 x 10 Tablets; 3 x 10 Tablets; 10 x 10 Tablets

Pagaminta:

M/S MICRO LABS LIMITED

Pakuotės lapelis

BIDOL
_Consumer Medication Information Leaflet (RiMUP)_
(Tramadol Hydrochloride 37.5mg and Paracetamol 325mg Tablets)
1
WHAT IS IN THIS LEAFLET
1.
What BIDOL is used for
2.
How BIDOL works
3.
Before you use BIDOL
4.
How to use BIDOL
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of BIDOL
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT IS BIDOL USED FOR
BIDOL tablets are used to treat
moderate to severe pain when your
doctor recommends that a
combination of tramadol
hydrochloride and paracetamol is
needed.
HOW BIDOL WORKS
BIDOL tablets contain two different
medicines called Tramadol and
Paracetamol. Tramadol is an opioid
analgesic that acts on the central
nervous system. The other active
component (Paracetamol) analgesic
properties of paracetamol may
involve central and peripheral
effects.
BEFORE YOU USE BIDOL
-When you must not use it

If you are hypersensitive or
have had an allergic
reaction (for instance skin
rash, swelling of the face,
wheezing or difficulty
breathing) to tramadol,
paracetamol or any of the
other ingredients in BIDOL

In cases of acute alcohol
poisoning

If you are taking sleeping
pills, pain relievers or
medicines that affect mood
and emotions

If you are also taking
medicines called
monoamine oxidase
inhibitors (MAOIs) or have
taken MAOIs in the last 14
days before treatment with
BIDOL tablets. MAOIs are
used in the treatment of
depression or Parkinson’s
disease

If you have a severe liver
disorder

If you have epilepsy that is
not adequately controlled by
your current medicine

If you are less than 12 years
old

If you have slow or shallow
breathing, or other breathing
problems

If you are pregnant

If you are breastfeeding
Do not take BIDOL tablets if any of
the above applies to you. If you are
not sure, talk to your doctor or
pharmacist before taking BIDOL
tablets.
-Before you start to use it
Talk to your doctor or pharmacist
before taking this medicine if you:

Take other medicines
con

Prekės savybės

_Cytochromes P450 (CYP) 2D6 Ultra Rapid Metabolism_
Some individuals may be CYP2D6 ultra-rapid metabolisers. These
individuals convert tramadol more rapidly than other people into its
more
potent opioid metabolites O-desmethyltramadol (M1). This rapid
conversion
could result in higher than expected opioid-like side effects
including life-
threatening respiratory depression. The prevalence of this CYP2D6
phenotype varies widely and has been estimated at 0.5 to 1% in
Chinese,
Japanese and Hispanics, 1 to 10% in Caucasians, 3% in African
Americans,
and 16-28% in North Africans, Ethiopians and Arabs. Data are not
available
for other ethnic groups.
Tramadol hydrochloride and Paracetamol tablets should be used with
caution in opioid dependent patients, or in patients with cranial
trauma, in
patients prone to convulsive disorder, biliary tract disorders, in a
state of
shock, in an altered state of consciousness for unknown reasons, with
problems affecting the respiratory centre or the respiratory function,
or with
an increased intracranial pressure.
Paracetamol in over dosage may cause hepatic toxicity in some
patients.
At therapeutic doses, tramadol has the potential to cause withdrawal
symptoms. Rarely, cases of dependence and abuse have been reported.
Symptoms of withdrawal reactions, similar to those occurring during
opiate
withdrawal may occur.
In one study, use of tramadol during general anaesthesia with
enflurane and
nitrous oxide was reported to enhance intra-operative recall. Until
further
information is available, use of tramadol during light planes of
anaesthesia
should be avoided.
_Respiratory Depression: _Administer Bidol Tablet cautiously in
patients at risk
for respiratory depression, including patients with substantially
decreased
respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory
depression, as in these patients, even therapeutic doses of Bidol
Tablet may
decrease respiratory drive to the point of apnea. In these patients,
alternative
non-opioid analgesics should be considered. When