ACTIMOL SUSPENSION 250MG5ML

Nchi: Malesia

Lugha: Kiingereza

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

Viambatanisho vya kazi:

Paracetamol

Inapatikana kutoka:

IDAMAN PHARMA MANUFACTURING SDN BHD

INN (Jina la Kimataifa):

Paracetamol

Vitengo katika mfuko:

60 ml; 60 ml; 60 ml

Viwandani na:

IDAMAN PHARMA MANUFACTURING SDN BHD

Taarifa za kipeperushi

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
ACTIMOL SUSPENSION 250MG/5ML
_ _
Paracetamol (250mg/5ml)
Page 1 of 3
WHAT IS IN THIS LEAFLET
1.
What ActiMol Suspension is
used for
2.
How ActiMol Suspension works
3.
Before you use ActiMol
Suspension
4.
How to use ActiMol Suspension
5.
While you are using ActiMol
Suspension
6.
Side effects
7.
Storage and disposal of ActiMol
Suspension
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT ACTIMOL SUSPENSION IS USED
FOR
ActiMol Suspension is used for the
relief of fever including fever after
vaccination,
additionally
to
treat
headache and symptoms of cold and
flu. Besides that, it also reduces pain
of
toothache
and
discomfort
of
teething.
HOW ACTIMOL SUSPENSION WORKS
ActiMol
Suspension
works
as
analgesic (pain relief) and antipyretic
(anti-fever)
with
minimal
anti-
inflammatory properties.
BEFORE YOU USE ACTIMOL SUSPENSION
_ _
_ _
_ _
_ _
_ _
ALLERGY ALERT:
Paracetamol may cause
severe skin reactions. Symptom may
include
skin
reddening,
blisters
or
rash. These could be signs of a serious
condition.
If
these
reactions
occur,
stop use and seek medical assistance
right away.
_- When you must not use it _
You must not take this medicine and
should
talk
to
your
doctor
or
pharmacist if:
• You are allergic to Paracetamol or to
other ingredients in it.
• You are not sure whether you should
start taking this medicine.
_ _
_- Before you start to use it _
Tell your doctor if:
• You have allergies to Paracetamol
• You have kidney or liver problem.
ActiMol Suspension should be given
with care to patients with impaired
kidney
or
liver
function.
ActiMol
Suspension should also be given with
care to patients taking other drugs that
affect the liver.
_Pregnancy and lactation _
This product is intended to be used in
children.
Talk to your doctor or your pharmacist
before taking this medicine if you are
pregnant,
thinking
of
becoming
pregnant or are breastfeeding.
_- Taking other medicines _
Tell your doctor or p

Tabia za bidhaa

ACTIMOL SUSPENSION 250MG/5ML
PRODUCT DESCRIPTION
An orange suspension with a mentholated sweet and sour
orange taste.
COMPOSITION
Each 5ml contains:
• Active Ingredient: Paracetamol 250 mg
• Preservatives: Methylparaben 9 mg and Propylparaben 1 mg
PHARMACODYNAMICS
ATC Code: N02 BE01.
Pharmacotherapeutic group: Other Analgesics and Antipyretics
(Anilides).
Mechanism of Action
Paracetamol is an analgesic and antipyretic. Its mechanism of
action
is
believed
to
include
inhibition
of
prostaglandin
synthesis, primarily within the central nervous system.
Pharmacodynamic effects
The lack of peripheral prostaglandin inhibition confers important
pharmacological properties such as the maintenance of the
protective prostaglandins within the gastrointestinal tract.
Paracetamol is, therefore, particularly suitable for: patients with
a history of disease or patients taking concomitant medication,
where peripheral prostaglandin inhibition would be undesirable
(such as, for example, those with a history of gastrointestinal
bleeding or the elderly).
PHARMACOKINETICS
Absorption
Paracetamol is rapidly and almost completely absorbed from
the gastrointestinal tract.
Distribution
Binding
to
plasma
proteins
is
minimal
at
therapeutic
concentrations.
Metabolism
Paracetamol is metabolized in the liver and excreted in the urine
mainly as glucuronide and sulfate conjugates.
Elimination
Less than 5% is excreted as unchanged paracetamol.
INDICATIONS
ActiMol Suspension 250mg/5ml is used for the relief of:
• Fever
• Headache and symptoms of cold and flu
• Toothache and discomfort of teething
• Fever after vaccination
SYSTEM
ORGAN CLASS
FREQUENCY
PROLONGED
USAGE OR
OVERDOSAGE
SIGNIFICANT
RARE
POTENTIALLY
FATAL
NOT KNOWN
Gastrointestinal
disorders
Nervous
system
disorders
Blood and
lymphatic
disorders
Skin and
subcutaneous
tissue
Angioedema
Thrombocytopenia,
Leukopenia,
Neutropenia,
Pancytopenia,
Methaemoglobi
naemia,
Agranulocytosis
Acute renal
tubular
necrosis
Hepatotoxicity
Hepatic
necrosis
Nephrotoxicity
Hypersensitivity
reactions