PONSTAN TABLET 500MG

Country: Малезија

Језик: Енглески

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

Активни састојак:

MEFENAMIC ACID

Доступно од:

PFIZER (MALAYSIA) SDN. BHD.

INN (Међународно име):

MEFENAMIC ACID

Јединице у пакету:

500Tablet Tablets

Произведен од:

Pt. Pfizer Indonesia

Информативни летак

Pfizer Confidential
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
PONSTAN
®
TABLET
Mefenamic Acid (500 mg)
PLD Title
: Mefenamic Acid (PONSTAN)
PLD Date
: 25 September 2020
Country
: Malaysia
Reference Document
: Malaysia CLD dated 20 January 2020
Reason for change
: PfLEET Number 2020-0060076 (S2) - To update as per new effective CLD
dated 20
January 2020
: To update serial number
Pfizer Confidential
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
PONSTAN
®
TABLET
Mefenamic Acid (500 mg)
1
WHAT IS IN THIS LEAFLET
1.
What Ponstan is used for
2.
How Ponstan works
3.
Before you use Ponstan
4.
How to use Ponstan
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Ponstan
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
11.
Serial Number
WHAT PONSTAN IS USED FOR
Ponstan is used to relieve:

Pain due to rheumatoid arthritis
including Still's Disease,

Pain due to osteoarthritis,

Muscle pain,

Trauma-related pain,

Pain after injury,

Toothaches,

Headaches,

Pain following an operation,

Pain after childbirth,

Painful menstruation
(dysmenorrhea),

Fever in children over 6 months
of age.

It is used to treat pre-menstrual
syndrome and also abnormally
heavy bleeding due to
dysfunctional causes or the
presence of an intrauterine device
(IUD)
HOW PONSTAN WORKS
Ponstan contains the active substance
mefenamic acid which belongs to a
group of medicines called non-
steroidal anti-inflammatory drugs
(NSAIDs). These medicines reduce
pain (analgesic) and swelling, (anti-
inflammatory) and brings down fever
(antipyretic)
BEFORE YOU USE PONSTAN
-
_When you must not use it_
Do not take Ponstan if:
- you are allergic (hypersensitive)
to mefenamic acid or any of the
other ingredients of this
medicine;
- you show any signs of allergy
(such as asthma, hay fever or
hives) to aspirin or other
NSAIDs. An allergic reaction
may include swelling of the face,
lips, mouth, tongue or throat
which may cause difficulty in
swallowing or breath

Карактеристике производа

Pfizer Confidential
1
PONSTAN
MEFENAMIC ACID
1.0
NAME OF THE MEDICINAL PRODUCT
PONSTAN
2.0
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredient: Mefenamic acid
Mefenamic acid is available as:
Coated Tablets containing 500 mg mefenamic acid
3.0
PHARMACEUTICAL FORM
Elliptical, smooth, yellow film coated tablets, embossed with 'P-D'
logo on one side
and bisected line on the other side.
4.0
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Mefenamic acid is indicated for:
1) The symptomatic relief of RHEUMATOID ARTHRITIS (including STILL'S
DISEASE),
OSTEOARTHRITIS, and PAIN including muscular, traumatic and dental
pain, headaches
of most etiology, post-operative and postpartum pain
2) The symptomatic relief of PRIMARY DYSMENORRHEA
3) MENORRHAGIA due to dysfunctional causes or the presence of an
intrauterine
device (IUD) when organic pelvic pathology has been excluded
4) Premenstrual syndrome
5) The relief of PYREXIA IN PEDIATRIC PATIENTS OVER 6 MONTHS OF AGE
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Undesirable effects may be minimized by using the minimum effective
dose for the
shortest duration necessary to control symptoms.
The oral dosage form of mefenamic acid may be taken with food if
gastrointestinal
upset occurs.
_Mild to moderate pain/rheumatoid arthritis/osteoarthritis in adults
and adolescents _
_over 14 years of age_: 500 mg three times daily.
Pfizer Confidential
2
_Dysmenorrhea_: 500 mg three times daily, to be administered at the
onset of
menstrual pain and continued while symptoms persist according to the
judgement
of the physician.
_Menorrhagia:_ 500 mg three times daily, starting with the onset of
bleeding and
associated symptoms and continued according to the judgement of the
physician.
_Premenstrual syndrome_: 500 mg three times daily, starting with the
onset of
symptoms and continued until the anticipated cessation of symptoms
according to
the judgement of the physician.
_For Still's Disease or antipyretic action in infants and children
over 6 months to 14 _
_years:_ 19.5 mg/kg to 25 mg/kg of