Dolofast Sachets 50mg Powder for Oral Solution

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

DICLOFENAC POTASSIUM

Boleh didapati daripada:

DKSH MALAYSIA SDN. BHD.

INN (Nama Antarabangsa):

DICLOFENAC POTASSIUM

Unit dalam pakej:

9 Sachets

Dikeluarkan oleh:

MIPHARM S.P.A.

Risalah maklumat

DOLOFAST
®
SACHETS 50MG POWDER FOR ORAL SOLUTION
Diclofenac Potassium (50mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What Dolofast is used for
2.
How Dolofast works
3.
Before you use Dolofast
4.
How to use Dolofast
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Dolofast
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT DOLOFAST
IS USED FOR
In
migraine
attacks,
Dolofast
is
effective in relieving the headache as
well as in improving the accompanying
symptoms such as nausea and vomiting.
Dolofast
can
be
used
for
short-term
treatment of the following conditions:
Sprains, strains, or other injuries.
Pain and swelling after surgery.
Painful menstrual periods.
Migraine attacks.
Infections of the ear, nose or throat.
HOW DOLOFAST WORKS
Dolofast
belongs
to
a
group
of
medicines
called
“non-steroidal
anti-
inflammatory drugs” (NSAIDs), which
are used to treat pain and inflammation.
Dolofast
relieves
the
symptoms
of
inflammation,
such
as
pain
and
swelling, and also reduces fever. It has
no effect on the causes of inflammation
or fever.
If you have any questions about how
Dolofast works or why this medicine
has been prescribed to you, ask your
doctor.
BEFORE YOU USE DOLOFAST
-
_When you must not use it _
Follow all instructions given to you by
your
doctor
or
pharmacist
carefully,
even
if
they
differ
from
the
general
information contained in this leaflet.
DO NOT TAKE DOLOFAST
IF YOU ARE
allergic to diclofenac or to
any of the other ingredients of Dolofast
listed in Section Product Description of
this leaflet.
If
you
have
ever
had
an
allergic
reaction after taking medicines to treat
inflammation
or
pain
(e.g.
acetylsalicylic acid/aspirin, (diclofenac
or ibuprofen). Reactions may include
asthma,
runny
nose,
skin
rash,
face
swelling.
If
you
think
you
may
be
allergic, ask your doctor for advice.
If you
have
stomach or
intestinal
ulcer.
If
you
have
or
previously
had
gastrointestinal bleeding, symptoms o

Ciri produk

1
1. NAME OF THE MEDICINAL PRODUCT
Dolofast Sachets 50mg Powder for Oral Solution.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
The
active
ingredient
is
potassium
[o-[(2,6-dichlorophenyl)-amino]-phenyl-acetate
(diclofenac
potassium).
One sachet contains 50 mg of diclofenac potassium.
One sachet also contains 50mg aspartame (E951).
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Powder for oral solution.
White to light yellow powder for oral solution.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Short-term treatment of all grades of pain and inflammation in the
following acute conditions:
-
Postoperative inflammation and pain, e.g. following orthopaedic or
dental procedures.
-
Painful post-traumatic inflammatory conditions, e.g. sprains.
-
Inflammatory and/or painful gynaecological conditions, e.g. primary
dysmenorrhoea or adnexitis.
-
Migraine attacks with or without aura.
-
As a coadjuvant treatment for severe painful and inflammatory
infections of the ears, nose or
throat, e.g. pharyngotonsillitis, otitis.
-
Painful spinal cord syndromes.
-
Rheumatoid arthritis.
-
In line with the general principals of medicine, appropriate
therapeutic measures should be taken
to treat the underlying disease. Fever alone is not an indication.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
DOSAGE
As a general recommendation, the dose should be individually adjusted.
Adverse effects may be
minimized by using the lowest effective dose for the shortest duration
necessary to control symptoms
(see section 4.4 Special warnings and precautions for use).
ESTABLISHED
CARDIOVASCULAR
DISEASE
OR
SIGNIFICANT
CARDIOVASCULAR
RISK
FACTORS
Treatment with diclofenac is generally not recommended in patients
with established cardiovascular
disease or uncontrolled hypertension. If needed, patients with
established cardiovascular disease,
uncontrolled hypertension or significant risk factors for
cardiovascular disease should be treated with
Dolofast only after careful consideration and only at doses
≤
100 mg daily if treated