Areston 12.5mg film-coated tablets

Country: মাল্টা

ভাষা: ইংরেজি

সূত্র: Medicines Authority

সক্রিয় উপাদান:

DICLOFENAC POTASSIUM

থেকে পাওয়া:

Medochemie Limited 1-10 Constantinoupleos Street, 3011 Limassol, Cyprus

এটিসি কোড:

M01AB05

INN (International Name):

DICLOFENAC POTASSIUM 12.5 mg

ফার্মাসিউটিকাল ফর্ম:

FILM-COATED TABLET

রচনা:

DICLOFENAC POTASSIUM 12.5 mg

প্রেসক্রিপশন টাইপ:

POM

Therapeutic area:

ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS

অনুমোদন অবস্থা:

Authorised

অনুমোদন তারিখ:

2018-11-09

তথ্য লিফলেট

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ARESTON 12.5MG FILM-COATED TABLETS
Diclofenac potassium
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even
if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Areston is and what it is used for
2.
What you need to know before you take Areston
3.
How to take Areston
4.
Possible side effects
5.
How to store Areston
6.
Contents of the pack and other information
1.
WHAT ARESTON IS AND WHAT IT IS USED FOR
Areston is a painkiller, which also reduce inflammation (swelling) and
lower body temperature
Areston is used in the treatment of rheumatic pain, muscular pain,
headache, dental pain, menstrual pain,
acute lower back pain, pain and fever associated with the flu, sore
throat and colds.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ARESTON
If this medicine has been prescribed by a doctor, follow carefully the
instructions of the doctor. These
instructions may differ from the general information in this leaflet.
DO NOT TAKE ARESTON:
-
If you are allergic to diclofenac, soya oil, peanut oil or any of the
other ingredients of this medicine
(listed in section 6). Signs of a hypersensitivity reaction include
swelling of the face and mouth
(angioedema), breathing problems, chest pain, runny nose, skin rash or
any other allergic type
reaction.
-
If you have established heart disease and/or cerebrovascular disease
e.g. if you have had a heart
attack, stroke, mini-stroke (TIA) or blockages to blood vessels to the
heart or brain or an operation
to clear or bypass blockages; or the pumping power of your heart is
reduced giv

পণ্য বৈশিষ্ট্য

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Areston 12.5mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 12.5mg diclofenac potassium.
Excipient(s) with known effect:
Each tablet contains 70.5mg lactose monohydrate and 0.17mg lecithin
(contains soya oil).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
White, capsule shaped biconvex tablets with dimensions 5x10 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rheumatic
pain,
muscular
pain,
headache,
dental
pain,
symptomatic
treatment
of
primary
dysmenorrhea, acute low back pain, cold and flu symptoms, including
fever relief, sore throats and
colds.
This product in indicated for use in adults and children aged 14 years
and over.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Undesirable effects may be minimised by using the lowest effective
dose for the shortest duration
necessary to control symptoms (see section 4.4).
_Adults and children aged 14 years and over _
Initially two tablets, followed by one tablet every 4 to 6 hours as
needed. No more than 6 tablets (75
mg) should be taken in any 24 hour period.
Areston is intended for short-term use, up to 5 days for relief of
pain and 3 days for relief of fever.
_Paediatric population _
Areston 12.5mg film-coated tablets are not recommended for use in
children under 14 years of age.
_Elderly _
Elderly patients should be treated with the lowest effective dose (see
section 4.4).
_Renal impairment _
Areston 12.5 mg is contraindicated in patients with severe renal
impairment or renal failure (see section
4.3).
spcdiclKtab1.7-DCP-MT
2
No specific studies have been conducted in patients with impaired
renal function, therefore, no specific
dose adjustment can be recommended. Caution is recommended when
Areston 12.5 mg is administered
to patients with mild to moderate renal impairment (see section 4.4).
_Hepatic impairment _
Areston 12.5 mg is contraindicated in patients with severe hepatic
impai