CATAFLAM 50 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

DICLOFENAC AS POTASSIUM

Available from:

NOVARTIS ISRAEL LTD

ATC code:

M01AB05

Pharmaceutical form:

TABLETS

Composition:

DICLOFENAC AS POTASSIUM 50 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

NOVARTIS SAGLIK, GIDA VE TARIM URUNLERI SAN.VE TIC. A.S., TURKEY

Therapeutic group:

DICLOFENAC

Therapeutic area:

DICLOFENAC

Therapeutic indications:

Management of pain and primary dysmenorrhea, when prompt pain relief is desired.

Authorization date:

2020-11-30

Patient Information leaflet

عم نمازتلاب هلوانت بجي يذلا ةدعملا
ةيامحل
ً
ارخآ
ً
ءاود بيبطلا فصي نأ زئاجلا نم
تنك اذإ وأ ،
ً
انسم تنك اذإ ،قباسلا يف ةدعملاب لكاشم
نم تيساق اذإ ةصاخ ،ءاودلا اذه
.كلذل ةفاضلإاب ةنيعم ةيودأ لوانتت
ءاودلا لوانت ةيفيكو ىتم
.ماعطلا ةبجو دعب وأ ءانثأ ءاودلا لوانت
لضف
ُ
ي
.ءام وأ بارش عم هلمكأب صرقلا علب بجي
.ةعرسب لمعتل ملافاتاك صارقأ ميمصت مت
دقل
.رملأا اذه لوح تايطعم دجوت لا ،صرقلا
غضم وأ قحس ،رطش زوجي لا
ربكأ
ً
ايئاود
ً
ارادقم أطخلاب تلوانت اذإ
أطخلاب لفط علب اذإ وأ ،
ً
اطرفم
ً
ايئاود
ً
ارادقم أطخلاب ،
ً
ارخآ
ً
اصخش وأ تنأ تلوانت اذإ
ةبلع رضحأو ىفشتسملا يف ئراوطلا ةفرغ
ىلإ وأ بيبطلا ىلإ
ً
اروف هجوت ،ءاودلا نم
.كعم ءاودلا
.بيبطلا ةيصوت بسح جلاعلا ىلع ةبظاوملا
بجي ءاودلا لوانت تيسن اذإ
.كركذت لاح يئاود رادقم لوانت بجي
،ددحملا تقولا يف ءاودلا اذه لوانت تيسن
اذإ
فعاضم يئاود رادقم لوانت زوجي لاف
،مداقلا يئاودلا رادقملا دعوم
ً
ابيرقت ناح اذإ نكل
تقولا يف يلاتلا يئاودلا رادقملا طقف
لوانت .يسنملا يئاودلا رادقملا نع
ضيوعتلل
صارقأ 3( غلم 150 هردق يئاود رادقم زواجت
زوجي لا .بيبطلا رشتسإو يدايتعلإا
.ةعاس 24 للاخ )غلم 50 تاذ
نسحت أرط ولو ىتح ،بيبطلا ةراشتسإ نودب
ءاودلاب جلاعلا نع فقوتلا زوجي لا
.ةيحصلا كتلاح ىلع رادقملا نم دكأتلاو ءاودلا عب�

Summary of Product characteristics

CAT API MAR23 V3
UK SmPC Feb2023
Business Use Only
1.
TRADE NAME OF THE MEDICINAL PRODUCT
CATAFLAM
® 50 MG
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50mg of diclofenac potassium
Chemical name: Potassium-[o-[(2,
6-dichlorophenyl)-amino]-phenyl]-acetate
Excipient(s) with known effect:
Sucrose
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablets
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Management of pain and primary dysmenorrhea, when prompt pain relief
is desired.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
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).
GENERAL TARGET POPULATION
The recommended initial daily dose is 100 to 150 mg. In milder cases,
75 to 100 mg daily is usually sufficient.
The total daily dose should generally be divided into 2 or 3 separate
doses, as applicable.
In primary dysmenorrhoea, the daily dose should be individually
adjusted and is generally 50 to 150 mg. An initial
dose of 50 mg is usually sufficient. If necessary, an initial dose of
100 mg can be prescribed with a maximum of
200 mg/day reached over the course of several menstrual cycles.
Treatment should be started on appearance of
the first symptoms and, depending on the symptomatology, continued for
a few days.
In migraine an initial dose of 50 mg should be taken at the first
signs of an impending attack. In cases where pain
relief within 2 hours after the first dose is not sufficient, a
further dose of 50 mg may be taken. If needed, further
doses of 50 mg may be taken at intervals of 4-6 hours, not exceeding a
total dose of 200 mg per day.
SPECIAL POPULATIONS
PAEDIATRICS
Cataflam
®
tablets are not recommended for use in children and adolescents below
14 years of age.
For adolescents aged 14 years and over, a daily dose of 75 to 100 mg
is usually sufficient.
The maximum da