ABITREN SUPPOSITORIES 50 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

DICLOFENAC SODIUM

Available from:

ABIC LTD.

ATC code:

M01AB05

Pharmaceutical form:

SUPPOSITORIES

Composition:

DICLOFENAC SODIUM 50 MG

Administration route:

RECTAL

Prescription type:

Required

Manufactured by:

TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL

Therapeutic group:

DICLOFENAC

Therapeutic area:

DICLOFENAC

Therapeutic indications:

Rheumatoid arthritis, osteoarthritis, low back pain and other acute musculoskeletal .Disorders such as periarthritis, tendinitis, tenosynovitis, bursitis, sprains, strains and dislocation, ankylosing spondylitis and acute gout.Control of pain and inflammation in orthopedic, dental, and other monor surgery.

Authorization date:

2021-03-31

Patient Information leaflet

اهديربت ناكملإاب ،اهلاخدإ نكمي لا
ثيحب ةوخر ةليتفلا تناك اذإ :ةظحلام
نم رايت تحت اهعضو ةطساوب وأ ،ةقيقد 30
وحن للاخ داربلا يف نيزختلاب
.فلاغلا عزن لبق درابلا ءاملا
:ةليتفلا لاخدإ ةيفيك
.
ً
اديج كيدي لسغإ ،
ً
لاوأ
.1
ليهستل ءاملا نم ليلقلاب ةليتفلا بيطرت
ناكملإاب .ةليتفلا نع فلاغلا عزنإ
.2
.لاخدلإا
ةطساوب جرشلا ةحتف لخادل
ً
اقيمع فطلب ةليتفلا لخدأو كبناج ىلع
قلتسإ
.3
.عبصلأا
.ةليتفلا لاخدإ دعب
ً
اديج كيدي لسغإ
.4
ةبقارمو صوحف
ريداقم لامعتسا مزلي يذلا جلاعلا يف وأ
،ءاودلاب ل
ّ
وطملا جلاعلا ةرتف للاخ
زئاجلا نم .ىلكلاو دبكلا فئاظوو لوب ،مد
صوحف ءارجإ بجي ،ةيلاع ةيئاود
بيبطلا ةراشتسإ دعب جلاعلا فاقيإ مزلي
يذلا ،دبكلا تاميزنإب عافترإ ثودح
.)"ةيبناجلا ضارعلأا" - 4 ةرقفلا رظنأ(
ضرم ثودحل ةماه راطخأ نم وأ دوجوم يبلق
ضرم نم يناعت تنك اذإ
جلاعلا ةلصاوم كيلع ناك اذإ اميف رخلآ
نيح نمو ديدج نم كبيبط م
ّ
يقي ،يبلق
.عيباسأ ةعبرأ نع ديزت ةرتفل جلاعتت تنك
اذإ ةصاخ ،ءاودلاب
ءاودلا لامعتسإ تيسن اذإ
رادقم لامعتسإ بجيف ،صصخملا تقولا يف
ءاودلا اذه لامعتسإ تيسن اذإ
نيرادقم لامعتسإ لاوحلأا نم لاح يأب
زوجي لا نكل ،كلذب كركذت لاح يئاود
.ةيوس نييئاود
.بيبطلا ةيصوت بسح جلاعلا ىلع ةبظاوملا
بجي
ربكأ
ً
ايئاود
ً
ارادقم أطخلاب تلمعتسإ اذإ
،ءاودلا نم أطخلاب ل�

Summary of Product characteristics

Abitren Suppositories 50 mg FW 04/2023 Notification
Summary of Product Characteristics
Abitren Suppositories 50 mg
Suppositories
1.
NAME OF THE MEDICINAL PRODUCT
Abitren Suppositories 50 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active substance is
sodium-[o-[(2,6-dichlorophenyl)-amino]-phenyl]-acetate (diclofenac
sodium).
Each suppository contains 50mg diclofenac sodium.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suppositories for rectal use.
4.
CLINICAL PARTICULARS
4.1 Therapeutic indications
Rheumatoid arthritis, osteoarthritis, low back pain and other acute
musculoskeletal disorders such as
periarthritis, tendinitis, tenosynovitis, bursitis, sprains, strains
and dislocation, ankylosing spondylitis and
acute gout.
Control of pain and inflammation in orthopedic, dental, and other
minor surgery.
4.2
Posology and method of administration
As a general recommendation, the dose should be given for the shortest
possible duration.
Because of their dosage strength, Abitren Supposotories 50 mg is not
suitable for children and adolescents.
Generally 2 suppositories daily are recommended, usually administered
at night. In more severe cases,
combined therapy with tablets is recommended. The daily dose should
not exceed 150 mg of diclofenac.
Special populations
Elderly
Although the pharmacokinetics of diclofenac sodium suppositories are
not impaired to any clinically
relevant extent in elderly patients, nonsteroidal anti-inflammatory
drugs should be used with particular
caution in such patients who generally are more prone to adverse
reactions. In particular it is
recommended that the lowest effective dosage be used in frail elderly
patients or those with a low body
weight (see also Precautions) and the patient should be monitored for
GI bleeding during NSAID
therapy.
Cardiovascular and significant cardiovascular risk factors
Diclofenac is contraindicated in patients with established congestive
heart failure (NYHA II-IV),
ischemic heart disease, peripheral arterial disease and/or
cerebro