BETAREN 100 S.R.

Kraj: Izrael

Język: angielski

Źródło: Ministry of Health

Składnik aktywny:

DICLOFENAC SODIUM

Dostępny od:

DEXCEL LTD, ISRAEL

Kod ATC:

M01AB05

Forma farmaceutyczna:

TABLETS SLOW RELEASE

Skład:

DICLOFENAC SODIUM 100 MG

Droga podania:

PER OS

Typ recepty:

Required

Wyprodukowano przez:

DEXCEL LTD, ISRAEL

Grupa terapeutyczna:

DICLOFENAC

Dziedzina terapeutyczna:

DICLOFENAC

Wskazania:

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.

Data autoryzacji:

2021-03-31

Ulotka dla pacjenta

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Charakterystyka produktu

Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Betaren 100 S.R.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Diclofenac sodium 100 mg
Excipient with known effect:
Each tablet contains approximately 111.5 mg sucrose.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Slow release tablets
Pink, round, biconvex, film coated tablets, with an embossment
"DICL100" on one
side.
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, Betaren is not suitable for children
and adolescents.
The tablets should be swallowed whole with liquid, preferably with
meals and must
not be divided or chewed.
Generally 1 tablet daily is recommended. If gastrointestinal upset
occurs, the dose
may be taken with food, milk or antacids.
Where the symptoms are most pronounced during the night or in the
morning,
Betaren should preferably be taken in the evening.
4.3
CONTRAINDICATIONS

Hypersensitivity to the active substance or to any of the excipients
listed in section
6.1.

Active, gastric or intestinal ulcer, bleeding or perforation.

History of gastrointestinal bleeding or perforation, relating to
previous NSAIDs
therapy.
Page 2 of 11

Active, or history of recurrent peptic ulcer/haemorrhage (two or more
distinct
episodes of proven ulceration or bleeding).

Last trimester of pregnancy (see section 4.6).

Hepatic failure

Renal failure

Established congestive heart failure (NYHA-II-IV), ischemic heart
disease,
peripheral arterial disease and/or cerebrovascular disease

Like other no