SWISS RELIEF DUAL RELEASE

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

DICLOFENAC SODIUM

Available from:

PADAGIS ISRAEL AGENCIES LTD, ISRAEL

ATC code:

S01BC03

Pharmaceutical form:

CAPSULES

Composition:

DICLOFENAC SODIUM 75 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

SWISS CAPS GMBH, GERMANY

Therapeutic group:

DICLOFENAC

Therapeutic area:

DICLOFENAC

Therapeutic indications:

As a non-steroidal anti-inflamatory analgesic in symptomatic management of rheumatoid arthritis osteoarthritis and ankylosying spondylitis acute musculo-skeletal disorders such as periarthritis tendenitis tensynovitis bursitis sprains strains and dislocations relief of pain in fractures low back pain acute gout psoriatic arthropathy. In the management of pain and inflammation associated with orthopaedic dental and minor surgery.

Authorization date:

2014-11-30

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
Swiss Relief Dual Release, 75 mg capsules
1. NAME OF THE MEDICINAL PRODUCT
Swiss Relief Dual Release
75 mg capsule
Diclofenac sodium
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule, hard, contains 75 mg diclofenac sodium (25 mg diclofenac
sodium in gastro-resistant form, 50 mg
diclofenac sodium in prolonged-release form).
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Capsules, hard.
Size 2 hard gelatine capsule with light blue cap and transparent body.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
As a non-steroidal anti-inflammatory analgesic in symptomatic
management of rheumatoid arthritis, osteoarthritis
and ankylosying spondylitis, acute musculo-skeletal disorders such as
periarthritis, tendinitis, tensynovitis, bursitis,
sprains, strains and dislocations, relief of pain in fractures, low
back pain, acute gout, psoriatic arthropathy.
In the management of pain and inflammation associated with
orthopaedic, dental and minor surgery.
4.2 Posology and method of administration
Posology:
Diclofenac is dosed in relation to the severity of the condition. The
recommended dose range for adults is
between 50 and 150 mg diclofenac sodium per day.
Age:
Single dose:
Number of Swiss Relief Dual Release
capsules
Total daily dose:
Number of Swiss Relief Dual Release
capsules
Adults
1
(equivalent to 75 mg diclofenac sodium)
2
(equivalent to 150 mg diclofenac sodium)
Method of administration and duration of use:
Swiss Relief Dual Release is swallowed whole (without chewing) and
with plenty of liquid.
Those with sensitive stomachs are recommended to take Swiss Relief
Dual Release during meals.
The duration of use is decided by the treating physician.
For rheumatic diseases, it may be necessary to take Swiss Relief Dual
Release over a prolonged period of time.
Undesirable effects can be minimised if the lowest effective dose
required to achieve symptomatic control is used over
the shortest possible period of time (see section 4.4 Special warnings
and preca