Diclo-Denk 100 Rectal suppositories rectal

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

diclofenac (diclofenac sodium)

Available from:

Haupt Pharma Wulfing GmbH

ATC code:

M01AB05

INN (International Name):

diclofenac (diclofenac sodium)

Dosage:

100mg

Pharmaceutical form:

suppositories rectal

Units in package:

(10/2x5/)

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2018-02-27

Patient Information leaflet

_Diclo-Denk 100 Rectal_
Suppository – rectal use
Non-steroidal antiphlogistic/antirheumatic
Active substance: diclofenac
Package leaflet: Information for the patient
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START
USING 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 DICLO-DENK 100 RECTAL IS
AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU
USE DICLO-DENK 100 RECTAL
3.
HOW TO USE DICLO-DENK 100 RECTAL
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE DICLO-DENK 100 RECTAL
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
What Diclo-Denk 100 Rectal is and what
it is used for
Diclo-Denk 100 Rectal is a pain-relieving and anti-inflam-
matory drug and belongs to the class of non-steroidal
antiphlogistic/antirheumatic agents (NSAIDs).
Therapeutic indications
Symptomatic treatment of pain and inflammation in case
of:
•
acute joint inflammation (acute arthritides) including
gout attack
•
chronic
joint
inflammation
(chronic
arthritides),
especially in case of rheumatoid arthritis (chronic
polyarthritis)
•
Bechterew’s disease (ankylosing spondylitis) and
other inflammatory rheumatoid disorders of the spine
•
acute inflammatory condition of degenerative joint
or spinal disorders (arthroses and spondylarthroses)
•
inflammatory soft tissue rheumatisms
•
painful swelling or inflammation after injuries.
2.
What you need to know before you use
Diclo-Denk 100 Rectal
Do not use Diclo-Denk 100 Rectal
•
if you are allergic to diclofenac, acetylsalicylic acid,
ibuprofen, any other NSAID or to any of the other
ingredients of this medicine (list

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Diclo-Denk 100 Rectal
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: diclofenac sodium
Each suppository contains 100 mg diclofenac sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suppository
Ivory coloured, homogenous suppository.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Symptomatic treatment of pain and inflammation in case of:
-
acute arthritides (including gout attack)
-
chronic arthritides, especially rheumatoid arthritis (chronic
polyarthritis)
-
ankylosing spondylitis (Bechterew’s disease) and other inflammatory
rheumatoid disorders of the
spine
-
acute inflammatory condition of arthroses and spondylarthroses
-
inflammatory soft tissue rheumatisms
-
painful swelling or inflammation after injuries.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dose of diclofenac depends on the severity of the illness. The
recommended daily dose for adults is
between 50 mg and 150 mg of diclofenac sodium.
AGE
SINGLE DOSE
TOTAL DAILY DOSE
Adults
1 suppository
(equivalent to
100 mg diclofenac sodium)
1 suppository
(equivalent to
100 mg diclofenac sodium)
Method of administration
Diclo-Denk 100 Rectal should be inserted deep into the anus, if
possible, after a bowel movement.
Not to be taken by mouth, as per rectal administration only.
Duration of administration
The attending doctor will decide how long the treatment should take.
2
Prolonged use of Diclo-Denk 100 Rectal can be necessary for rheumatic
diseases.
Undesirable effects may be minimised by using the lowest effective
dose for the shortest duration
necessary to control symptoms (see section 4.4).
Special patient groups
_Elderly patients (65 years and older) _
No particular dosage adjustment is required (see section 4.4). For
medical reasons, caution is indicated
especially in elderly patients who are frail or with a low body
weight.
_Impaired renal function _
Diclo-Denk 100 Rectal is contraindicated in patients with severe renal
fail