Diclo-Denk 100 Rectal suppositories rectal

Država: Armenija

Jezik: engleski

Izvor: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktivni sastojci:

diclofenac (diclofenac sodium)

Dostupno od:

Haupt Pharma Wulfing GmbH

ATC koda:

M01AB05

INN (International ime):

diclofenac (diclofenac sodium)

Doziranje:

100mg

Farmaceutski oblik:

suppositories rectal

Jedinice u paketu:

(10/2x5/)

Tip recepta:

Prescription

Status autorizacije:

Registered

Datum autorizacije:

2023-01-10

Uputa o lijeku

Version: 50001011-003
1
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 is and what it is used for
2.
What you need to know before you use Diclo-Denk
3.
How to use Diclo-Denk
4.
Possible side effects
5.
How to store Diclo-Denk
6.
Contents of the pack and other information
1.
WHAT DICLO-DENK IS AND WHAT IT IS USED FOR
Diclo-Denk is a pain-relieving and anti-inflammatory 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
DO NOT USE DICLO-DENK
•
if you are allergic to diclofenac, acetylsalicylic acid, ibuprofen,
any other NSAID or to any of the
other ingredients of this medicine (listed in section 6). Signs of a
hypersensitivity reaction include
swelling

Svojstava lijeka

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Diclo-Denk 100 Rectal
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: diclofenac
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
failure (se