DIATRIM

Land: Israel

Språk: engelsk

Kilde: Ministry of Health

Aktiv ingrediens:

DIACEREIN

Tilgjengelig fra:

TRIMA ISRAEL PHARMACEUTICAL PRODUCTS MAABAROT LTD

ATC-kode:

M01AX21

Legemiddelform:

CAPSULES

Sammensetning:

DIACEREIN 50 MG

Administreringsrute:

PER OS

Resept typen:

Required

Produsert av:

TRIMA ISRAEL PHARMACEUTICAL PRODUCTS MAABAROT LTD, ISRAEL

Terapeutisk gruppe:

DIACEREIN

Terapeutisk område:

DIACEREIN

Indikasjoner:

Symptomatic treatment of functional symptoms of osteoarthritis.

Autorisasjon dato:

2014-11-30

Informasjon til brukeren

PATIENT PACKAGE INSERT IN
ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed with
a doctor’s prescription only
DIATRIM
CAPSULES
ACTIVE INGREDIENT: Each capsule contains:
Diacerein 50 mg
Inactive ingredients in the preparation - see
section 6 “Further Information”.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE
USING THE MEDICINE. This leaflet contains concise
information about the medicine. If you have further
questions, refer to the doctor or pharmacist.
This medicine has been prescribed to treat your
ailment. Do not pass it on to others. It may harm
them even if it seems to you that their ailment
is similar.
The medicine is not intended for children and
adolescents under 15 years of age.
∙ The preparation is not intended for patients
with liver disease or with a history of liver
disease.
∙ While using the preparation, monitor for early
signs of hepatic injury, such as: increased
liver enzymes, tiredness, loss of appetite,
jaundice, abdominal pain, nausea, vomiting,
change in stool color combined with change
in color of the urine, reduced consciousness
or itching of the skin.
In case these signs develop, stop the
treatment and refer to a doctor.
∙ Taking Diatrim can often cause to diarrhea
and consequently increase the risk of
dehydration and hypokalemia.
To reduce the risk of developing severe
diarrhea:
∘ It is recommended to start treatment
with a lower dosage of 50 mg per day for
the first 2-4 weeks of treatment with the
medicine.
∘ If you develop diarrhea, stop treatment with
the medicine and refer to a doctor as soon
as possible.
∙ If you are 65 years of age or older, be sure to
more closely monitor side effects that may
develop.
1. WHAT IS THE MEDICINE INTENDED FOR?
For symptomatic treatment of osteoarthritis.
THERAPEUTIC GROUP: Nonsteroidal anti-inflammatory
drugs, anti-osteoarthritic.
2. BEFORE USING THE MEDICINE DO NOT USE THIS MEDICINE IF:
∙ you are sensitive/allergic to the active
ingredient or to any of the other ingredients
containe

Preparatomtale

PRESCRIBING INFORMATION
1. NAME OF THE MEDICINAL PRODUCT
DIATRIM CAPSULES
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains diacerein 50 mg.
This product contains 240 mg lactose per capsule.
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Opaque No. 1 hard gelatin capsule with dark blue cap and white body.
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
Symptomatic treatment of functional symptoms of osteoarthritis.
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS (aged over 15 years).
As some patients may experience loose stools or diarrhea, the
recommended starting dose is
50 mg once daily with evening meal for the first 2 to 4 weeks of
treatment, after which the
recommended daily dose is 50mg twice daily .
The treatment should be taken with food, one capsule with breakfast
and the other capsule
with evening meal. The capsules must be swallowed intact, without
opening them, together
with a glass of water.
In patients older than 65 years, caution should be exercised during
use of this medicine; close
supervision and monitoring of adverse reactions should be performed.
In the elderly, and in moderate renal impairment, there is no need to
change the dosage.
In severe renal insufficiency (creatinine clearance below 30 ml/min),
the daily dosage are to
be halved.
4.3. CONTRAINDICATIONS
•
Inflammatory organic bowel disease (ulcerative colitis, Crohn’s
disease).
•
Intestinal obstruction or partial obstruction.
•
Abdominal pain syndromes of indeterminate etiology.
•
Known allergy to rhein (
substance in
the anthraquinone group) and substances with
similar activity.
•
Known hypersensitivity to any excipient.
•
Current and/or history of liver disease.
4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE
DIARRHEA
Intake of diacerein frequently leads to diarrhea (see chapter 4.8)
that can consequently lead to
dehydration and hypokalemia.
In case of diarrhea, patients should be advised to stop diacerein
treatment and contact their
doctor to discuss treatment alternatives.
I