DOXI-OM 500MG CAPSULE,HARD

Country: Cyprus

Language: Greek

Source: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

Active ingredient:

CALCIUM DOBESILATE

Available from:

M K STAVRINOS LTD (0000003059) 3 ERACLEOUS, LEFKOSIA, 1501, 21074

ATC code:

C05BX01

INN (International Name):

CALCIUM DOBESILATE

Dosage:

500MG

Pharmaceutical form:

CAPSULE,HARD

Composition:

CALCIUM DOBESILATE (0020123802) 500MG

Administration route:

ORAL USE

Prescription type:

Εθνική Διαδικασία

Therapeutic area:

CALCIUM DOBESILATE

Product summary:

Νομικό καθεστώς: Με Ιατρική Συνταγή που Επαναλαμβάνεται

Patient Information leaflet

_PIL Doxium CY_
PACKAGE LEAFLET: INFORMATION FOR THE USER
DOXI-OM
® 500
500 MG, CAPSULES, HARD
Calcium dobesilate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 Doxi-OM
®
500 is and what it is used for
2.
What you need to know before you take Doxi-OM
®
500
3.
How to take Doxi-OM
®
500
4.
Possible side effects
5.
How to store Doxi-OM
®
500
6.
Contents of the pack and other information
1.
WHAT DOXI-OM
® 500 IS AND WHAT IT IS USED FOR
Microangiopathies, in particular diabetic retinopathy.
Clinical signs of chronic venous insufficiency in the lower limbs
(pain, cramps, paresthesia,
oedema, stasis dermatosis), as adjuvant in superficial
thrombophlebitis.
Haemorrhoidal syndrome, microcirculation disorders of arteriovenous
origin.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DOXI-OM
® 500
DO NOT TAKE DOXI-OM
® 500
-
If you are allergic to calcium dobesilate or any of the other
ingredients of this medicine
(listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Doxi-OM
®
500.
In very rare cases, the administration of Doxi-OM
®
500 may cause agranulocytosis, a
disease in which a severe reduction of white blood cells results in a
higher risk of infections.
In this situation, the symptoms may include high fever, infections of
oral cavity (tonsillitis),
sore throat, inflammation of the genital or anal region, or other
symptoms that are common
_PIL Doxium CY_
signs of infection. If you have these symptoms you must stop the
treatment immediately and
inform your d

Summary of Product characteristics

_SmPC Doxium CY_
_- 1 -_
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Doxi-OM
®
500, 500 mg capsules, hard
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 hard capsule contains 500 mg of calcium dobesilate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule, hard
Opaque capsules with a yellow capsule body and a dark green cap
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Microangiopathies, in particular diabetic retinopathy.
Clinical signs of chronic venous insufficiency in the lower limbs
(pain, cramps,
paresthesia, oedema, stasis dermatosis), as adjuvant in superficial
thrombophlebitis.
Haemorrhoidal syndrome, microcirculation disorders of arteriovenous
origin.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_For adults only_
Generally 500 to 1000 mg (1 capsule once or twice a day)
Dosage should be adapted individually according to the severity of the
case.
Treatment duration, which is generally between a few weeks and several
months,
depends on the disease and its evolution.
_Renal impairment _
The safety and efficacy of calcium dobesilate have not been studied in
patients with
renal impairment. Since the drug is excreted by the urinary route,
caution is required
in case of renal insufficiency. Thus, the dose may be reduced when
administering
Doxi-OM
®
500 to these patients, especially in patients with severe renal
insufficiency
requiring dialysis.
_Hepatic impairment _
_SmPC Doxium CY_
_- 2 -_
The safety and efficacy of calcium dobesilate have not been studied in
patients with
hepatic impairment. Thus, caution is required when administering
Doxi-OM
®
500 to
these patients.
Method of administration
Doxi-OM
®
500 is designed for oral administration. Doxi-OM
®
500 should be taken
during or right after meals, to minimise any gastric discomfort.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in
section 6.1.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
The dose may be reduced in case of severe renal i