Diosper Tablet, film coated

Land: Malta

Språk: engelsk

Kilde: Medicines Authority

Aktiv ingrediens:

HESPERIDIN, DIOSMIN

Tilgjengelig fra:

Kleva S.A. 189 Parnithos Avenue, 13671 Acharnai, Attiki, Greece

ATC-kode:

C05CA03

INN (International Name):

HESPERIDIN 50 mg DIOSMIN 450 mg

Legemiddelform:

FILM-COATED TABLET

Sammensetning:

HESPERIDIN 50 mg DIOSMIN 450 mg

Resept typen:

POM

Terapeutisk område:

VASOPROTECTIVES

Autorisasjon status:

Authorised

Autorisasjon dato:

2005-11-25

Informasjon til brukeren

COMPOSITION
PHARMACEUTICAL FORM
STRENGTH
PRESENTATION-PACKAGING
THERAPEUTIC CATEGORY
THE INFORMATION OF THIS LEAFLET REFERS ONLY TO THE PRODUCT PRESCRIBED
BY YOUR PHYSICIAN: DIOSPER .
PLEASE READ IT CAREFULLY. IT PROVIDES IMPORTANT INFORMATION BUT IT
DOES NOT EXPLAIN EVERYTHING. IF YOU
NEED MORE INFORMATION ASK YOUR PHARMACIST OR YOUR PHYSICIAN.
INDICATIONS
CONTRA-INDICATIONS
DRUGS CAN CURE, BUT CAN ALSO CREATE PROBLEMS WHEN ARE NOT TAKEN AS
PRESCRIBED BY PHYSICIANS.
PRECAUTIONS
DRUG INTERACTIONS
BEFORE USING THIS MEDICINE PLEASE INFORM YOUR PHYSICIAN ABOUT ALL
MEDICINES YOU MAY USE, INCLUDING
THESE YOU HAVE BOUGHT WITHOUT PRESCRIPTION.
ADMINISTRATION
DOSAGE
Active ingredients
Excipients
Pregnancy and lactation
:
Diosmin + Hesperidin
:
Sodium starch
glycollate,
Cellulose
microcrystalline,
Gelatine,
Magnesium
stearate, Talc.
Coating:
White beeswax,
OPADRY-OY-S-37207 Beige.
OPADRY OY S
Beige consists of
Glycerol
Hypromellose
Macrogol
Sodium lauryl
sulfate
Iron oxide yellow E
Ironoxide red E
Titanium dioxide E
Magnesium Stearate
Film coated tablets
Each tablet contains 450 mg Diosmin and 50 mg Hesperidin
Salmon-pink oval tablets in PVC/aluminum blisters printed with the
product's characteristics. Each blister
contains 10 tablets. Packed in boxes of 3 blisters (30 tablets)
together with a drug information leaflet.
Phlebotonic, meaning that DIOSPER is a product that increases the
venous tone and protects the vessels.
DIOSPER can be administered:
as supplementary therapy for the complications of chronic venous
insufficiency of the lower limbs.
for the treatment of haemorrhoidal disease.
DIOSPER is contra-indicated to patients hypersensitive to any
substance contained in the drug.
Even if
there are no studies demonstrating teratogenesis to humans,
DIOSPER
should not
be
administered during the first three months of pregnancy.
It has not been studied if the active ingredients are excreted to
breast milk, therefore the use of DIOSPER
should be avoided during lactation.
Interactions regarding the administration of DIOSPER w

Preparatomtale

Page 1 of 4 

_ _
1.  
TRADE  NAME OF THE PRODUCT 

D I O S P E R
® 

2.  
QUALITATIVE AND QUANTITATIVE COMPOSITION 

One  film-coated  tablet  contains  500mg  of  microionised  purified  flavonoid  fraction 
corresponding to: 
•

90% of diosmin, equivalent to 450mg per tablets 
•

10% of flavoinoids expressed as hesperidine, equivalent to 50mg per tablet 

3.     
PHARMACEUTICAL FORM 

Film coated tablets. 

4.     
CLINICAL PARTICULARS 

4.1.   
 THERAPEUTIC INDICATIONS 
-  DIOSPER
®
  may  be  used  for  the  treatment  of  organic  and  functional  chronic  venous 
insufficiency of the lower limbs 
- Symptomatic treatment of acute haemorrhoidal attacks. 

4.2     
POSOLOGY AND METHOD OF ADMINISTRATION 
DIOSPER is used orally. Tablets should be swallowed with a small amount of water, during 
meals. 

_CHRONIC VENOUS INSUFFICIENCY _
The usual dose is 2 tablets daily, one at midday and one in the evening during meals. 

_HAEMORRHOIDAL ATTACK _
A 4-day course of 6 tablets daily, followed by 4 tablets daily over the next 3 days. 

4.3 
CONTRAINDICATIONS  

Page 2 of 4 
DIOSPER
®
  is  contra-indicated  in  patients,  who  have  shown  hypersensitivity  to  any  of  the 
substances present in the drug. 

4.4 
SPECIAL WARNINGS AND PRECAUTIONS FOR USE  
DIOSPER
®
 contains glycerol, an excipient that may cause headaches, gastric disorders and 
diarrhoea. 
The  administration  of  this  medicine  for  the  symptomatic  treatment  of  acute  haemorrhoidal 
attack  does  not  substitute  the  treatment  of  other  rectal  problems.  The  treatment  should  be 
short-term.  If  the  symptoms  persist,  a  rectal  examination  sho