Doxiproct

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CALCIUM DOBESILATE, LIDOCAINE HYDROCHLORIDE

Available from:

OM PHARMA S.A. R. da Industria, 2, 2610-088 Amadora, Lisboa, Portugal

ATC code:

C05BX01

INN (International Name):

CALCIUM DOBESILATE 4 g LIDOCAINE HYDROCHLORIDE 2 g

Pharmaceutical form:

OINTMENT

Composition:

CALCIUM DOBESILATE 4 g LIDOCAINE HYDROCHLORIDE 2 g

Prescription type:

POM

Therapeutic area:

VASOPROTECTIVES

Authorization status:

Withdrawn

Authorization date:

2006-11-20

Patient Information leaflet

COMPOSITION
Active principles
Calcium dobesilate, lidocaine hydrochloride.
Calcium dobesilate: 40 mg, lidocaine hydrochloride: 20 mg,
antiox. (E 320, E 310), macrogol 300, propyleneglycol. Excipients
for 1 g of ointment.
PROPERTIES/EFFECTS
Calcium dobesilate acts on the capillary walls by regulating their
impaired physiological functions - i.e. increased permeability
and decreased resistance - and on different signs of
inflammation. It also has an antithrombotic activity.
Lidocaine hydrochloride, a local anesthetic, contributes to
relieve pain.
Doxiproct reduces inflammation, bleeding, oozing of serous
fluids and brings a rapid relief of the signs and symptoms linked
to inflammation of the anal region, such as pain, burning,
pruritus and sensation of tension.
PHARMACOKINETICS
No pharmacokinetic data are available. It is, however, known
that the active principles contained in Doxiproct are partly
resorbed by the skin.
INDICATIONS AND USAGE
Internal and external hemorrhoids. Anal pruritus, anitis,
perianitis, cryptitis, papillitis, acute hemorrhoidal thrombosis,
anal fissures.
Pre- and postoperative treatment in cases of hemorrhoidectomy.
DOSAGE AND ADMINISTRATION
2-3 times daily.
In the morning and at bedtime apply, if possible after defecation.
In cases of internal hemorrhoids, use the cannula by screwing 
it to the tube. 
Insert the cannula as deep as possible in the anus then press
gently the tube while withdrawing it. In this case, the tube 
is sufficient for 10 applications.
In case of external hemorrhoids or anal pruritus apply a thin
layer of the ointment several times a day.
The duration of the treatment is generally of some days. 
The doctor must be informed if, after 1 to 2 weeks of treatment,
the symptomatology has not improved or has worsened. 
The treatment should not be repeated without previous 
medical advice.
LIMITATIONS FOR USE
CONTRAINDICATIONS
Hypersensitivity towards the components of Doxiproct.
Children under 14.
PRECAUTIONS
In case of renal insufficiency, the application of Doxiproct

Summary of Product characteristics

Page 1 of 4 
SUMMARY OF PRODUCT CHARACTERISTICS 

1. 
NAME OF THE MEDICINAL PRODUCT 

DOXIPROCT
®
 Ointment 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

_Active principles : _Calcium dobesilate, lidocaine
hydrochloride._ _

Calcium dobesilate : 40 mg, lidocaine hydrochloride : 20 mg, antiox. (E 320, E 310), 
macrogol 300, propyleneglycol. Excipients for 1 g of ointment. 

3. 
PHARMACEUTICAL FORM 

Ointment, topical preparation and rectal route. 

4. 
CLINICAL PARTICULARS 

4.1. 
Therapeutic indications 

Internal and external hemorrhoids. Anal pruritus, anitis, perianitis, cryptitis, papillitis, 
acute hemorrhoidal thrombosis, anal fissures. 
Pre- and postoperative treatment in cases of hemorrhoidectomy. 

4.2. 
Posology and method of administration 

2 - 3 times daily. 
In the morning and at bedtime apply the ointment, if
possible after defecation. 
In cases of internal hemorrhoids, use the cannula by screwing it to the tube. Insert the 
cannula as deep as possible in the anus then press gently the
tube while withdrawing it. 
In this case, the tube is sufficient for 10 applications. 
In  case  of  external  hemorrhoids  or  anal  pruritus  apply  a  thin  layer  of  the  ointment 
several times a day. 
The duration of the treatment is generally of some days. The doctor must be informed 
if,  after  1  to  2  weeks  of  treatment,  the  symptomatology  has  not  improved  or  has 
worsened.  The  reconduction  of  the  treatment  should  not  be  done  without  a  prior 
medical advice. 

4.3. 
Contra-indications 

Hypersensitivity towards the components of Doxiproct. 

4.4. 
Special warnings and precautions for use 

Page 2 of 4 
In  case  of  renal  insufficiency,  Doxiproct  should  not  be  used  during  long  peri