Doloproct 1mg + 40mg suppositories

Land: Malta

Sprog: engelsk

Kilde: Medicines Authority

Aktiv bestanddel:

FLUOCORTOLONE PIVALATE, LIDOCAINE HYDROCHLORIDE

Tilgængelig fra:

Jenapharm GmbH & Co. KG

ATC-kode:

C05AX03

INN (International Name):

FLUOCORTOLONE PIVALATE, LIDOCAINE HYDROCHLORIDE

Lægemiddelform:

SUPPOSITORY

Sammensætning:

FLUOCORTOLONE PIVALATE 1 milligram(s) ; LIDOCAINE HYDROCHLORIDE 40 milligram(s)

Recept type:

POM

Terapeutisk område:

VASOPROTECTIVES

Autorisation status:

Authorised

Autorisation dato:

2005-09-28

Indlægsseddel

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PACKAGE LEAFLET
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PACKAGE LEAFLET: INFORMATION FOR THE USER
DOLOPROCT 1 MG + 40 MG SUPPOSITORIES
fluocortolone pivalate + lidocaine hydrochloride (water free)

.
<[To be completed nationally]>
WHAT IS IN THIS LEAFLET
1.
What Doloproct is and what it is used for
2.
What you need to know before you use Doloproct
3.
How to use Doloproct
4.
Possible side effects
5.
How to store Doloproct
6.
Contents of the pack and other information
1.
WHAT DOLOPROCT IS AND WHAT IT IS USED FOR
Doloproct contains two different active substances: fluocortolone
pivalate and lidocaine
hydrochloride.
-
The active substance fluocortolone pivalate belongs to the group of
corticosteroids. It
lowers the production of substances that cause inflammation in your
body. This relieves
ailment such as swelling, itching and smarting.
-
The active substance lidocaine hydrochloride belongs to the group of
local anaesthet

Produktets egenskaber

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SUMMARY OF PRODUCT CHARACTERISTICS
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1.
NAME OF THE MEDICINAL PRODUCT
Doloproct 1 mg + 40 mg suppositories
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 Doloproct suppository contains: 1 mg fluocortolone pivalate and 40
mg lidocaine hydrochloride
(water free).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suppositories
Yellowish-white suppositories
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Symptomatic relief of pain and inflammation in adults for:
-
haemorrhoidal disease and
non-infectious proctitis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
One suppository should be inserted twice a day, once in the morning
and once in the evening. With
improvement of symptoms, it is in many cases sufficient to insert one
suppository per day or every
second day.
The total duration of treatment should not exceed 2 weeks.
_Paediatric population _
Doloproct is not recommended for use in children below 18 years due to
a lack of data on safety
and efficacy.
Method of administration
It is advisable to administer Doloproct after defaecation. The anal
region should be cleaned
thoroughly prior to use.
Insert the suppositories deep into the anus.
4.3
CONTRAINDICATIONS
Doloproct is contra-indicated in case of topical infections in the
affected area and if symptoms of
the following disorders are present in the affected area:
-
specific skin lesions (syphilis, tuberculosis)
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-
chickenpox
-
vaccination reactions
-
herpes genitalis.
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Since Doloproct contains the active substance lidocaine and
approximately 30% of the dose applied
is systemically available, this should be considered in patients
taking medicines to treat irregular
heart beat (arrhythmia).
Care should be taken to ensure that Doloproct s does not come into
contact with the eyes. It is
advisable to wash one's hands thoroughly after use.
If suppositories have become softe