VERRUMAL SOLUTION

Land: Israel

Sprog: engelsk

Kilde: Ministry of Health

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Indlægsseddel Indlægsseddel (PIL)
31-03-2021
Produktets egenskaber Produktets egenskaber (SPC)
31-03-2021

Aktiv bestanddel:

FLUOROURACIL; SALICYLIC ACID

Tilgængelig fra:

NEOPHARM LTD

ATC-kode:

D11AF

Lægemiddelform:

SOLUTION

Sammensætning:

SALICYLIC ACID 10 G / 100 G; FLUOROURACIL 0.5 G / 100 G

Indgivelsesvej:

TOPICAL

Recept type:

Required

Fremstillet af:

ALMIRALL HERMAL GMBH, GERMANY

Terapeutisk gruppe:

WART AND ANTI-CORN PREPARATIONS

Terapeutiske indikationer:

Common warts ( special form : plantar warts, on areas of the sole of the foot that are subjected to pressure), plane juvenile warts of the extremities.

Autorisation dato:

2020-10-31

Indlægsseddel

                                1
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
VERRUMAL SOLUTION
Solution for topical application
ACTIVE INGREDIENTS:
Each 100 gr contain:
Fluorouracil 0.5 gr
Salicylic acid 10 gr
For the list of inactive ingredients and allergens in the medicinal
product, see section 6.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet
contains concise information about this medicine.
If you have any further questions, consult with your doctor or
pharmacist.
IT IS RECOMMENDED TO READ THIS LEAFLET WITH ANOTHER FAMILY MEMBER.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm
them, even if it seems to you that their medical condition is similar
to yours.
1. WHAT IS THIS MEDICINE INTENDED FOR?
For the treatment of common warts (warts beneath the soles of the feet
in areas where
pressure is applied to the soles of the feet) and flat warts on hands
and feet.
THERAPEUTIC GROUP: anti-wart and keratolytic agents.
2. BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE:
–
if you are sensitive/allergic to the active ingredients, fluorouracil
or salicylic
acid (salicylates), or to any of the other ingredients of this
medicine that are
listed in section 6.
–
if you are breastfeeding.
–
if you are pregnant or if there is a concern that you may be pregnant.
–
to treat infants.
–
on patients suffering from renal insufficiency.
–
if you are undergoing treatment for chickenpox and/or for herpes
zoster; if you
took brivudine, sorivudine and/or their derivatives (antiviral
medicines for the
treatment of herpes zoster).
The active ingredient, fluorouracil, concomitantly with brivudine,
sorivudine or
their derivatives, may significantly exacerbate the side effects of
Verrumal.
Treatment with Verrumal may be started, at the very earliest, four
weeks after
completing the treatment for herpes zoster with brivudine or
sorivudine.
If you are being treated or were recently tr
                                
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Produktets egenskaber

                                1
VERRUMAL®
1. NAME OF THE MEDICINAL PRODUCT
Verrumal Solution
Solution, topical
Fluorouracil, Salicylic acid
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
100 g of solution contains:
Fluorouracil 0.5 g; salicylic acid 10.0 g
Other excipient with known effect: dimethyl sulfoxide 8.0 g and 160 mg
alcohol (ethanol) per g.
For a full list of excipients, see Section 6.1.
3. PHARMACEUTICAL FORM
Solution, topical.
Verrumal Solution is a clear, colourless to slightly yellow-orange
solution.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Common warts (special form: plantar warts, on areas of the sole of the
foot that are subjected to pressure),
plane juvenile warts of the extremities.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Generally Verrumal Solution is applied to every wart two to three
times daily.
The average duration of treatments is six weeks. It must be applied
consistently every single day.
After successful treatment further treatment should follow for approx.
one week.
Children
Verrumal Solution must not be used on babies.
Method of administration
For application to the skin.
Verrumal Solution must only be used on the wart and not on the healthy
skin around the wart; if necessary,
cover the surrounding skin with a paste or cream. It is recommended
that wipe the brush on the neck of the
bottle before dabbing it on. With very small warts you should use a
toothpick or something instead of a
brush for more precise application.
2
Before reapplying Verumal Solution the coating should be removed every
time by simply pulling it off.
In case of periungual and in particular subungual warts, make sure
that the nail matrix is not damaged and
that Verrumal Solution does not get into the nail bed.
The area to be treated should not be larger than 25 cm².
Experience has shown that in many cases, e.g. with very prominent
common warts and planar warts on the
soles of the feet, it is better if the dead tissue is removed by a
doctor after treatment with Verrumal Solu-
tion.
4.3 CONTRAINDICATIONS
Hypersensitivity to 
                                
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