Contractubex Gel

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

HEPARIN SODIUM, EXTRACTUM CEPAE, ALLANTOIN

Available from:

Merz Pharmaceuticals GmbH Eckenheimer Landstrasse 100, D-60318 Frankfurt am Main, Germany

ATC code:

D03AX

INN (International Name):

HEPARIN SODIUM 5000 IU EXTRACTUM CEPAE 10 g ALLANTOIN 1 g

Pharmaceutical form:

GEL

Composition:

HEPARIN SODIUM 5000 IU EXTRACTUM CEPAE 10 g ALLANTOIN 1 g

Prescription type:

OTC

Therapeutic area:

PREPARATIONS FOR TREATMENT OF WOUNDS AND ULCERS

Authorization status:

Authorised

Authorization date:

2006-11-07

Patient Information leaflet

1/4
PACKAGE LEAFLET: INFORMATION FOR THE USER
CONTRACTUBEX
® GEL
Active substances: Extr. Cepae, Heparin sodium, Allantoin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
Always use this medicine exactly as described in this leaflet or as
your doctor or pharmacist has told you.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
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.
-
You must talk to a doctor if you do not feel better or if you feel
worse.
WHAT IS IN THIS LEAFLET
1.
What Contractubex
®
is and what it is used for
2.
What you need to know before you use Contractubex
®
3.
How to use Contractubex
®
4.
Possible side effects
5.
How to store Contractubex
®
6.
Contents of the pack and other information
1.
WHAT CONTRACTUBEX
® IS AND WHAT IT IS USED FOR
Contractubex
®
is used to treat various types of scars once the lesions have closed.
Contractubex
®
works to suppress the growth of scar tissue and has a loosening and
smoothening effect on
scar tissue. It also works to reduce redness, warmth, swelling and
pain (anti-inflammatory).
Contractubex
®
is to be used in patients with movement-restricting, hypertrophic,
keloid (scars that are thick,
raised, and sometimes differently coloured than your surrounding skin)
and cosmetically disfiguring scars
after operations, amputations, burns and accidents; after contractures
such as Dupuytren’s contracture (a
constricting of the hand) and traumatic tendon contractures as well as
atrophic scars (scars that form a hole
or wrinkle in the skin).
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE CONTRACTUBEX
®
DO NOT USE CONTRACTUBEX
®
-
If you are allergic (hypersensitive) to Extr. Cepae, heparin sodium,
or allantoin, parabens (methyl 4-
hydroxybenzoates), sorbic acid, Citronellol, Geraniol, Benzyl Alcohol,
Citral and Linalool or any of the

Summary of Product characteristics

Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Contractubex Gel
Active substances: Extr. Cepae, heparin sodium, allantoin
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
100 g gel contains:
Active substances:
Extr. Cepae
10.0 g liquid extract from onion (Allium Cepa L., Bulbus (0,16:1)).
Extraction solvent: water. Excipient: ethanol.
Heparin sodium 5000 IU
Allantoin
1.0 g
Excipients: sorbic acid (E200), methyl-4-hydroxybenzoate (218),
fragrance with Citronellol,
Geraniol, Benzyl Alcohol, Citral and Linalool
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gel
Opaque gel of light beige to light brown colour.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hypertrophic,
keloidal,
movement-restricting
and
cosmetically
disfiguring
scars
after
operations, amputations, burns, accidents; contractures such as
Dupuytren's contracture and
traumatic tendon contractures; cicatricial strictures (atrophic
scars). Contractubex is used to
treat these types of scars once the lesions have closed.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Apply to the skin or scar tissue several times daily and gently
massage in until the gel has
been completely absorbed. In the case of old, hard scars, allow the
gel to take effect overnight
under a dressing.
Dependent on the extent and thickness of the scar or contracture,
treatment will be necessary
for
several weeks or months. When treating fresh scars, physical irritants
such as extreme
cold or UV light or heavy massaging should be avoided.
4.3
CONTRAINDICATIONS
Page 2 of 6
Hypersensitivity to the active substances Extr. Cepae, heparin sodium,
or allantoin, to sorbic
acid, methyl-4-hydroxybenzoate (parabens), Citronellol, Geraniol,
Benzyl Alcohol, Citral und
Linalool or any of the other ingredients.
4.4
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
Contractubex contains methyl-4hydroxybenzoate, which may cause
allergic reactions
(possibly delayed). Contractubex contains sorbic acid, which may cause
local skin reactions,
e.g. contact derm