Package leaflet: Information for the patient

Contractubex, (50 IU + 100 mg + 10 mg)/g, gel
Sodium heparin, liquid extract of onion, allantoin
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
a doctor or pharmacist.

Keep this leaflet, as you may need to read it again.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement or if you feel worse, consult your doctor.

Table of contents of the leaflet:

What Contractubex is and what it is used for
Important information before using Contractubex
How to use Contractubex
Possible side effects
How to store Contractubex
Contents of the pack and other information

1. What Contractubex is and what it is used for

Contractubex is a scar treatment medicine used after complete wound healing.
Contractubex has anti-proliferative, anti-inflammatory, smoothing and tissue-relaxing effects on scar tissue.
Indications
Scars restricting movement, enlarged scars (hypertrophic, swollen, keloid-shaped), cosmetically undesirable post-surgical scars, scars after amputations, burn scars and traumatic scars, contractures e.g. of fingers (Dupuytren's contracture), tendon contractures caused by trauma and scar shrinkage.
Contractubex is indicated for use in adults and in children and adolescents aged above 1 year up to 17 years.

2. Important information before using Contractubex

When not to use Contractubex:

if the patient is allergic to heparin, onion extract, allantoin, or any of the other ingredients of this medicine (listed in section 6);

Warnings and precautions
Before starting treatment with Contractubex, discuss it with your doctor or pharmacist.
Apply only after complete wound healing. Treatment should be started as early as possible after the scar appears.
If signs of hypersensitivity occur, discontinue use of Contractubex.
When treating large skin areas, symptoms related to systemic effects of heparin may occur.

Children and adolescents
Instructions for use in children and adolescents, see section 3.
Due to lack of data, Contractubex should not be used in children under 1 year of age.

Contractubex with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently used, as well as any medicines the patient plans to use.
There is no data available on interactions. To date, no interactions between Contractubex and other medicines have been reported.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Contractubex should not be used during pregnancy.
When breastfeeding, do not apply Contractubex to the breast area.

Driving and operating machinery
Contractubex has no effect or has a negligible effect on the ability to drive and operate machinery.

Contractubex contains:

methyl parahydroxybenzoate, which may cause allergic reactions (including delayed-type reactions).
sorbic acid, which may cause local skin reactions, e.g. contact dermatitis.
a fragrance ingredient containing citronellol, geraniol, benzyl alcohol, citral, and linalool, which may cause allergic reactions.
13.5 mg of alcohol (ethanol) in 1 g of gel (1.35% m/m). Alcohol may cause a stinging sensation on damaged skin. The product is flammable. Keep away from fire and do not use near open flames, lit cigarettes, or certain devices (e.g. hair dryers).

3. How to use Contractubex

This medicine should always be used exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Unless otherwise advised by a doctor, the medicine is usually applied several times a day, gently massaged into the skin or scar tissue. For hardened and old scars, a dressing containing Contractubex may be applied overnight.
Treatment lasts from several weeks to several months, depending on the size of the scar or presence of contractures. During treatment of fresh scars, physical irritants such as low temperatures, UV radiation, excessive rubbing, and other mechanical irritations should be avoided.

Use in children and adolescents
In children over 1 year of age, the gel may be applied to scar tissue once or twice daily.
Due to lack of data, Contractubex should not be used in children under 1 year of age.
If you have any questions about the use of this medicine, consult a doctor or pharmacist.

Use of more Contractubex than recommended
No cases of overdose have been reported.
When treating large skin areas, symptoms related to systemic effects of heparin may occur.

Missed dose of Contractubex
Do not use a double dose to make up for a missed dose.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this product may cause adverse reactions, although not everybody experiences them.
The most frequently reported adverse reactions were reactions at the site of application (see also section "Contractubex contains").
The following adverse reactions were reported during a study conducted in 592 patients treated with Contractubex.
Common (may affect up to 1 in 10 people):
itching (pruritus), intense redness (erythema), dilated blood capillaries in the skin (spider veins), deepening of scar (scar atrophy).
Uncommon (may affect up to 1 in 100 people):
skin discoloration (hyperpigmentation), thinning of the skin.
The following adverse reactions have been reported spontaneously:
Frequency not known (frequency cannot be estimated from the available data):
small pus-filled blisters on the skin (pustular rash), allergic reaction (hypersensitivity), abnormal skin sensations (paresthesia), swelling, pain at the site of application, local skin reactions (contact dermatitis), urticaria, rash, itching, redness, skin irritation, small solid round lumps (nodules), dermatitis, burning sensation of the skin, peeling at the site of application, sensation of tightness of the skin.
Contractubex is well tolerated, even during long-term use.
During treatment with Contractubex, itching may occur, which results from changes in scar tissue and does not require discontinuation of treatment.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safe use of the medicine.

5. How to store Contractubex

Do not store above 25 °C.
Shelf life after first opening the tube: 6 months.
Keep out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. Doing so will help protect the environment.

6. Contents of the pack and other information

What Contractubex contains
The active substances are:
sodium heparin, onion extract, and allantoin.
Each 1 g of gel contains 50 IU of sodium heparin, 100 mg of onion extract, and 10 mg of allantoin.
Excipients:
ethanol, sorbic acid (E 200), methyl 4-hydroxybenzoate (E 218), xanthan gum, polyethylene glycol 200,
perfume oil Fragrance 30263773 Rosae containing citronellol, geraniol, benzyl alcohol, citral, and linalool (see section 2), purified water.

What Contractubex looks like and contents of the pack
An opaque gel ranging in colour from light beige to light brown, in a tube packed in a cardboard box.
Available pack sizes: tubes containing 20 g, 50 g, or 100 g of gel, placed in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Merz Pharmaceuticals GmbH
Eckenheimer Landstrasse 100
60318 Frankfurt/Main
Germany
e-mail: [email protected]

Manufacturer
Merz Pharma GmbH & Co. KGaA
Eckenheimer Landstrasse 100
60318 Frankfurt/Main
Germany