Contractubex

Package Leaflet: Information for the Patient

Contractubex, (50 IU + 100 mg + 10 mg)/g, Gel

Sodium heparin, onion extract, allantoin

Read the package 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 package leaflet for the patient or as directed by a doctor or pharmacist.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse, they should contact their doctor.

Table of Contents of the Leaflet:

• 1. What is Contractubex and what is it used for
• 2. Important information before using Contractubex
• 3. How to use Contractubex
• 4. Possible side effects
• 5. How to store Contractubex
• 6. Package contents and other information

1. What is Contractubex and what is it used for

Contractubex is a scar treatment used after the wound has completely healed.
Contractubex has anti-proliferative, anti-inflammatory, smoothing, and loosening effects on scar tissue.

Indications

Scars that restrict movement, enlarged (hypertrophic, swollen, keloid-like), unsightly post-operative scars, scars after amputations, burn scars, and accident scars, contractures (e.g., Dupuytren's contracture), tendon contractures caused by injuries, and scar contraction.
Contractubex is indicated for use in adults and children over 1 year of age 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, the patient should discuss it with their doctor or pharmacist.
Contractubex should be used after the wound has completely healed. Treatment should be started as soon as possible after the scar appears.
If signs of hypersensitivity occur, the use of Contractubex should be discontinued.
During treatment of large skin areas, systemic effects of heparin may occur.

Children and adolescents

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

Contractubex and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
There are no data on interactions. No interactions between Contractubex and other medicines have been reported so far.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before using this medicine.
Contractubex should not be used during pregnancy.
During breastfeeding, the medicine should not be applied to the breast area.

Driving and using machines

Contractubex has no or negligible influence on the ability to drive and use machines.

What Contractubex contains

• methyl parahydroxybenzoate, which may cause allergic reactions (possible late reactions).
• sorbic acid, which may cause local skin reactions, such as contact dermatitis.
• a fragrance substance containing citronellol, geraniol, benzyl alcohol, citral, and linalool, which may cause allergic reactions.
• 13.5 mg of ethanol (alcohol) per 1 g of gel (1.35% m/m). Alcohol may cause a burning sensation on damaged skin. The medicine is flammable. Keep away from fire and do not use near an open flame or lit cigarette, or certain appliances (e.g., hair dryers).

3. How to use Contractubex

This medicine should always be used exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist.
In case of doubt, the patient should consult their doctor or pharmacist.
Unless otherwise directed by the doctor, the medicine is usually applied several times a day, gently rubbing it into the skin or scar tissue.
In the case of hardened and long-standing scars, a dressing with Contractubex can be applied at night.
Treatment lasts from several weeks to several months, depending on the size of the scar or the presence of contracture.
During treatment of fresh scars, physical stimuli such as low temperatures, UV radiation, and excessive rubbing or other mechanical irritations should be avoided.

Use in children and adolescents

In children over 1 year of age, the gel can be applied to scar tissue once or twice a day.
Due to the lack of data, Contractubex should not be used in children under 1 year of age.
In case of any questions about the use of this medicine, the patient should consult their doctor or pharmacist.

Using more than the recommended dose of Contractubex

No cases of overdose have been reported.
During treatment of large skin areas, systemic effects of heparin may occur.

Missing a dose of Contractubex

A double dose should not be used to make up for a missed dose.
In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Contractubex can cause side effects, although not everybody gets them.
The most commonly reported side effects were reactions at the site of application (see also the section "What Contractubex contains").
The following side effects were reported in a study of 592 patients treated with Contractubex.
Common (occurring in no more than 1 in 10 patients):
itching (pruritus), severe redness (erythema), spider veins on the skin (telangiectasia), deepening of the scar (scar atrophy).
Uncommon (occurring in no more than 1 in 100 patients):
skin discoloration (hyperpigmentation), skin thinning.
The following side effects 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 injection site, local skin reactions (contact dermatitis), hives, rash, itching, redness, skin irritation, small, solid, round nodules (papules), skin inflammation, burning sensation on the skin, peeling at the injection site, feeling of skin tightness.
Contractubex is well tolerated, even during long-term use.
During treatment with Contractubex, itching may occur, which is a result of scar changes and does not require discontinuation of treatment.

Reporting side effects

If any side effects occur, including any not listed in this leaflet, the patient should inform their doctor or pharmacist.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Contractubex

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.
The patient should ask their pharmacist how to dispose of medicines no longer required.
This will help protect the environment.

6. Package contents and other information

What Contractubex contains

The active substances of the medicine are:
sodium heparin, onion extract, and allantoin.
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 parahydroxybenzoate (E 218), xanthan gum, macrogol 200, fragrance substance Perfume oil Fragrance 30263773 Rosae, containing citronellol, geraniol, benzyl alcohol, citral, and linalool (see section 2), purified water.

What Contractubex looks like and what the package contains

A non-transparent gel with a color from light beige to light brown in a tube packaged in a cardboard box.
Available packages: tube containing 20 g, 50 g, or 100 g of gel, placed in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization 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

Date of last revision of the leaflet: