Cepan

Package Leaflet: Information for the User

Cepan, Cream

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 or as directed by your doctor or pharmacist.

• Keep this package leaflet, you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. See section 4.
• If there is no improvement or if you feel worse, contact your doctor.

Table of Contents of the Package Leaflet

• 1. What is Cepan and what is it used for
• 2. Important information before using Cepan
• 3. How to use Cepan
• 4. Possible side effects
• 5. How to store Cepan
• 6. Contents of the package and other information

1. What is Cepan and what is it used for

Cepan is a cream for topical application to the skin. It contains four active substances: ethanol extract of onion, chamomile tincture, sodium heparin, and allantoin.
The medicine causes the scar to become more elastic, flatten, and fade. Using the medicine Cepan early enough prevents the formation of scars.
Cepan prevents the formation of hypertrophic scars. Additionally, it enhances swelling, softening, and relaxation of scar tissue, positively affecting collagen structure. The medicine easily penetrates deep into the scar.
The cream accelerates tissue regeneration, reducing the inflammatory response, and also eliminates the feeling of tension and itching.

Indications for use of Cepan:

• local treatment of scars and keloids after burns and surgical procedures;
• treatment of contractures;
• treatment of eyelid scars;
• treatment of scars after boils, ulcers, and acne.

2. Important information before using Cepan

When not to use Cepan

Do not use the medicine if you are allergic to the active substances or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

If you experience any symptoms of hypersensitivity (such as redness, itching) at the site of application of Cepan cream, discontinue use and consult your doctor or pharmacist.
When using Cepan to treat eyelid scars, be careful not to get it into your eyes.

Cepan and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
No interaction between Cepan and other topical medicines has been found.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.
There is no data on the safety of using the medicine in pregnant and breastfeeding women.

Driving and using machines

No effect of the medicine on the ability to drive and use machines, as well as on psychophysical performance, has been found.

The medicine contains cetostearyl alcohol, sodium lauryl sulfate, ethanol, methyl parahydroxybenzoate, propyl parahydroxybenzoate

• Due to the presence of cetostearyl alcohol, the medicine may cause local skin reactions (e.g., contact dermatitis).
• The medicine contains a maximum of 8.34 mg of sodium lauryl sulfate per gram of cream. Sodium lauryl sulfate may cause local skin irritation (such as stinging or burning) or exacerbate skin reactions caused by other medicines applied to the same skin area.
• This medicine contains up to 160 mg of alcohol (ethanol) per gram of cream. The medicine may cause burning of damaged skin. In newborns (premature and full-term), high concentrations of ethanol may cause severe local reactions and systemic toxicity due to significant absorption through immature skin (especially under occlusive dressings).
• The medicine contains methyl parahydroxybenzoate and propyl parahydroxybenzoate and may cause allergic reactions (possible late reactions).

3. How to use Cepan

This medicine should always be used exactly as described in this package leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The medicine is intended for topical application to the skin.
Cepan should be used after the wound has completely healed.

Recommended dosage

Adults and children:
unless otherwise directed by your doctor, apply a thin layer of Cepan cream to the scar, gently massaging, 2 or 3 times a day.
In the treatment of old and hardened scars, as well as in contractures, it is recommended to apply a small amount of cream to a sterile gauze and apply it to the scar for 30 to 60 minutes.
Depending on the age of the scar, treatment lasts from several weeks to several months.
The effects of treatment depend on regular use of the medicine. Treatment should be started as soon as possible after the appearance of the scar. Using the cream often allows you to avoid reoperation or transplantation.
If there is no improvement or if you feel worse, contact your doctor.

Using more than the recommended dose of Cepan

When using the medicine topically, overdose is practically impossible.
In case of accidental ingestion, contact your doctor or pharmacist.

Missing a dose of Cepan

Do not use a double dose to make up for a missed dose.
If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
At the beginning of treatment, redness and burning of the skin may occur. These symptoms are rare.
If they occur, reduce the use of the medicine until they disappear. If reducing the use of the medicine does not make the skin irritation disappear, discontinue the medicine and contact your doctor.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist or nurse. 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 gather more information on the safety of the medicine.

5. How to store Cepan

Keep the medicine out of the sight and reach of children.
Store in a temperature below 25°C. Store in the original package.
Do not use this medicine after the expiry date stated on the package. The expiry date refers to the last day of the month stated.
Cepan can be used for 6 months from the date of first use, without exceeding the expiry date stated on the package.
In this window, enter the date of first use of the medicine:
Medicines should not be disposed of via wastewater or household waste containers. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Cepan contains

• The active substances of the medicine are: ethanol extract of onion, chamomile tincture, sodium heparin, and allantoin.

100 g of cream contains:
ethanol extract of onion (Alii cepae extractum fluidum)
20.0 g
chamomile tincture (Matricariae tinctura)
5.0 g
sodium heparin (Heparinum natricum)5000.0 IU
allantoin (Allantoinum)1.0 g
1 g of cream contains up to 160 mg of ethanol.

• Other ingredients (excipients) are: a mixture of cetostearyl alcohol and sodium lauryl sulfate; liquid paraffin; white petrolatum; self-emulsifying mixture of mono- and diglycerides of highly saturated fatty acids and potassium stearate; glycerol; methyl parahydroxybenzoate (E 218); propyl parahydroxybenzoate (E 216); purified water.

What Cepan looks like and what the package contains

The medicine is a yellowish cream.
Package: aluminum tube, internally lacquered, closed with a membrane and a PE cap, containing 35 g of cream, placed in a cardboard box with a package leaflet.

Marketing authorization holder and manufacturer

Zakłady Farmaceutyczne „UNIA” Spółdzielnia Pracy
ul. Chłodna 56/60, 00-872 Warsaw
tel.: 22 620 90 81 ext. 190, fax: 22 654 92 40
e-mail: [email protected]
The content of the Cepan package leaflet is available in the Ulotka Audio system under the national, free phone number: 800 706 848.

Date of last revision of the package leaflet: