Cepan

Package leaflet: Information for the user

Cepan, cream
Please read all of this leaflet carefully before you start using this medicine, because it contains
important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If your symptoms do not improve or if you feel worse, you should consult your doctor.

Contents of the leaflet

1. What Cepan is and what it is 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 pack and other information

1. What Cepan is and what it is 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 softens scars, making them flatter and paler. Early use of Cepan helps prevent scar formation.
Cepan prevents the development of hypertrophic scars. Furthermore, it enhances swelling, softening,
and loosening of scar tissue, exerting a beneficial effect on collagen structure. The cream penetrates
deeply into the scar very easily.
The cream accelerates tissue regeneration, reduces inflammatory reactions, and also relieves feelings of tightness
and itching.
Indications for use of Cepan:

• Local treatment of scars and keloids following burns and surgical procedures;
• Treatment of contractures;
• Treatment of eyelid scars;
• Treatment of scars following boils, ulcers, and acne.

2. Information before using Cepan

When not to use Cepan
Do not use this medicine if the patient is allergic to the active substances or to any of the
other ingredients of this medicine (listed in section 6).

Warnings and precautions
If any signs of hypersensitivity (such as redness, itching) occur at the site of application of Cepan cream, discontinue use and consult a doctor or pharmacist.
When using Cepan for the treatment of scars on the eyelids, care must be taken to avoid contact with the eyes.

Cepan and other medicines
Inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines planned for future use.
No interaction has been reported between Cepan and other medicines applied topically to the skin.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
There is no data available on the safety of using this medicine in pregnant or breastfeeding women.

Driving and operating machinery
No influence of the medicine on the ability to drive or operate machinery, or on psycho-motor performance, has been observed.

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

• Due to the presence of cetostearyl alcohol, this medicine may cause local skin reactions (e.g. contact dermatitis).
• The medicine contains up to 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 area of skin.
• This medicine contains up to 160 mg of alcohol (ethanol) per 1 g of cream. The medicine may cause a burning sensation on damaged skin. In newborns (premature infants and full-term newborns), high concentrations of ethanol may cause severe local and systemic toxicity due to significant absorption through immature skin (especially under occlusive dressing).
• The medicine contains methyl parahydroxybenzoate and propyl parahydroxybenzoate, which may cause allergic reactions (including delayed-type reactions).

3. How to use Cepan

This medicine should always be used exactly as described in this patient leaflet or as directed by a
physician or pharmacist. If in doubt, consult a doctor or pharmacist.
This medicine is intended for topical application to the skin.
Cepan should be applied after the wound has completely healed.
Recommended dosage
Adults and children:
Unless otherwise advised by a physician, apply a thin layer of Cepan cream to the scar and gently massage in
2 or 3 times daily.
For treatment of old and hardened scars as well as contractures, a small amount of cream should be applied
onto a sterile gauze dressing and placed on the scar for 30 to 60 minutes.
Depending on the age of the scar, treatment may last from several weeks to several months.
Treatment results depend on consistent, regular use of the medicine. Treatment should begin as early
as possible after scar formation. Regular use of the cream often helps avoid the need for repeat surgery
or skin grafting.
If there is no improvement, or if the patient's condition worsens, consult a physician.
Use of more Cepan than recommended
Overdose is practically impossible with topical use.
In case of accidental oral ingestion, consult a doctor or pharmacist.
Missed dose of Cepan
Do not apply a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody will experience them.
At the beginning of treatment, redness and burning sensation of the skin may occur. These symptoms are rare.
If they occur, the use of the medicine should be reduced until symptoms resolve. If reducing the use of the medicine does not alleviate skin irritation, the medicine should be discontinued and a doctor should be consulted.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide 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 below 25 °C. Keep in the original packaging.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Cepan can be used for 6 months after the date of first use, provided that this does not extend beyond the expiry date printed on the packaging.
Enter the date of first use of the medicine in this box:
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the pack and other information

What Cepan contains

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

100 g of cream contains:
ethanolic extract of onion (Alii cepae extractum fluidum) 20.0 g
tincture of chamomile (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 components (excipients) are: mixture of cetearyl alcohol and sodium lauryl sulfate; liquid paraffin; white soft paraffin; 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 contents of the pack
The medicine is a yellowish cream.
Packaging: an aluminum tube, internally lacquered, sealed with a membrane and a PE cap,
containing 35 g of cream, placed in a cardboard box with a leaflet.

Marketing Authorisation 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 package leaflet of Cepan is available in the Audio Leaflet system via the nationwide, free telephone number: 800 706 848.