Medulan

Package leaflet: Information for patients

Medulan, 30 mg/g, gel
Diclofenacum natricum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet to be able to read it again if necessary.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed strictly for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What Medulan is and what it is used for

Medulan contains the active substance diclofenac sodium and is a non-steroidal anti-inflammatory drug in the form of a topical gel. Medulan is applied to the skin in adult patients for the treatment of a skin condition called actinic keratosis, caused by long-term exposure to sunlight.

2. Important information before using the medicine Medulan

When not to use Medulan

• if the patient is allergic to diclofenac or any of the other ingredients of this medicine (listed in section 6),
• if the patient has previously experienced allergic reactions such as rash (urticaria), breathing problems (wheezing) or nasal catarrh (allergic rhinitis) after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs,
• if the patient is in the last three months of pregnancy.

Warnings and precautions
Before starting to use Medulan, discuss this with your doctor or pharmacist.

• Systemic adverse reactions cannot be ruled out when Medulan is used over large areas of skin or for prolonged periods. Contact your doctor if the patient:
• has current or past history of gastric ulcer or gastrointestinal bleeding,
• has heart, liver or kidney disease,
• has any blood clotting disorders or is prone to bruising.
• During treatment with Medulan, avoid exposure to sunlight and do not use sunbeds. If skin reactions occur, discontinue use of the medicine.
• Do not apply to wounds, infected skin or skin lesions caused by skin inflammation.
• Avoid contact of Medulan with the eyes or mucous membranes of the nose or mouth, and do not swallow. If Medulan is accidentally ingested, contact a doctor immediately.
• Discontinue use of Medulan and consult a doctor if extensive rash develops.
• After applying diclofenac-containing medicines to the skin, breathable (non-occlusive) dressings may be used. Do not use air-tight, occlusive dressings.

Children and adolescents
The dosage range and indications for use of Medulan in children and adolescents have not been established.

Medulan and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines planned for future use.
Interactions with other medicines are unlikely with Medulan.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Medulan must not be used during the last three months of pregnancy. Medulan should not be used during the first six months of pregnancy unless clearly necessary and advised by a doctor.
If treatment is necessary during this period, the lowest effective dose should be used for the shortest possible duration.
Oral forms (e.g. tablets) of Medulan may cause adverse effects in the unborn child. It is not known whether the same risk applies to Medulan when applied to the skin.
Consult your doctor if you are breastfeeding. Medulan may be used with caution during breastfeeding, but should not be applied to the skin of the breast area.
If the patient is pregnant, planning pregnancy, or breastfeeding, and the doctor considers treatment with Medulan appropriate, the medicine must not be applied to an area of skin larger than one third of the body surface, and must not be used for longer than three weeks.

Medulan contains benzyl alcohol
This medicine contains 10 mg of benzyl alcohol per gram of gel.
Benzyl alcohol may cause allergic reactions and mild local irritation.

3. How to use Medulan

This medicine should always be used exactly as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
The gel is intended for external use on the skin only.

• Before use, pierce the aluminium seal covering the opening with the cap.
• Gently apply a small amount of gel to the affected area of skin requiring treatment. The amount of gel used should vary according to the size of the skin area to be treated. Usually, 0.5 grams of gel (corresponding to the size of a pea) is sufficient, and no more than 8 grams of gel per day should be applied to a skin surface of 5 cm x 5 cm.
• Medulan gel may be applied twice daily, unless otherwise directed by a doctor. A mild cooling sensation on the skin may occur during application.
• The usual duration of treatment is 60 to 90 days. Maximum therapeutic effect has been observed after approximately 90 days of treatment. Complete healing may not occur until one month after completion of treatment.

Apply the gel to the affected areas of the body and gently massage into the skin. Afterwards, wipe hands with a paper towel and then wash them, unless the hands themselves are the area to be treated.
If too much gel is accidentally applied, wipe off the excess with a paper towel.
Dispose of the paper towel in the household waste container, which helps significantly reduce the release of diclofenac into the aquatic environment.
Wait several minutes after application to allow the gel to dry before applying a dressing.

Use of more Medulan than recommended
Remove any excess gel by wiping with a paper towel.

Missed dose of Medulan
Continue using the medicine as directed.
Do not use a double dose to make up for a missed dose.

If you have further questions about the use of this medicine, consult your doctor or
pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following adverse reactions occur, discontinue use of Medulan and contact your doctor as soon as possible:
Rash (urticaria), breathing problems (wheezing), facial swelling, nasal discharge (allergic rhinitis).
Such symptoms may indicate an allergic reaction to Medulan.

If any of the following common adverse reactions are severe or persist for more than a few days, discontinue use of Medulan and contact your doctor: itching, rash, skin redness, inflammation, contact dermatitis, pain, and blisters.

Other commonly occurring adverse reactions: (may affect up to 1 in 10 patients)

• irritation or tingling at the site of gel application
• conjunctivitis
• hypersensitivity
• pain upon touching the skin
• numbness and tingling
• muscle stiffness
• dermatitis
• skin eruption
• dry skin
• swelling
• rash (including scaling or blistering)
• skin flaccidity
• skin ulcer.

Uncommonly occurring adverse reactions: (may affect up to 1 in 100 patients)

• eye pain
• tearing or dry eyes
• abdominal pain
• diarrhoea
• nausea
• hair loss
• facial swelling
• excessive bleeding or excessive sebum secretion
• rash resembling measles.

Rarely occurring adverse reactions: (may affect up to 1 in 1,000 patients)

• dermatitis with large blisters.

Very rarely occurring adverse reactions: (occur in fewer than 1 in 10,000 patients)

• gastric bleeding
• kidney function disorders
• breathing difficulties (asthma)
• infection of skin rash
• skin photosensitivity.

Transient hair discoloration at the site of application has been reported, usually resolving after discontinuation of the medicine.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions 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.: 22 49-21-301, fax: 22 49-21-309,
website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the Marketing Authorisation Holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Medulan

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the tube and carton after: EXP.
The expiry date refers to the last day of the stated month.
Do not store in the refrigerator or freeze.
Duration of use after first opening: 6 months.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

What Medulan contains

• The active substance is: sodium diclofenac. 1 g of gel contains 30 mg of sodium diclofenac.
• Other ingredients are: sodium hyaluronate, benzyl alcohol, polyethylene glycol monomethyl ether 350, purified water.

What Medulan looks like and contents of the pack
Medulan medicinal product is a homogeneous, transparent, colourless to pale yellow or orange gel, packed in aluminium tubes containing 25 g, 50 g, 60 g, 90 g or 100 g of gel.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Aristo Pharma Sp. z o.o.
ul. Baletowa 30
02-867 Warsaw
+48 22 855 40 93

Importer
Aristo Pharma GmbH
Wallenroder Strasse 8-10
13435 Berlin
Germany

This medicinal product is authorised in the European Economic Area countries under the following names:
Germany Diclofenac Aristo 30 mg/g gel
Poland Medulan
Italy Rindox