Medulan

Package Leaflet: Information for Patients

Medulan, 30 mg/g, Gel

Diclofenac Sodium

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Medulan and what is it 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 pack and other information

1. What is Medulan and what is it used for

Medulan contains the active substance diclofenac sodium and is a non-steroidal anti-inflammatory medicine in the form of a gel for topical use. Medulan is used on the skin for the treatment of skin disease, known as solar keratosis, caused by prolonged exposure to sunlight, in adult patients.

2. Important information before using Medulan

When not to use Medulan

• if you are allergic to diclofenac or any of the other ingredients of this medicine (listed in section 6),
• if you have had allergic reactions, such as rash (hives), breathing difficulties (wheezing) or runny nose (allergic rhinitis) after using acetylsalicylic acid or other non-steroidal anti-inflammatory medicines,
• if you are in the last three months of pregnancy.

Warnings and precautions

Before starting to use Medulan, discuss it with your doctor or pharmacist.

• It cannot be excluded that systemic side effects may occur after using Medulan on large areas of skin and for a longer period. You should contact your doctor if you:
• have or have had stomach ulcers or stomach bleeding
• have heart, liver, or kidney disease
• have bleeding disorders or are prone to bruising.
• While using Medulan, avoid exposure to sunlight and sunlamps. If skin reactions occur, discontinue use.
• Do not use on wounds, infected skin, or skin changes caused by skin inflammation.
• Do not let Medulan come into contact with your eyes or the mucous membranes of your nose or mouth, and do not swallow it. If Medulan is accidentally swallowed, contact your doctor immediately.
• You should stop using Medulan and consult your doctor if you develop a widespread rash.
• After applying Medulan to the skin, you can use non-occlusive (permeable) dressings. Do not use airtight occlusive dressings.

Children and adolescents

The use of Medulan in children and adolescents has not been established.

Medulan and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about any medicines you plan to take.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Medulan must not be usedduring the last three months of pregnancy. Medulan should not be used during the first six months of pregnancy, unless clearly necessary and prescribed by your doctor.

If treatment is necessary during this period, use the lowest dose for the shortest possible time.

Oral forms (e.g., tablets) of Medulan may cause side effects in the unborn child. It is not known if the same risk applies to Medulan used on the skin.

Consult your doctor if you are breastfeeding. Medulan can be used with caution during breastfeeding, but do not apply it to the breast skin.

If you are pregnant, planning to have a baby, or breastfeeding, and your doctor considers treatment with Medulan necessary, do not apply it to an area of skin larger than one-third of the body surface and do not use it for more 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

Always use this medicine exactly as your doctor or pharmacist has told you.

The gel is for use on the skin only.

• Before use, pierce the aluminum membrane covering the opening with the cap.
• Gently spread a small amount of gel on the skin surface that needs treatment. The amount of gel varies depending on the size of the skin surface that needs treatment. Usually, 0.5 grams of gel (about the size of a pea) and no more than 8 grams of gel per day are applied to a skin surface of 5 cm x 5 cm.
• Medulan can be used twice a day, unless your doctor has told you otherwise. When spreading the gel on the skin, a mild cooling sensation may occur.
• The treatment period is usually 60 to 90 days. The maximum effect of the medicine is observed after a treatment period of about 90 days. Complete healing may not occur before one month after the end of treatment.

Apply the gel to the affected areas and gently rub it into the skin. Then, wipe your hands with a paper towel and wash them, unless they are the areas 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, which helps to significantly reduce the release of diclofenac into the aquatic environment.

Before applying a dressing, let the gel dry on the skin for a few minutes.

If you use more Medulan than you should

Remove the excess gel by wiping with a paper towel.

If you forget to use Medulan

Continue using the medicine as prescribed.

Do not use a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Medulan can cause side effects, although not everybody gets them.

If you experience any of the following side effects, stop using Medulan and contact your doctor immediately:

Rash (hives), breathing difficulties (wheezing), face swelling, runny nose (allergic rhinitis). These symptoms may indicate an allergy to Medulan.

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

Other common side effects (may affect up to 1 in 10 people):

• irritation or tingling at the application site
• conjunctivitis
• allergic reactions
• pain when touching the skin
• numbness and tingling
• muscle stiffness
• skin inflammation
• rash
• dry skin
• swelling
• rash (including scaling or blisters)
• skin thinning
• skin ulcer.

Uncommon side effects (may affect up to 1 in 100 people):

• eye pain
• tearing or dryness of the eyes
• abdominal pain
• diarrhea
• nausea
• hair loss
• face swelling
• excessive bleeding or excessive sebum production
• rash similar to that seen in measles.

Rare side effects (may affect up to 1 in 1,000 people):

• skin inflammation with large blisters.

Very rare side effects (affect less than 1 in 10,000 people):

• stomach bleeding
• kidney problems
• breathing difficulties (asthma)
• infection of skin rash
• increased sensitivity of the skin to sunlight.

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

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Post-Marketing Surveillance 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.: 22 49-21-301, fax: 22 49-21-309,

website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Medulan

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the tube and carton after: EXP.

The expiry date refers to the last day of that month.

Do not store in a refrigerator or freeze.

Shelf-life after first opening: 6 months.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required.

This will help protect the environment.

6. Contents of the pack and other information

What Medulan contains

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

What Medulan looks like and contents of the pack

Medulan is a homogeneous, transparent, colorless to light yellow or orange gel packed in aluminum tubes containing 25 g, 50 g, 60 g, 90 g, or 100 g of gel.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization 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 medicine is authorized in the Member States of the European Economic Area under the following names:

Germany

Diclofenac Aristo 30 mg/g gel

Poland

Medulan

Italy

Rindox

Date of last revision of the leaflet:March 2025