Difortan

Leaflet attached to the packaging: Patient Information

Difortan 100 mg/g gel

Etofenamate

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

This medicine should always be used exactly as described in the leaflet or as advised by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement after 7 days or if the patient feels worse, they should contact their doctor.

Table of Contents of the Leaflet

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

1. What is Difortan and what is it used for

Difortan contains etofenamate, which is a non-steroidal anti-inflammatory drug for topical use, applied directly to the painful area, and has the following effects:

• analgesic;
• reducing swelling and inflammation.

Difortan can be used in adults for the treatment of:

• muscle and joint injuries, such as bruises, sprains, and strains, as well as tendonitis;
• rheumatic diseases (rheumatism), such as arthritis and degenerative joint disease.

Difortan is a medicine intended for external use on the skin and should not be applied to the eyes or mucous membranes.

2. Important information before using Difortan

When not to use Difortan:

• if the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6);
• in pregnant women;
• on damaged or infected skin, including skin areas with wounds and eczema (a type of skin inflammation);
• in children under 12 years of age.

Warnings and precautions

Before starting to use Difortan, the patient should discuss it with their doctor or pharmacist. Difortan is applied to the skin, directly to the painful area, and there is a risk of absorption into the bloodstream, which may cause effects in other parts of the body beyond the application site. The risk of such effects is minimal and depends, among other things, on the surface area exposed to the medicine, the amount used, and the duration of exposure. Particular caution should be exercised when using Difortan:

• in case of allergy to other non-steroidal anti-inflammatory drugs for topical use;
• if the area where Difortan is applied is exposed to sunlight, as photodermatosis (a skin inflammation that may appear as redness and itching in the area of application after sun exposure) may occur. If any of these symptoms occur, the patient should contact their doctor or pharmacist immediately;
• if the medicine is used near mucous membranes (e.g., in the mouth) or eyes;
• in case of liver or kidney function disorders.

Difortan and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. Difortan may change the effects of other medicines taken. For this to happen, Difortan, applied to the skin, must be absorbed into the bloodstream. Since Difortan is absorbed into the bloodstream in a negligible amount, it is unlikely to affect the effects of other medicines. The patient should consult their doctor or pharmacist before starting to use Difortan if they are taking any of the following medicines, as they may affect the action of the medicine or increase the risk of side effects:

• medicines used to control blood pressure, including diuretics;
• medicines used to thin the blood;
• lithium, used in the treatment of bipolar affective disorder.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine. Difortan must not be used in pregnant women or in cases where pregnancy is suspected. Difortan can be used by women who are breastfeeding.

Driving and using machines

The likelihood that the use of Difortan will affect the ability to drive and use machines is low.

3. How to use Difortan

This medicine should always be used exactly as described in the patient information leaflet or as advised by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist. Before each use and after each use, the patient should wash their hands, unless the painful area is on their hands. The medicine is intended for use on undamaged skin, directly on the painful area. During each application, the patient should use approximately 2.5 to 5 cm of gel. The medicine should be spread over the entire painful area, gently rubbing it in. Difortan should be used in adults as follows:

Pain and/or inflammation relief should be felt after 3 or 4 days of treatment with Difortan. Difortan should not be used for more than 14 days in the case of muscle or joint injuries or 21 days in the case of arthritis and joint pain in degenerative joint disease, unless otherwise advised by a doctor. If symptoms worsen or do not improve after 7 days of therapy, the patient should contact their doctor. In case of liver or kidney function disorders, the patient should consult their doctor, as it may be necessary to adjust the dose of Difortan.

In case of accidental contact with Difortan

Difortan should not be applied to damaged or infected skin. In case of accidental contact with the eyes, mucous membranes (e.g., the mouth), or damaged skin, the area should be rinsed thoroughly with running water. If irritation persists, the patient should consult their doctor or pharmacist.

In case of accidental or intentional ingestion of Difortan

The patient should immediately go to the hospital, where appropriate treatment will be administered, taking the packaging and tube of the medicine with them.

Using a higher dose of Difortan than recommended

There are no known cases of Difortan overdose due to application to the skin in amounts greater than recommended.

Missing a dose of Difortan

The patient should not use a double dose to make up for a missed dose.

Stopping the use of Difortan

Treatment can be stopped at any time without the need for special measures; however, the problem may recur in the affected area. If the patient has any further doubts about the use of this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Difortan can cause side effects, although not everybody gets them. The patient should stop using Difortan and contact their doctor immediately if they experience any of the following side effects:

• Hypersensitivity, which is a type of allergic reaction in the form of a skin rash (redness and spots on the skin), shortness of breath, and difficulty swallowing.
• Bullous reactions (extensive skin changes involving redness, peeling, and large blisters).
• Photodermatosis (a skin inflammation that may appear as redness and itching in the area of application after sun exposure).

The risk of these reactions is higher at the beginning of treatment and, in most cases, they occur within the first month of therapy. The following side effects may occur, described according to their frequency:

Common: may affect up to 1 in 10 people

• Itching (pruritus);
• Redness (appearance of red spots on the skin);
• Local skin irritation, which usually disappears after stopping treatment.

Uncommon: may affect up to 1 in 100 people

• Contact dermatitis (skin inflammation in the area of application);
• Allergic dermatitis (skin inflammation due to an allergy to Difortan);
• Photodermatosis (a skin inflammation that may appear as redness and itching in the area of application after sun exposure).

Rare: may affect up to 1 in 1,000 people

• Urticaria (hives with itching);
• Bullous reactions (extensive skin changes involving redness, peeling, and large blisters), including Stevens-Johnson syndrome;
• Toxic epidermal necrolysis.

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should consult 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, ul. Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, e-mail: [email protected]

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

Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Difortan

The medicine should be stored out of sight and reach of children. There are no special storage temperature recommendations. The medicine should be stored in its original packaging to protect it from light. After the first opening, the medicine should be used within 6 months. Do not use this medicine after the expiry date stated on the packaging after the EXP symbol. The expiry date refers to the last day of the month stated. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Difortan contains

• The active substance of Difortan is etofenamate.
• The other ingredients are: isopropyl alcohol, glycerol, trometamol, carbomers, and purified water.

What Difortan looks like and what the pack contains

Difortan is sold in an aluminum tube with an internal epoxy-phenolic coating, closed with an aluminum membrane and a HDPE cap, containing 50 or 100 g of gel. The outer packaging is a cardboard box. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

US Pharmacia Sp. z o.o., ul. Ziębicka 40, 50-507 Wrocław

Manufacturer:

Laboratórios Basi – Indústria Farmacêutica, S.A., Parque Industrial Manuel Lourenço Ferreira, lote 15 e 16, 3450-232 Mortágua, Portugal, Tel.: +351 231 920 250, Fax: +351 231 921 055, E-mail: [email protected]. For more detailed information, the patient should contact the representative of the marketing authorization holder: USP Zdrowie Sp. z o.o., ul. Poleczki 35, 02-822 Warszawa, Tel.: +48 (22) 543 60 00

Date of last revision of the leaflet: May 2018