Difortan

Package leaflet: Information for the patient

Difortan 100 mg/g gel
Etofenamate
Please read carefully the entire leaflet 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 directed by a
physician or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 7 days, or if you feel worse, consult your doctor.

Table of contents of the leaflet

1. What Difortan is and what it is 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 Difortan is and what it is used for

Difortan contains etofenamate, a non-steroidal anti-inflammatory drug for topical application to the skin, directly to the painful area, and has the following actions:

• Analgesic (pain-relieving);
• Anti-inflammatory and anti-edematous (reduces swelling and inflammation).

Difortan may be used in adults for the treatment of:

• Musculoskeletal injuries such as contusions, strains, sprains, and ligament inflammation;
• Rheumatic conditions (rheumatism), such as arthritis and degenerative joint disease.

Difortan is intended for external use on the skin only and must 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 to any of the other ingredients of this medicine (listed in section 6);
• in pregnant women;
• on damaged or infected skin, including areas of skin with wounds and rashes (a type of skin inflammation);
• in children under 12 years of age.

Warnings and precautions
Before starting to use Difortan, discuss this with your doctor or pharmacist.
Difortan is applied to the skin, directly to the painful area. There is a risk of absorption into the bloodstream, which may cause effects in other parts of the body beyond the site of application. The risk of such effects is minimal and depends, among other factors, on the surface area exposed to the medicine, the amount used, and the duration of exposure.
Special caution is required when using Difortan:

• in case of allergy to other non-steroidal anti-inflammatory medicines for topical use;
• if the area where Difortan has been applied is exposed to sunlight, as photodermatosis may occur (this is a skin reaction that may manifest as redness and itching at the application site following sun exposure). If any of these symptoms occur, contact your doctor or pharmacist immediately;
• if the medicine is used near mucous membranes (e.g., in the mouth) or eyes;
• in case of impaired liver or kidney function.

Difortan and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Difortan may alter the effects of other medicines. For this to occur, Difortan, applied to the skin, must be absorbed into the bloodstream. Since Difortan is absorbed into the bloodstream only to a very small extent, it is unlikely to affect the action of other medicines.
Contact your doctor or pharmacist before starting to use Difortan if you are taking any of the following medicines, as they may interact with the medicine or increase the risk of adverse 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, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Difortan must not be used in pregnant women or if pregnancy is suspected.
Difortan may be used by women during breastfeeding.
Driving and operating machinery
The likelihood that the use of Difortan will affect the ability to drive or operate machinery is low.
3. How to use Difortan
This medicine should always be used exactly as described in the patient leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Hands should be washed before and after each use, unless the painful area is on the hands.
The medicine is intended for use on intact skin, applied directly to the painful area.
For each application, use approximately 2.5 to 5 cm of gel.
The medicine should be spread over the entire painful area, gently rubbed in.
Difortan should be used in adults as follows:

Pain and/or inflammation should begin to decrease within 3 or 4 days of treatment with Difortan.
Do not use Difortan for longer than 14 days in the case of muscle or joint injuries, or 21 days in the case of joint inflammation and joint pain associated with degenerative joint disease, unless otherwise advised by a physician.
If symptoms worsen or no improvement is observed after 7 days of therapy, consult a doctor.
In case of impaired liver or kidney function, consult a doctor, as dose adjustment of Difortan may be necessary.

In case of accidental contact with Difortan
Do not apply Difortan to damaged or infected skin.
In case of accidental contact with the eyes, mucous membranes (e.g., oral cavity), or damaged skin, rinse the affected area thoroughly with running water. If irritation persists, consult a doctor or pharmacist.

In case of accidental or intentional ingestion of Difortan
Seek immediate medical attention at a hospital, bringing the medication packaging and tube with you for appropriate treatment.

Use of a higher than recommended dose of Difortan
There are no known cases of overdose with Difortan following application of a larger than recommended amount to the skin.

Missed application of Difortan
Do not apply a double dose to make up for a missed dose.

Discontinuation of Difortan treatment
Treatment may be discontinued at any time without the need for special measures; however, pain or swelling may recur at the affected site.

If you have any further questions regarding the use of this medication, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Treatment with Difortan should be stopped immediately and medical advice should be sought without delay if any of the following adverse reactions occur:

• Hypersensitivity, which is a type of allergic reaction manifesting as skin rash (skin lesions with redness), dyspnoea and difficulty in swallowing.
• Bullous lesions (extensive skin lesions involving redness, desquamation and large blisters).
• Photoallergic dermatitis (an inflammatory skin condition which may present as redness and itching at the site of application following exposure to sunlight).

The risk of occurrence of these reactions is higher at the beginning of treatment and in most cases they appear within the first month of therapy.
The following adverse reactions may occur, described according to their frequency:
Common: may affect up to 1 in 10 people

• Pruritus (itching);
• Erythema (appearance of red spots on the skin);
• Local skin irritation, which usually resolves after discontinuation of treatment.

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

• Contact dermatitis (inflammatory skin reaction at the site of application);
• Allergic dermatitis (inflammatory skin reaction due to allergy to Difortan);
• Photoallergic dermatitis (an inflammatory skin condition which may present as redness and itching at the site of application following exposure to sunlight).

Rare: may affect up to 1 in 10,000 people

• Urticaria (itchy rash);
• Bullous lesions (extensive skin lesions with redness, desquamation and large blisters), including Stevens-Johnson syndrome;
• Toxic epidermal necrolysis.

Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, consult a physician or pharmacist.
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
ul. Al. Jerozolimskie 181C
02 - 222 Warsaw
Tel.: + 48 22 49 21 301
Faks: + 48 22 49 21 309
e-mail: [email protected]
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Difortan

Keep the medicine out of sight and reach of children.
There are no special storage temperature requirements.
Store in the original packaging to protect from light.
After first opening, the medicine should be used within a maximum of 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 stated month.
Medicines must not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer in use.
Such measures help protect the environment.

6. Contents of the packaging and other information

What Difortan contains

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

What Difortan looks like and contents of the pack
Difortan is supplied in an aluminium tube internally coated with an epoxy-phenolic lacquer,
closed with an aluminium membrane and a cap made of HDPE, containing 50 or 100 g of gel.
Outer packaging: cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
US Pharmacia Sp. z o.o.
Ziębicka Street 40
50-507 Wrocław
Poland

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 further information, please contact the representative of the Marketing Authorisation Holder:
USP Zdrowie Sp. z o.o.
Poleczki Street 35
02-822 Warsaw
Poland
Tel.: +48 (22) 543 60 00