Felogel Мax

Package Leaflet: Information for the Patient

Felogel Max, 23.2 mg/g, Gel

Diclofenac Diethylammonium

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

This medicine should always be used exactly as described in this package leaflet or as directed by your doctor or pharmacist.

• You should keep this leaflet, so you can read it again later.
• If you need advice or further information, you should speak to your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor. See section 4.
• If after 7 days there is no improvement or you feel worse, you should contact your doctor.

Table of Contents of the Leaflet

• 1. What is Felogel Max, 23.2 mg/g, Gel and what is it used for
• 2. Important information before using Felogel Max, 23.2 mg/g, Gel
• 3. How to use Felogel Max, 23.2 mg/g, Gel
• 4. Possible side effects
• 5. How to store Felogel Max, 23.2 mg/g, Gel
• 6. Contents of the pack and other information

1. What is Felogel Max, 23.2 mg/g, Gel and what is it used for

Felogel Max, 23.2 mg/g, Gel contains the active substance diclofenac, which belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs). It is specially designed for application to the skin and has increased skin penetration. The active substance acts on deep tissues affected by inflammation.

Felogel Max, 23.2 mg/g, Gel is used to relieve pain, swelling, and inflammation in various painful conditions affecting the joints and muscles.

It is indicated for use in:

Adults and adolescents aged 14 years and older

For the local symptomatic relief of pain, swelling, and inflammation in cases of:

• soft tissue injuries, tendon, ligament, muscle, and joint injuries, such as sprains, strains, and bruises, as well as back pain (sports injuries);
• limited forms of soft tissue rheumatism: tendonitis (e.g., tennis elbow), bursitis, shoulder-arm syndrome, and periarthritis.

Adults (aged 18 years and older)

For the symptomatic relief of pain in limited forms of degenerative joint diseases, such as peripheral joint osteoarthritis and spine osteoarthritis.

2. Important information before using Felogel Max, 23.2 mg/g, Gel

When not to use Felogel Max, 23.2 mg/g, Gel

• if you are allergic (hypersensitive) to diclofenac or other medicines used to treat pain, fever, or inflammation, such as ibuprofen or acetylsalicylic acid (a substance also used to reduce blood clotting) or other nonsteroidal anti-inflammatory drugs or any of the other ingredients of this medicine (listed in section 6). In case of doubt, consult your doctor or pharmacist. Symptoms of an allergic reaction may include: wheezing or shortness of breath; skin rash with blisters or hives; swelling of the face or tongue; runny nose;

if you have asthma attacks (shortness of breath), hives (skin rash), angioedema, or acute rhinitis caused by the administration of acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs, regardless of whether you have chronic asthma or not;

• on open wounds, inflammatory or infected skin, as well as eczema or mucous membranes;
• in children and adolescents under 14 years of age;
• during the last three months of pregnancy.

Warnings and precautions

Before starting treatment with Felogel Max, you should discuss it with your doctor:

• if you are more prone to asthma attacks (so-called drug-induced intolerance or asthma induced by painkillers) or local skin swelling or mucous membrane swelling (so-called Quincke's edema) or hives, if you have asthma, hay fever, nasal polyps, or chronic obstructive pulmonary disease, chronic respiratory infections (especially those associated with symptoms similar to hay fever), or hypersensitivity to other painkillers and anti-rheumatic drugs, regardless of type. In these patients, Felogel Max may only be used under certain precautions (emergency readiness) and under direct medical supervision. The same applies to patients allergic to other substances, e.g., those with skin reactions, itching, or hives.
• You should avoid applying the medicine to large areas of skin and for a long time, unless advised by your doctor. If Felogel Max is applied to a large area of skin and for a long time, it cannot be ruled out that systemic side effects may occur due to the use of Felogel Max. Due to the increased risk of side effects, caution should be exercised if you are taking other medicines containing diclofenac or painkillers known as NSAIDs, such as acetylsalicylic acid or ibuprofen.
• You should only use Felogel Max on undamaged, non-diseased, or non-injured skin. You should avoid contact with mucous membranes of the mouth. If you have stomach or duodenal ulcers (or a history of them), you should tell your doctor or pharmacist before using the gel.
• Felogel Max, 23.2 mg/g, Gel is for external use only. Do not use the medicine in the mouth. Do not swallow. After applying the medicine, you should wash your hands, unless they are the area being treated. You should be careful not to get the medicine into your eyes. If this happens, you should rinse your eyes thoroughly with clean water. If discomfort persists, you should contact your doctor or pharmacist.
• After applying the gel to the skin, you can use a permeable (non-occlusive) dressing, but first, you should let the gel dry on the skin for a few minutes. You should not use a hermetic occlusive dressing.
• If symptoms worsen or do not improve after 7 days, you should consult your doctor.
• If a skin rash occurs after using the medicine, you should discontinue treatment with this medicine.
• While using this medicine, you should avoid exposure to sunlight, including sunbeds. You should take precautions to prevent a child from touching the area where the gel was applied.

In case of any questions before using Felogel Max, 23.2 mg/g, Gel, you should consult your doctor or pharmacist.

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Children and adolescents

Felogel Max is contraindicated in children and adolescents under 14 years of age.

Felogel Max, 23.2 mg/g, Gel and other medicines

You should tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take, including those available without a prescription.

In the case of planned use of Felogel Max on the skin, no interactions are known so far.

You should not use combination therapy with Felogel Max and oral NSAIDs, unless the benefits outweigh the risks and periodic laboratory tests are performed. You should avoid concomitant use of Felogel Max on the treated skin area with other topical products, including sunscreens, cosmetics, balms, moisturizing creams, insect repellents, or other topical medicines.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using this medicine.

You should not use Felogel Max during the last three months of pregnancy. During the first six months of pregnancy, you should not use Felogel Max unless it is necessary and advised by your doctor. If use is necessary, you should use the smallest dose for the shortest possible time. After oral administration of diclofenac (e.g., tablets), side effects may occur in the unborn child. It is not known whether this risk also applies to the use of the medicine on the skin.

Felogel Max, 23.2 mg/g, Gel should only be used under medical supervision during breastfeeding, as diclofenac passes into breast milk in small amounts. However, Felogel Max, 23.2 mg/g, Gel should not be applied to the breast of breastfeeding mothers or to other large areas of skin or for a long time.

If you are pregnant or breastfeeding, you should consult your doctor or pharmacist.

Driving and using machines

Felogel, Max 23.2 mg/g, Gel, when used as directed, has no or negligible influence on the ability to drive and use machines.

Felogel Max, 23.2 mg/g, Gel contains:

• propylene glycol (E1520), which may cause skin irritation.
• butylhydroxytoluene (E321), which may cause local skin reactions (e.g., contact dermatitis) or eye and mucous membrane irritation.

3. How to use Felogel Max, 23.2 mg/g, Gel

This medicine should always be used exactly as described in the package leaflet or as directed by your doctor or pharmacist.

In case of doubt, you should consult your doctor or pharmacist.

How much Felogel Max, 23.2 mg/g, Gel to use

Adults and adolescents aged 14 years and older:

Apply the gel 2 times a day (preferably in the morning and evening) to the painful area.

How to use Felogel Max, 23.2 mg/g, Gel

• 1. To remove the seal before first use, you should unscrew and remove the cap. Use the other side of the cap to put it on the tube, twist, and remove the seal from the tube.

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• 2. Gently squeeze a small amount of gel from the tube and apply it to the painful or swollen area, slowly rubbing the medicine into the skin. The required amount will vary depending on the size of the painful or swollen area; usually, an amount similar in size to a cherry or walnut, corresponding to 2-4 g of gel, is sufficient. The maximum daily dose is 8 g. When rubbing in the gel, you may notice a slight cooling effect. Leave the gel to dry for a few minutes before applying a permeable dressing (see also section 2, Warnings and precautions).
• 3. Unless your hands are being treated, you should wash them after rubbing in the gel to avoid accidental contact with the mouth and eyes (see section 2).

Elderly patients

Dose adjustment is not necessary. Elderly patients should pay special attention to side effects and, if necessary, consult their doctor or pharmacist.

Renal or hepatic impairment

No dose reduction is necessary.

Use in children and adolescents (under 14 years of age)

Felogel Max is contraindicated in children and adolescents under 14 years of age (see section 2, "When not to use Felogel Max").

Felogel Max, 23.2 mg/g, Gel is for external use only.

How long to use Felogel Max, 23.2 mg/g, Gel

Adults and adolescents aged 14 years and older:

You should not use the gel for more than 14 days in cases of post-traumatic conditions (e.g., resulting from sprains, strains, or bruises) and soft tissue rheumatism (e.g., tendonitis, swelling around the elbow or knee).

Adults (aged 18 years and older)

You should not use the gel for more than 21 days in cases of osteoarthritis.

Longer use of the medicine requires the doctor's consent.

If pain and swelling do not improve within 7 days or worsen, you should inform your doctor.

In the case of adolescents aged 14 years and older, if symptoms worsen or do not improve within 7 days, the patient or the adolescent patient's parent should consult a doctor.

Using more than the recommended dose of Felogel Max, 23.2 mg/g, Gel

• Overdose is unlikely to occur when using more than the recommended dose of Felogel Max, as absorption into the bloodstream is low when applied to the skin. In case of significant exceedance of the recommended dose during skin application, the gel should be removed and washed off with water.
• If you or your child accidentally swallow the gel, you should contact your doctor immediately.

Missing a dose of Felogel Max, 23.2 mg/g, Gel

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If you miss a dose of Felogel Max, 23.2 mg/g, Gel at the right time, you should use it as soon as you remember, and then continue treatment as usual. You should not use a double dose to make up for the missed dose.

In case of any further doubts about using this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

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

Some rare and very rare side effects may be serious.

If you experience any of the following symptoms of an allergic reaction, you should STOPusing Felogel Max, 23.2 mg/g, Gel and immediately contact your doctor or pharmacist:

• Blisters; hives (these side effects occur rarely, may affect up to 1 in 10,000 people).
• Wheezing, shortness of breath, or feeling of pressure in the chest (asthma) (these side effects occur very rarely, may affect less than 1 in 10,000 people).
• Swelling of the face, lips, tongue, or throat (these side effects occur very rarely, may affect less than 1 in 10,000 people).

Other side effects that may occur are usually mild, transient, and harmless (in case of doubt, you should inform your doctor or pharmacist).

Common side effects (may affect up to 1 in 10 people)

• Skin inflammation (including contact dermatitis), skin rash, itching, redness, or burning of the skin, eczema.

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

• Pustular rash
• The skin may be more sensitive to sunlight. Possible symptoms include sunburn with itching, swelling, and blistering.

Frequency not known

• Burning sensation at the site of application. Dryness of the skin.

In case of application to large areas of skin and long-term use, it cannot be entirely ruled out that systemic side effects may occur (e.g., effects on the kidneys, liver, or gastrointestinal tract, systemic hypersensitivity reactions), as they may occur after systemic administration of diclofenac-containing medicines.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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

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.

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5. How to store Felogel Max, 23.2 mg/g, Gel

The medicine should be stored out of sight and reach of children.

Store in a temperature below 25°C. Store in the original packaging to protect from light.

Do not use this medicine after the expiry date stated on the carton and tube after EXP. The expiry date refers to the last day of the month stated.

Shelf life after first opening the tube: 6 months for the 60 g packaging and 12 months for the 120 g packaging.

Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Felogel Max, 23.2 mg/g, Gel contains

• The active substance is diclofenac in the form of diclofenac diethylammonium. 1 g contains 23.2 mg of diclofenac diethylammonium, which corresponds to 20 mg of diclofenac sodium.
• The other ingredients (excipients) are: butylhydroxytoluene (E 321); carbomers, cocoyl caproyl caprate, diethylamine, isopropyl alcohol, liquid paraffin (E 905a); macrogol ether cetostearyl, oleyl alcohol, propylene glycol (E 1520); cineole; purified water.

What Felogel Max, 23.2 mg/g, Gel looks like and contents of the pack

Felogel Max, 23.2 mg/g, Gel is a white creamy gel of uniform consistency.

60 g or 120 g of the medicinal product is filled in a tightly closed aluminum tube with a membrane coated with an epoxy-phenolic lacquer on the inside, with a PP screw cap with a piercer.

Each tube, along with the package leaflet and instructions for use, is placed in a cardboard box.

Not all pack sizes may be marketed.

Marketing authorization holder

Sopharma Warszawa Sp. z o.o.

Al. Jerozolimskie 136, 02-305 Warsaw

tel. 22 613 39 30

Manufacturer

SOPHARMA AD

16 Iliensko Shosse Str.

1220 Sofia, Bulgaria

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Bulgaria: Фелоран Плюс 2.32% гел

Estonia: Felogel

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Latvia: Felogel 23.2 mg/g gels

Poland: Felogel Max

Date of last revision of the leaflet:01.2025

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