Felogel max

Package leaflet: Information for the patient

Felogel Max, 23.2 mg/g, gel
Diclofenacum diethylammonium
Please read the entire 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 patient 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 a pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor. See section 4.
• If there is no improvement or if your condition worsens after 7 days, consult your doctor.

Table of contents

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

Felogel Max, 23.2 mg/g, gel contains the active substance diclofenac, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). It is specially formulated for topical application and has enhanced 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 joints and muscles.

It is indicated for use in:

Adults and adolescents aged 14 years and older
For local symptomatic relief of pain, swelling, and inflammation in:

• Soft tissue injuries, tendon, ligament, muscle and joint injuries, e.g. due to sprains, strains and contusions, and back pain (sports injuries);
• Localized soft tissue rheumatism: tendonitis (e.g. tennis elbow), bursitis, shoulder-hand syndrome, and periarticular inflammation (periarthritis).

Adults (aged 18 years and older)
For symptomatic relief of pain in localized degenerative joint diseases, such as osteoarthritis of peripheral joints and spinal joints.

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

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

• if the patient is allergic (hypersensitive) to diclofenac or other medicines used to treat pain, fever or inflammation, such as ibuprofen or acetylsalicylic acid (the substance used also to reduce blood clotting) or other non-steroidal anti-inflammatory drugs, or any of the other ingredients of this medicine (listed in section 6). If in doubt, consult a 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 the patient has asthma attacks (shortness of breath), urticaria (skin rash), angioedema, or acute rhinitis induced by acetylsalicylic acid or other non-steroidal anti-inflammatory drugs, regardless of whether the patient suffers from chronic asthma or not;

• on open wounds, inflamed or infected skin areas, skin eruptions, or mucous membranes;

• in children and adolescents under 14 years of age;

• during the last three months of pregnancy.

Warnings and precautions
Before starting to use Felogel Max, discuss this with your doctor:

• you are more prone to asthma attacks (so-called drug-induced intolerance or analgesic-induced asthma), localized swelling of the skin or mucous membranes (so-called Quincke's edema), or urticaria, if you suffer from asthma, hay fever, nasal mucosa swelling (so-called nasal polyps), chronic obstructive pulmonary disease, chronic respiratory tract infections (especially associated with symptoms resembling hay fever), or hypersensitivity to other pain-relieving and anti-rheumatic drugs, regardless of type. In such patients, Felogel Max should be used only with specific precautions (readiness for emergency situations) and under direct medical supervision. The same applies to patients allergic to other substances, e.g., those experiencing skin reactions, itching, or urticaria.
• Avoid using the medicine on large areas of skin and for prolonged periods unless directed by a doctor. If Felogel Max is applied over a large skin surface and for a long time, systemic adverse effects due to the use of Felogel Max cannot be excluded. Due to the increased risk of adverse effects, caution is required if the patient is taking other medicines containing diclofenac or painkillers known as NSAIDs, such as acetylsalicylic acid or ibuprofen.
• Use Felogel Max only on intact, healthy, and non-wounded skin. Avoid contact with mucous membranes of the mouth. If the patient has a stomach or duodenal ulcer (current or past history), inform the doctor or pharmacist before using the gel.
• Felogel Max, 23.2 mg/g, gel is intended for external use only. Do not use in the mouth. Do not swallow. After applying the medicine, wash your hands unless they are the area being treated. Take care to avoid getting Felogel Max, 23.2 mg/g, gel into the eyes. If this occurs, rinse the eyes thoroughly with clean water. If discomfort persists, contact a doctor or pharmacist.
• After applying the gel to the skin, a permeable (non-occlusive) dressing may be applied, but allow the gel to dry on the skin for several minutes first. Do not use an airtight, occlusive dressing.
• If symptoms worsen or do not improve after 7 days, consult a doctor.
• If a skin rash occurs after applying the medicine, discontinue treatment with this product.
• While using this medicine, avoid exposure to sunlight, including in solariums. Take precautions to prevent children from touching the area where the gel has been applied.

If you have any questions before using Felogel Max, 23.2 mg/g, gel, consult your doctor or pharmacist.
Page 2 of 7
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
Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take, including those available without a prescription.
No interactions are currently known when planning topical application of Felogel Max.
Do not combine treatment with Felogel Max and oral NSAIDs unless benefits outweigh risks, and periodic laboratory tests are performed. Avoid simultaneous use of Felogel Max on the treated skin area with other topical agents, including sunscreens, cosmetics, balms, moisturizing creams, insect repellents, or other topical medicines.
Pregnancy and breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
Do not use Felogel Max during the last three months of pregnancy. During the first six months of pregnancy, do not use Felogel Max unless necessary and recommended by a doctor. If use is necessary, apply the lowest possible dose for the shortest possible time. Oral forms of diclofenac-containing medicines (e.g., tablets) may cause adverse effects in the unborn child. It is unknown whether the same risk applies when the medicine is used topically.
Felogel Max, 23.2 mg/g, gel should be used during breastfeeding only under medical supervision, as diclofenac passes into breast milk in small amounts. However, Felogel Max, 23.2 mg/g, gel should not be applied to the breasts of breastfeeding mothers or to other large skin areas or for prolonged periods.
If you are pregnant or breastfeeding, consult your doctor or pharmacist.
Driving and operating machinery
Felogel Max, 23.2 mg/g, gel, when used as directed, has no effect or negligible effect on the ability to drive or operate machinery.
Felogel Max, 23.2 mg/g, gel contains:

• propylene glycol (E1520), which may cause skin irritation.
• butylated hydroxytoluene (E321), which may cause local skin reactions (e.g., contact dermatitis) or irritation of the eyes and mucous membranes.

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

This medicine should always be used according to the instructions in the patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

How much Felogel Max, 23.2 mg/g, gel should be used

Adults and adolescents aged 14 years and older:
Apply the gel twice daily (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, unscrew and remove the cap. Use the other side of the cap to place it onto the tube, twist and remove the seal from the tube.

Page 3 of 7

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

Elderly patients
Dose adjustment is not necessary. Elderly patients should pay particular attention to possible adverse effects and consult a doctor or pharmacist if needed.

Renal or hepatic impairment
There is no need to reduce the dose.

Use in children and adolescents (under 14 years of age)
Felogel Max should not be used 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:
Do not use the gel for longer than 14 days in cases of traumatic conditions (e.g. sprains, strains, bruises) and soft tissue rheumatism (e.g. tendinitis, elbow or knee swelling).

Adults (aged 18 years and older):
Do not use the gel for longer than 21 days in cases of degenerative joint disease.
Prolonged use requires medical approval.

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

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

Use of more than the recommended dose of Felogel Max, 23.2 mg/g, gel

• Overdose is unlikely when more than the recommended dose of Felogel Max is used, as systemic absorption through the skin is low. In case of significant overdose during topical application, remove the gel and wash the area with water.
• If the patient or a child accidentally swallows the gel, contact a doctor immediately.

Missed dose of Felogel Max, 23.2 mg/g, gel

Page 4 of 7
If a dose of Felogel Max, 23.2 mg/g, gel is missed, apply it as soon as remembered, then continue treatment as usual. Do not apply a double dose to make up for the missed application.

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

4. Possible adverse reactions

Like all medicines, this product may cause adverse reactions, although not everyone experiences them.
Some rare and very rare adverse reactions may be serious.
If any of the following allergic symptoms occur in a patient, STOP using
Felogel Max, 23.2 mg/g, gel immediately and contact a doctor or pharmacist at once:

• Skin rash with blisters; urticaria (these adverse reactions occur rarely, affecting 1 to 10 out of 10,000 patients).
• Wheezing, shortness of breath, or feeling of tightness in the chest (asthma) (these adverse reactions occur very rarely, affecting fewer than 1 in 10,000 patients).
• Swelling of the face, lips, tongue, or throat (these adverse reactions occur very rarely, affecting fewer than 1 in 10,000 patients).

Other adverse reactions that may occur are usually mild, transient, and harmless (if in doubt, inform a doctor or pharmacist).
Common adverse reactions (may affect up to 1 in 10 people)

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

Very rare adverse reactions (may affect up to 1 in 10,000 patients)

• Pustular rash
• Skin may become more sensitive to sunlight. Possible symptoms include itchy sunburn, swelling, and blistering.

Frequency not known

• Burning sensation at the application site. Dry skin.

When Felogel Max is applied to large areas of skin and for prolonged periods, the possibility of systemic adverse reactions (e.g. affecting the kidneys, liver, or gastrointestinal tract, systemic hypersensitivity reactions) cannot be completely ruled out, as such reactions may occur following systemic administration of medicines containing diclofenac.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor 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:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309,
website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.
Page 5 of 7

5. How to store Felogel Max 23.2 mg/g gel

Keep this medicine out of sight and reach of children.
Store below 25°C. Keep in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the outer carton and tube after EXP. The expiry date refers to the last day of the stated month.
Storage period after first opening of the tube: 6 months for the 60 g pack and 12 months for the 120 g pack.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such practices 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, equivalent to 20 mg of sodium diclofenac.
• Other components (excipients) are: butylated hydroxytoluene (E 321); carbomers, cetyl caprylocaprate, diethylamine, isopropyl alcohol, liquid paraffin (E 905a); macrogol cetostearyl ether, 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, homogeneous gel.
The medicinal product is supplied in 60 g or 120 g in a hermetically sealed aluminium tube with
a membrane internally coated with epoxy-phenolic lacquer, fitted with a PP cap with a piercing device.
Each tube is placed in a cardboard box together with the package leaflet and instructions for use.
Not all pack sizes may be marketed.

Marketing Authorisation 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 authorised in the European Economic Area member states under the following names:
Bulgaria: Feloran Plus 2.32% gel
Estonia: Felogel
Latvia: Felogel 23.2 mg/g gel
Poland: Felogel Max