Opokan-keto

Package Leaflet: Information for the Patient

Opokan-keto, 25 mg/g, Gel

Ketoprofen

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.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Opokan-keto and what is it used for

Opokan-keto is a medicinal product in the form of a gel with anti-inflammatory and analgesic effects. The active substance of the medicinal product, ketoprofen, is a non-steroidal anti-inflammatory drug (NSAID). Opokan-keto is used in adults for:

• post-traumatic muscle and joint pain;
• muscle and tendon inflammation;
• rheumatic pain;
• as an auxiliary treatment for inflammatory conditions in peripheral joint degenerative disease.

2. Important information before using Opokan-keto

When not to use Opokan-keto

• if the patient is hypersensitive to ketoprofen (the active substance) or any of the other ingredients of this medicinal product (listed in section 6) and to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (e.g. ibuprofen, diclofenac, metamizole, butadiene, and others), tiaprofenic acid, fenofibrate, UV filters, perfumes. The symptoms of hypersensitivity may be: runny nose, hives, difficulty breathing, swelling of the lips, face, throat, or tongue;
• if the patient has experienced symptoms of hypersensitivity in the form of runny nose, hives, or asthma (shortness of breath) while being treated with acetylsalicylic acid or other NSAIDs;
• use of the medicinal product should be stopped immediately in case of skin reactions, including skin reactions after concurrent use of products containing octocrylene (octocrylene is one of the auxiliary substances used in various cosmetics and hygiene products such as shampoo, aftershave, shower gels and bath products, skin creams, lip balms, anti-wrinkle creams, makeup removers, hair lacquers to delay decomposition under the influence of light). The treated skin area should not be exposed to sunlight (even on cloudy days) or UV rays in a solarium during treatment and for 2 weeks after stopping

the use of the medicinal product;

• if the patient is in the last 3 months of pregnancy;
• on damaged or diseased skin (e.g. eczema, acne, open wound);
• in children and adolescents under 15 years of age.

Warnings and precautions

Before starting to use Opokan-keto, the patient should discuss it with their doctor or pharmacist:

• if the patient has circulatory failure;
• if the patient has kidney or liver function disorders.

The gel should not be applied to the skin outside the painful area.
Exposure to sunlight (even on cloudy days) or UVA rays on the skin areas where the medicinal product has been applied may cause severe skin reactions (photosensitivity).
Therefore, it is necessary:

• To protect the treated skin areas by wearing clothing during treatment and for 2 weeks after stopping the use of the medicinal product, in order to avoid the risk of photosensitivity.
• To wash hands thoroughly after each use of Opokan-keto.
• During prolonged use, it is recommended to wear protective gloves.
• A dressing should not be applied to the areas where the medicinal product has been applied.
• In case of any skin reactions, the use of the medicinal product should be stopped immediately and a doctor should be consulted.
• The medicinal product should not be used in the eye area or on the eyes and mucous membranes.
• In order to avoid skin hypersensitivity reactions to light during treatment and for 2 weeks after the end of treatment, direct sunlight (including solarium) should be avoided.
• In patients with asthma and chronic rhinitis, chronic sinusitis, and (or) nasal polyps, the risk of an allergic reaction to aspirin and (or) NSAIDs is higher than in the rest of the population.

The recommended treatment time should not be exceeded due to the increasing risk of contact dermatitis and photosensitivity reactions over time.

Children and adolescents

Opokan-keto should not be used in children and adolescents under 15 years of age.

Opokan-keto and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
In particular, the doctor should be informed if the patient is taking medicines containing prednisolone or methotrexate.
No interactions have been described between ketoprofen used topically and other medicines.

Pregnancy and breastfeeding

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 medicinal product.
Opokan-keto should not be used if the patient is in the last 3 months of pregnancy. During the first 6 months of pregnancy, Opokan-keto should not be taken unless the doctor considers it absolutely necessary. If treatment is necessary during this period, the smallest possible dose should be used for the shortest possible time.
Oral forms (e.g. tablets) of ketoprofen may cause side effects in the unborn child. It is not known whether the same risk is associated with the use of Opokan-keto on the skin.
The use of Opokan-keto is not recommended during breastfeeding, as the medicinal product passes into breast milk.

Driving and using machines

No negative effect of the medicinal product on the ability to drive and use machines has been reported.

Opokan-keto contains ethanol

This medicinal product contains 285.6 mg of alcohol (ethanol) per gram of gel.
It may cause a burning sensation on damaged skin.
The medicinal product is flammable. It should not be used near an open flame, lit cigarette, or certain devices (e.g. hair dryers).

3. How to use Opokan-keto

This medicinal product should always be used as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
The gel is for topical use, on the skin. The medicinal product should not be swallowed.
The dose and duration of treatment are determined by the doctor.
Recommended dose
Adults and adolescents over 15 years of age: 2-3 times a day, a small amount of gel should be applied to the skin in the painful area, gently massaging it into the skin. The gel should be applied to the smallest possible skin surface. The skin in the area of application should be undamaged. The amount of gel used depends on the surface of the painful area.
The daily dose should not exceed 15 g (7.5 g corresponds to approximately 14 cm of gel).
Treatment should last for the shortest possible time, but not longer than 7 days.
A dressing should not be applied to the treated skin area. Clothing can be worn on the skin area being treated.
After each use of the medicinal product, the tube should be tightly closed and hands washed, unless the hands are the area being treated.

Use in children

The efficacy and safety of ketoprofen in children under 15 years of age have not been established.

Using a higher dose of Opokan-keto than recommended

Overdose of ketoprofen used topically is unlikely.
In case of ingestion of the gel, the following may occur: drowsiness, nausea, vomiting.
In case of accidental ingestion of the medicinal product, the patient should immediately consult a doctor. The packaging of Opokan-keto should be taken to the doctor so that they know which medicinal product has been used.

Missing a dose of Opokan-keto

A double dose should not be used to make up for a missed dose.
In case of any further doubts about the use of this medicinal product, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Opokan-keto can cause side effects, although not everybody gets them.

Stop using the medicinal product and immediately consult a doctor or go to the nearest hospital if:

• angioedema (severe allergic reaction - sudden swelling of the face, limbs, or joints without itching and pain). Swelling in the head and neck area may cause difficulty swallowing and breathing;
• skin rash, for example, in the form of blisters, red nodules;
• severe skin reactions to light (photosensitivity). This is a sudden allergic reaction that can be life-threatening for the patient.

The following side effects may occur

Uncommon(occurring in 1 to 10 people per 1,000):

• local skin reactions such as: redness, itching, rash (itching, red, burning rash), burning sensation.

Rare(occurring in 1 to 10 people per 10,000):

• severe skin reactions such as blistering or pustular rash, which may spread or become generalized;
• severe skin reactions to sunlight, blistering dermatitis, urticaria, photosensitivity.

Very rare(occurring in less than 1 person per 10,000):

• -exacerbation of chronic kidney failure.

Side effects of unknown frequency(frequency cannot be estimated from available data):

• -local skin reactions that may spread beyond the application site;
• asthma attacks in patients allergic to acetylsalicylic acid or other NSAIDs;
• severe hypersensitivity reactions (anaphylactic reactions);
• -swelling of the face, lips, tongue, throat, or larynx, which may cause difficulty breathing or swallowing (angioedema).

Reporting side effects

If any side effects occur, including those not listed in this leaflet, the patient should inform their doctor or pharmacist.
Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181C, 02-222 Warsaw
Phone: +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, more information can be collected on the safety of the medicinal product.

5. How to store Opokan-keto

The medicinal product should be stored out of sight and reach of children.
The medicinal product should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the given month.
Store in a temperature below 25°C, transport in covered vehicles.
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 pack and other information

What Opokan-keto contains

• The active substance of the medicinal product is ketoprofen. 1 g of gel contains 25 mg of ketoprofen .
• The other ingredients are: ethanol 96%, levomenthol, purified water, trometamine, carbomer (Carbopol 980 NF).

What Opokan-keto looks like and contents of the pack

Opokan-keto is a colorless to slightly yellowish gel with a possible slight opalescence.
The product packaging is: an aluminum tube containing 50 g or 100 g of the product, placed in a cardboard box.

Marketing authorization holder and manufacturer

Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
tel. (42) 22-53-100

Date of last revision of the leaflet: