Opokan Actigel

Leaflet attached to the packaging: patient information

OPOKAN ACTIGEL, 100 mg/g, gel

Naproxen

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 this patient leaflet or as directed 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 those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If after 7 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

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

1. What is Opokan Actigel and what is it used for

Opokan Actigel contains the active substance naproxen, which has analgesic, anti-inflammatory, and antipyretic effects.

Indications for use

• muscle and joint pain after injury (sprains, strains, bruises),
• back pain,
• pain in degenerative joint disease and rheumatoid arthritis.

2. Important information before using Opokan Actigel

When not to use Opokan Actigel

• if the patient is allergic to naproxen or any of the other ingredients of this medicine (listed in section 6);
• if the patient is allergic to other non-steroidal anti-inflammatory drugs (NSAIDs) and salicylates;
• if the patient has damaged skin (cuts, open, weeping wounds, eczema);
• in children under 3 years of age;
• if the patient is in the third trimester of pregnancy.

Warnings and precautions

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

• if the patient has liver and/or kidney failure;
• if the patient has stomach and/or duodenal ulcer disease;
• if the patient has blood clotting disorders;
• if the patient has circulatory failure;
• if the patient is elderly (over 65 years of age).

During the use of Opokan Actigel, the following warnings should be observed.

• The medicine should not be applied to a large area of skin or for a long time, as naproxen is absorbed into the blood and may cause side effects (listed in section 4: Possible side effects).
• If an allergic reaction or skin changes occur at the site of application of Opokan Actigel, the patient should contact their doctor.
• The patient should avoid contact of the medicine with the eyes and mucous membranes. In case of accidental contact, these areas should be thoroughly rinsed with plenty of cold water.
• After applying Opokan Actigel to the skin, the area should not be covered with any dressing (especially foil or occlusive dressing), as this increases the absorption of the medicine (see section 4: Possible side effects).
• During treatment and for 2 weeks after the end of treatment, the patient should avoid exposure to sunlight and sunbathing (including in a solarium), as the medicine may cause sensitivity to sunlight and UV radiation.

Effect on laboratory test results
Naproxen may alter the values of adrenal cortex function tests and increase the values of 5-hydroxyindoleacetic acid, a serotonin metabolite.

Children

Do not use in children under 3 years of age.

Opokan Actigel 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.
So far, no interaction has been found between naproxen applied topically to the skin and other medicines. However, in the case of long-term use of naproxen on large areas of skin, interactions may occur.
Concomitant topical use of other medicines may cause or exacerbate their irritating effects. Therefore, two topical medicines should not be used on the same skin area at the same time.

Opokan Actigel may enhance the effects of:

• oral anticoagulant medicines (used to reduce blood clotting);
• sulfonamides (medicines used to treat bacterial infections);
• oral medicines used to treat diabetes (sulfonylurea derivatives);
• acetylsalicylic acid and other non-steroidal anti-inflammatory drugs - NSAIDs (e.g., ibuprofen);
• phenytoin, hydantoin, and valproic acid derivatives (medicines used to treat epilepsy);
• methotrexate (a medicine used to treat certain cancers and rheumatoid arthritis);
• lithium (a medicine used to treat depression);
• digoxin (a medicine used to treat heart failure and arrhythmias);
• aminoglycosides (antibiotics used to treat bacterial infections).

Do not use Opokan Actigel with:

• probenecid (a medicine used to treat gout), as it increases the concentration of naproxen in the blood;
• medicines that lower blood pressure, as naproxen may reduce their effectiveness;
• medicines that increase urine production (e.g., furosemide) due to the risk of electrolyte disturbances in the blood (sodium, potassium).

Pregnancy and breastfeeding

Oral forms (e.g., tablets) of naproxen may cause side effects in the unborn child. It is not known whether the same risk occurs when using Opokan Actigel on the skin.
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.
Pregnancy
Do not use Opokan Actigel during the last 3 months of pregnancy. Do not use Opokan Actigel during the first 6 months of pregnancy, unless absolutely necessary and recommended by a doctor. If treatment is necessary during this period, the patient should take the smallest dose for the shortest time possible.
Breastfeeding
Opokan Actigel should not be used in breastfeeding women.

Driving and using machines

There is no data on the effect of the medicine on the ability to drive and use machines.

Opokan Actigel contains propylene glycol, ethanol, and dimethyl sulfoxide

Propylene glycol

The medicine contains 100 mg of propylene glycol in each gram of gel.

Etanol

This medicine contains 285.6 mg of alcohol (ethanol) in each gram of gel.
It may cause burning of damaged skin.
The medicine is flammable. Do not use near open fire, lit cigarette, or certain devices (e.g., hair dryer).

Dimethyl sulfoxide

The medicine may cause skin irritation.

3. How to use Opokan Actigel

This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.
Method of administration
The medicine is intended for topical use on the skin.
A small amount of gel (about 5 cm of squeezed strip) should be applied to the painful areas 4 to 5 times a day, gently rubbing until the gel is completely absorbed.
The maximum daily dose of naproxen applied topically is 500 mg (about 25 cm of squeezed gel strip). 5 cm of squeezed gel strip contains approximately 100 mg of naproxen.
The gel should be applied to clean, dry skin.
After each application of the gel, the hands should be washed thoroughly.
Duration of treatment
The medicine should not be used for more than 7 days without consulting a doctor.
Children
Do not use in children under 3 years of age.

Using a higher dose of Opokan Actigel than recommended

In case of using a larger amount of medicine than recommended, the applied gel should be immediately washed off with soap and water, and then the recommended amount of medicine should be applied.
In case of accidental ingestion of naproxen, the patient should see a doctor as soon as possible.
Drowsiness, nausea, vomiting may occur.
Ingestion of large doses of the medicine may cause respiratory depression, coma, convulsions, gastrointestinal bleeding, changes in blood pressure, acute kidney failure. If the overdose occurred less than 1 hour ago, vomiting should be induced (provided the patient is conscious).

Missing a dose of Opokan Actigel

The patient should continue using the medicine without increasing the next dose.
A double dose should not be used to make up for a missed dose.
If the patient has any further doubts about using this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Opokan Actigel can cause side effects, although not everybody gets them.
Using the medicine on large areas of skin or under a dressingmay cause the following side effects, which are very rare:

• itching, rash (itchy, red bumps on the skin), urticaria (light red, itchy blisters on the skin), burning, redness of the skin;
• severe allergic reactions such as: difficulty breathing, coughing fits, facial swelling, shortness of breath, palpitations (irregular, rapid heartbeat).

Opokan Actigel increases the sensitivity of the skin to sunlight (see section: Warnings and precautions).
Prolonged use of the gel, especially on large areas of skinmay cause side effects characteristic of systemic naproxen effects, such as:

• gastrointestinal disorders (nausea, vomiting, constipation, diarrhea, heartburn, abdominal pain);
• worsening of stomach and/or duodenal ulcer disease;
• jaundice (yellowing of the skin and whites of the eyes);
• kidney function disorders;
• headache and dizziness;
• weakness of concentration, insomnia;
• ringing in the ears, vision disturbances.

If any of the above symptoms occur, the patient should stop using the medicine and consult their doctor.

Reporting side effects

If 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 of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. 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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Opokan Actigel

The medicine should be stored out of sight and reach of children.
Store at a temperature below 25°C. Protect from light and moisture. Store in tightly closed tubes.
Do not use this medicine after the expiry date stated on the tube and carton.
The expiry date refers to the last day of the month.
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 Opokan Actigel contains

• The active substance of the medicine is naproxen. 1 g of gel contains 100 mg of naproxen (as naproxen sodium).
• The other ingredients are: dimethyl sulfoxide, ethanol 96%, propylene glycol, hydroxypropyl cellulose, purified water.

What Opokan Actigel looks like and what the packaging contains

The medicine is a gel, colorless to straw-colored, without visible impurities and sediment. It may exhibit opalescence.
The packaging of the medicine is an aluminum tube with a membrane, a rubber ring, and a polypropylene screw cap, placed in a cardboard box containing 50 g of gel.

Marketing authorization holder and manufacturer

Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
phone: +48 42 22-53-100

Date of last revision of the leaflet: