OPOKAN 15 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Opokan max, 15 mg, tablets
   1. You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Opokan max and what is it used for
   1. Indications for use of Opokan max:
   2. WARNING: Opokan max should only be taken by patients who have not achieved the desired result with a dose of 7.5 mg of meloxicam in relieving pain.
   3. WARNING: Opokan max may only be taken by patients who have not achieved the desired result with a dose of 7.5 mg of meloxicam.
4. Important information before taking Opokan max
   1. When not to take Opokan max
   2. Warnings and precautions
   3. Opokan max is not recommended for use during episodes of acute pain.
   4. Children and adolescents
   5. Elderly
   6. Opokan max and other medicines
   7. Do not take Opokan max with the following medicines:
   8. Opokan max with food and drink
   9. Pregnancy, breastfeeding, and fertility
   10. Driving and using machines
   11. Opokan max contains lactose monohydrate and sodium
   12. Lactose monohydrate
   13. Sodium
5. How to take Opokan max
   1. Recommended dose: Adults if necessary
   2. Elderly and patients with increased risk of side effects:
   3. Method of administration:
   4. Taking a higher dose of Opokan max than recommended
   5. In case of taking a higher dose of Opokan max than recommended or suspected overdose, you should immediately consult a doctor or go to the nearest hospital emergency department.
   6. Symptoms of NSAID overdose are usually limited to:
   7. Severe poisoning can lead to serious side effects of the medicine (see section 4):
   8. Missing a dose of Opokan max
6. Possible side effects
   1. You should stop taking Opokan max and consult your doctor or the nearest hospital immediately if you experience:
   2. General side effects of non-steroidal anti-inflammatory drugs (NSAIDs)
   3. Side effects of meloxicam - the active substance of Opokan max are as follows:
   4. Side effects caused by non-steroidal anti-inflammatory drugs (NSAIDs) but not yet reported with Opokan max:
   5. Reporting side effects
7. How to store Opokan max
8. Contents of the pack and other information
   1. What Opokan max contains
   2. What Opokan max looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. Date of last revision of the leaflet:

Leaflet attached to the packaging: patient information

Opokan max, 15 mg, tablets

Meloxicam

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or nurse.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or you feel worse, you should contact your doctor.

Table of contents of the leaflet

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

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

Opokan max contains the active substance meloxicam. Meloxicam belongs to a group of so-called non-steroidal anti-inflammatory drugs (NSAIDs), which are used to reduce inflammation and pain in the joints and muscles.

The medicine has anti-inflammatory, analgesic, and antipyretic effects.

Indications for use of Opokan max:

The medicine is used in adults when a dose of 7.5 mg of meloxicam was not sufficiently effective, for short-term treatment of exacerbations of symptoms of rheumatoid diseases such as rheumatoid arthritis, juvenile rheumatoid arthritis, and ankylosing spondylitis, as an anti-inflammatory and analgesic in musculoskeletal and muscle pain (e.g., back pain, neck pain, knee pain) in the course of rheumatoid and degenerative joint diseases.

Do not use for more than 7 days without consulting a doctor.

WARNING: Opokan max should only be taken by patients who have not achieved the desired result with a dose of 7.5 mg of meloxicam in relieving pain.

WARNING: Opokan max may only be taken by patients who have not achieved the desired result with a dose of 7.5 mg of meloxicam.

2. Important information before taking Opokan max

When not to take Opokan max

• if you are allergic to meloxicam or any of the other ingredients of this medicine (listed in section 6);
• if you have experienced a sudden allergic reaction (anaphylactic shock) when taking other non-steroidal anti-inflammatory drugs (NSAIDs), including aspirin (acetylsalicylic acid) - symptoms such as wheezing, feeling of pressure in the chest, shortness of breath (asthma), skin rash (hives), nasal congestion due to swelling of the nasal mucosa (nasal polyps), sudden swelling of the skin or mucous membranes, such as swelling around the eyes, face, lips, mouth or throat, which may make breathing difficult (angioedema);
• if you have severe liver failure;
• if you have severe kidney failure and are not on dialysis;
• if you have severe heart failure;
• if you have experienced bleeding from the stomach or intestines or perforation of the stomach or intestines when taking anti-inflammatory drugs (NSAIDs);
• if you have active or recurrent stomach or duodenal ulcers (you have had at least two episodes of confirmed ulcers or bleeding);
• if you have had a hemorrhagic stroke or other bleeding, such as gastrointestinal bleeding;
• if you are in the third trimester of pregnancy or breastfeeding;
• if you are under 18 years old.

If you are unsure whether any of the above points apply to you, you should consult your doctor.

Warnings and precautions

Opokan max is intended for patients who have not achieved the desired result with a dose of 7.5 mg of meloxicam.

Before starting treatment with Opokan max, you should discuss it with your doctor or pharmacist if:

• you have had a sudden allergic reaction (anaphylactic shock) within 20 minutes of taking the medicine (see section 4: Possible side effects);
• you have stomach or duodenal ulcers or esophagitis. This medicine can be given to patients who have been completely cured of the disease;
• you have diabetes;
• you have high cholesterol levels;
• you have high blood pressure, as this increases the risk of heart attack or stroke;
• you have mild or moderate heart failure (symptoms include swelling);
• you have ischemic heart disease, peripheral artery disease, or cerebrovascular disease, as this increases the risk of arterial thrombosis;
• you have gastrointestinal diseases (ulcerative colitis or Crohn's disease), as this increases the risk of gastrointestinal bleeding. If gastrointestinal bleeding occurs, the medicine should be discontinued immediately;
• you have kidney function disorders. You should have your kidney function regularly monitored. A lower-strength Opokan (7.5 mg, tablets) may be more suitable;
• you have reduced circulating blood volume (hypovolemia), which may occur in the case of significant blood loss or burns, surgery, or low fluid intake;
• you have liver function disorders; the medicine may cause slight, transient increases in liver enzyme activity in the blood (ASAT and ALAT);
• you are elderly, as this increases the risk of kidney, liver, and heart function disorders. Your doctor will prescribe regular check-ups;
• you are planning a pregnancy or having difficulty getting pregnant, as the medicine may have a negative effect on fertility. You should stop taking the medicine;
• you have a high potassium level in your blood, previously diagnosed by your doctor;
• you have ever experienced a persistent rash (drug rash) after taking meloxicam or other oxicams (e.g., piroxicam), characterized by round or oval, red, and swollen spots on the skin, usually recurring in the same place (in the same areas), blisters, hives, and itching.

If you are unsure whether any of the above circumstances apply to you, you should consult your doctor before starting treatment with Opokan max.

You should stop taking Opokan max immediately if you notice bleeding (causing black stools) or gastrointestinal ulcers (causing abdominal pain).

Taking medicines like Opokan max may be associated with a slight increase in the risk of heart attack (myocardial infarction) or stroke. This risk increases with long-term use of high doses of the medicine. You should not take higher doses or use the medicine for longer than recommended (see section 3: How to take Opokan max). If you have heart function disorders, have had a stroke, or are suspected of having an increased risk of these disorders (e.g., high blood pressure, diabetes, high cholesterol levels, smoking), you should discuss your treatment with your doctor or pharmacist.

Opokan max has been associated with potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis), which initially appear as red spots or round patches on the torso, often with central blisters.

Additional symptoms that may be observed include oral ulcers, throat, nose, genital, and conjunctival inflammation (red and swollen eyes). These potentially life-threatening skin rashes are often accompanied by flu-like symptoms. The rash can develop into generalized blisters or skin peeling. The highest risk of severe skin reactions occurs in the first few weeks of treatment. In patients who have developed Stevens-Johnson syndrome or toxic epidermal necrolysis while taking Opokan max, meloxicam should not be restarted.

If a rash or the above symptoms occur, you should stop taking Opokan max and seek medical attention immediately, informing your doctor that you are taking this medicine.

Special considerations for patients with kidney function disorders

Patients on dialysis with severe kidney failure should not take a dose higher than 7.5 mg of meloxicam per day.

Opokan max is not recommended for use during episodes of acute pain.

Opokan max may mask signs of infection (e.g., fever). If you suspect you have an infection, you should contact your doctor.

Children and adolescents

Opokan max should not be used in children and adolescents under 18 years old.

Elderly

If you are elderly, you should take Opokan max with special caution due to the increased risk of side effects. Consultation with a doctor is recommended.

Opokan max and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

Do not take Opokan max with the following medicines:

• other non-steroidal anti-inflammatory drugs, including salicylates(e.g., acetylsalicylic acid in a single dose of 500 mg and a daily dose of 3000 mg), as concurrent use with Opokan max may increase the risk of ulcers and gastrointestinal bleeding;
• diuretics(which increase urine production, e.g., furosemide), as concurrent use with Opokan max may cause severe kidney failure in dehydrated patients. Patients taking Opokan max and diuretics should receive plenty of fluids (to drink and/or administered intravenously in infusions). Before starting treatment, your doctor will check your kidney function;
• oral or parenteral anticoagulants(used to prevent blood clots); concurrent use with Opokan max may increase the risk of bleeding;
• thrombolytic and antiplatelet agents(medicines that dissolve blood clots);
• blood pressure-lowering medicines:ACE inhibitors (e.g., captopril, enalapril); angiotensin II receptor antagonists (so-called sartans); beta-blockers; concurrent use of these medicines with Opokan max may cause severe kidney function disorders and reduce their therapeutic effect.
• cyclosporine, tacrolimus(a medicine used in patients after organ transplantation or in the case of severe skin diseases, rheumatoid arthritis, or nephrotic syndrome); your doctor will regularly monitor your kidney function;
• trimethoprim(a medicine used to treat urinary tract infections);
• potassium salts(medicines used to treat low potassium levels in the blood);
• intrauterine contraceptive devices;Opokan max may reduce their effectiveness. It is necessary to use an additional method of contraception, e.g., a condom;
• corticosteroids(e.g., used as anti-inflammatory or to treat allergic reactions) - concurrent use with Opokan max may increase the risk of ulcers and gastrointestinal bleeding;
• lithium(a medicine used to treat certain mental illnesses);
• selective serotonin reuptake inhibitors (SSRIs)- used to treat depression;
• methotrexate(a cytostatic medicine used to treat cancer or severe uncontrolled skin diseases and active rheumatoid arthritis);
• cholestyramine(a medicine that lowers cholesterol levels in the blood);
• deferazirox- used to treat chronic high iron levels in the body;
• pemetrexed- used to treat cancer;
• oral antidiabetic medicines(sulfonylurea derivatives, nateglinide) - used to treat diabetes. Your doctor should ensure regular monitoring of your blood sugar levels to detect potential hypoglycemia.

Opokan max with food and drink

Opokan max should be taken during meals, with a glass of water.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor or pharmacist before taking this medicine.

Pregnancy

You should not take Opokan max if you are in the last 3 months of pregnancy, as it may harm your unborn baby or cause complications during delivery. It may cause kidney and heart problems in the unborn baby. It may increase the risk of bleeding in you and your baby and cause delayed or prolonged labor. During the first 6 months of pregnancy, you should not take Opokan max unless your doctor considers it absolutely necessary. If treatment is necessary during this period or when trying to conceive, you should use the smallest dose for the shortest possible time.

From the 20th week of pregnancy, Opokan max may cause the unborn baby to have a narrowed blood vessel (ductus arteriosus) in the heart or kidney problems, which can lead to low amniotic fluid levels around the baby (oligohydramnios). If treatment is necessary for a longer period than a few days, your doctor may recommend additional monitoring.

Breastfeeding

Opokan max is contraindicated in breastfeeding women.

Fertility

This medicine may make it harder for you to get pregnant. You should tell your doctor if you are planning to get pregnant or are having trouble getting pregnant.

Driving and using machines

If you experience side effects such as dizziness, blurred vision, including blurred vision, drowsiness, or other central nervous system disorders, you should not drive or operate machinery.

Opokan max contains lactose monohydrate and sodium

Lactose monohydrate

If you have been diagnosed with intolerance to some sugars, you should consult your doctor before taking this medicine.

Sodium

The medicine contains 4.69 mg of sodium per tablet.

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Opokan max

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.

Taking this medicine for the shortest period necessary to relieve symptoms reduces the risk of side effects.

Recommended dose: Adults if necessary

1 tablet (15 mg of meloxicam) once a day. The maximum recommended dose of the medicine is 1 tablet once a day.

Opokan max may only be taken by patients who have not achieved the desired result with a dose of 7.5 mg of meloxicam.

If after taking Opokan max your symptoms do not improve after 3 days of treatment or if your symptoms worsen despite taking the medicine, you should contact your doctor immediately.

Do not use for more than 7 days without consulting a doctor.

Elderly and patients with increased risk of side effects:

You should exercise special caution when taking Opokan max in the elderly and in patients with an increased risk of side effects.

A consultation with a doctor is recommended. If pharmacological treatment is decided by a doctor, they may prescribe a dose of 7.5 mg. Depending on the effectiveness and tolerance of the medicine, the doctor may increase the dose to 15 mg of meloxicam.

Kidney function disorders:patients on dialysis with severe kidney failure should not take a dose higher than 7.5 mg of meloxicam per day.

Liver function disorders:dose reduction is not necessary in patients with mild or moderate liver function disorders.

Use in children and adolescents:Opokan max should not be used in children and adolescents under 18 years old.

If you think the effect of Opokan max is too strong or too weak, or if you do not feel any improvement after 3 days, you should consult your doctor or pharmacist.

Method of administration:

• The medicine should be taken during meals, with a glass of water.
• Opokan max should be taken once a day (in a single dose).
• The maximum daily dose is 15 mg (1 tablet).

Taking a higher dose of Opokan max than recommended

In case of taking a higher dose of Opokan max than recommended or suspected overdose, you should immediately consult a doctor or go to the nearest hospital emergency department.

Symptoms of NSAID overdose are usually limited to:

• weakness (feeling of lack of energy);
• drowsiness;
• nausea and vomiting;
• abdominal pain (in the upper abdomen). These symptoms usually disappear after stopping Opokan max. The patient may experience gastrointestinal bleeding (gastrointestinal bleeding).

Severe poisoning can lead to serious side effects of the medicine (see section 4):

• increased blood pressure (hypertension);
• acute kidney failure;
• liver function disorders;
• shallow breathing or respiratory arrest (respiratory depression);
• loss of consciousness (coma);
• seizures (convulsions);
• circulatory collapse (cardiovascular collapse);
• cardiac arrest;
• immediate allergic reactions (hypersensitivity), including:
• fainting;
• shortness of breath;
• skin reactions.

Missing a dose of Opokan max

You should not take a double dose to make up for a missed dose. You should take the next dose at the scheduled time.

If you have any further doubts about the use of 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.

You should stop taking Opokan max and consult your doctor or the nearest hospital immediately if you experience:

Any allergic reactions (hypersensitivity), which may manifest as:

• skin reactions, such as itching (pruritus), blistering, and peeling of the skin, which can be life-threatening (Stevens-Johnson syndrome, toxic epidermal necrolysis), soft tissue damage (mucosal lesions), or erythema multiforme (see section 2). Erythema multiforme is a severe allergic skin reaction causing spots, red or purple stripes or blisters on the skin. It can also occur on the lips, eyes, and other moist areas of the body;
• swelling of the skin or mucous membranes, such as swelling around the eyes, face, and lips, mouth or throat, which may make breathing difficult, swelling of the ankles and feet (peripheral edema);
• shortness of breath or asthma attacks;
• liver inflammation. This can cause symptoms such as:
• yellowing of the skin and eyes (jaundice);
• abdominal pain, loss of appetite.

Any symptoms of gastrointestinal disorders, in particular:

• bleeding (causing black stools);
• gastrointestinal ulcers (causing abdominal pain).

Gastrointestinal bleeding, ulcers, or perforation of the gastrointestinal tract can sometimes be severe and potentially life-threatening, especially in the elderly.

If you have previously experienced any gastrointestinal disorders due to long-term use of NSAIDs, you should immediately consult your doctor, especially if you are elderly. Your doctor may monitor your progress.

If taking Opokan max causes vision disturbances, you should not drive or operate machinery.

General side effects of non-steroidal anti-inflammatory drugs (NSAIDs)

The use of some non-steroidal anti-inflammatory drugs (NSAIDs) may be associated with a slight increase in the risk of arterial thrombosis (e.g., heart attack or stroke), especially when using the medicine in high doses and for long-term treatment.

NSAID treatment has been associated with reports of edema, high blood pressure, and heart failure.

The most common side effects observed are related to the gastrointestinal tract (stomach and intestine disorders):

• stomach and duodenal ulcers;
• perforation of the intestinal wall or gastrointestinal bleeding (sometimes fatal, especially in the elderly).

The following side effects have been reported with NSAIDs:

• nausea (nausea) and vomiting;
• diarrhea;
• gas and bloating;
• constipation;
• indigestion (dyspepsia), abdominal pain;
• black stools due to gastrointestinal bleeding;
• bloody vomiting;
• mouth ulcers;
• worsening of inflammatory bowel disease (e.g., exacerbation of ulcerative colitis or Crohn's disease).

Liver inflammation has been observed less frequently.

Side effects of meloxicam - the active substance of Opokan max are as follows:

Very common:may occur more frequently than in 1 in 10 people

• gastrointestinal disorders, such as indigestion (dyspepsia), nausea (nausea), and vomiting, abdominal pain, constipation, bloating, diarrhea.

Common:may occur less frequently than in 1 in 10 people

• headache.

Uncommon:may occur less frequently than in 1 in 100 people

• dizziness (feeling of emptiness in the head);
• dizziness or feeling of spinning (vertigo);
• drowsiness (somnolence);
• anemia (reduced hemoglobin levels in the blood);
• increased blood pressure (hypertension);
• flushing (temporary flushing of the face and neck);
• fluid and sodium retention;
• increased potassium levels (hyperkalemia). This can lead to symptoms such as:
• heart rhythm disorders;
• palpitations (feeling of heartbeat);
• muscle weakness;
• reflux (regurgitation of food from the stomach into the esophagus);
• gastritis;
• gastrointestinal bleeding;
• mouth ulcers;
• immediate allergic reactions (hypersensitivity);
• itching, skin rash;
• edema caused by fluid retention, including ankle and foot swelling (peripheral edema);
• sudden swelling of the skin or mucous membranes, such as swelling around the eyes, face, lips, mouth, or throat, which may make breathing difficult (angioedema);
• temporary liver function test abnormalities (e.g., increased liver enzyme activity, such as ASAT and ALAT). Your doctor may detect these changes with a blood test;
• abnormal kidney function test results (e.g., increased creatinine or urea levels).

Rare:may occur less frequently than in 1 in 1,000 people

• mood disorders;
• nightmares;
• blood disorders, including:
• abnormal blood count;
• reduced white blood cell count (leukopenia);
• reduced platelet count (thrombocytopenia). These side effects can increase the risk of infection and symptoms such as bruising or nosebleeds;
• ringing in the ears (tinnitus);
• palpitations (feeling of heartbeat);
• stomach or duodenal ulcers;
• esophagitis;
• asthma attacks (in people allergic to aspirin or other NSAIDs);
• blistering skin reactions or skin peeling (Stevens-Johnson syndrome and toxic epidermal necrolysis);
• hives;
• vision disturbances, including:
• blurred vision;
• conjunctivitis (inflammation of the eyes);
• colitis (inflammation of the colon).

Very rare:may occur less frequently than in 1 in 10,000 people

• skin reactions with blisters and peeling; erythema multiforme. Erythema multiforme is a severe allergic skin reaction causing spots, red or purple stripes or blisters on the skin. It can also occur on the lips, eyes, and other moist areas of the body;
• liver inflammation. This can cause symptoms such as:
• yellowing of the skin and eyes (jaundice);
• abdominal pain, loss of appetite;
• acute kidney failure, especially in patients with risk factors such as heart disease, diabetes, or kidney disease;
• perforation of the intestinal wall;
• complete destruction of certain kidney cells (acute tubular necrosis);
• protein in the urine (nephrotic syndrome with proteinuria).

Frequency not known(frequency cannot be estimated from the available data):

• confusion, disorientation;
• shortness of breath and skin reactions (anaphylactic and/or anaphylactoid reactions) caused by exposure to sunlight (photosensitivity reactions);
• heart failure reported in association with NSAID treatment;
• pancreatitis;
• infertility in women, delayed ovulation;
• a characteristic skin allergic reaction known as persistent drug rash, usually recurring in the same place (in the same areas) after re-administration of the medicine and may appear as itching, round or oval, red, and swollen spots on the skin, blisters (hives).

Side effects caused by non-steroidal anti-inflammatory drugs (NSAIDs) but not yet reported with Opokan max:

• acute kidney failure due to changes in kidney structure;
• very rare cases of kidney inflammation (interstitial nephritis);
• death of some kidney cells (acute tubular necrosis or renal papillary necrosis);
• protein in the urine (nephrotic syndrome with proteinuria).

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:

Jerozolimskie Avenue 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.

5. How to store Opokan max

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

Store in a closed container, at a temperature not exceeding 25°C, in a dry place.

Do not use this medicine after the expiry date stated on the packaging after: EXP.

The expiry date refers to the last day of the month.

Lot - means batch number

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

6. Contents of the pack and other information

What Opokan max contains

• The active substance of the medicine is meloxicam. Each tablet contains 15 mg of meloxicam.
• The other ingredients (excipients) are: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, cornstarch, sodium citrate, colloidal anhydrous silica, magnesium stearate.

What Opokan max looks like and contents of the pack

Opokan max is available in tablet form.

The packaging contains 10 tablets. The blister pack is packaged in a cardboard box.

Marketing authorization holder

Aflofarm Farmacja Polska Sp. z o.o.

Partyzancka 133/151

95-200 Pabianice

Tel. +48 (42) 22-53-100

Manufacturer

Aflofarm Farmacja Polska Sp. z o.o.

Szkolna 31

95-054 Ksawerów

Date of last revision of the leaflet: