Opokan

Leaflet accompanying the packaging: patient information

Opokan, 7.5 mg, tablets

Meloxicam

It is essential to 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 advised by a doctor or pharmacist.

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• 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 there is no improvement or the patient feels worse after 7 days, they should contact their doctor.

Table of contents of the leaflet

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

1. What is Opokan and what is it used for

Opokan belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs). The medicine has anti-inflammatory, analgesic, and antipyretic effects. It is used for musculoskeletal and joint pain (e.g., back pain, lumbar pain, knee pain) in the course of rheumatoid and degenerative joint diseases. Opokan is intended for adults and children and adolescents aged 16 and older.

Indications for use of Opokan:

• Short-term treatment of exacerbations of rheumatoid disease symptoms, such as: rheumatoid arthritis, juvenile rheumatoid arthritis, ankylosing spondylitis.

If there is no improvement or the patient feels worse after 7 days, they should contact their doctor.

2. Important information before taking Opokan

When not to take Opokan

• if the patient is allergic to meloxicam or any of the other ingredients of this medicine (listed in section 6);
• if, while taking other nonsteroidal anti-inflammatory drugs (NSAIDs) or acetylsalicylic acid (aspirin), the patient has experienced: wheezing, chest tightness, 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 the patient has severe liver dysfunction;

• if the patient has severe renal impairment and is not being treated with dialysis;
• if, while taking anti-inflammatory drugs (NSAIDs), the patient has experienced: gastrointestinal bleeding or perforation;
• if the patient has active or recurrent peptic ulcer disease (with at least two episodes of confirmed ulceration or bleeding);
• if the patient has had a stroke or other bleeding, e.g., gastrointestinal bleeding;
• if the patient has severe heart failure;
• in women in the third trimester of pregnancy;
• in children and adolescents under 16 years of age.

If the patient is unsure whether any of the above points apply to them, they should consult their doctor.

Warnings and precautions

Before starting treatment with Opokan, the patient should discuss it with their doctor or pharmacist.

• if the patient has experienced an anaphylactic reaction (anaphylactic shock), occurring within 20 minutes of administering the medicine (see section 4: Possible side effects),
• if the patient has stomach or duodenal ulcers or esophageal inflammation. This medicine can be given to patients who have been completely cured of the disease,
• if the patient has diabetes, high cholesterol, or high blood pressure; the risk of heart attack or stroke increases,
• if the patient has mild or moderate heart failure (with symptoms such as swelling),
• if the patient has coronary artery disease, peripheral artery disease, or cerebrovascular disease, as this increases the risk of arterial thrombosis,
• if the patient has 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,
• if the patient has renal impairment; regular monitoring of kidney function is necessary,
• if the patient has decreased circulating blood volume (hypovolemia), which may occur in the case of significant blood loss or burns, surgery, or low fluid intake,
• if the patient has liver dysfunction; the medicine may cause minor, transient increases in liver enzyme activity in the blood (ASAT and ALAT),
• if the patient is elderly, as the risk of renal, liver, and heart disorders increases. The doctor will order regular tests,
• if the patient is planning a pregnancy or having difficulty conceiving, as the medicine has a negative effect on fertility. The medicine should be discontinued in this case,
• if the patient has high potassium levels in the blood, previously diagnosed by a doctor,
• if the patient has ever experienced a persistent rash (drug rash) after taking meloxicam or other oxicams (e.g., piroxicam), characterized by round or oval, red, and swollen patches on the skin, usually recurring in the same place (in the same places), blisters, hives, and itching.

Taking such medicines as Opokan may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. This risk increases with long-term use of high doses of the medicine. Do not exceed the recommended dose and duration of treatment (see section 3). In case of heart problems, previous stroke, or suspected risk of these disorders (e.g., high blood pressure, diabetes, high cholesterol, smoking), the patient should discuss treatment with their doctor or pharmacist. The patient should stop taking Opokan immediately if they notice bleeding (causing black stools) or gastrointestinal ulcers (causing abdominal pain). In connection with the use of Opokan, potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported, initially appearing 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 detachment. The highest risk of severe skin reactions occurs in the first few weeks of treatment. In patients who have experienced Stevens-Johnson syndrome, toxic epidermal necrolysis while taking Opokan, meloxicam should not be restarted. If a rash or the above symptoms occur, the patient should stop taking Opokan and seek medical advice immediately, informing their doctor about taking this medicine. Opokan is not recommended for the treatment of acute pain attacks. Opokan may mask signs of infection (e.g., fever). If the patient suspects they have an infection, they should contact their doctor. Taking the medicine in the smallest effective dose for the shortest necessary period to alleviate symptoms reduces the risk of side effects.

Children and adolescents

Do not use in children and adolescents under 16 years of age.

Opokan and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

Do not take Opokan with the following medicines:

• other nonsteroidal anti-inflammatory drugs, including salicylates(e.g., acetylsalicylic acid in a single dose of 500 mg and a daily dose of 3000 mg); concomitant use with Opokan may increase the risk of gastrointestinal ulcers and bleeding,
• diuretics(increasing urine production, e.g., furosemide); concomitant use with Opokan may cause severe renal impairment in dehydrated patients. Patients receiving Opokan and diuretics should receive plenty of fluids (to drink and/or administered intravenously in drips). Before starting treatment, the doctor will examine kidney function,
• oral or parenteral anticoagulants(used to prevent blood clots); concomitant use with Opokan may exacerbate 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.

Concomitant use of the above medicines with Opokan may cause severe renal impairment and reduce their therapeutic effect.

• cyclosporine, tacrolimus(a medicine used in patients after organ transplantation or in cases of severe skin diseases, rheumatoid arthritis, or nephrotic syndrome); the doctor will regularly monitor 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 may reduce their effectiveness. It is necessary to use an additional method of contraception, e.g., a condom,
• corticosteroids(e.g., used anti-inflammatory or to treat allergic reactions); concomitant use with Opokan may increase the risk of gastrointestinal ulcers and 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 tumors);
• oral antidiabetic medicines(sulfonylurea derivatives, nateglinide) - used to treat diabetes. The doctor should ensure systematic monitoring of the patient's blood sugar levels for the occurrence of hypoglycemia.

Opokan with food and drink

The medicine should be taken during meals, with a glass of water.

Pregnancy, breastfeeding, and fertility

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 taking this medicine. Pregnancy Do not take Opokan if the patient is in the last 3 months of pregnancy, as it may harm the unborn child or cause complications during delivery. It may cause kidney and heart problems in the unborn child. It may increase the risk of bleeding in the patient and their child and cause delayed or prolonged labor. During the first 6 months of pregnancy, Opokan should not be used unless the doctor considers it absolutely necessary. If treatment is necessary during this period or when trying to conceive, the smallest possible dose should be used for the shortest possible time. From the 20th week of pregnancy, Opokan may cause the unborn child to have a narrowed blood vessel (ductus arteriosus) in the heart or kidney problems, which can lead to low levels of amniotic fluid surrounding the child (oligohydramnios). If treatment is necessary for a longer period than a few days, the doctor may recommend additional monitoring. Breastfeeding Opokan is not recommended for women who are breastfeeding. Before taking this medicine, the patient should consult their doctor or pharmacist. Fertility Opokan may have a negative effect on female fertility and make it difficult to conceive. Do not use in women who have difficulty conceiving or who are undergoing tests related to infertility.

Driving and using machines

In case of side effects such as dizziness, vision disturbances, including blurred vision, drowsiness, or other central nervous system disorders, the patient should not drive vehicles or operate machines.

Opokan contains lactose monohydrate and sodium

Lactose monohydrate

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

Sodium

The medicine contains 2.35 mg of sodium in each 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

This medicine should always be taken exactly as described in this patient leaflet or as advised by a doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.

Recommended dose

The recommended dose is 1 tablet (7.5 mg) per day. Elderly patients: 1 tablet (7.5 mg) per day.

Patients at increased risk of side effects, patients with renal impairment, patients with liver impairment:

Do not exceed the dose of 7.5 mg per day.Use in children and adolescents:do not use Opokan in children and adolescents under 16 years of age.

Method of administration:

• The medicine is taken orally during meals, with a glass of water.
• Opokan should be taken once a day (in a single dose).

If symptoms worsen or do not improve after 7 days, the patient should contact their doctor.

Taking a higher dose of Opokan than recommended

In case of taking a higher dose of Opokan than recommended or suspected overdose, the patient should immediately consult their 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 resolve after discontinuing Opokan. 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 renal failure;
• liver dysfunction;
• 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

Do not take a double dose to make up for a missed dose. Take the next dose at the scheduled time. In case of further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

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

Stop taking Opokan and consult a doctor or the nearest hospital immediately if the patient experiences:

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 (a severe allergic skin reaction causing spots, red or purple stripes or blisters on the skin, which can also occur on the lips, eyes, and other moist body parts);
• swelling of the skin or mucous membranes, such as swelling around the eyes, face, lips, mouth, or throat, which can make breathing difficult;
• 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 side effects, in particular:

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

Gastrointestinal bleeding or perforation can sometimes be severe and potentially life-threatening, especially in elderly patients. If the patient has previously experienced any gastrointestinal disorders due to long-term use of NSAIDs, they should immediately consult their doctor, especially if they are elderly. The doctor may monitor the patient's progress. If Opokan causes vision disturbances, the patient should not drive vehicles or operate machines.

General side effects of nonsteroidal anti-inflammatory drugs (NSAIDs)

The use of some nonsteroidal anti-inflammatory drugs (NSAIDs) may be associated with a small increased risk of arterial thrombosis (e.g., heart attack or stroke), especially when used in high doses and for long-term treatment. Edema, high blood pressure, and heart failure have been reported in connection with NSAID treatment. The most common side effects observed are related to the gastrointestinal tract (stomach and intestine disorders):

• peptic ulcer disease;
• perforation of the intestinal wall or gastrointestinal bleeding (sometimes fatal, especially in elderly patients).

The following side effects have been reported after taking NSAIDs:

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

Liver inflammation is rarely observed.

Side effects of meloxicam - the active substance of Opokan

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

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

Common:may occur in less than 1 in 10 people

• headaches. Uncommon:may occur in less than 1 in 100 people
• dizziness (feeling of emptiness in the head);
• dizziness or feeling of spinning (of vestibular origin);
• 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 more than usual);
• muscle weakness;
• reflux (regurgitation of stomach contents into the esophagus);
• gastritis;
• gastrointestinal bleeding;
• mouth ulcers;
• immediate allergic reactions (hypersensitivity);
• itching, skin rash;
• edema caused by fluid retention, including edema of the lower limbs;
• sudden swelling of the skin or mucous membranes, such as swelling around the eyes, face, lips, mouth, or throat, which can make breathing difficult (angioedema);
• temporary changes in liver function tests (e.g., increased liver enzyme activity, such as aminotransferases, or increased bilirubin levels). The doctor may detect these changes through a blood test;
• abnormalities in renal function tests (e.g., increased creatinine or urea levels).

Rare:may occur in less than 1 in 1000 people

• mood disorders;
• nightmares;
• blood morphology disorders, including:
• abnormal blood smear;
• 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 bleeding from the nose.
• ringing in the ears (tinnitus);
• palpitations (feeling of heartbeat);
• peptic ulcer disease;
• esophagitis;
• asthma attacks (in patients 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 eye or eyelids);
• colitis (inflammation of the colon).

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

• blistering skin reactions and erythema multiforme. Erythema multiforme is a severe allergic skin reaction causing spots, red or purple stripes or blisters on the skin, which can also occur on the lips, eyes, and other moist body parts;
• liver inflammation. This can cause symptoms such as:
• yellowing of the skin and eyes (jaundice);
• abdominal pain, loss of appetite;
• acute renal failure, especially in patients with risk factors such as heart disease, diabetes, or kidney disease;
• perforation of the intestinal wall.

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

• confusion, disorientation;
• shortness of breath and skin reactions (anaphylactic and/or anaphylactoid) rashes caused by exposure to sunlight (reactions to light);
• heart failure reported in connection with NSAID treatment;
• complete loss of certain types of white blood cells (agranulocytosis), especially in patients taking Opokan with other medicines that may have a suppressive or destructive effect on the bone marrow (myelotoxic medicines). This can cause:
• sudden fever;
• throat pain;
• infections;
• pancreatitis;
• infertility in women, delayed ovulation;
• a characteristic skin allergic reaction, known as persistent rash (drug rash), usually recurring in the same place (in the same places) after re-administration of the medicine and may have the appearance of itching, round or oval, red, and swollen patches on the skin, blisters (hives).

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

• acute renal failure due to changes in kidney structure;
• very rare cases of interstitial nephritis (inflammation of the kidney tissue);
• renal cell necrosis (acute tubular necrosis);
• presence of protein in the urine (nephrotic syndrome with proteinuria).

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 Adverse Reaction 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, more information can be collected on the safety of the medicine.

5. How to store Opokan

The medicine should be stored out of sight and reach of children. Store in a closed package, at a temperature not exceeding 25°C, in a dry place. Do not use this medicine after the expiration date stated on the packaging after: EXP. The expiration date refers to the last day of the specified month. Lot - means batch number 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 contains

• The active substance of the medicine is meloxicam. Each tablet contains 7.5 mg of meloxicam.
• The other ingredients are: microcrystalline cellulose, lactose monohydrate, pregelatinized starch, corn starch, sodium citrate, colloidal anhydrous silica, magnesium stearate.

What Opokan looks like and contents of the package

Opokan is a tablet. The tablets are yellow, round, flat, with a dividing line on one side. The line allows the tablet to be divided. The package contains 10 tablets (1 blister), 20 tablets (2 blisters), or 30 tablets (3 blisters), packaged with the patient leaflet in a cardboard box.

Marketing authorization holder

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

Manufacturer

Aflofarm Farmacja Polska Sp. z o.o. ul. Szkolna 31, 95-054 Ksawerów

Date of the last revision of the leaflet: