Opokan

Package Leaflet: Information for the Patient

Opokan, 7.5 mg, Oral Disintegrating Tablets

Meloxicam

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the package leaflet or as directed by the doctor or pharmacist.

• The package leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, the pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the package leaflet, the doctor or pharmacist should be informed. See section 4.
• If there is no improvement after 7 days or if the patient feels worse, the doctor should be contacted.

Table of Contents of the Package 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 package 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). It contains the active substance meloxicam. Opokan has anti-inflammatory and analgesic effects. It is used for musculoskeletal and joint pain (e.g., back pain, neck pain, knee pain) in rheumatoid and degenerative joint diseases.

Indications for use of Opokan:

• Short-term treatment of exacerbations of rheumatoid diseases, such as rheumatoid arthritis, juvenile rheumatoid arthritis, and ankylosing spondylitis.

If there is no improvement after 7 days or if the patient feels worse, the doctor should be consulted.

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 the patient is allergic to other nonsteroidal anti-inflammatory drugs (NSAIDs), such as acetylsalicylic acid;
• if the patient has experienced asthma attacks or allergic reactions (e.g., hives, angioedema) after taking other NSAIDs (e.g., acetylsalicylic acid);
• if the patient has severe liver dysfunction;
• if the patient has severe kidney failure and is not undergoing dialysis;
• if the patient has active or recurrent peptic ulcer disease (with at least two confirmed episodes of 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 and during breastfeeding;
• in children and adolescents under 16 years of age.

Warnings and precautions

Taking medicines like 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. The recommended dose and duration of treatment should not be exceeded (see section 3).

Opokan is not recommended for the treatment of acute pain attacks.

Before starting treatment with Opokan, the patient should discuss the following with the doctor or pharmacist:

• if the patient has experienced an anaphylactic reaction (a severe allergic reaction) within 20 minutes of taking the medicine (see section 4: Possible side effects);
• if the patient has a history of peptic ulcer disease or esophagitis. The medicine can be given to patients who have been completely cured of the disease;
• if the patient has asthma, as the medicine may cause bronchospasm;
• if the patient has diabetes, high cholesterol, or hypertension, as the risk of heart attack or stroke may increase;
• if the patient has mild or moderate heart failure (with symptoms such as edema);
• if the patient has coronary artery disease, peripheral artery disease, or cerebrovascular disease, as the risk of arterial thrombosis may increase;
• if the patient has gastrointestinal diseases (ulcerative colitis or Crohn's disease), as the risk of gastrointestinal bleeding may increase. If gastrointestinal bleeding occurs, the medicine should be discontinued immediately;
• if the patient has kidney or liver dysfunction - regular monitoring of kidney function is recommended;
• if the patient is over 65 years of age, as the risk of kidney, liver, and heart disorders may increase. The doctor will order regular check-ups;
• Opokan may mask the symptoms of an existing infection (e.g., fever). If the patient suspects an infection, they should contact the doctor.

In connection with the use of meloxicam, potentially life-threatening skin reactions have been reported (Stevens-Johnson syndrome, toxic epidermal necrolysis), which initially appear as red spots or circular patches on the torso, often with central blisters. Additional symptoms that may be observed include oral, throat, nasal, and genital ulcers, as well as conjunctivitis (red and swollen eyes). These potentially life-threatening skin reactions are often accompanied by flu-like symptoms. The rash may 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, meloxicam should not be restarted. If a rash or any of the above symptoms occur, the medicine should be discontinued and medical advice should be sought immediately.

Children and adolescents

Opokan should not be used in children and adolescents under 16 years of age.

Opokan and other medicines

The patient should inform the doctor or pharmacist about all medicines they are currently taking or plan to take.

The following medicines should not be taken with Opokan:

• 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), as concurrent use with Opokan may increase the risk of gastrointestinal ulcers and bleeding;
• Diuretics(e.g., furosemide) - concurrent use with Opokan may cause severe kidney failure in dehydrated patients. Patients receiving both Opokan and diuretics should drink plenty of fluids (to drink and/or administered intravenously in drips). The doctor will check kidney function before starting treatment;
• Oral anticoagulants(used to prevent blood clots) - concurrent use with Opokan may increase the risk of bleeding;
• Thrombolytic agents(medicines that dissolve blood clots);
• Medicines that lower blood pressure:angiotensin-converting enzyme inhibitors (e.g., captopril, enalapril), angiotensin II receptor antagonists (sartans), beta-blockers;
• Cyclosporine, tacrolimus(a medicine used in patients who have undergone organ transplantation or have severe skin diseases, rheumatoid arthritis, or nephrotic syndrome) - the doctor will regularly monitor kidney function;
• Intrauterine devices- Opokan may reduce their effectiveness;
• Corticosteroids(adrenal cortex hormones) - concurrent 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);
• Oral medicines used to treat diabetes;
• Cholestyramine- a medicine that lowers cholesterol levels in the blood;
• Deferasirox- used to treat chronic high iron levels in the body;
• Pemetrexed- used to treat cancer.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult the doctor or pharmacist before taking this medicine.

Pregnancy

Opokan should not be used during the first and second trimesters of pregnancy, unless the doctor considers it absolutely necessary. If Opokan is taken during the first and second trimesters of pregnancy, the lowest possible dose should be used for the shortest possible time.

Opokan should not be used during the last 3 months of pregnancy (third trimester), as it may have serious effects on the fetus, particularly on its cardiovascular and respiratory systems, as well as the kidneys, even after a single dose.

Breastfeeding

Opokan passes into breast milk, so breastfeeding should be avoided during treatment with this medicine.

Fertility

Opokan may have a negative effect on female fertility and make it more difficult to become pregnant. It should not be used in women who have difficulty becoming pregnant or who are undergoing fertility testing.

Driving and using machines

If the patient experiences side effects such as dizziness, vision disturbances, drowsiness, or disorientation, they should not drive or operate machinery.

Opokan contains aspartame

The medicine contains 2.7 mg of aspartame per tablet.

Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria, a rare genetic disorder in which phenylalanine accumulates in the body due to its impaired excretion.

3. How to take Opokan

This medicine should always be taken exactly as described in the package leaflet or as directed by the doctor or pharmacist. In case of doubt, the doctor or pharmacist should be consulted.

Recommended dose

1 oral disintegrating tablet (7.5 mg) per day.

Elderly patients:1 oral disintegrating tablet (7.5 mg) per day.

Patients with kidney failure:the dose should not exceed 7.5 mg per day.

Patients with liver failure:the dose should not exceed 7.5 mg per day.

Method of administration:

• The tablet should be placed in the mouth, on the tongue, and allowed to dissolve (about 5 minutes), then swallowed. The tablets should not be chewed or swallowed whole. Taking Opokan does not require drinking water or other fluids.
• Opokan should be taken once a day (in a single dose).

If symptoms worsen or do not improve after 7 days, the doctor should be contacted.

Use in children and adolescents

Opokan should not be used in children and adolescents under 16 years of age.

Overdose of Opokan

In case of overdose, the doctor or pharmacist should be informed immediately.

Overdose symptoms may include:

• weakness (feeling of lack of energy);
• nausea, vomiting, abdominal pain;
• drowsiness. These symptoms usually resolve after discontinuation of the medicine. The patient may experience gastrointestinal bleeding.

In case of severe poisoning, the following may occur:

• hypertension;
• acute kidney failure;
• liver dysfunction;
• shallow breathing or respiratory arrest (respiratory depression);
• coma, seizures;
• cardiovascular collapse (acute circulatory failure);
• cardiac arrest;
• allergic reaction (see section 4: Possible side effects).

Missed dose of Opokan

A double dose should not be taken to make up for a missed dose.

Treatment with the medicine should be continued without increasing the next dose.

In case of further doubts about the use of this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

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

The doctor or hospital should be informed immediately if the following occur:

• allergic reaction occurring within 20 minutes of taking the medicine (hives, severe swelling of the face, lips, or throat, difficulty breathing, speaking, or swallowing, rapid heartbeat, pallor, anxiety, sweating, dizziness, loss of consciousness, respiratory or cardiac arrest);
• angioedema (a severe allergic reaction - sudden swelling of the face, limbs, or joints without itching or pain). Swelling in the head and neck area may cause difficulty swallowing or breathing;
• appearance of blisters on the skin and/or mucous membranes, which, after rupture, form painful sores, often accompanied by fever, muscle, and joint pain (this is known as Stevens-Johnson syndrome);
• skin reactions with blisters and erythema multiforme. Erythema multiforme is a severe allergic skin reaction causing spots, red or purple stripes, or blisters on the skin. It may also occur on the lips, eyes, and other moist areas of the body.

General side effects associated with the use of nonsteroidal anti-inflammatory drugs (NSAIDs)

The severity of symptoms may occur, especially in patients with hypersensitivity to acetylsalicylic acid or other NSAIDs, as well as in the elderly.

Opokan may increase the risk of heart attack or stroke.

The use of some NSAIDs may be associated with a small increase in the risk of arterial thrombosis (e.g., heart attack or stroke), especially when used in high doses and for long-term treatment.

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

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

The following side effects have been reported with NSAIDs:

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

Side effects that may occur after taking Opokan

Opokan

Very common:occur in more than 1 in 10 patients

• gastrointestinal disorders, such as indigestion, nausea, vomiting, abdominal pain, bloating, constipation, diarrhea.

Common:occur in 1 to 10 patients in 100

• headache.

Uncommon:occur in 1 to 10 patients in 1,000

• gastrointestinal bleeding (vomiting blood or coffee ground-like material, black stools, or blood in stools);
• gastritis;
• reflux;
• stomatitis;
• liver dysfunction (e.g., increased liver enzyme activity, such as aminotransferases, or increased bilirubin levels);
• immediate allergic reactions (hypersensitivity);
• dizziness (feeling of emptiness in the head);
• drowsiness (somnolence);
• increased blood pressure;
• flushing;
• itching;
• skin rash;
• edema caused by fluid retention, including edema of the ankles/feet (peripheral edema);
• hyperkalemia (elevated potassium levels). This may cause: cardiac arrhythmias, palpitations (when the patient feels their heartbeat more than usual), muscle weakness;
• abnormal liver function tests;
• anemia (reduced hemoglobin levels).

Rare:occur in 1 to 10 patients in 10,000

• colitis;
• peptic ulcer disease;
• esophagitis;
• blood disorders, including: - abnormal blood smear - decreased white blood cell count (leukopenia) - decreased platelet count (thrombocytopenia) (may increase the risk of bleeding and bruising);
• mood disorders;
• nightmares;
• vision disturbances (including blurred vision, conjunctivitis);
• tinnitus;
• palpitations (feeling of rapid heartbeat);
• asthma attacks (wheezing, coughing, difficulty breathing);
• skin reactions with blisters and peeling (Stevens-Johnson syndrome and toxic epidermal necrolysis);
• urticaria.

Very rare:occur in less than 1 in 10,000 patients

• perforation of the gastrointestinal tract;
• hepatitis - may cause symptoms such as: yellowing of the skin and eyes (jaundice), abdominal pain, loss of appetite;
• acute kidney failure (manifested by decreased urine output, blood in urine, cloudy urine, swelling of the ankles, nausea, vomiting), particularly in patients with risk factors such as heart disease, diabetes, or kidney disease.

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

• confusional state;
• disorientation;
• skin reactions (anaphylactic and/or anaphylactoid) caused by exposure to sunlight (photosensitivity reactions);
• 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 drugs). This may cause:
• sudden fever;
• throat pain;
• infections;
• pancreatitis;
• photosensitivity. Side effects caused by nonsteroidal anti-inflammatory drugs (NSAIDs) but not yet reported with Opokan:
• 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);
• presence of protein in the urine (nephrotic syndrome with proteinuria).

Reporting side effects

If any side effects occur, including any side effects not listed in the package leaflet, the doctor or pharmacist should be informed. 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, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, e-mail: [email protected]. 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 temperature below 30°C.

Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the package and other information

What Opokan contains

• The active substance of the medicine is meloxicam. One oral disintegrating tablet contains 7.5 mg of meloxicam.
• The other ingredients are: mannitol, granulated mannitol, anhydrous colloidal silica, povidone 30, microcrystalline cellulose, crospovidone (Type A), aspartame (E 951), orange flavor 0471034, magnesium stearate.

What Opokan looks like and what the package contains

Opokan is a light yellow, round, flat, bilayer tablet with an orange odor, with a diameter of 7.7 mm to 8.3 mm. The package contains 20 oral disintegrating tablets. Peel-off blisters made of paper/aluminum/PE/PVC/aluminum/OPA are packaged in a cardboard box.

Marketing authorization holder and importer

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 package leaflet: