Product Description

Opokan is an anti-inflammatory and analgesic medicinal product used to relieve pain in bones, joints, and muscles (e.g., back pain, spinal pain, knee pain) occurring in the course of rheumatoid arthritis and osteoarthritis. It contains meloxicam (Meloxicamum) and belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs).
Opokan may be used by adults and adolescents aged 15 years and older.
The product is available as round, flat, uncoated yellow tablets with a slight score line on one side to facilitate splitting.

Indications

Opokan is indicated for the short-term treatment of exacerbations of symptoms in rheumatic diseases such as:

• rheumatoid arthritis,

• juvenile rheumatoid arthritis,

• ankylosing spondylitis.

Composition

One tablet contains:

• Active substance: meloxicam 7.5 mg

• Excipients: microcrystalline cellulose, lactose monohydrate, pregelatinized starch, maize starch, sodium citrate, colloidal anhydrous silica, magnesium stearate.

Pharmacological Action

Analgesic, anti-inflammatory, and antipyretic effects.

Dosage and Administration

This medicine should be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If you are unsure, consult a healthcare professional.

• Adults and adolescents ≥ 15 years: 1 tablet (7.5 mg) once daily.

• Elderly patients: 1 tablet (7.5 mg) once daily.

• Renal impairment: do not exceed 7.5 mg per day.

• Hepatic impairment: do not exceed 7.5 mg per day.

• Children below 15 years: Opokan must not be used.

Opokan should be taken orally with food, with water or another liquid.
The recommended regimen is a single daily dose.
The maximum daily dose is 7.5 mg (1 tablet).

If symptoms worsen or do not improve after 7 days, contact a doctor.

Contraindications

Do not use Opokan in case of:

• hypersensitivity to any ingredient of the product,

• hypersensitivity to other NSAIDs (e.g., acetylsalicylic acid),

• previous episodes of bronchospasm, asthma attacks, urticaria, nasal polyps, or angioedema induced by NSAIDs,

• severe hepatic impairment,

• severe renal impairment in patients not undergoing dialysis,

• severe heart failure,

• active or recurrent peptic ulcer disease (≥ 2 confirmed episodes of ulceration or bleeding),

• history of cerebrovascular bleeding or other active bleeding (e.g., gastrointestinal bleeding),

• 3rd trimester of pregnancy and breastfeeding,

• age below 15 years,

• infertility or ongoing infertility evaluation (do not use in women experiencing difficulty conceiving).

Storage

• Store out of the sight and reach of children.

• Store below 25°C, in the original packaging, in a dry place.

• Do not use after the expiry date printed on the packaging (expiry date refers to the last day of that month).

• Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of unused medicines to help protect the environment.

Side Effects

Like all medicines, Opokan may cause side effects, although not everybody experiences them.

The risk of adverse reactions is higher in patients with hypersensitivity to acetylsalicylic acid or other NSAIDs, and in elderly individuals.
Opokan may slightly increase the risk of heart attack or stroke.

Common (1 to 10 in 100 patients):

• nausea, vomiting, abdominal pain, bloating,

• constipation, diarrhea,

• light-headedness,

• headache,

• anaemia,

• oedema (including ankle swelling),

• rash (itchy, red skin lesions).

Uncommon (1 to 10 in 1,000 patients):

• gastrointestinal bleeding (vomiting blood, coffee-ground vomitus, black or bloody stools),

• gastric or duodenal ulcers,

• oesophagitis,

• stomatitis,

• transient hepatic function disorders,

• renal function disorders (e.g., raised creatinine or urea),

• increased blood pressure,

• palpitations,

• reduction in white blood cell count,

• thrombocytopenia (increased bleeding/bruising risk),

• granulocytopenia,

• flushing,

• urticaria,

• dizziness, drowsiness, tinnitus.

Rare (1 to 10 in 10,000 patients):

• hepatitis,

• gastritis,

• ulcerative colitis,

• renal failure (reduced urine output, haematuria, cloudy urine, ankle oedema, nausea, vomiting),

• severe allergic reaction within 20 minutes of administration (rash, facial/lip/throat swelling, breathing difficulty, hypotension, bradycardia/tachycardia, pallor, anxiety, sweating, dizziness, loss of consciousness, respiratory arrest, cardiac arrest),

• asthma attacks (wheezing, cough, breathing difficulty),

• Stevens–Johnson syndrome,

• toxic epidermal necrolysis,

• erythema multiforme,

• mood changes,

• nightmares, insomnia,

• disorientation,

• visual disturbances (e.g., blurred vision),

• photosensitivity,

• angioedema.

Frequency not known:

• pancreatitis.

Interactions

Inform your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.

Do not use Opokan together with:

• other NSAIDs, including salicylates (e.g., single 1 g or daily 3 g aspirin doses),

• diuretics (e.g., furosemide),

• oral anticoagulants (increased bleeding risk),

• antihypertensive medicines:

  • ACE inhibitors,

  • angiotensin II receptor blockers (sartans),

  • beta-blockers,

• ciclosporin (monitor renal function),

• intrauterine contraceptive devices (reduced contraceptive effectiveness—use additional protection),

• corticosteroids,

• lithium,

• methotrexate,

• oral antidiabetics,

• cholestyramine.

Warnings and Precautions

Consult a doctor before using Opokan if:

• you have experienced anaphylactic reactions,

• you have a history of gastric/duodenal ulcers or oesophagitis/gastritis (may be used only if fully healed),

• you have asthma (risk of bronchospasm),

• you have diabetes, high cholesterol, or hypertension (increased cardiovascular risk),

• you have mild or moderate heart failure,

• you have coronary artery disease, peripheral arterial disease, or cerebrovascular disease,

• you have inflammatory bowel disease (ulcerative colitis, Crohn’s disease),

• you have renal impairment or reduced circulating blood volume,

• you have hepatic impairment,

• you are over 65 years old (increased risk of renal, hepatic, and cardiovascular disorders),

• you are planning pregnancy or undergoing infertility evaluation (meloxicam may impair fertility),

• you may have an infection, as the drug can mask symptoms.

Opokan, like other NSAIDs, may slightly increase the risk of heart attack or stroke, particularly with high doses or prolonged use.

Do not exceed recommended doses or treatment duration.

Overdose symptoms may include:

• allergic reaction,

• nausea, vomiting, abdominal pain,

• headache, dizziness, insomnia or drowsiness,

• hypertension,

• renal or hepatic dysfunction,

• respiratory depression or arrest,

• seizures,

• cardiac arrest,

• coma.

If you miss a dose, continue the next dose as scheduled. Do not double the dose.

Children and Adolescents

Do not use in patients under 15 years of age.

Pregnancy, Breastfeeding, and Fertility

• If pregnant, breastfeeding, planning pregnancy, or suspecting pregnancy, consult a doctor before using this medicine.

• Opokan may adversely affect the fetus.

• Use during the 1st and 2nd trimester is not recommended unless clearly necessary.

• Contraindicated during the 3rd trimester.

• Meloxicam passes into breast milk—do not use while breastfeeding.

• Opokan may impair female fertility.

Driving and Using Machines

If dizziness, drowsiness, visual disturbances, or disorientation occur, do not drive or operate machinery.

Lactose Content

If you have been told you have an intolerance to certain sugars, consult your doctor before taking this medicine.