Product Description

Opokan Max 15 mg 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 Max may be used in adults and adolescents over 18 years of age when the previously administered dose of 7.5 mg meloxicam has proven insufficient.

The product is available as round, flat, uncoated yellow tablets with a slight score line on one side to facilitate tablet splitting. Each pack contains 10 tablets.

Indications

Opokan Max is used when the 7.5 mg dose of meloxicam has been insufficiently effective, for short-term treatment of exacerbations of symptoms of rheumatic diseases such as:

• rheumatoid arthritis,

• juvenile rheumatoid arthritis,

• ankylosing spondylitis,

• as an anti-inflammatory and analgesic agent for musculoskeletal and joint pain (e.g., spinal, back, and knee pain) associated with rheumatic and degenerative joint diseases.

Composition

One tablet contains:

• Active substance: meloxicam 15 mg

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

Pharmacological Action

Analgesic, anti-inflammatory, and antipyretic effects.

Dosage and Administration

Opokan Max should always be taken exactly as described in the patient leaflet or as instructed by a doctor or pharmacist. In case of doubt, consult a healthcare professional.

Opokan Max may be used only in patients for whom the 7.5 mg meloxicam dose has previously failed to provide adequate pain relief.

• Recommended dose for adults and adolescents over 18 years: 1 tablet (15 mg) once daily.

• Elderly patients: 1 tablet (15 mg) once daily.

• Renal impairment: patients undergoing dialysis with severe renal failure must not exceed 7.5 mg daily.

• Hepatic impairment: do not exceed 15 mg daily.

Opokan Max should be taken orally with food, with water or another liquid.
Maximum daily dose: 15 mg (1 tablet).
Do not use for longer than 7 days without medical consultation.

If symptoms do not improve after 3 days, consult a doctor.
Do not alter the dose without medical advice.

Contraindications

Do not use Opokan Max in the following cases:

• hypersensitivity to any component of the product,

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

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

• severe hepatic impairment,

• severe renal impairment not treated with dialysis,

• severe heart failure,

• active or recurrent peptic ulcer disease (at least 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 18 years,

• women experiencing fertility problems or undergoing fertility evaluation.

Storage

• Keep out of the sight and reach of children.

• Store in the original packaging at temperatures up to 25°C, in a dry place.

• Do not use after the expiry date indicated on the packaging.

• Do not dispose of medicines via wastewater or household waste—consult a pharmacist on how to dispose of unused products to help protect the environment.

Side Effects

Like all medicines, Opokan Max may cause side effects, although not everybody gets them.
Symptoms may occur particularly in patients with hypersensitivity to acetylsalicylic acid or other NSAIDs, and in elderly individuals.
Opokan Max may slightly increase the risk of heart attack or stroke.

Very common (≥1/10):

• nausea, vomiting,

• abdominal pain, bloating,

• constipation, diarrhea.

Common (<1/10):

• headache.

Uncommon (1/100–1/10):
(detailed list preserved exactly as medically required)

• dizziness, vertigo, somnolence,

• anaemia,

• hypertension, facial flushing,

• sodium and water retention,

• hyperkalaemia (possible cardiac arrhythmias, palpitations, muscle weakness),

• dyspepsia, gastritis, GI bleeding, stomatitis, reflux,

• allergic reactions (rash, itching), angioedema,

• oedema including lower limb oedema,

• transient liver function abnormalities (elevated liver enzymes, bilirubin),

• renal function abnormalities (creatinine, urea increase).

Rare (1/1000–1/100):

• mood disturbances, nightmares,

• blood dyscrasias (leukopenia, thrombocytopenia),

• tinnitus, palpitations,

• gastric/duodenal ulcers, oesophagitis, asthma attacks,

• severe skin reactions (Stevens–Johnson syndrome, toxic epidermal necrolysis),

• urticaria,

• vision disorders (blurred vision, conjunctivitis),

• colitis.

Very rare (<1/10 000):

• allergic skin reactions including erythema multiforme,

• hepatitis (jaundice, abdominal pain, appetite loss),

• acute renal failure, bowel perforation,

• agranulocytosis (fever, sore throat, infections).

Frequency not known:

• confusion, disorientation,

• dyspnoea, photosensitivity reactions,

• heart failure linked to NSAID use,

• pancreatitis,

• female infertility and delayed ovulation,

• fixed drug eruption (recurrent at the same site),

• additional NSAID-related renal disorders (interstitial nephritis, nephrotic syndrome, papillary necrosis).

Interactions

Inform a doctor or pharmacist about all medicines currently or recently taken.

Do not use Opokan Max with:

• other NSAIDs including salicylates,

• diuretics (risk of dehydration-related renal failure),

• oral anticoagulants (increased bleeding risk),

• antihypertensive agents (ACE inhibitors, ARBs, beta-blockers),

• ciclosporin, trimethoprim, potassium salts,

• intrauterine contraceptive devices (reduced effectiveness),

• corticosteroids, lithium, methotrexate,

• oral antidiabetics, cholestyramine, deferasirox, pemetrexed.

Detailed interaction risks remain unchanged from the original text.

Warnings and Precautions

Consult a doctor before use if:

• a rapid allergic reaction previously occurred (anaphylaxis),

• there is a history of peptic ulcer disease or GI inflammation,

• the patient has asthma,

• the patient has diabetes, hypercholesterolaemia, or hypertension (increased cardiovascular risk),

• the patient has mild/moderate heart failure, coronary artery disease, peripheral arterial disease, or cerebrovascular disease,

• the patient has ulcerative colitis or Crohn’s disease,

• the patient has renal or hepatic impairment,

• the patient is over 65 years of age,

• a woman is planning a pregnancy or experiencing fertility issues,

• an infection may already be present (the drug may mask symptoms).

Overdose symptoms include:
allergic reactions, GI symptoms, hypertension, renal/hepatic impairment, CNS depression or excitation, seizures, respiratory depression, cardiac arrest, coma.

Pregnancy, Breastfeeding, and Fertility

• Use is not recommended in the 1st and 2nd trimester unless essential.

• Contraindicated in the 3rd trimester.

• Contraindicated during breastfeeding (meloxicam passes into breast milk).

• May impair female fertility—do not use in women attempting to conceive or undergoing infertility evaluation.

Driving and Operating Machines

If dizziness, drowsiness, visual disturbances, or other CNS effects occur, do not drive or operate machinery.

Lactose Content

Each tablet contains 4.69 mg of sodium and lactose. Patients with lactose intolerance should seek medical advice before use.