Rantudil forte (Capsules) Instructions for Use

Marketing Authorization Holder

Meda Manufacturing GmbH (Germany)

ATC Code

M01AB11 (Acemetacin)

Active Substance

Acemetacin (Rec.INN registered by WHO)

Dosage Form

Rantudil forte

Capsules 60 mg: 20, 50, or 100 pcs.

Dosage Form, Packaging, and Composition

10 pcs. – blisters (2) – cardboard packs.
10 pcs. – blisters (5) – cardboard packs.
10 pcs. – blisters (10) – cardboard packs.

Clinical-Pharmacological Group

NSAID

Pharmacotherapeutic Group

NSAID

Pharmacological Action

NSAID. By blocking COX, it disrupts the synthesis of prostaglandins and the production of ATP. It has anti-inflammatory, antipyretic, and analgesic effects, and inhibits platelet aggregation.

The analgesic effect is due to both central and peripheral action.

It affects the thermoregulation center, reducing temperature in febrile conditions.

It reduces platelet aggregation, adhesion, and thrombus formation by suppressing the synthesis of thromboxane A₂ in platelets.

Indications

Chronic rheumatoid arthritis, chronic psoriatic arthritis, osteoarthritis, ankylosing spondylitis, gouty arthritis, myositis, tenosynovitis, tendosynovitis, bursitis, lumbago, sciatica, postoperative inflammation, soft tissue damage, superficial vein thrombophlebitis.

ICD codes

Dosage Regimen

Take orally.

Depending on the indications and severity of the disease, adults – 60 mg 1-3 times/day.

For gout exacerbation – 180 mg/day in 3 doses until clinical symptoms disappear. If necessary, for patients without erosive-ulcerative lesions of the gastrointestinal tract, the dose can be temporarily increased to 300 mg/day at the beginning of treatment: 120 mg once, then 60 mg every 8 hours. This dosing regimen, if necessary, can be maintained on the 2nd day. When symptoms subside, the dose should be reduced.

Maximum dose 600 mg/day.

For doses exceeding 180 mg/day, do not use for more than 7 days.

Adverse Reactions

From the digestive system nausea, vomiting, weakness, abdominal pain, diarrhea, anorexia, occult gastrointestinal bleeding, ulceration of the stomach or duodenum; rarely – stomatitis, aphthous stomatitis, toxic hepatitis.

From the nervous system headache, dizziness, drowsiness, increased fatigue; less often – anxiety, confusion, psychosis, hallucinations, depression, irritability, peripheral neuropathy.

From the musculoskeletal system rarely – muscle weakness, weakness in muscles.

From metabolism rarely – edema, hyperkalemia, increased urea content, hyperproteinemia, hyperglycemia, glucosuria.

From the cardiovascular system rarely – increased blood pressure, angina pectoris.

From the hematopoietic system leukopenia, anemia, thrombocytopenia, agranulocytosis, pancytopenia.

From the sensory organs rarely – tinnitus, hearing or vision impairment, diplopia; with long-term use – impaired retinal function with discoloration and clouding of the cornea.

Other allergic reactions, photodermatitis, urination disorders, metrorrhagia, intensification of inflammation symptoms.

Contraindications

Erosive-ulcerative lesions of the gastrointestinal tract (in the acute phase), gastrointestinal bleeding, “aspirin” asthma, hemophilia, hemorrhagic diathesis, hypoprothrombinemia, portal hypertension, vitamin K deficiency, renal failure, first and third trimesters of pregnancy, lactation period, hypersensitivity to acemetacin.

Use in Pregnancy and Lactation

Contraindicated for use in the first and third trimesters of pregnancy and during the lactation (breastfeeding) period.

Special Precautions

Use with caution in patients with gout, in liver diseases, in children under 12 years of age with hyperthermia due to viral diseases (risk of developing Reye’s syndrome).

Patients should not consume alcohol during treatment.

Effect on ability to drive vehicles and mechanisms

Acemetacin may negatively affect the ability to concentrate and the speed of psychomotor reactions.

Drug Interactions

Inducers of microsomal oxidation (phenytoin, ethanol in small doses, barbiturates, zixorin, rifampicin, phenylbutazone, tricyclic antidepressants) increase the production of hydroxylated active metabolites.

Acemetacin reduces the effectiveness of uricosuric drugs; enhances the effect of anticoagulants, antiplatelet agents, fibrinolytics, side effects of mineralocorticoids, glucocorticosteroids, estrogens; reduces the effectiveness of antihypertensive and diuretic agents; potentiates the hypoglycemic effect of sulfonylurea derivatives.

Antacids and cholestyramine reduce the absorption of acemetacin.

Acemetacin increases the blood concentration of lithium and methotrexate preparations.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.