Artrocol
(Ketoprofen)




COMPOSITION

Rectal suppository contains

Active substance: ketoprofen 100 mg.

Excipient: hard fat.

THERAPEUTIC INDICATIONS

Symptomatic therapy of painful inflammatory processes of various origin:

- rheumatoid arthritis;

- ankylosing spondylitis;

- psoriatic arthritis;

- reactive arthritis;

- gout, pseudogout;

- osteoarthrosis;

- extra-articular rheumatism (tendinitis, bursitis, adhesive capsulitis).

Pain syndrome (including post-operational and post-traumatic pains, algodysmenorrhea, pains in tumor metastasis).

CONTRAINDICATIONS

- hypersensitivity to ketoprofen, acetylsalicylic acid and other NSAIDs;

- history of allergic reactions (bronchial spasm, asthma, rhinitis, urticaria) after administration of acetylsalicylic acid or other NSAIDs;

- exacerbation of peptic ulcer;

- evident gastro-intestinal bleeding or the onset gastro-intestinal bleeding induced by NSAIDs in history;

- severe disturbances of hepatic and renal function;

- severe heart failure;

- records of proctitis and rectal bleedings in history;

- III trimester of pregnancy and lactation;

- children and adolescents under 14 years old.

ADVERSE EFFECTS

The parameters of the side effect frequency used below are determined in the following way: common (from ≥ 1/100 to < 1/10), uncommon (from ≥ 1/1000 to < 1/100), rare (from ≥ 1/10000 to < 1/1000), very rare (< 1/10000), unspecified frequency (the parameters of frequency can’t be evaluated according to available data).

Gastrointestinal tract: common – abdominal pain, nausea, vomiting; uncommon – constipation, flatulence, diarrhea; rare – stomatitis.

Nervous system: rare – headache, drowsiness, dizziness, paresthesia.

Organ of vision: rare – visual disturbances; very rare – conjunctivitis.

Hematopoietic system: rare – anemia; unspecified frequency – thrombocytopenia, agranulocytosis.

Allergic reactions: uncommonitching, urticaria, exfoliative dermatitis; very rare – angioedema, anaphylactoid reactions.

Other: rare – tinnitus; very rare – hepatic and renal function impairment.

Local reactions: rare – burning feeling, mucosal irritation.

DOSAGE AND ADMINISTRATION

Artrocol suppositories are indicated for rectal administration.

In adult patients: 1 suppository 1-2 times daily.

Rectal suppositories can be co-administered with ketoprofen dosage forms for systemic or external use. Maximal daily dose of ketoprofen (including different dosage forms administration) is 300 mg.

Suppositories are inserted deep into the rectum following defecation. Suppositories should not be divided in parts, as changing storage conditions can impair active substance distribution.

Since the risk of adverse reactions is dose- and use-dependent, minimal recommended dose should be taken for as short as possible.

SPECIAL INDICATIONS

Cross sensitivity to acetylsalicylic acid and other NSAIDs is likely. Artrocol should be administered with caution in parallel with acetylsalicylic acid and other NSAIDs, lithium formulations, antihypertensive drugs, diuretics, methotrexate, antidiabetic drugs and anticoagulants.

Long-term administration of ketoprofen requires regular hematologic control and control of hepatic and renal function tests, especially in elderly patients.

Ketoprofen should be prescribed with caution in patients with arterial hypotension and cardiac diseases that are characterized by body fluid retention, blood pressure control is recommended.

Ketoprogen should be prescribed with caution in patients with gastric and duodenal ulcer, or gastrointestinal bleeding in history, impairment of renal or hepatic function.

Ketoprofen should be prescribed with caution in elderly patients due to increased risk of side effects.

Ketoprofen, like other NSAIDs, can disguise symptoms of underlying infectious disease.

Like other drugs inhibiting cyclooxygenase/prostaglandin synthesis, ketoprofen can impair fertilization, therefore it is not recommended in female patients, who are planning to get pregnant.

PREGNANCY AND LACTATION

Administration of Artrocol in the first and second trimesters of pregnancy is possible only if the expected benefit overweighs a potential risk.

Administration of medicine is contraindicated during the third trimester of pregnancy and lactation.

MANUFACTURED FORM AND PACKAGE

Rectal suppositories.

5 suppositories in a strip.

1 or 2 strips together with a leaflet in a carton box.

Musculo-Skeletal system

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