Ketoprofen
Overview
Ketoprofen
Rectal suppositories, 100 mg
COMPOSITION
Each suppository contains the active substance ketoprofen 100 mg.
Excipients: medium-chain saturated triglycerides, semi-synthetic solid glycerides.
WHAT IT IS USED FOR
A non-steroidal anti-inflammatory drug (NSAID) with analgesic, anti-inflammatory and antipyretic effects. It is used for the symptomatic treatment of inflammatory and degenerative rheumatic conditions (rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, gout, osteoarthritis, extra-articular rheumatism) and to relieve pain in painful conditions: post-traumatic and post-operative pain, pain from bone metastases and dysmenorrhoea.
HOW IT WORKS
Ketoprofen reduces the production of prostaglandins, substances involved in pain, inflammation and fever. This relieves pain, swelling and joint stiffness.
HOW TO USE
Administered rectally. Adults and children over 15 years: one 100 mg suppository once or twice a day. The maximum daily dose is 200 mg. Use the lowest effective dose for the shortest possible time. Not for use in children under 15 years.
WHEN IT SHOULD NOT BE USED
hypersensitivity to ketoprofen or to any of the excipients;
a history of asthma, bronchospasm, rhinitis, urticaria or other allergic reactions to ketoprofen, acetylsalicylic acid or other NSAIDs;
active gastric or duodenal ulcer, or a history of gastrointestinal bleeding or perforation;
bleeding (gastrointestinal, cerebrovascular or other), haemorrhagic diathesis;
severe renal, hepatic or cardiac failure;
proctitis or rectal bleeding (recent or in the past);
third trimester of pregnancy;
children under 15 years of age.
Important to know
Use with caution in patients with high blood pressure, heart disease, kidney or liver disorders, asthma, lupus and in the elderly. Long-term treatment requires medical monitoring.
Seek medical advice immediately if abdominal pain, black stools or a skin rash occur. During treatment, avoid alcohol and take care when driving or operating machinery (possible drowsiness, dizziness, vision disturbances). Read the package leaflet carefully before use.
Possible side effects
Common: digestive disturbances (dyspepsia, nausea, abdominal pain, vomiting).
Uncommon: constipation, diarrhoea, flatulence, gastritis, headache, dizziness, drowsiness, skin rash, itching, local oedema.
Rare or frequency not known: ulcer and gastrointestinal bleeding, severe allergic reactions, vision disturbances, serious skin reactions, kidney or liver damage.
If side effects occur, stop using the product and consult a doctor or pharmacist.
STORAGE
Store below 25 °C. Do not freeze. Keep out of the reach of children. Shelf life: 36 months.
QUESTIONS AND CONTACTS
For questions about the medicine, please consult your doctor or pharmacist. Manufacturer: FARMAPRIM SRL, 5 Crinilor str., Porumbeni village, Criuleni district, Republic of Moldova, MD-4829. Pharmacovigilance: safety@farmaprim.md.
Brief information prepared on the basis of the approved Summary of Product Characteristics. It does not replace consultation with a doctor or pharmacist and does not contain all information about the medicine. Always read the package leaflet.