📌 COMPOSITION

Each F/C tablet contains: Ketoprofen B.P. 100 mg.

📌 DESCRIPTION

Keto 100 (Ketoprofen) is a propionic acid derivative of non‑steroidal anti‑inflammatory drugs. It has anti‑inflammatory, analgesic and antipyretic effects by inhibiting prostaglandin synthesis in body tissues through inhibiting cyclo‑oxygenase enzyme. It is readily absorbed from the gastrointestinal tract; peak plasma concentrations occur about 0.5 to 2 hours after a dose. It is 99% bound to plasma proteins. It is metabolised mainly by conjugation with glucuronic acid and excreted mainly in the urine.

📌 INDICATIONS

Keto 100 is indicated in the following cases:

• Rheumatoid arthritis, ankylosing spondylitis, spondyloarthritis and degenerative arthritis.
• Acute musculoskeletal disorders such as bursitis, tendinitis, synovitis, tenosynovitis and capsulitis.
• Fibrositis, cervical spondylitis, low back pain (strain, lumbago, sciatica, fibrositis) and shoulder pain.
• Painful inflammatory conditions in gynaecology, e.g., primary dysmenorrhoea or pelvic inflammatory disease.
• Microcrystalline arthritis such as gout and postoperative pain.

📌 DOSAGE AND ADMINISTRATION

Keto 100 is indicated for adults and children more than 15 years, and should be taken with a large glass of water during meals.

• Short‑term symptomatic treatment: The recommended dose is 100 mg Keto 100 three times daily.
• Long‑term symptomatic treatment: The dose is 100 to 200 mg Keto 100 once daily.
• Patients with renal insufficiency and elderly patients: It is advisable to reduce the initial dose, then to adjust it, if necessary, depending on renal tolerance.

📌 RESTRICTIONS ON USE

Contraindications

• Hypersensitivity to Ketoprofen or other non‑steroidal anti‑inflammatory drugs.
• Active stomach or intestinal ulcer, serious liver disease, serious kidney disease or serious heart disease.
• Bronchial asthma, gastrointestinal haemorrhage, cerebrovascular haemorrhage or any haemorrhage in progress.
• Pregnancy starting from the 6th month.

Precautions

Before using Ketoprofen, inform your physician in case of a history of asthma associated with chronic rhinitis, coagulation disorders, congenital galactosaemia, glucose or galactose malabsorption syndrome or lactase deficiency.

Effects on the capacity to drive vehicles or use machines

Ketoprofen may produce dizziness, drowsiness or visual disorders. If one of these symptoms occurs, avoid driving vehicles or using machines.

Use in Pregnancy and Lactation

Ketoprofen can be prescribed by a physician during the first five months of pregnancy, if necessary. As of the 6th month of pregnancy, it should not be used in any case. It is also not recommended for lactating women.

📌 DRUG INTERACTIONS

Don't use Ketoprofen with the following drugs:

• Other NSAIDs at high dose, oral anticoagulants, heparin, lithium, methotrexate, platelet aggregation inhibitors (e.g., clopidogrel), potassium salts, diuretics, ACE inhibitors, angiotensin II inhibitors, cyclosporin, tacrolimus, trimethoprim, beta‑blockers, intrauterine device and pentoxifylline.

📌 ADVERSE EFFECTS

Ketoprofen is well tolerated and its adverse effects are usually mild and transient. The common adverse effects reported are: dyspepsia, nausea, vomiting, abdominal pain, headache, dizziness, tinnitus, photosensitivity, visual disturbances and renal impairment.

📌 OVERDOSAGE

In case of overdose, symptomatic and supportive treatment should be given. Symptoms may include nausea, vomiting, abdominal pain, drowsiness, dizziness, headache, blurred vision and confusion. In large doses, gastrointestinal bleeding and renal failure may occur. Gastric lavage or activated charcoal is recommended within one hour of overdose ingestion.

📌 STORAGE INSTRUCTIONS

Store below 25°C in a dry place.

📌 PHARMACEUTICAL FORMS

• Keto 100: Pack of 30 tablets and hospital packs of different sizes.

📌 INSTRUCTIONS TO THE PATIENT

• Medicament is a product which affects your health, and its consumption contrary to instructions is dangerous for you.
• Follow strictly the doctor's prescription, the method of use and the instructions of the pharmacist who sold the medicament.
• The doctor and the pharmacist are experts in medicine, its benefits and risks.
• Do not by yourself interrupt the period of treatment prescribed for you.
• Do not repeat the same prescription without consulting your doctor.

Keep medicament out of reach of children

012-06-078 7/12 | Mfd. By: Saba Pharma | P.O. Box: 4265 Sana'a / Yemen | Council of Arab Health Ministers | Union of Arab Pharmacists