📌 COMPOSITION

Each F/C tablet contains: Etoricoxib 60 mg or 90 mg.

📌 DESCRIPTION

Etrotop (Etoricoxib) is one of a group of medicines called selective cyclo-oxygenase enzyme type 2 (COX-2) inhibitors, belonging to the non-steroidal anti-inflammatory drugs (NSAIDs) family. Etrotop inhibits the action of COX-2, which is responsible for the synthesis of prostaglandins from arachidonic acid, thus reducing inflammation and pain caused by prostaglandins. Selective COX-2 inhibitors have less activity on COX-1, and therefore have fewer gastrointestinal side effects compared to traditional NSAIDs.

📌 INDICATIONS

• Etrotop helps to reduce pain and swelling (inflammation) in the joints and muscles of patients with osteoarthritis, rheumatoid arthritis, ankylosing spondylitis and gout.
• Etrotop is also used for the short‑term treatment of moderate pain after dental surgery in patients 16 years and older.

📌 DOSAGE & ADMINISTRATION

It is important that you use the lowest daily dose that controls pain and should not take Etrotop for longer than necessary. Etrotop can be taken with or without food.

• Osteoarthritis: The recommended dose is 30 mg once a day, increased to a maximum of 60 mg once a day if needed.
• Rheumatoid arthritis & Ankylosing spondylitis: The recommended dose is 60 mg once a day, increased to a maximum of 90 mg once a day if needed.
• Acute pain conditions: The dose should not exceed 120 mg daily in acute pain, for a maximum of 8 days.
• Gout: The recommended dose is 120 mg once a day, which should only be used for the acute painful period, limited to a maximum of 8 days of treatment.
• Post‑operative dental surgery pain: The recommended dose is 90 mg once daily, limited to a maximum of 3 days of treatment.
• Patients with mild liver disease: Do not take more than 60 mg/day.
• Patients with moderate liver disease: Do not take more than 30 mg/day.
• Elderly patients: No dose adjustment is necessary; as with other drugs, caution should be taken in elderly patients.
• No dose adjustment is necessary for patients with creatinine clearance ≥ 30 ml/min. The use of etoricoxib in patients with creatinine clearance < 30 ml/min is contraindicated.

📌 RESTRICTIONS ON USE

Contraindications

• Hypersensitivity to etoricoxib or non‑steroidal anti‑inflammatory drugs.
• Peptic ulcer or active gastrointestinal bleeding.
• Serious liver or kidney disease.
• Children under 16 years of age.
• Inflammatory bowel disease, such as Crohn's disease, ulcerative colitis, or colitis.
• High blood pressure that has not been controlled by treatment.
• Heart problems or stroke.

Precautions

• Caution should be taken in patients with: a history of bleeding or ulcer in the stomach and intestine, dehydration, swelling due to fluid retention, high blood pressure, heart, liver or kidney disease, diabetes, high cholesterol.
• The risk of heart disease increases in smokers or elderly patients over 65 years of age.
• Patients treated for an infection: Etrotop can mask or hide a fever, which is a sign of infection.

Effect on the ability to drive vehicles and use machines

Dizziness and sleepiness have been reported in some patients taking Etrotop. Do not drive or use machines if you experience dizziness or sleepiness.

Use in pregnancy and lactation

Etrotop should not be used during pregnancy and lactation.

📌 DRUG INTERACTIONS

• Caution should be taken when Etrotop is co‑administered with the following drugs: anticoagulants, rifampicin, methotrexate, ciclosporin or tacrolimus, lithium, ACE inhibitors and angiotensin receptor blockers (examples include enalapril and ramipril, and losartan and valsartan), diuretics, digoxin, minoxidil, salbutamol, oral contraceptives, hormone replacement therapy.
• Do not take high doses of aspirin or other anti‑inflammatory drugs with Etrotop.
• Patients who, after taking aspirin or other NSAIDs including COX‑2 inhibitors, experience bronchospasm, cut rhinitis, nasal polyps, angioneurotic oedema, urticaria or allergic‑type reactions.

📌 ADVERSE EFFECTS

• Very common: Stomach pain.
• Common: Weakness and fatigue, dizziness, headache, constipation, wind, gastritis, heartburn, diarrhoea, indigestion, nausea, vomiting, inflammation and pain after tooth extraction, swelling of the legs and/or feet, changes in blood tests related to the liver, palpitations, increased blood pressure.

📌 STORAGE INSTRUCTIONS

Store below 30°C in a dry place.

📌 PHARMACEUTICAL FORMS

Etrotop 60, 90 tablets: Pack of 14 tablets and hospital packs of different sizes.