Bezafibrate Sustained-Release Tablets have a definite effect in regulating blood lipids. However, like all medicines, they may cause adverse reactions.

I. What are the side effects of bezafibrate?

1. Serious side effects (seek medical attention immediately)

Although the incidence of the following side effects is unknown, they may be life-threatening once they occur. Discontinue the drug immediately and seek medical attention:

(1) Rhabdomyolysis: Manifested as muscle pain, weakness, elevated creatine kinase (CK), and dark-colored urine (myoglobinuria), which may lead to acute renal failure.

(2) Anaphylactic shock / hypersensitivity reactions: Such as facial edema, lip swelling, dyspnea, skin rash, etc.

(3) Hepatic dysfunction / jaundice: Symptoms including fatigue, loss of appetite, yellowing of the skin or sclera, and elevated transaminases.

2. Common side effects (incidence: 1%–5%)

(1) Gastrointestinal system: Abdominal pain, nausea, decreased appetite, abdominal distension, diarrhea, stomatitis.

(2) Skin: Rash, pruritus.

(3) Psychoneurological system: Headache, dizziness, somnolence, insomnia, numbness.

(4) Musculoskeletal system: Elevated CK, muscle pain, muscle spasm.

(5) Liver: Abnormal liver function such as elevated AST, ALT, LDH.

(6) Kidney: Elevated BUN and creatinine (especially in patients with renal insufficiency).

(7) Others: Elevated uric acid, fatigue, alopecia, taste disturbance, edema, frequent urination, etc.

3. Rare side effects (incidence: < 1%)

(1) Vomiting, constipation, gastric ulcer, heartburn, dry mouth.

(2) Urticaria, photosensitivity.

(3) Anemia, leukopenia, platelet abnormalities.

(4) Hypoglycemia, impotence, gallstones, fever, etc.

II. How to relieve and manage side effects?

1. Management of muscle‑related symptoms

(1) Early recognition: If unexplained muscle pain or weakness occurs, discontinue the drug immediately and check CK levels.

(2) Dose reduction or discontinuation: According to the instructions, dose reduction or drug withdrawal should be considered when muscle symptoms such as elevated CK appear.

(3) Avoid triggers: Avoid strenuous exercise and dehydration; extra caution is required especially when used in combination with statins.

2. Relief of gastrointestinal discomfort

(1) Take after meals: It is recommended to take this drug with morning and evening meals to reduce gastrointestinal irritation.

(2) Diet adjustment: Avoid greasy and spicy foods; choose a light, easily digestible diet.

(3) Persistent symptoms: If nausea or abdominal pain persists, consult a doctor promptly and adjust the medication regimen if necessary.

3. Management of abnormal liver function

(1) Regular monitoring: Liver function, especially transaminase levels, should be checked regularly during treatment.

(2) Discontinuation criteria: If obvious liver injury or jaundice occurs, discontinue the drug immediately and seek medical help.

(3) Avoid hepatotoxic substances: Avoid alcohol during treatment to reduce liver burden.

4. Management of abnormal renal function

(1) Monitor renal function: Regularly check creatinine and BUN, especially in elderly patients or those with pre‑existing renal impairment.

(2) Prompt discontinuation: If renal function deteriorates, discontinue the drug immediately and take measures to protect renal function.

(3) Avoid combination with nephrotoxic drugs: Such as cyclosporine; use cautiously under medical guidance.

5. Management of skin reactions

(1) Mild rash / pruritus: Antihistamines or topical antipruritic ointments may be tried; seek medical advice if symptoms persist.

(2) Photosensitivity: Avoid prolonged sun exposure during treatment; take adequate sun protection measures when going out.

(3) Severe reactions: Urticaria, facial edema, etc., may be precursors of hypersensitivity. Discontinue the drug immediately and seek medical attention.

III. Storage requirements for Bezafibrate Sustained-Release Tablets

1. Storage temperature and environment

(1) Store at room temperature: Keep at room temperature, away from high temperature, humidity and direct sunlight.

(2) Protect from moisture: Special attention should be paid to moisture protection after opening, especially for bulk medicines outside the blister pack.

2. Precautions before use

(1) PTP packaging: Always remove the tablet from the PTP blister before administration. Do not swallow the blister whole, as it may injure the esophagus.

(2) Sustained‑release formulation: This product is a sustained‑release tablet and should be swallowed whole. Do not chew, split or crush it, otherwise rapid drug release may occur and increase the risk of side effects.