Simvastatin Tablet Package Insert

The excipients in this product are: lactose, pregelatinized starch, butylated hydroxyanisole, vitamin C, citric acid, microcrystalline cellulose, magnesium stearate, hydroxypropyl cellulose, red iron oxide, talc, hydroxypropyl methylcellulose, titanium dioxide, and yellow iron oxide.
【Characteristics】
This product is a film-coated tablet; upon removal of the coating, it appears white to pale yellow.

【Indications】
Hyperlipidemia
In patients with primary hypercholesterolemia, including heterozygous familial hypercholesterolemia, hyperlipidemia, or mixed hyperlipidemia, when dietary management and other nonpharmacologic therapies are inadequate, this product, in conjunction with dietary control, may be used to reduce elevated total cholesterol, low-density lipoprotein cholesterol, apolipoprotein B, and triglycerides, while increasing high-density lipoprotein cholesterol, thereby lowering the low-density lipoprotein cholesterol/high-density lipoprotein cholesterol ratio and the total cholesterol/high-density lipoprotein cholesterol ratio.
In patients with homozygous familial hypercholesterolemia, in combination with dietary management and non-dietary therapies, this product can be used to reduce elevated
Elevated total cholesterol, low-density lipoprotein cholesterol, and apolipoprotein B.
Coronary heart disease
For patients with coronary heart disease complicated by hypercholesterolemia, this product is indicated for:
Reduce the risk of death;
Reduce the risk of coronary heart disease–related mortality and nonfatal myocardial infarction;
Reduce the risk of stroke and transient ischemic attack;
Reduce the risk of cardiac vascular reconstruction procedures (coronary artery bypass grafting and percutaneous transluminal coronary angioplasty);
To slow the progression of coronary atherosclerosis, including reducing the formation of new lesions and total occlusions.
Pediatric patients with heterozygous familial hypercholesterolemia
In adolescent boys and girls aged 10 to 17 with heterozygous familial hypercholesterolemia (at least one year after menarche), in combination with dietary management, this product may be used to reduce total cholesterol, low-density lipoprotein cholesterol, triglycerides, and apolipoprotein B.
【Specifications】
10mg
【Usage and Dosage】
Prior to initiating treatment with this product, patients should follow a standard cholesterol-lowering diet and continue to adhere to it throughout the course of therapy.
The recommended dosage range is 5 to 40 mg per day, administered as a single evening dose; the specific dose should be individualized based on baseline low-density lipoprotein cholesterol levels, the recommended treatment target, and the patient’s response. Dose adjustments should be made at intervals of at least 4 weeks.
The recommended starting dose is 10 mg or 20 mg once daily in the evening. For patients at high risk of coronary heart disease events due to a history of coronary heart disease, diabetes, peripheral vascular disease, stroke, or other cerebrovascular diseases, the recommended starting dose is 20–40 mg per day. For patients who require only moderate reduction in low-density lipoprotein cholesterol, the starting dose is 10 mg.
----Restrict use to a dose of 80 mg per day

【Storage】Store sealed at temperatures below 25°C.
【Packaging】Orally administered solid dosage form in high-density polyethylene bottles, 30 tablets per bottle; polyvinyl chloride/polyethylene/polyvinylidene chloride blister.
Packaged in medicinal composite rigid blisters and pharmaceutical aluminum foil, available in boxes of 6, 10, 12, 20, 24, and 30 tablets.
【Shelf Life】24 months
[Implementation Standard] Drug Registration Standard of the National Medical Products Administration: YBH11712023
[Approval Number] National Drug Approval No. H20066221
[Marketing Authorization Holder]
Name: Guangdong Bidi Pharmaceutical Co., Ltd.
Registered Address: No. 66, Bidi Avenue, Yueshan Town, Kaiping City, Guangdong Province
Postal code: 529331
Telephone numbers: (0750) 2789348 (product inquiries), 2763089 (quality inquiries)
400-8899-328 (National Service Hotline)
Fax number: (0750)2789285
Website: http://www.pdpharm.com
【Manufacturing Enterprise】
Company Name: Guangdong Bidi Pharmaceutical Co., Ltd.
Production Address: No. 66, Bidi Avenue, Yueshan Town, Kaiping City, Guangdong Province
Postal code: 529331
Telephone numbers: 0750-2789348 (product inquiries) and 2763089 (quality inquiries).
400-8899-328 (National Service Hotline)
Fax number: 0750-2789285
Website: http://www.pdpharm.com