Leaflet SINTENAL 20mg film-coated tablets

Product code:
W42159001
Quantity:
30
Indicated for:
dyslipidemia
Route of administration:
oral
Substance:
simvastatin (statin lipid-lowering agent)
ATC
C10AA01 — Cardiovascular system | Lipid modifying agents | Lipid modifying agents, plain | Hmg coa reductase inhibitors

Precautions:

Avoid grapefruit

Avoid grapefruit

Avoid grapefruit and grapefruit juice.

Hepatotoxicity

Hepatotoxicity

This medicine may affect the liver.

Major drug interactions

Major drug interactions

This medicine may have important interactions with other medicines.

Myopathy / rhabdomyolysis

Myopathy / rhabdomyolysis

Seek medical advice if unexplained muscle pain occurs.

Requires periodic laboratory tests

Requires periodic laboratory tests

Periodic laboratory tests may be required during treatment.

Pregnancy warning

Pregnancy warning

Use during pregnancy only on medical advice.

Simvastatin is a medication used to lower cholesterol and triglyceride levels in the blood, and it is indicated for the prevention of cardiovascular diseases such as heart attack and stroke. It belongs to the class of statins, which work by inhibiting the enzyme HMG-CoA reductase, responsible for cholesterol production in the liver.

Simvastatin is taken orally, usually once daily in the evening, as cholesterol synthesis is more active at night. It is used in combination with a healthy diet, exercise, and other cholesterol-lowering measures.

Common side effects include headaches, nausea, constipation, mild muscle pain, and fatigue. In rare cases, it may cause more serious reactions, such as rhabdomyolysis (a severe condition involving muscle tissue breakdown), liver dysfunction, or elevated liver enzyme levels.

Simvastatin is contraindicated in individuals with active liver disease, pregnant or breastfeeding women, and those taking certain medications that may interact with it (such as some antifungals or antibiotics). It is important for patients to follow their doctor's recommendations and undergo regular blood tests to monitor liver function and cholesterol levels.

General data about SINTENAL 20mg

Substance:
simvastatin
Date of latest medicines list:
01-06-2026
Product code:
W42159001
Concentration:
20mg
Pharmaceutical form:
film-coated tablets
Quantity:
30
Product type:
Generic medicine
Price:
16.97 RON
Prescription status:
P-6L — Medicines dispensed with a medical prescription that is not retained by the pharmacy and may be renewed; the prescription may be used for 6 months from the date of issue.

Marketing authorisation

Manufacturer:
AC HELCOR S.R.L. - ROMANIA
Holder:
AC HELCOR PHARMA S.R.L. - ROMANIA
Number:
12054/2019/01
Shelf life:
2 years

Concentrations available for simvastatin

  • 10mg
  • 20mg
  • 30mg
  • 40mg
  • 5mg
  • 80mg

Compensation lists for SINTENAL 20mg Helcor

A - Sublist A with 90% discount from the reference price

Price
16.97 RON
Copayment
8.40 RON
Patient
8.57 RON