Medication info
Newmacol Soft Capsule

Newmacol Soft Capsule

Prescription medicationSoft capsule경구
Ingredient · strength
Omega-3-Acid Ethyl Esters 90›1000mg / 1 capsuleRosuvastatin Calcium›5.2mg / 1 capsule
Manufacturer / importer
(주)유유제약
Appearance
A white film-coated soft capsule filled with a pale yellow oily substance.
Packaging
8 capsules/PTP[X4], 8 capsules/PTP[X7], 8 capsules/PTP[X10], 8 capsules/PTP[X12], 10 capsules/PTP[X10], 30 capsules/bottle
Approval status
Active

MFDS item code 202008413 · Approved 2020.12.01 · Insurance code 644503220

Summary

Main use
LDL-cholesterol control and treatment of mixed dyslipidemia.
Who takes it
Adults
Adult dose
Administered only to adults, take 2 to 4 capsules once daily with meals to avoid gastrointestinal discomfort (1,000 mg of omega-3 ethyl esters and 5 mg of rosuvastatin per capsule).

Ingredients

Manufacturer
(주)유유제약

Efficacy & effects

LDL-cholesterol control and treatment of mixed dyslipidemia.

  • Coronary artery disease
  • abnormal LDL cholesterol levels
  • abnormal triglyceride levels
  • mixed dyslipidemia.
View approved original text

Rosuvastatin monotherapy effectively lowers LDL cholesterol levels in high-risk adult patients with coronary artery disease, helping to reduce the risk of cardiovascular diseases. However, patients with mixed dyslipidemia who cannot adequately control triglyceride levels may require additional management. Therefore, it is used to improve blood lipid levels by focusing on controlling LDL cholesterol.

How to take

Adult dose

Administered only to adults, take 2 to 4 capsules once daily with meals to avoid gastrointestinal discomfort (1,000 mg of omega-3 ethyl esters and 5 mg of rosuvastatin per capsule).

Precautions

This medication should not be used in certain patients. For example, it should not be administered to patients with allergies to any of its components or with liver function issues. Additionally, it should not be used in patients with muscle diseases, those taking certain immunosuppressants, patients with severe renal impairment, pregnant or nursing women, or children under 18 years of age. When administering this medication, liver function and muscle condition should be periodically monitored, and if symptoms such as muscle pain or weakness occur, the physician should be notified immediately. Patients with renal impairment, hypothyroidism, a history of genetic muscle diseases, or those with alcohol abuse should be particularly cautious. The medication should be administered carefully to patients with a history of liver disease or heavy alcohol consumption, and it is important to test liver enzyme levels before and after treatment. Also, if symptoms such as severe muscle pain, weakness, or fever arise while taking this medication, it is crucial to consult medical personnel immediately. This medication may interact with other drugs, so it is important to inform healthcare providers about any medications currently being taken. In particular, concomitant use with immunosuppressants, certain antibiotics, antifungals, or fibrate medications may increase the risk of muscle-related side effects. Pregnant or nursing women should avoid using this medication, and women who may become pregnant should use appropriate contraception. Safety and efficacy have not been fully established in elderly patients or children, so caution is necessary. While taking this medication, patients should maintain a diet and exercise regimen for health management, and regular check-ups are necessary to assess treatment effectiveness. In case of overdose, there is no specific antidote, so treatment is symptomatic, and monitoring of liver function and muscle enzyme levels is necessary. Finally, this medication should be stored out of the reach of children and not transferred to another container.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blistering, skin peeling, pain in oral/eye mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities accompanied by cough and fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, vision disturbances, paralysis, urine.

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • nasopharyngitis
  • periodontitis
  • upper respiratory tract infection
  • erythema
  • myalgia
Show 24 more
  • arthralgia
  • increased tear secretion
  • presbyopia
  • increased serum alkaline phosphatase
  • increased serum potassium
  • hypokalemia
  • gallstones
  • diabetes
  • headache
  • dizziness
  • constipation
  • pancreatitis
  • itching
  • rash
  • weakness
  • hematuria
  • diarrhea
  • thrombocytopenia
  • hepatitis
  • transaminase elevation
  • hair loss
  • eczema
  • sweating
  • cataract.

Not everyone experiences these, and they can vary from person to person.

Storage

This medication may be sensitive to air and moisture, so it should be stored in a tightly closed container. It is advisable to maintain a storage temperature between 1 degree and 30 degrees Celsius. Proper storage can safely preserve the efficacy of the medication.

Appearance and packaging

Appearance

A white film-coated soft capsule filled with a pale yellow oily substance.

Package unit

8 capsules/PTP[X4], 8 capsules/PTP[X7], 8 capsules/PTP[X10], 8 capsules/PTP[X12], 10 capsules/PTP[X10], 30 capsules/bottle

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.