1. Product Description and Use

Cholib is a prescription medicine that contains two active substances:

• 
  

  Fenofibrate (145 mg) – from the class of fibrates, which reduces triglycerides and increases HDL cholesterol.

  
  


• 
  

  Simvastatin (20 mg) – from the statin class, which lowers LDL cholesterol and overall cholesterol levels.

  
  

Indication (What it is used for):
Cholib is used in adults with mixed dyslipidemia (high triglycerides and low HDL cholesterol) in addition to a high LDL level, to reduce the risk of cardiovascular events.
It is prescribed when diet and single-agent therapy (either statin or fibrate) do not sufficiently control blood lipid levels.

2. Dosage Instructions

• 
  

  The recommended dose is one tablet per day, taken with food in the evening.

  
  


• 
  

  Tablets should be swallowed whole with water.

  
  


• 
  

  Do not crush or chew the tablets.

  
  


• 
  

  Continue cholesterol-lowering diet during treatment.

  
  


• 
  

  Do not take more than one tablet per day.

  
  

3. Warnings and Precautions

Do not take Cholib if you:

• 
  

  Are allergic to fenofibrate, simvastatin, or any excipient.

  
  


• 
  

  Have liver disease, gallbladder disease, or pancreatitis.

  
  


• 
  

  Are pregnant or breastfeeding.

  
  


• 
  

  Take certain medications (e.g., ciclosporin, danazol, potent CYP3A4 inhibitors like itraconazole, ketoconazole, HIV protease inhibitors, etc.)

  
  

Talk to your doctor before taking Cholib if you:

• 
  

  Have kidney, liver, or thyroid problems.

  
  


• 
  

  Consume large amounts of alcohol.

  
  


• 
  

  Have a history of muscle disorders or are over 70 years of age.

  
  


• 
  

  Have hypothyroidism or low albumin levels.

  
  


• 
  

  Have personal or family history of muscle disease or previous statin-related muscle issues.

  
  


• 
  

  Are taking medicines that interact with simvastatin or fenofibrate.

  
  

Monitoring:

• 
  

  Your doctor may carry out blood tests to check liver, kidney, and muscle enzyme levels before and during treatment.

  
  

4. Side Effects

Common side effects (may affect up to 1 in 10 people):

• 
  

  Increased liver enzymes

  
  


• 
  

  Digestive disorders: abdominal pain, nausea, diarrhea

  
  


• 
  

  Headache

  
  

Uncommon (up to 1 in 100):

• 
  

  Muscle pain or weakness

  
  


• 
  

  Fatigue, dizziness

  
  


• 
  

  Itching or rash

  
  


• 
  

  Gallstones

  
  


• 
  

  Elevated creatinine or urea

  
  

Rare but serious:

• 
  

  Myopathy, rhabdomyolysis (serious muscle damage, potentially fatal)

  
  


• 
  

  Liver inflammation or jaundice

  
  


• 
  

  Pancreatitis

  
  


• 
  

  Severe skin reactions (e.g., Stevens-Johnson syndrome)

  
  


• 
  

  Interstitial lung disease

  
  

Stop taking Cholib and seek urgent medical help if you experience:

• 
  

  Muscle pain, tenderness, or weakness

  
  


• 
  

  Signs of liver problems (yellowing of the skin or eyes, dark urine)

  
  


• 
  

  Allergic reactions (swelling, rash, difficulty breathing)

  
  

5. Ingredients

Active Ingredients:

• 
  

  Fenofibrate 145 mg (as fenofibric acid)

  
  


• 
  

  Simvastatin 20 mg

  
  

Other Ingredients (Excipients):

• 
  

  Tablet core: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, pregelatinized starch, sodium laurilsulfate, and magnesium stearate.

  
  


• 
  

  Film coating: hypromellose, titanium dioxide (E171), macrogol 400, and iron oxide yellow (E172).