Cholib

When both LDL cholesterol and triglyceride levels need to be managed together, a combination product can simplify treatment and target multiple aspects of the lipid profile in a single daily tablet. Cholib tablets are a prescription-only combination medicine containing fenofibrate and simvastatin, licensed for adults with mixed dyslipidaemia who are already stable on the individual components. Each tablet provides two complementary mechanisms of lipid control, statin-mediated LDL reduction and fibrate-mediated triglyceride management. A prescription can only be issued following a clinical consultation.

Cholib is a branded fixed dose combination prescription medicine manufactured by Mylan (Viatris). Each tablet contains fenofibrate 145 mg and simvastatin 20 mg. Fenofibrate is a fibrate medicine that primarily lowers triglycerides and raises HDL cholesterol. Simvastatin is a statin medicine that primarily lowers LDL cholesterol. Combining both active ingredients in a single once daily tablet is intended to make treatment more convenient for patients who require both classes of lipid-lowering medicine.

Cholib is licensed in the UK for the treatment of mixed dyslipidaemia in adults who are already stabilised on the same doses of fenofibrate 145 mg and simvastatin 20 mg as separate medicines. This is an important prescribing restriction: Cholib is not intended for patients who are starting lipid lowering therapy for the first time, or for patients who have not yet been individually stabilised on fenofibrate and simvastatin at these specific doses. It is a simplification treatment for established, stable patients.

Cholib is available in a single tablet strength: 145 mg fenofibrate and 20 mg simvastatin. It is taken once daily in the evening. Because both active ingredients carry their own side effect and interaction profiles, prescribers will assess both components carefully before considering Cholib appropriate.

Cholib lowers lipid levels through the combined actions of its two active ingredients, each working through a distinct mechanism.

Simvastatin: HMG-CoA Reductase Inhibition. Simvastatin is a prodrug that is converted in the liver to its active form. It inhibits HMG-CoA reductase, the rate-limiting enzyme in cholesterol synthesis. By reducing the liver's own cholesterol production, simvastatin causes liver cells to upregulate LDL receptors, capturing more LDL cholesterol from the bloodstream. The result is a significant reduction in plasma LDL cholesterol. Simvastatin also modestly lowers triglycerides and raises HDL cholesterol.

Fenofibrate: PPAR Alpha Activation. Fenofibrate is converted in the body to fenofibric acid, the active form. Fenofibric acid activates PPAR alpha receptors, which regulate genes involved in fatty acid metabolism. PPAR alpha activation increases the activity of lipoprotein lipase, the enzyme that breaks down triglyceride rich particles in the blood, leading to a significant fall in plasma triglycerides. Fenofibrate also reduces VLDL production by the liver and raises HDL cholesterol by increasing the production of apolipoprotein A-I and A-II.

Together, simvastatin and fenofibrate provide complementary lipid control: simvastatin addresses LDL management while fenofibrate addresses triglyceride reduction and HDL improvement. This dual action is the clinical rationale for using this combination in mixed dyslipidaemia, where both LDL and triglycerides are outside target ranges. However, combining a fibrate with a statin also carries an increased risk of muscle related adverse effects compared to either medicine alone, which is reflected in the prescribing restrictions for Cholib.

Always take Cholib exactly as your prescriber instructs. Read the Patient Information Leaflet supplied with your medicine before starting treatment.

• Take one Cholib tablet once daily in the evening, with or without food.
• Swallow the tablet whole with a glass of water. Do not crush or chew the tablet.
• Avoid large quantities of grapefruit juice during treatment, as it inhibits CYP3A4 and increases simvastatin blood levels, raising the risk of muscle side effects.

If you miss a dose, take it as soon as you remember on the same evening. If you only remember the following morning, skip the missed dose and take the next dose as normal in the evening. Do not take two doses on the same day. Do not stop taking Cholib without speaking to your prescriber first.

Your prescriber will suggest blood tests to check your lipid levels periodically. Liver function and muscle markers may also be monitored. If you develop any unexplained muscle pain, tenderness, or weakness, contact your prescriber promptly.

Cholib is available in a single strength: fenofibrate 145 mg and simvastatin 20 mg per tablet. One tablet is taken once daily in the evening. This fixed dose combination is appropriate only for patients who have already been stabilised on fenofibrate 145 mg and simvastatin 20 mg as separate medicines. If your prescriber determines that a different dose of either component is needed, separate tablets of each medicine would be required rather than Cholib.

The simvastatin 20 mg dose in Cholib is a moderate intensity statin dose. If your LDL cholesterol requires a higher intensity statin, Cholib at this fixed dose would not be appropriate and your prescriber would need to consider separate medicines to allow independent dose adjustment. All dose decisions are made by your prescriber. Do not change your treatment without medical advice.

Cholib can cause side effects from either of its active components.

Common Side Effects (may affect up to 1 in 10 people):

• Gastrointestinal effects including abdominal pain, nausea, flatulence, and diarrhoea (related primarily to the fenofibrate component).
• Muscle aches or weakness (myalgia). Contact your prescriber if you experience unexplained muscle pain, tenderness, or weakness.
• Headache.

Uncommon Side Effects (may affect up to 1 in 100 people):

• Raised liver enzymes, monitored as part of standard care.
• Dizziness.
• Skin rash or itching.
• Sleep disturbances.

Serious Side Effects — Seek Urgent Medical Attention: Go to your nearest accident and emergency department or call 999 immediately if you experience severe muscle pain, weakness, or cramps, particularly with dark, tea coloured urine (rhabdomyolysis risk, higher when a fibrate and statin are combined); signs of significant liver problems such as yellowing of the skin or eyes, severe abdominal pain, or very dark urine; or signs of a severe allergic reaction such as sudden widespread rash, difficulty breathing, or swelling of the face, lips, tongue, or throat.

Cholib tablets may be suitable if you:

• Are an adult with mixed dyslipidaemia who is already taking both fenofibrate 145 mg and simvastatin 20 mg as separate tablets and your prescriber has determined that switching to the combined tablet is appropriate.
• Have been clinically stable on these specific doses and your lipid levels are well controlled on the combination.
• Are already prescribed Cholib and require a repeat prescription through an online prescribing service.

Cholib tablets are not suitable if you:

• Are not already taking both fenofibrate 145 mg and simvastatin 20 mg as individual medicines. Cholib is a simplification medicine, not a treatment to start from scratch.
• Require a higher dose of simvastatin than 20 mg for adequate LDL control, or a different dose of fenofibrate.
• Are taking certain medicines that interact significantly with simvastatin, including amiodarone, verapamil, diltiazem, amlodipine, and lomitapide.
• Are pregnant or planning to become pregnant. Simvastatin is contraindicated in pregnancy.
• Are breastfeeding.
• Have active liver disease or persistently elevated liver enzymes.
• Have severe kidney impairment.
• Have a history of photoallergy or phototoxicity from fibrate medicines.
• Have severely elevated triglyceride levels that suggest a predisposition to fibrate-associated myopathy risk.
• Have a known allergy or hypersensitivity to fenofibrate, simvastatin, or any excipient listed in the SmPC.
• Are under 18 years of age.

Important Drug Interactions: Medicines that increase simvastatin blood levels and raise myopathy risk include ciclosporin, danazol, strong CYP3A4 inhibitors (itraconazole, ketoconazole, HIV protease inhibitors, clarithromycin, erythromycin), amiodarone, verapamil, diltiazem, amlodipine, and niacin at lipid-lowering doses — some combinations are contraindicated. Gemfibrozil is contraindicated with simvastatin. Warfarin and other anticoagulants may have their effect modestly increased — INR monitoring advisable. Colchicine increases myopathy risk. Grapefruit juice increases simvastatin blood levels — avoid large quantities.

Cholib is a Prescription Only Medicine. The clinical consultation is the essential first step. A prescription will only be issued if a registered prescriber concludes, based on their individual assessment of your circumstances, that Cholib is clinically appropriate for you.

During your online consultation with Pharmacy Planet, a registered prescriber will review your current lipid-lowering medicines, lipid levels, liver and kidney function where available, current medicines, and other relevant medical history. The prescriber will confirm that you are already stabilised on fenofibrate 145 mg and simvastatin 20 mg as separate medicines, assess whether switching to Cholib is clinically appropriate, and check that no interaction prevents this combination at these specific doses.

Not all consultations will result in a prescription. The prescriber may determine that Cholib is not appropriate, that separate medicines better suit your needs, or that a review by your GP or specialist is needed first.