This site is intended for UK healthcare professionals
Medscape UK Univadis Logo
Medscape UK Univadis Logo

Fenofibrate with simvastatin oral

Updated 2 Feb 2023 | Fibrates Statins


Oral formulations of fenofibrate with simvastatin

Drugs List

  • CHOLIB 145mg+20mg tablets
  • CHOLIB 145mg+40mg tablets
  • fenofibrate 145mg and simvastatin 20mg tablets
  • fenofibrate 145mg and simvastatin 40mg tablets
  • Therapeutic Indications


    Mixed dyslipidaemia: adjunct to diet and exercise

    Fenofibrate with simvastatin is indicated as adjunctive therapy to diet and exercise in high cardiovascular risk patients with mixed dyslipidaemia to reduce triglycerides and increase HDL-C levels when LDL-C levels are adequately controlled with the corresponding dose of simvastatin monotherapy.


    Response should be monitored by determination of serum lipid values (total cholesterol (TC), LDL-C, triglycerides (TG)).


    One tablet daily.


    One tablet daily.

    Additional Dosage Information

    Dose of fenofibrate with simvastatin should not exceed 145 mg/20 mg daily in patients taking amiodarone, amlodipine, diltiazem or verapamil.


    Children under 18 years
    Creatine kinase levels over 5 times upper limit of normal
    Photoallergic or phototoxic reactions to fibrates
    Photosensitivity to ketoprofen
    Within 7 days of discontinuing fusidic acid
    Gall bladder disorder
    Gallbladder disease
    Hereditary fructose intolerance
    Renal impairment - eGFR below 60 ml/minute/1.73 m squared
    Serum transaminases above 3 times upper limit of normal
    Severe hepatic impairment
    Unexplained elevated serum transaminases

    Precautions and Warnings

    Family history of hereditary muscular disorders
    Females of childbearing potential
    High alcohol intake
    Major surgery
    Patients over 65 years
    Severe trauma
    Glucose-galactose malabsorption syndrome
    Hereditary muscular disorder
    History of hepatic impairment
    History of muscular toxicity secondary to fibrates
    History of muscular toxicity secondary to HMG-CoA reductase inhibitors
    History of non-traumatic rhabdomyolysis
    History of renal impairment
    History of venous thromboembolism
    Lactose intolerance
    Renal impairment - eGFR 60 to 89 ml/minute/1.73 m squared

    Advise ability to drive/operate machinery may be affected by side effects
    Correct hypothyroidism before treatment
    Exclude/correct secondary causes of dyslipidaemia prior to treatment
    Contains lactose
    Contains soya or soya derivative
    Contains sunset yellow (E110) - may cause allergic reaction
    Preparation contains sucrose
    Measure creatine kinase levels prior to treatment if risk of rhabdomyolysis
    Perform liver function tests before commencing therapy
    Monitor blood glucose in high risk patients
    Monitor creatine kinase levels in patients at risk of rhabdomyolysis
    Monitor creatine kinase levels in patients reporting myalgia
    Monitor serum creatinine
    Repeat liver function tests within 3 months and at 12 months
    Advise patient to report any symptoms of interstitial lung disease
    Advise patients to report muscle pain/tenderness/weakness
    Advise patients to report signs of hepatic damage (malaise, jaundice etc.)
    Discontinue if hepatitis develops
    Discontinue if myopathy is suspected
    Advise patient to seek advice at first indications of pregnancy
    Discontinue if ALT level exceeds 3 times the upper limit of normal
    Discontinue if AST level exceeds 3 times the upper limit of normal
    Discontinue if creatine kinase levels >5 times upper limit of normal
    Discontinue if evidence of interstitial lung disease
    Discontinue if muscular symptoms are severe
    Discontinue prior to surgery
    Advise patient grapefruit products may increase plasma level
    Dietary restrictions should be maintained

    Statin therapy has been associated with the development of myalgia, myopathy and rhabdomyolysis, which can rarely be fatal. Myopathy is dose related.
    Routine monitoring of creatinine kinase is not necessary in asymptomatic patients.
    Do not measure creatine kinase levels following strenuous exercise or in the presence of other factors affecting CK levels. If CK is greater than 5 times the upper limit of normal (ULN) levels prior to treatment, re-measure 5 to 7days later.
    If symptoms of myopathy resolve and levels of creatinine kinase reduce, treatment can be reinitiated at the lowest dose and with close monitoring.

    Some evidence suggests that statins as a class, raises blood glucose levels and in some patients, at a high risk of future diabetes, may produce a level of hyperglycaemia where formal diabetes care is appropriate. This risk, however, is outweighed by the reduction in vascular risk with statins and therefore should not be a reason for stopping statin treatment. Patients at risk ( raised fasting glucose, raised body mass index at baseline, history of hypertension and raised triglycerides) should be monitored both clinically and biochemically according to national guidelines.

    Pancreatitis has been reported in patients taking fenofibrate. This may be as a result of a direct drug effect, obstruction of the common bile duct or a failure of efficacy in patients with severe hypertriglyceridaemia.

    Pregnancy and Lactation


    Fenofibrate with simvastatin is contraindicated in pregnancy.

    Fenofibrate is contraindicated during pregnancy.

    Although there is insufficient data in humans, animal studies have demonstrated embryotoxicity and therefore fenofibrate should not be taken during pregnancy. Schaefer (2007) states inadvertent treatment with fenofibrate does not necessitate termination of pregnancy or requirement for invasive diagnostic procedures. It is unknown if it crosses the placenta.

    Simvastatin is contraindicated during pregnancy.

    A mixture of human malformations have been reported with the used of statins in the first trimester, these include; VATER-association, neural tube defects, holoprosencephaly, other CNS malformations and limb abnormalities (Schaefer, 2007). None of these malformations have occurred in significant enough quantities to enable causality to be concluded. However, the theoretical risks of reducing cholesterol availability during embryo development should be considered since simvastatin may reduce the foetal levels of mevalonate which is a precursor of cholesterol biosynthesis. The suspension of treatment throughout pregnancy is not considered likely to have a detrimental effect on the long term course of hyperlipidaemia. For these reasons simvastatin should not be used during pregnancy. Schaefer (2007) concludes that inadvertent treatment with a statin during pregnancy, does not require a termination of pregnancy, however, treatment should be stopped immediately and a detailed ultrasound examination should considered.

    The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( ) or if this is unavailable at the backup site ( ).


    Fenofibrate with simvastatin is contraindicated in breastfeeding.

    Fenofibrate is contraindicated during breastfeeding.

    There is no data available on the excretion of fenofibrate or its metabolites into breast milk. Lactating mothers should be advised not to breastfeed their child during treatment especially due to the infant's need for cholesterol and the carcinogenicity observed in rats treated with this product. An alternative drug is preferred, especially while nursing a newborn or pre-term infant. The relative low molecular weight (about 319) of the active metabolite suggest that it is excreted into the breast milk (Briggs, 2011). Schaefer (2007) suggests that there is no disadvantage to the mother if treatment is stopped during breastfeeding.

    Simvastatin is contraindicated while breastfeeding.

    At the time of writing, there is little published experience concerning the use of statins during breastfeeding. Due to the possible inhibition of cholesterol biosynthesis by statins, there is a theoretical risk posed to the neonate. The products of cholesterol biosynthesis, including cholesterol are essential for neonatal development. Therefore, the use of statins is contraindicated while breastfeeding. The suspension of treatment while breastfeeding is not considered likely to detrimentally affect the long term course of hyperlipidaemia, therefore simvastatin use during breastfeeding is not recommended.

    Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
    Specialist advice is available from the UK Drugs in Lactation Advisory Service at

    Side Effects

    Abdominal pain
    Alanine aminotransferase increased
    Biliary colic
    Blood urea increased
    Creatine phosphokinase increased
    Deep vein thrombosis (DVT)
    Diabetes mellitus
    Erectile dysfunction
    Erythema multiforme
    Gamma glutamyl transferase (GGT) increased
    Haemoglobin decrease
    Hepatic failure
    Homocysteine level increased
    Hypersensitivity reactions
    Immune mediated necrotizing myopathy
    Impaired memory
    Increase in alkaline phosphatase
    Increase in serum glucose
    Increase in serum transaminases
    Increased glycated haemoglobin (HbA1c) levels
    Increased platelet count
    Interstitial lung disease
    Memory loss
    Muscle spasm
    Peripheral neuropathy
    Pulmonary embolism
    Serum creatinine increased
    Sexual dysfunction
    Sleep disturbances
    Stevens-Johnson syndrome
    Toxic epidermal necrolysis
    Upper respiratory tract infection
    White blood cell count decreased


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: March 2016

    Reference Sources

    Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

    Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

    Joint Formulary Committee. British National Formulary (online) London: BMJ Group and Pharmaceutical Press Accessed on 14 March 2016.

    Medications and Mothers' Milk, Sixteenth Edition (2014) Hale, T and Rowe, H, Hale Publishing, Plano, Texas.

    Summary of Product Characteristics: Cholib 145mg/20mg film coated tablets. BGP Products Ltd. Revised April 2015.
    Summary of Product Characteristics: Cholib 145mg/40mg film coated tablets. BGP Products Ltd. Revised April 2015.

    US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
    Available at:
    Fenofibrate Last revised: 6 December 2013
    Last accessed: 14 March 2016

    US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
    Available at:
    Simvastatin Last revised: 7 September 2013
    Last accessed: 14 March 2016

    Access the full UK drug database with a FREE Medscape UK Account
    It takes just a few minutes, and you’ll get unlimited access to information on over 11,000 UK drugs.
    Register for Free

    Already a member? Log in

    Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content

    FDB Logo

    FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.