Lofat

Fenofibrate
Capsule

What Lofat® capsules are and what they are used for?
Lofat® is a preparation of Fenofibrate that belongs to a group of medicines, commonly known as fibrates. These medicines are used to lower the level of fats (lipids) in the blood. For example, the fats known as triglycerides.
Lofat® (Fenofibrate) capsules are used, alongside a low fat diet and other non-medical treatments such as exercise and weight loss, to lower levels of fats in the blood.
Lofat®(Fenofibrate) capsules can be used in addition to other medicines (statins) in some circumstances when levels of fats in the blood are not controlled with a statin alone.

What you need to know before you take Lofat® capsules
Do not take Lofat® (Fenofibrate) capsules and tell your doctor if you:

  • are allergic to fenofibrate or any of the other ingredients in the capsules.
  • have developed a sensitivity to sunlight or artificial light (e.g. sunbeds) when taking fibrates (e.g. fenofibrate or bezafibrate) or ketoprofen (used for muscle and bone disorders, gout or period pain).
  • have severely impaired liver function.
  • have gallbladder or liver disease.
  • have severe kidney problems.
  • have problems with your pancreas.
  • are giving Fenofibrate capsules to a child or adolescent.

Lofat® (Fenofibrate) capsules must not be used in children and adolescents under 18.

Warnings and precautions
Talk to your doctor or pharmacist before taking Lofat® (Fenofibrate) capsules if you:

  • have had impaired kidney function.
  • have severely increased levels of a type of fat (triglycerides) in the blood (severe hypertriglyceridemia) (seen in a blood test).
  • have any of the following which may increase the risk of you developing abnormal muscle breakdown:
    • impaired kidney function
    • an underactive thyroid
    • a high alcohol intake
    • are over 70 years old
    • have had or have a family member with a history of hereditary muscular disorders.
  • have decreased levels of a certain protein in the blood (hypoalbuminemia) (seen in a blood test).
  • are already taking a fibrate (e.g. bezafibrate) or a statin (e.g. atorvastatin), especially if you have muscle disease.
  • have poorly controlled diabetes mellitus (type II).
  • have nephrotic syndrome characterized by large amounts of protein in the urine, water retention and increased levels of fats in the blood.
  • have a condition which effects the amount of protein in the blood (dysproteinemia).
  • have obstructive liver disease.
  • are taking medicines which may affect fat metabolism (e.g. thiazides, beta blockers, corticosteroids or antiretrovirals).

Other medicines and Lofat® capsules
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines especially:

  • oral anti-coagulants e.g. warfarin (used to prevent blood clotting).
  • statins e.g. atorvastatin- used to lower cholesterol.
  • cyclosporine- used to suppress the immune system.
  • phenylbutazone- a non-steroidal anti-inflammatory drug.
  • other fibrates e.g. bezafibrate- used to lower cholesterol and other fats (lipids) in the blood.
  • estrogen or medicines which contain estrogen (contraceptives).

Pregnancy and breast-feeding
Fenofibrate capsules should not be used if you are pregnant or breast-feeding. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Lofat® capsules contain lactose
If you have been told you have an intolerance to some sugars, contact your doctor before taking this medicine, as it contains a type of sugar called lactose.

Tests
Your doctor may want to carry out tests to monitor the levels of certain enzymes within your body.

How to take Lofat® capsules?
Taking this medicine

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Swallow the capsules whole with water during a meal.

How much to take?
Adults:
One capsule a day. Your doctor will monitor your response to the treatment.
Elderly:
No dose modifications necessary for this age group.
Children and adolescents:
Lofat® (Fenofibrate) capsules must not be used in children and adolescents under 18.

Impaired kidney function
If you have impaired kidney function, your doctor may prescribe you a lower dose.
If you take more than you should
If you (or someone else) swallow a lot of capsules at the same time, or you think a child may have swallowed any, contact your nearest hospital emergency department or tell your doctor immediately.
If you forget to take the capsules
Do not take a double dose to make up for a forgotten dose. If you forget to take a dose, take it as soon as you remember it and then take the next dose at the right time.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Lofat® (Fenofibrate) capsules and tell your doctor immediately if you develop:

  • Muscle poisoning: muscle pain, breakdown, inflammation, cramps or weakness, increase in the levels of a certain enzyme within the body (seen in a blood test).

Contact your doctor immediately if you develop:

  • An allergic reaction: swelling of the face, lips, tongue or throat, itchy skin rash, narrowing of the airways causing difficulty breathing or swallowing.
  • Hepatitis: yellowing of the skin or whites of the eyes (jaundice), itching.

Tell your doctor if you notice any of the following side effects or notice any other effects not listed:
Common (may affect up to 1 in 10 people)
Headache, tiredness, spinning sensation, stomach or intestine disorders such as feeling or being sick, stomach pains, diarrhea and wind. Skin rash, itching, a skin rash with pale or red irregular raised patches with severe itching, sensitivity to sunlight or artificial light (e.g. sun beds) which may include reddening of the skin, blisters or lumps.
Uncommon (may affect up to 1 in 100 people)
Increased levels of a certain enzyme within the body (seen in a test), muscle toxicity (muscle pain, inflammation, cramps and weakness), blood clotting, inflammation of the pancreas causing stomach and back pain.
Rare (may affect up to 1 in 1,000 people)
Disorder of the nerves causing weakness, tingling and numbness (peripheral neuropathy), hair loss, increase in blood levels of creatinine and urea, loss of sex drive, decreased levels of hemoglobin and white blood cells.
If you notice increased bruising, nosebleeds, sore throats, infections, excessive tiredness, breathlessness on exertion or abnormal paleness of the skin, you should tell your doctor who may want you to have a blood test.
Very rare (may affect up to 1 in 10,000 people)
Lung disease (interstitial pneumopathies), inflammation of the liver (hepatitis) causing yellowing of the skin or whites of the eyes (jaundice) or tiredness, development of gallstones, abnormal muscle breakdown which can lead to kidney problems (rhabdomyolysis).
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
By reporting side effects, you can help provide more information on the safety of this medicine.

How to store Lofat®capsules?
Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Store in the original package.
Do not use Lofat® (Fenofibrate) capsules after the expiry date stated on the label/carton. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist or physician how to throw away medicines you no longer use. These measures will help protect the environment.


Lofat Prescribing Information

Located in: Cardiovascular