► Apo-Feno 200M (fenofibrate) - Practical Medicine

Apo-Feno 200M (fenofibrate) - hard capsules

The name of the preparation Character; dose; package Manufacturer Price 100% Price after refund In which pharmacy?
Apo-Feno 200M hard capsules; 200 mg (1 capsule contains 200 mg micronized fenofibrate); 30 caps. Apotex Inc. 19.75 0.00

Note: reimbursed drug prices are in line with the regulations in force from July 1, 2018.

The preparation contains the substance:fenofibrate

The drug is available on prescription

What is Apo-Feno?

A medicine that reduces blood lipids.

What does Apo-Feno contain and how does it work?

The active substance is fenofibrate. It is a substance belonging to a group of medicines called fibrates, which are used to lower the level of lipids (cholesterol, triglycerides) in the blood. The risk of cardiovascular disease, including coronary heart disease, is associated with increased blood lipid levels, especially with an increased concentration of the cholesterol fraction present in a form associated with low density lipoproteins (LDL cholesterol). Fibrates by molecular mechanisms activate in liver cells the synthesis of proteins and key enzymes for lipid metabolism, which causes changes in the metabolism of lipoproteins (protein-lipid molecules). The effect of such fibrates is to reduce the concentration of low and very low density lipoproteins, which means lower LDL cholesterol and triglycerides in the blood. In addition, the concentration of high-density lipoproteins (HDL) in the blood is increased, which have a protective effect on the arterial walls. Fibrates are used to treat hypercholesterolemia and hypertriglyceridemia. Fibrates reduce the incidence of cardiovascular events.

When should I use Apo-Feno?

The preparation is indicated for the treatment of:
· Severe hypertriglyceridemia with normal or low high density (HDL) cholesterol
· Mixed hyperlipidaemia, if the use of statin drugs is contraindicated or if they are not tolerated
· Mixed hyperlipidemia in people at high risk of cardiovascular disease, as an adjunct to statin therapy, if the concentration of triglycerides and high density (HDL) cholesterol are not sufficiently controlled.
The preparation should be used as an addition to the diet and other non-pharmacological treatments (eg physical exercise, weight loss), when they prove to be insufficient.

When not to use this preparation?

Unfortunately, even if there are indications to use the preparation, it can not always be used. You can not use the preparation if you are allergic (you are hypersensitive) to any of the ingredients. You can not use the preparation if you are present:
· Severe liver failure
· Severe renal failure (creatinine clearance less than 20 ml / min)
· Gallbladder disease (cholelithiasis, cholecystitis)
· Chronic or acute pancreatitis, with the exception of acute pancreatitis in the course of severe hypertriglyceridaemia
· Hypersensitivity to light or phototoxic reactions after using fibrates or substances with a similar chemical structure, e.g. Ketoprofen
· Type I hyperlipoproteinaemia with increased plasma concentrations of chylomicrons and triglycerides, but with normal levels of very low density lipoproteins (VLDL).
Do not use in children and adolescents up to 18 years of age.
The preparation is contraindicated during pregnancy and breast-feeding.

Take special care with Apo-Feno?

Certain diseases and other circumstances may constitute a contraindication to use or indication to change the dosage of the preparation. In some situations it may be necessary to carry out specific check-ups.
Pharmacological treatment should be preceded by non-pharmacological treatment, ie maintaining a proper low-lipid diet, losing weight and increasing physical activity. The appropriate diet should be continued during the period of application. It is also necessary to treat all diseases that may cause lipid disorders such as: type 2 diabetes, hypothyroidism, nephrotic syndrome, dysproteinemia, liver problems with difficult outflow of bile, alcoholism.
People with hypothyroidism and people with diabetes should remain under close medical supervision.
Tell your doctor if you are taking thiazide diuretics, beta blockers or hormonal contraceptives and estrogens. These medicines may cause an increase in blood lipids.
Caution should be exercised in people with impaired renal function. Usually, at the beginning of treatment, your doctor will prescribe blood creatinine levels. If it exceeds the upper limit of normal, your doctor will advise you to reduce your dose or stop using it. A dose reduction may also be necessary in the elderly with impaired renal function.
Fenofibrate may increase the secretion of cholesterol in the bile, which may lead to the development of cholelithiasis. In people with cholelithiasis the use of the preparation is not recommended.
Due to the increased risk of cholelithiasis and an increased risk of rhabdomyolysis, the preparation should not be used in parallel with other medicines from the group of fibrates.
There are no data on the use of the preparation in patients with hepatic impairment. Be careful.
Before and during the treatment, your doctor will recommend regular (every 3 months) liver function tests. The use of the preparation may increase the activity of liver enzymes (aminotransferases) determined in blood laboratory tests. It is usually mild and transient. In case of elevated aminotransferase (AST or ALT aminotransferase), if the marked value exceeds the upper limit of normal by 3 times, the physician may recommend discontinuation of the preparation.
The use of the preparation may be associated with the onset of pancreatitis. If symptoms occur such as: severe pain in the middle part of the abdomen, sometimes also in the back, flatulence, vomiting, significant weakness, please consult a physician immediately. These symptoms may be accompanied by inflammation of the pancreas. The risk of pancreatitis is increased in people who have gallstones or deposits in the bile ducts. Particular care should be taken in people who have had pancreatitis in the past.
The preparation may increase the effect of anticoagulants. If anticoagulants are used in parallel, regular monitoring of blood coagulation parameters is necessary.
Fenofibrate, like other fibrates, can cause muscle damage and very rarely rhabdomyolysis, a set of symptoms associated with damage and muscle breakdown. Rhabdomyolysis may be accompanied by acute renal failure . Rhabdomyolysis may be life-threatening, in very rare cases leading to death. If during the treatment period you notice increased muscle sensitivity to touch (tenderness), pain, spasms or muscle weakness, you should immediately consult a doctor. These symptoms may occur without complications, but may also be associated with the occurrence and development of rhabdomyolysis and may require discontinuation of the preparation. These symptoms are accompanied by increased creatine kinase (CK) activity, detectable in laboratory tests.This kinase is an enzyme important for muscle work, and its activity is a biochemical indicator of muscle damage. In the case of significantly increased CK activity (more than 5 times the upper limit of normal values ​​exceeded), the physician will recommend discontinuation of the preparation.
Particular care should be taken in patients at increased risk of rhabdomyolysis:
· In the elderly (over 70 years)
· With impaired renal function
· With a reduced concentration of albumin in the blood (with hypoalbuminemia), e.g. in the course of nephrotic syndrome
· Hypothyroidism
· With hereditary muscle diseases
· Who have had muscle side effects in the past with statin or fibrates
· Alcohol abusers.
If you know or suspect you belong to any of the above groups, inform your prescriber before using this medicine. Your doctor will assess the risk-benefit ratio of the treatment and will make the appropriate decision. It may recommend you perform more often laboratory tests and remain under strict control.
The risk of rhabdomyolysis increases significantly when other fibrates or statin drugs are used in parallel, especially if muscle disease has occurred in the past.
Rarely, acute cutaneous hypersensitivity reactions may occur, resulting in the need for hospital treatment.
There is insufficient and complete data on the efficacy and safety of the preparation in children. The use of the preparation in children is contraindicated.
Elderly patients do not need to adjust their dosage.
Your doctor will recommend periodic blood lipid tests (total cholesterol, LDL cholesterol, triglycerides). If, after 3 months of treatment, your lipid levels are not sufficiently reduced, your doctor will prescribe additional or different treatment.
Additional information about the other ingredients of the preparation:
the preparation contains lactose; people with galactose intolerance, lactase deficiency or malabsorption of Glucose -galactose should not use this preparation.

Does this preparation affect the ability to drive vehicles?
There are no reports on the effects of the preparation on the ability to drive and use machines.

Dosage of Apo-Feno

The preparation is in the form of capsules. It is intended for oral use. The capsules should be taken with food, swallowed whole with a small amount of water. Do not exceed the recommended doses because it will not increase the effectiveness of the drug and may harm your health and life. If you have any doubts regarding the use of the preparation, consult a physician. The doctor will determine the individual dosage depending on the clinical situation and the patient's response to treatment. During the treatment period, a (standard) low-lipid diet should be used (continued) and appropriate physical activity should be maintained.
Recommended starting dose: 1 capsule (100 mg) once a day. If necessary, after 4-8 weeks the doctor will decide to increase the dose. The maximum daily dose is: 3 capsules of Apo-Feno 100 mg (300 mg) in 3 divided doses (100 mg in the morning, 100 mg in the afternoon and 100 mg in the evening) or 1 capsule of Apo-Feno 200 M (200 mg) in single dose.
In elderly people with normal renal function, there is no need to adjust the dosage.
In patients with impaired renal function, your doctor will prescribe regular blood creatinine levels and, depending on the results, recommend a dose reduction. If creatinine clearance is less than 60 ml / min but greater than 20 ml / min, caution should be used. If the creatinine clearance is less than 20 ml / min, the preparation is contraindicated.
There are no data on the use of the preparation in patients with hepatic impairment.

Can Apo-Feno be used during pregnancy and breastfeeding?

During pregnancy, do not use any medicine without consulting your doctor!
It is very important that before using any medicine during pregnancy or breastfeeding, consult a physician and explain beyond any doubt the potential risks and benefits associated with the use of the drug.If you are pregnant or plan to become pregnant, please inform the doctor prescribing the prescription for this medicine.
There are no adequate studies regarding the use of the preparation in pregnant women. The use of the preparation in pregnancy is contraindicated, unless in the opinion of the doctor it is absolutely necessary.
The use of the preparation is contraindicated during breast-feeding.

Can I use other preparations in parallel?

Tell your doctor about all medicines you have recently taken, including those that are over the counter. In particular, inform your doctor if you use:
· fibrates
· statins
· Anticoagulants
· Immunosuppressive drugs, including cyclosporine
· Ion exchange resins (cholestyramine, colestipol).
Fenofibrate may increase the effect of anticoagulants (eg Warfarin ) and increase prothrombin time, resulting in a risk of bleeding. In patients using such combination therapy, the blood coagulation parameters (prothrombin time) must be determined at the frequency recommended by the physician. Your doctor will recommend adjusting the dose of anticoagulants appropriately.
Parallel use of other fibrates or statins is not recommended. If necessary, special care is required due to the increased risk of myopathy and rhabdomyolysis. Special attention should be paid to any disturbing muscle symptoms and to be closely supervised.
When using immunosuppressive drugs, including ciclosporin, the risk of acute renal failure increases. Renal function must be closely monitored and if your kidneys fail, your doctor will advise you to stop using it.
Parallel ion exchange resins (cholestyramine, colestipol) may reduce the absorption of fenofibrate. The preparation should be taken at least 1 hour before or 4-6 hours after taking the ion-exchange resin.

What side effects can occur?

Like all medicines, Apo-Feno can cause side effects, although they will not occur in all patients who use this medicine. Remember that the expected benefits of using the drug are usually greater than the damage resulting from the occurrence of side effects.
Common: digestive, gastrointestinal or intestinal disorders (abdominal pain, nausea, vomiting, diarrhea and flatulence), moderate increase in serum transaminases.
Uncommon: headaches, thromboembolism (pulmonary embolism, deep vein thrombosis), pancreatitis, development of gallstones, pruritus, rash, urticaria, scattered muscle pain, myositis, spasms and muscle weakness, impaired potency, increase in blood creatinine.
Rarely, alopecia, decrease in hemoglobin and white blood cell count, increase in serum urea, hepatitis, hypersensitivity to light, increase in serum urea may occur.
In addition, interstitial lung diseases, complications of cholelithiasis (eg cholecystitis, cholangitis, biliary colic), rhabdomyolysis (decomposition of striated muscles) may occur with unknown frequency.

Other preparations on the Polish market containing fenofibrate

Biofibrate (hard capsules)
Fenardin (hard capsules)
Grofibrat (hard capsules)
Grofibrat 200 (hard capsules)
Grofibrat S (coated tablets)
Lipanthyl 200 M (capsules)
Lipanthyl 267 M (capsules)
Lipanthyl NT 145 (coated tablets)
Lipanthyl Supra 160 (coated tablets)
Lipanthyl Supra 215 mg (coated tablets)