Apo-feno 200m

Package Leaflet: Information for the Patient

Apo-Feno 200 M

200 mg, hard capsules
(Fenofibrate)

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Apo-Feno 200 M and what is it used for
• 2. Important information before taking Apo-Feno 200 M
• 3. How to take Apo-Feno 200 M
• 4. Possible side effects
• 5. How to store Apo-Feno 200 M
• 6. Contents of the pack and other information

1. What is Apo-Feno 200 M and what is it used for

Apo-Feno 200 M belongs to a group of medicines known as fenofibrates. These medicines are used to lower the level of fats (lipids) in the blood. Examples of such fats include triglycerides.
Apo-Feno 200 M is used in combination with a low-fat diet and other non-drug treatments, such as physical exercise and weight loss, to lower the level of fats in the blood.
Apo-Feno 200 M may also be used as an adjunct to other medicines (statins) if the level of fats in the blood cannot be controlled with statins alone.

2. Important information before taking Apo-Feno 200 M

When not to take Apo-Feno 200 M:

• if you are allergic to fenofibrate or any of the other ingredients of this medicine (listed in section 6),
• if you have severe liver impairment,
• if you have severe kidney impairment,
• if you have symptomatic gallbladder disease (gallstones, cholecystitis),
• if you are sensitive to light or have phototoxic reactions when taking fibrates or ketoprofen,
• if you have hyperlipoproteinemia type I, with increased chylomicron and triglyceride levels in the serum but normal VLDL levels,
• if you have chronic or acute pancreatitis, except for acute pancreatitis due to severe hypertriglyceridemia.

Before starting fenofibrate treatment, your doctor will treat any underlying conditions that may be causing secondary hypercholesterolemia, such as type 2 diabetes, hypothyroidism, nephrotic syndrome, dysproteinemia, liver disease with impaired bile flow, and alcoholism.

Warnings and precautions

Before taking Apo-Feno 200 M, discuss the following with your doctor or pharmacist:

• if you have kidney problems,
• it is likely that patients taking fenofibrate may experience side effects that have been reported with other fibrate medicines, such as clofibrate, gemfibrozil, ciprofibrate, and bezafibrate. If such side effects occur, tell your doctor,
• if you are taking other fibrate medicines. Apo-Feno 200 M should not be taken with other fibrate medicines. Excessive cholesterol excretion into the bile may cause gallstones. In patients treated with fenofibrate and gemfibrozil, muscle breakdown may occur,
• if you are taking atorvastatin, cerivastatin, fluvastatin, lovastatin, pravastatin, simvastatin, beta-blockers, thiazide diuretics, or estrogens. Tell your doctor before taking Apo-Feno 200 M,
• if you have gallstones. Fenofibrate increases cholesterol excretion into the bile, which may promote the formation of gallstones,
• if you have liver problems or if liver problems occur during fenofibrate treatment. The doctor may recommend periodic (every 3 months) testing of liver enzyme levels (AST, ALT, GGTP). If the problems persist, only the doctor can decide to change the treatment. If liver enzyme levels increase 2-3 times above normal, the doctor will decide to stop the medicine,
• if you have pancreatitis or have had pancreatitis in the past, tell your doctor. The effectiveness of Apo-Feno 200 M may be reduced, and bile duct obstruction or even gallstones may occur,
• if you are taking anticoagulant medicines, tell your doctor,
• if you have factors that increase the risk of muscle problems (myopathy) and (or) muscle breakdown (rhabdomyolysis). These include: age over 70, personal or family history of muscle disease, kidney problems, hypothyroidism, and alcoholism. In patients with these conditions, the risk of muscle breakdown is higher. The doctor will decide whether to treat with fenofibrate. The risk of toxic effects on muscles may increase if the medicine is taken with another fibrate or statins. If muscle pain, tenderness, or weakness occur, contact your doctor immediately. The doctor will recommend a test to measure creatine kinase levels. If the levels increase 5 times above normal, the doctor will decide to stop fenofibrate treatment,
• if you have diabetes or hypothyroidism. You should consult your doctor frequently,
• if you experience acute, severe skin reactions that require hospital treatment. At the start of treatment, a transient decrease in hemoglobin (red blood cell pigment) levels, hematocrit (ratio of red blood cells to blood serum) values, and white blood cell count may occur. Very rarely, a decrease in platelet count and a decrease in granulocyte count (a type of white blood cell) have been reported,
• if the medicine is taken by elderly patients. Apo-Feno 200 M can be taken without reducing the dose.

Before starting Apo-Feno 200 M treatment, your doctor will recommend a test to measure lipid levels in the blood, as well as a low-fat diet, physical exercise, and maintaining a healthy weight.
In female patients with hyperlipidemia who are taking estrogens or oral contraceptives containing estrogens, the doctor will check if the hyperlipidemia is primary or secondary (possible increase in lipid levels caused by oral estrogens).
Periodically, the doctor may recommend laboratory tests to measure blood lipid levels and cholesterol and triglyceride levels. These tests are necessary to determine the correct dose of fenofibrate. If after two months of taking Apo-Feno 200 M, the levels of triglycerides and cholesterol do not decrease satisfactorily, the doctor will decide to change the treatment.
The safety and efficacy of the medicine in children have not been fully established.

Apo-Feno 200 M and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take. In particular, tell your doctor if you are taking:

• blood-thinning medicines, such as warfarin. Apo-Feno 200 M may increase their effect. The doctor will decide to reduce the dose of the blood-thinning medicine and recommend frequent testing of prothrombin time to adjust the dose of the blood-thinning medicine,
• other fibrate medicines or HMG-CoA reductase inhibitor medicines, which increases the risk of acute myopathy, muscle breakdown, and acute kidney failure,
• cyclosporine, which increases the adverse effect of fenofibrate on the kidneys. Apo-Feno 200 M increases the toxic effect of other immunosuppressive medicines on the kidneys. If you are taking these medicines, the doctor will consider reducing their doses,
• cholestyramine or colestipol. Apo-Feno 200 M should be taken at least 1 hour before or 4 to 6 hours after taking these medicines.

Apo-Feno 200 M with food and drink

The absorption of fenofibrate increases by about 35% if the medicine is taken with food. Apo-Feno 200 M should be taken with meals. The capsule should be swallowed whole, with a small amount of liquid.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy:
There have been no adequate and well-controlled studies with fenofibrate in pregnant women. Women of childbearing age should be particularly cautious and remain under constant medical supervision. If a woman becomes pregnant, she should immediately consult her doctor.
Breastfeeding:
Apo-Feno 200 M should not be taken by women who are breastfeeding. Breastfeeding mothers should seek the advice of their doctor as to whether they should discontinue breastfeeding or stop taking the medicine.

Driving and using machines

No effect of Apo-Feno 200 M on the ability to drive and use machines has been observed.

Apo-Feno 200 M contains lactose

Apo-Feno 200 M contains lactose. If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Apo-Feno 200 M contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means it is essentially sodium-free.

3. How to take Apo-Feno 200 M

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Your doctor will determine the appropriate dose of the medicine based on your condition, treatment, and potential risk.
During treatment, follow a low-fat diet and exercise regularly.
Take the medicine with meals. Swallow the capsule whole, with a small amount of liquid. Do not open or chew the capsules.
The recommended dose is 1 capsule of Apo-Feno 200 M once a day.
In patients with kidney problems (creatinine clearance greater than 20 ml/min and less than 100 ml/min) and the elderly, caution should be exercised. Treatment should be started with a daily dose of 100 mg of non-micronized fenofibrate or 67 mg of micronized fenofibrate.
In patients with severe kidney impairment (creatinine clearance less than 30 ml/min), the medicine is contraindicated.

Use in children and adolescents

Apo-Feno 200 M is not recommended for use in children under 18 years of age.
The duration of treatment depends on the indication and is determined by the doctor. Do not prolong treatment without consulting your doctor.

Overdose of Apo-Feno 200 M

If you have taken more than the recommended dose, contact your doctor or pharmacist immediately.
No cases of overdose or poisoning with fenofibrate have been reported. The doctor may administer symptomatic treatment, such as stomach lavage.

Missed dose of Apo-Feno 200 M

Do not take a double dose to make up for a forgotten dose. Take the next dose at the usual time.

Stopping treatment with Apo-Feno 200 M

If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Apo-Feno 200 M can cause side effects, although not everybody gets them.

If you experience any of the following serious side effects, stop taking Apo-Feno 200 M and contact your doctor immediately – you may need urgent medical treatment:

• allergic reaction, including swelling of the face, lips, tongue, and throat, which may cause difficulty breathing
• muscle spasms, muscle pain, hypersensitivity, or muscle weakness - these may be symptoms of muscle inflammation and breakdown, which can cause kidney damage or even death
• abdominal pain - this may be a symptom of pancreatitis
• chest pain and shortness of breath - these may be symptoms of blood clots in the lungs (pulmonary embolism)
• pain, redness, and swelling of the legs - these may be symptoms of blood clots in the legs (deep vein thrombosis)
• yellowing of the skin and whites of the eyes (jaundice) or increased liver enzyme levels - these may be symptoms of liver inflammation. If you experience any of these side effects, stop taking Apo-Feno 200 M and contact your doctor immediately.

Other side effects

Common (affects less than 1 in 10 people)

• diarrhea
• abdominal pain
• bloating with gas
• nausea
• vomiting
• increased liver enzyme levels in the blood - found in laboratory tests.

Uncommon (affects less than 1 in 100 people)

• headache
• gallstones
• decreased sex drive
• rash, itching, or red spots on the skin
• increased creatinine levels (a substance excreted by the kidneys) - found in laboratory tests.

Rare (affects less than 1 in 1,000 people)

• hair loss
• dizziness
• fatigue
• increased urea levels (a substance excreted by the kidneys) - found in laboratory tests
• increased sensitivity of the skin to sunlight, sunlamps, and sunbeds
• decreased hemoglobin levels (red blood cell pigment) and decreased white blood cell count - found in laboratory tests.

Frequency not known

• severe skin reactions (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis)
• chronic lung disease. If you experience unusual breathing problems, contact your doctor immediately.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Apo-Feno 200 M

Keep this medicine out of the sight and reach of children.
Store the medicine at a temperature below 25°C.
Do not use this medicine after the expiry date stated on the packaging after EXP.
The first two digits indicate the month, the next four digits indicate the year. The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Apo-Feno 200 M contains

The active substance is micronized fenofibrate.
One capsule contains 200 mg of micronized fenofibrate.
The other ingredients are:
croscarmellose sodium, lactose monohydrate, stearic acid, colloidal silicon dioxide.
Capsule content: iron oxide red (E 172), iron oxide yellow (E 172), titanium dioxide (E 171),
gelatin.

What Apo-Feno 200 M looks like and contents of the pack

Light orange, opaque hard capsules, marked with "Apo 200".
The pack contains 30 capsules.

Marketing authorization holder

Aurovitas Pharma Polska Sp. z o.o.

ul. Sokratesa 13D lok. 27
01-909 Warsaw
Poland

Importer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta

Date of last revision of the leaflet: 06.2021