FENOFIBRATE KERN PHARMA 160 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

Fenofibrate Kern Pharma 160 mg hard capsules EFG

Contents of the pack:

1. What Fenofibrate Kern Pharma is and what it is used for
2. What you need to know before you take Fenofibrate Kern Pharma
3. How to take Fenofibrate Kern Pharma
4. Possible side effects
5. Storage of Fenofibrate Kern Pharma
6. Contents of the pack and further information

1. What Fenofibrate Kern Pharma is and what it is used for

Fenofibrate Kern Pharma belongs to a group of medicines known as fibrates. These medicines are used to lower the level of fats (lipids) in the blood. For example, fats known as triglycerides.

Fenofibrate Kern Pharma is used, along with a low-fat diet and other non-drug treatments such as exercise and weight loss, to lower the levels of fats in the blood.

Fenofibrate Kern Pharma may be used in combination with other medicines (statins) in certain circumstances when a statin alone does not control the levels of fat in the blood.

2. What you need to know before you take Fenofibrate Kern Pharma

Do not take Fenofibrate Kern Pharma 160 mg capsules if:

• you are allergic to fenofibrate or any other ingredient of this medicine (listed in section 6).
• when taking other medicines (such as other fibrates or an anti-inflammatory medicine called ketoprofen), you have had an allergic reaction or skin lesion caused by sunlight or UV light.
• you have severe liver, kidney, or gallbladder disease.
• you have pancreatitis (inflammation of the pancreas that causes abdominal pain) not caused by high levels of fat in the blood.

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Warnings and precautions

Consult your doctor or pharmacist before starting to take fenofibrate if:

• you have kidney or liver problems.
• you may have inflammation of the liver (hepatitis - signs that include yellowing of the skin and the whites of the eyes (jaundice), increased liver enzymes (present in blood tests), stomach pain, and itching).
• you have an underactive thyroid gland (hypothyroidism).

Muscle effects

Stop taking fenofibrate and consult your doctor immediately if you experience:

• unexplained muscle cramps.
• muscle pain, tenderness, or weakness while taking this medicine.

This is because this medicine may cause muscle problems that can be serious. These problems occur rarely but include inflammation and destruction of muscle. This can cause kidney damage or even death.

Your doctor may perform a blood test to check the condition of your muscles before and after starting treatment.

The risk of muscle destruction is higher in some patients. Consult your doctor if:

• you are over 70 years old.
• you have kidney problems.
• you have thyroid problems.
• you drink large amounts of alcohol.
• you or a close relative have a hereditary muscle problem.
• you are taking medicines called "statins" to lower cholesterol, such as simvastatin, atorvastatin, pravastatin, rosuvastatin, or fluvastatin.
• you have had muscle problems during treatment with statins or fibrates, such as fenofibrate.

Other medicines and Fenofibrate Kern Pharma

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

• blood thinners to reduce blood thickness (such as warfarin).
• other medicines used to control fat levels in the blood (such as statins or fibrates). Taking a statin at the same time as fenofibrate may increase the risk of muscle problems.
• a type of medicine for treating diabetes (such as rosiglitazone or pioglitazone).
• cyclosporin (an immunosuppressant).

If any of the above circumstances apply to you (or you are in doubt), consult your doctor or pharmacist before taking fenofibrate.

Taking Fenofibrate Kern Pharma with food, drinks, and alcohol

The capsules should be swallowed whole with water. It is important to take the capsules with meals, as their absorption and release into the bloodstream are reduced if taken on an empty stomach.

Pregnancy, breastfeeding, and fertility

If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. As there is not enough experience with the use of fenofibrate in pregnancy, you should only use fenofibrate if your doctor considers it absolutely necessary.

It is not known whether the active ingredient of fenofibrate passes into breast milk. Therefore, you should not use fenofibrate if you are breastfeeding or planning to breastfeed your baby.

Driving and using machines

This medicine does not affect the ability to drive and use machines.

Fenofibrate Kern Pharma contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per capsule; this is essentially "sodium-free"

3. How to take Fenofibrate Kern Pharma

Follow exactly the instructions of administration of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.

Your doctor will determine the most suitable dose, depending on your condition, your usual medication, and your personal risk factors.

Taking the medicine

Swallow the capsule whole with a glass of water - as it does not work as well if your stomach is empty.

Also, remember that in addition to taking fenofibrate, it is also important that you:

• follow a low-fat diet.
• exercise regularly.

How much to take

The recommended dosage for adults is one capsule per day during one of the main meals, in combination with a suitable diet.

Patients with kidney problems

If you have kidney problems, your doctor may indicate that you take a lower dose. Consult your doctor or pharmacist about this.

Use in children and adolescents

The use of fenofibrate is not recommended in children under 18 years old.

If you take more Fenofibrate Kern Pharma than you should

In case of overdose, accidental ingestion, or if you suspect that someone else has taken your medicine, consult your doctor or call the Toxicology Information Service Telephone 915620420.

If you forget to take Fenofibrate Kern Pharma

• If you forget to take a dose, take the next dose with your next meal.
• Do not take a double dose to make up for the forgotten dose.

If you stop taking Fenofibrate Kern Pharma

Do not stop taking this medicine unless your doctor tells you to or the capsules make you feel unwell. This is because you require long-term treatment.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking fenofibrate and consult your doctor immediately if you notice any of the following side effects - you may need urgent medical treatment:

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

• muscle cramps or pain, tenderness, or weakness - these can be signs of muscle inflammation or rupture, which can cause kidney damage or even death.
• stomach pain - this can be a sign that the pancreas is inflamed (pancreatitis).
• chest pain and shortness of breath - these can be signs of a blood clot in the lungs (pulmonary embolism).
• pain, redness, or swelling in the legs - these can be signs of a blood clot in the leg (deep vein thrombosis).

Rare(may affect up to 1 in 1,000 people):

• allergic reaction - the signs can include swelling of the face, lips, tongue, or throat, which can cause difficulty breathing.
• yellowing of the skin and the whites of the eyes (jaundice), or an increase in liver enzymes - these can be signs of liver inflammation (hepatitis).

Not known(cannot be estimated from the available data)

• severe skin rash that reddens, scales, and swells the skin and resembles a severe burn.
• long-term lung problems.

Other side effects

Consult your doctor or pharmacist if you experience any of the following side effects:

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

• diarrhea
• stomach pain
• gas (flatulence)
• feeling sick (nausea)
• being sick (vomiting)
• increased liver enzymes in the blood - seen in blood tests
• increased homocysteine (excess of this amino acid in the blood has been associated with a higher risk of coronary heart disease, stroke, and peripheral vascular disease, although a causal relationship has not been established).

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

• headache
• gallstones
• decreased sexual desire
• skin rash, itching, or hives
• increased creatinine (produced by the kidneys); appears in blood tests.

Rare(may affect up to 1 in 1,000 people):

• hair loss
• increased urea (produced by the kidneys); appears in blood tests
• skin more sensitive to sunlight, sun lamp, and sunbed
• decrease in hemoglobin (which carries oxygen in the blood) and decrease in white blood cells - seen in blood tests

Not known(cannot be estimated from the available data)

muscle wasting

gallstone complications

feeling tired (fatigue)

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Fenofibrate Kern Pharma

Keep this medicine out of the sight and reach of children.

Do not store above 30°C. Store this medicine in the original packaging to protect it from light and moisture.

Do not use this medicine after the expiry date which is stated on the carton after "EXP". The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Fenofibrate Kern PharmaThe active substance is fenofibrate.

Each capsule contains 160 milligrams (mg) of fenofibrate.

The other ingredients are: lauroyl macrogolglycerides, polyethylene glycol, hydroxypropylcellulose, and sodium starch glycolate Type A. The capsule is composed of gelatin, red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172), titanium dioxide (E171), and indigo carmine (E132).

Appearance of the product and pack contents

The fenofibrate capsules are green (cap)/orange (body), size 0.

The capsules are packaged in thermoformed blister packs (ALU/PVC) in packs of 30, 50, 60, 90, or 100 capsules.

Not all pack sizes may be marketed.

Marketing authorisation holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer

SMB TECHNOLOGY, S.A.

Rue du Parc Industriel 39

B-6900 Marche-en-Famenne

Belgium

This medicine is authorised in the Member States of the European Economic Area under the following names:

Belgium Fenosup Lidose 160 mg capsule, hard

Spain Fenofibrate Kern Pharma hard capsules EFG

Date of last revision of this leaflet: September 2023

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/.