Fenofibrate Kern Pharma 160 mg hard capsules EFG

Patient Information Leaflet

Introduction

Package Leaflet: Information for the patient

Fenofibrate Kern Pharma 160 mg hard capsules EFG

Package leaflet:

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

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

Fenofibrato Kern Pharma belongs to a group of medicines known as fibrates. These medicines are used to reduce the level of fats (lipids) in the blood, such as fats known as triglycerides.

Fenofibrato Kern Pharma is used, together with a low-fat diet and other non-medical treatments such as exercise and weight loss, to reduce the levels of fats in the blood.

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

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

Do not take Fenofibrate Kern Pharma 160 mg capsules if:

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

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Warnings and precautions

Talk to your doctor or pharmacist before starting fenofibrate if:

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

Muscle effects

Stop taking fenofibrate and contact 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, which can be serious. These problems are rare but may include muscle inflammation and breakdown. This could lead to kidney damage or even death.

Your doctor may carry out a blood test to check your muscle condition before and after starting treatment.

The risk of muscle breakdown 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 family member has an inherited muscle disorder.
• you are taking medicines called “statins” to lower cholesterol, such as simvastatin, atorvastatin, pravastatin, rosuvastatin or fluvastatin.
• you have previously experienced 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 need to take any other medicines.

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

• anticoagulants used to thin the blood (such as warfarin).
• other medicines used to control blood fat levels (such as statins or fibrates). Taking a statin together with fenofibrate may increase the risk of muscle problems.
• certain medicines used to treat diabetes (such as rosiglitazone or pioglitazone).
• cyclosporine (an immunosuppressant).

If any of the above circumstances apply to you (or if you have any doubts), 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 food, 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 insufficient experience with the use of fenofibrate during pregnancy, fenofibrate should only be used if your doctor considers it absolutely necessary.

It is unknown whether the active ingredient in 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 your ability to drive or operate machinery.

Fenofibrate Kern Pharma contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per capsule; hence, it is essentially “sodium-free”.

3. How to take Fenofibrate Kern Pharma

Follow exactly the administration instructions for this medicine as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

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

How to take the medicine

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

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 an appropriate diet.

Patients with renal problems

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

Use in children and adolescents

The use of fenofibrate is not recommended in individuals under 18 years of age.

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 at 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 missed dose.

If you stop taking Fenofibrate Kern Pharma

Do not stop taking this medicine unless your doctor tells you to, or if 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 adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Stop taking fenofibrate and contact your doctor immediately if you notice any of the following adverse effects – you may need urgent medical treatment:

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

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

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

• allergic reaction – signs may include swelling of the face, lips, tongue, or throat, which may cause difficulty breathing.
• yellowing of the skin or whites of the eyes (jaundice), or increased liver enzymes – these may be signs of liver inflammation (hepatitis).

Not known (frequency cannot be estimated from available data):

• severe skin rash causing redness, peeling, and swelling of the skin resembling a severe burn.
• long-term lung problems.

Other adverse effects

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

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

• diarrhoea
• stomach pain
• gas (flatulence)
• feeling unwell (nausea)
• discomfort (vomiting)
• elevated liver enzyme levels in the blood – detected in blood tests
• increased homocysteine (elevated levels of this amino acid in the blood have been associated with an increased 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); detected in blood tests.

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

• hair loss
• increased urea (produced by the kidneys); detected in blood tests
• increased skin sensitivity to sunlight, sunlamps, or solariums
• decreased haemoglobin (carries oxygen in the blood) and decreased white blood cells – detected in blood tests.

Not known (frequency cannot be estimated from available data):

• muscle wasting
• complications of gallstones
• feeling of exhaustion (fatigue)

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse 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 its original packaging to protect it from light and moisture.

Do not use this medicine after the expiry date stated on the packaging after “EXP”. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point in your pharmacy. If you are in doubt, please ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Fenofibrate Kern Pharma The active substance is fenofibrate.

Each capsule contains 160 milligrams (mg) of fenofibrate.

The other components are: lauroyl macrogol glycerides, polyethylene glycol, hydroxypropylcellulose, and sodium starch glycolate Type A. The capsule shell consists of gelatin, iron oxide red (E172), iron oxide yellow (E172), iron oxide black (E172), titanium dioxide (E171), and indigotine I (E132).

Appearance of the product and contents of the container

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

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

Only certain pack sizes may be marketed.

Marketing Authorization 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 medicinal product is authorized in the European Economic Area member states under the following names:

Belgium Fenosup Lidose 160 mg capsule, hard

Spain Fenofibrate Kern Pharma hard capsules EFG

Date of the most recent review of this leaflet: September 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.es/.