Fenofibrate Teva 200 mg hard capsules EFG
Spain
Table of Contents
Patient Information Leaflet
Introduction
Package Leaflet: Information for the patient
Fenofibrate Teva 200 mg hard capsules EFG
Read the entire leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any side effects, talk to your doctor or pharmacist, including any side effects not listed in this leaflet. See section 4.
Leaflet Contents:
- What Fenofibrate Teva is and what it is used for
- What you need to know before taking Fenofibrate Teva
- How to take Fenofibrate Teva
- Possible side effects
- How to store Fenofibrate Teva
- Contents of the pack and other information
1. What Fenofibrato Teva is and what it is used for
Fenofibrato Teva belongs to a group of medicines commonly known as fibrates. These medicines are used to reduce the level of fats (lipids) in the blood, such as fats known as triglycerides.
Fenofibrato Teva is used together with a low-fat diet and other non-medicinal treatments such as exercise and weight loss, to reduce fat levels in the blood.
Fenofibrato Teva may be used together with other medicines (statins) in certain circumstances when a statin alone does not control fat levels in the blood.
2. What you need to know before taking Fenofibrate Teva
Do not take Fenofibrate Teva
- If you are allergic to fenofibrate or to any of the other ingredients of this medicine (listed in section 6).
- If you have photosensitivity (an allergic reaction caused by exposure to sunlight or ultraviolet rays) or phototoxic reactions during treatment with fibrates (medicines that modify lipid levels) or ketoprofen (an anti-inflammatory medicine).
- If you have liver, kidney, or gallbladder problems.
- If you have pancreatitis (inflammation of the pancreas, causing abdominal pain) not caused by high levels of fat in the blood.
Do not take Fenofibrate Teva if any of the above apply to you (or if you are unsure), consult your doctor or pharmacist before taking this medicine.
Warnings and precautions
Talk to your doctor or pharmacist before taking Fenofibrate Teva:
- If you have any liver or kidney problems.
- If you may have an inflamed liver (hepatitis): symptoms include yellowing of the skin and whites of the eyes (jaundice), increased liver enzymes (shown in blood tests), stomach pain, and itching.
- If you have an underactive thyroid gland (hypothyroidism).
If any of the above apply to you (or you are unsure), consult your doctor or pharmacist before taking Fenofibrate Teva.
Effects on muscles
Stop taking Fenofibrate Teva 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 uncommon but include inflammation and breakdown of muscles. This can lead to kidney damage or even death.
Your doctor may perform blood tests to monitor your muscles before and during treatment.
The risk of muscle breakdown is higher in some patients. In particular, inform your doctor if:
- You have kidney problems.
- You have thyroid problems.
- You have low levels of a certain protein in the blood (hypoalbuminemia).
- You are over 70 years old.
- You or a close relative have an inherited muscle disorder.
- You drink large amounts of alcohol.
- You have ever had muscle problems during treatment with statins or fibrates (such as fenofibrate, bezafibrate, or gemfibrozil).
- You are taking medicines called statins to lower cholesterol (such as simvastatin, atorvastatin, pravastatin, rosuvastatin, or fluvastatin) or other fibrates.
If any of the above apply to you (or you are unsure), talk to your doctor before taking Fenofibrate Teva.
Children and adolescents
Fenofibrate is not recommended in children and adolescents under 18 years of age due to insufficient clinical data.
Other medicines and Fenofibrate Teva
Inform 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 to thin the blood (e.g., warfarin).
- Other medicines to control blood fat levels (such as statins or fibrates). This is because taking a statin or another fibrate in addition to Fenofibrate Teva may increase the risk of muscle problems (see 'Warnings and precautions' above).
- A particular class of medicines used to treat diabetes (such as rosiglitazone or pioglitazone).
- Cyclosporine, an immunosuppressant.
If any of the above apply to you (or you are unsure), consult your doctor or pharmacist before taking Fenofibrate Teva.
Taking Fenofibrate Teva with food and drinks
You should take Fenofibrate Teva with meals, as it will work better than on an empty stomach.
Pregnancy and breastfeeding
Inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. This is because it is not known how Fenofibrate Teva may affect the fetus. Fenofibrate Teva should only be used if prescribed by your doctor.
Do not use Fenofibrate Teva if you are breastfeeding or plan to breastfeed. This is because it is not known whether fenofibrate passes into breast milk.
Driving and using machines
Fenofibrate Teva has no effect or negligible effect on the ability to drive and use machines.
Fenofibrate Teva contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per capsule; i.e., essentially “sodium-free”.
3. How to take Fenofibrate Teva
Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Your doctor will determine the appropriate dose for you, depending on your condition, your current treatment, and your individual risk status.
The recommended dose for adults is one capsule per day, including for elderly patients.
For proper use of this medicine, it is essential to undergo periodic medical monitoring.
If you have kidney problems
If you have renal impairment, your doctor may recommend a lower dose. Ask your doctor or pharmacist about this. Other doses and pharmaceutical forms of fenofibrate are available for cases in which the dose is not suitable with this medicine.
If you have liver problems
This medicine is not recommended for patients with hepatic insufficiency due to lack of data.
Use in children and adolescents
Fenofibrate is not recommended for use in children and adolescents under 18 years of age, as there is insufficient data available.
Route of administration
Oral use
Swallow the capsules whole with water. It is important to take the capsules with food, as they do not act in the same way when taken on an empty stomach.
To treat your elevated cholesterol levels, you should exercise regularly and follow the dietary recommendations provided by your doctor while taking this medicine.
If you take more Fenofibrate Teva than you should
If you accidentally ingest too many capsules or think that someone else may have swallowed some, contact your nearest hospital or inform your doctor immediately.
In case of overdose or accidental ingestion, consult your doctor immediately or call the Toxicology Information Service at telephone number 915 620 420, indicating the medicine and the amount ingested.
If you forget to take Fenofibrate Teva
If you forget to take a dose, take the next dose with your next meal. Then continue taking your capsule at the usual time. Do not take a double dose to make up for a missed dose.
If you stop taking Fenofibrate Teva
Do not stop taking Fenofibrate Teva unless your doctor tells you to, or if the capsules make you feel unwell. This is because abnormal levels of fats in the blood require long-term treatment.
Remember that taking Fenofibrate Teva is important, as is maintaining a low-fat diet and exercising regularly.
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 will experience them.
Stop taking Fenofibrate Teva and contact your doctor immediately if you notice any of the following serious adverse effects, as you may require urgent medical attention:
Uncommon: may affect up to 1 in 100 people
- Muscle cramps or pain, tenderness, or weakness: these may be symptoms of muscle inflammation and muscle breakdown, which can lead to kidney damage or even death.
- Stomach pain: this may be a symptom of inflammation of your pancreas (pancreatitis).
- Chest pain and feeling short of breath: this may be a sign of a blood clot in the lung (pulmonary embolism).
- Pain, redness, or swelling in legs: these may be symptoms 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 and whites of the eyes (jaundice), or increased liver enzymes: these may be symptoms of an inflamed liver (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.
Stop taking Fenofibrate Teva and contact your doctor immediately if you experience any of the above adverse effects.
Other adverse effects include:
Consult your doctor or pharmacist if you experience any of the following adverse effects:
Common: may affect up to 1 in 10 people
- Diarrhea,
- Stomach pain,
- Gas (flatulence),
- Feeling unwell (nausea),
- Discomfort (vomiting),
- Elevated liver enzymes in blood – observed in blood tests.
- Increased homocysteine (elevated levels of this amino acid in 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 red hives on the skin,
- 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,
- Skin more sensitive to sunlight, sunlamps, and sunbeds,
- Decreased hemoglobin (carries oxygen in blood) and decreased white blood cells – observed in blood tests.
Not known: frequency cannot be estimated from available data
- Muscle wasting,
- Complications of gallstones,
- Feeling of exhaustion (fatigue).
Consult your doctor or pharmacist if you experience any of the adverse effects listed above.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines website: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Fenofibrate Teva
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and the carton after EXP. The expiry date is the last day of the month indicated.
Store in the original packaging to protect from light. Keep the blister in the outer carton.
Medicines should not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Fenofibrate Teva
- The active substance is fenofibrate. Each capsule contains 200 mg of fenofibrate.
- The other components are: sodium lauryl sulfate, povidone, pregelatinized corn starch, crospovidone, sodium croscarmellose, sodium starch glycolate (from potato), colloidal anhydrous silica, and sodium stearyl fumarate. The capsule shell contains gelatin, titanium dioxide (E171), Allura Red AC, and printing ink containing shellac, black iron oxide, and propylene glycol.
Appearance of Fenofibrate Teva and contents of the pack
Hard gelatin capsule with red-orange opaque cap and body, filled with white or almost white powder containing small aggregates, printed with "FM200" on both the body and cap.
- Fenofibrate Teva 200 mg is available in packs of 1, 20, 28, 30, 50, 60, 84, 90, 100 or 300 (10x30) capsules.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Teva Pharma, S.L.U.
C/Anabel Segura 11, Edificio Albatros B, 1ª Planta
28108 Alcobendas, Madrid, Spain
Manufacturers
Pharmachemie B.V.
Swensweg 5, 2031 GA Haarlem
The Netherlands
TEVA Pharmaceutical Works Private Limited Company
Pallagi út 13, 4042 Debrecen
Hungary
Teva Operations Poland Sp. z o.o.
ul. Mogilska 80
31-546 Krakow
Poland
Teva Czech Industries s.r.o.
Ostravska 29, c.p. 305, Building No 80 Small OSD and building No 881 NOSD
747 70 Opava-Komarov
Czech Republic
This leaflet was last reviewed in March 2024
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/
You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the packaging. You may also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/72705/P_72705.html