Fenofibrate Teva 160 mg film-coated tablets EFG
SpainTable of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: Information for the patient
Fenofibrate Teva 160 mg film-coated tablets EFG
Read the entire leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet as 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 and must not be given to other people, even if they have the same symptoms, as it may harm them.
- If you experience any side effects, talk to your doctor or pharmacist, even if the side effects are 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 Fenofibrate Teva is and what it is used for
Fenofibrate 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.
Fenofibrate Teva is used together with a low-fat diet and other non-medicinal treatments such as exercise and weight loss, to reduce the levels of fats in the blood.
Fenofibrate 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 are allergic to peanuts, peanut oil, soy lecithin, or related products
- If while taking other medicines (such as other fibrates or a non-steroidal anti-inflammatory drug called ketoprofen), you have experienced an allergic reaction or skin injury caused by sunlight or UV light
- If you have severe liver, kidney, or gallbladder disease
- 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. If you are unsure, consult your doctor or pharmacist before taking Fenofibrate Teva.
Warnings and precautions
Talk to your doctor or pharmacist before taking Fenofibrate Teva:
- If you have kidney or liver problems
- If you 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
- If you have an underactive thyroid gland (hypothyroidism)
If any of the above apply to you (or if you have any doubts), consult your doctor or pharmacist before taking Fenofibrate Teva.
Fenofibrate Teva and muscle effects
Stop taking Fenofibrate Teva and contact your doctor immediately if you experience:
- Unexplained muscle cramps
- Muscle pain, tenderness, or weakness
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 can lead to kidney damage or even death.
Your doctor may perform blood tests to check your muscle condition before and during treatment. The risk of muscle problems is higher in certain patients. Specifically, consult your doctor if:
- You are over 70 years old
- You have kidney problems
- You have thyroid problems
- You or a close family member has an inherited muscle disorder
- You drink large amounts of alcohol
- You are taking medicines called “statins” to lower cholesterol (such as simvastatin, atorvastatin, pravastatin, rosuvastatin, or fluvastatina)
- You have previously experienced muscle problems during treatment with statins or fibrates (such as fenofibrate, bezafibrate, or gemfibrozil)
If any of the above apply to you (or if you have any doubts), consult your doctor or pharmacist before taking Fenofibrate Teva.
Your doctor may request regular blood tests to monitor your liver and kidney function.
Pancreatitis (inflammation of the pancreas causing abdominal pain) may occur in some patients taking fenofibrate: see the section above “Do not take Fenofibrate Teva” and section 4 below.
Taking Fenofibrate Teva with other medicines
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 (blood thinners) (e.g., warfarin): the risk of bleeding may increase
- Other medicines used to control blood fat levels (such as statins or fibrates). This is because taking a statin or another fibrate together with Fenofibrate Teva 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 apply to you (or if you have any doubts), consult your doctor or pharmacist before taking Fenofibrate Teva.
Pregnancy and breastfeeding
Tell your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. This is because it is unknown how Fenofibrate Teva may affect the newborn. Fenofibrate Teva should only be used if prescribed by your doctor.
Do not use Fenofibrate Teva if you are breastfeeding or planning to breastfeed. This is because it is unknown whether Fenofibrate Teva passes into breast milk.
Driving and using machines
This medicine does not affect your ability to drive or use tools or machines.
Fenofibrate Teva contains soy lecithin
It should not be used if you are allergic to peanuts, peanut oil, or soy (see “Do not take Fenofibrate Teva”).
Fenofibrate Teva contains lactose
If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.
Fenofibrate Teva contains sodium
This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially “sodium-free.”
3. How to take Fenofibrate Teva
Follow exactly the instructions for using 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.
Taking the medicine
Take the tablet with food, as it does not work as well if your stomach is empty.
- Swallow the tablet with a glass of water
- Do not crush or chew the tablet
Remember that in addition to taking Fenofibrate Teva, it is also important that you:
- Follow a low-fat diet
- Exercise regularly.
How much to take
The recommended dose is one tablet per day, including for elderly patients.
If you are currently taking 200 mg fenofibrate capsules, you may switch to one tablet of Fenofibrate Teva 160 mg. You will continue to receive the same amount of medicine.
If you have renal impairment
If you have kidney problems, your doctor may advise you to take a lower dose. Consult your doctor or pharmacist about this.
Use in children and adolescents
Fenofibrate Teva is not recommended for use in children and adolescents under 18 years of age.
If you take more Fenofibrate Teva than you should
If you accidentally take too many tablets or think a child has swallowed some, contact your nearest hospital or inform your doctor immediately.
In case of overdose or accidental ingestion, contact 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 take the following dose at your 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 tablets make you feel unwell. This is because long-term treatment is required. If your doctor discontinues the medicine, do not keep any remaining tablets unless your doctor tells you to.
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 one may cause adverse effects, although not everyone experiences them.
Stop taking Fenofibrato Teva and consult your doctor immediately if you experience any of the following serious 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 indicate inflammation of the pancreas (pancreatitis)
- Chest pain and shortness of breath: may be signs of a blood clot in the lung (pulmonary embolism)
- Pain, redness, or swelling in the legs: 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: 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
Stop taking Fenofibrato Teva and consult a doctor immediately if you notice any of the above side 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 patients
- Diarrhea
- Stomach pain
- Flatulence
- Feeling unwell (nausea)
- Vomiting
- Increased levels of liver enzymes in the blood – detected in blood tests
- Increased homocysteine (elevated levels of this amino acid in blood have 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 red spots 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 becoming more sensitive to sunlight, sunlamps, or tanning beds
- Decrease in hemoglobin (which carries oxygen in the blood) and white blood cells – detected in blood tests
Not known: frequency cannot be estimated from available data
- Muscle wasting
- Complications related to 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 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: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Fenofibrate Teva
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Keep out of the sight and reach of children.
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Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month indicated.
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Do not store above 25°C.
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Store in the original packaging. Keep the blister inside the outer carton.
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Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.
6. Contents of the pack and other information
Composition of Fenofibrate Teva
- The active substance is fenofibrate. Each film-coated tablet contains 160 mg of fenofibrate.
- The other components are: microcrystalline cellulose, povidone K-30, povidone K-25,
sodium croscarmellose, crospovidone, sodium starch glycolate (type A), sodium lauryl sulfate,
lactose monohydrate, colloidal anhydrous silica, sodium stearyl fumarate, polyvinyl
alcohol, partially hydrolysed, titanium dioxide (E171), talc, soybean lecithin and xanthan gum.
Appearance of Fenofibrate Teva and contents of the pack
- White or almost white, oval-shaped, film-coated tablet, marked with
“93” on one side and “7331” on the other.
- Fenofibrate Teva 160 mg is available in packs of 1, 10, 14, 15, 28, 30, 50, 56, 60, 84, 90
or 100 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Teva Pharma, S.L.U.
C/Anabel Segura 11, Edificio Albatros B, 1ª Planta
28108 Alcobendas, Madrid
Manufacturers
Pharmachemie B.V.
Swensweg 5, 2031 GA Haarlem
The Netherlands
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
Date of latest revision of this leaflet: January 2022
Detailed and up-to-date information on this medicinal product 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 medicinal product by scanning with your mobile phone (smartphone) the QR code included on the outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/72706/P_72706.html