Ezetimiba/atorvastatina pensa 10 mg/20 mg comprimidos recubiertos con pelÍcula efg
Introduction
Package Leaflet: Information for the User
Ezetimibe/Atorvastatin pensa 10 mg/20 mg Film-Coated Tablets
Read this package leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this package 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. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
- If you experience any side effects, talk to your doctor or pharmacist. See Section 4.
1. What is Ezetimiba/Atorvastatina pensa and what is it used for
Ezetimibe/Atorvastatin pensa is a medication that decreases high levels of cholesterol. Ezetimibe/Atorvastatin pensa contains ezetimibe and atorvastatin.
Ezetimibe/Atorvastatin is used in adults to decrease total cholesterol, "bad" cholesterol (low-density lipoprotein, LDL) and certain fatty substances called triglycerides that circulate in the blood. Additionally, this medication increases the concentrations of "good" cholesterol (high-density lipoprotein, HDL).
Ezetimibe/Atorvastatin acts by reducing cholesterol in two ways. It reduces the cholesterol absorbed in the digestive tract, as well as the cholesterol that your body produces on its own.
Cholesterol is one of the fatty substances that are found in the circulatory system. Your total cholesterol is composed mainly of LDL and HDL cholesterol.
LDL cholesterol is often referred to as "bad" cholesterol because it can accumulate in the walls of your arteries, forming plaques. Over time, this accumulation of plaque can cause a narrowing of the arteries. This narrowing can make the blood flow to vital organs such as the heart and brain slower or interrupted. This interruption of blood flow can trigger a myocardial infarction or a stroke.
HDL cholesterol is often referred to as "good" cholesterol because it helps to prevent the accumulation of bad cholesterol in the arteries and protects them from cardiovascular diseases.
Triglycerides are another type of fat present in your blood that can increase the risk of cardiovascular disease.
This medication is used in patients who cannot control their cholesterol levels solely with diet. While taking this medication, you should follow a cholesterol-lowering diet.
This medication is used, along with a cholesterol-lowering diet, if you have:
- high levels of cholesterol in the blood (primary hypercholesterolemia [familial heterozygous and non-familial]) or high levels of fatty substances in the blood (mixed hyperlipidemia):
- that are not well controlled with a statin alone
- for which a statin and ezetimibe have been used in separate tablets
- a genetic disorder (familial hypercholesterolemia), which increases the level of cholesterol in the blood. You may also receive other treatments.
- cardiovascular disease,ezetimibe/atorvastatinreduces the risk of myocardial infarction, stroke, coronary artery bypass grafting, or hospitalization for chest pain.
Ezetimibe/Atorvastatindoes not help you lose weight.
2. What you need to know before starting to take Ezetimibe/Atorvastatin
Do not take Ezetimiba/Atorvastatina if you think
- you are allergic to ezetimiba, atorvastatina or any of the other ingredients of this medicine (listed in section 6),
- you have or have had any liver disease,
- you have had any unexplained abnormal results in liver function blood tests,
- you are a woman of childbearing potential and are not using reliable contraceptive methods,
- you are pregnant, trying to become pregnant or breastfeeding,
- you are taking the combination of glecaprevir/pibrentasvir, ledipasvir/sofosbuvir for the treatment of hepatitis C.
Warnings and precautions
Consult your doctor or pharmacist before starting to take ezetimiba/atorvastatina.
- if you have had a previous stroke with intracranial hemorrhage, or have small fluid accumulations in the brain due to previous strokes,
- if you have kidney problems,
- if your thyroid gland has low activity (hypothyroidism),
- if you have had recurrent or unexplained muscle pain or discomfort or a personal or family history of muscle problems,
- if you have had muscle problems during previous treatment with other lipid-lowering medicines (e.g. other medicines containing "statins" or "fibrates"),
- if you regularly consume large amounts of alcohol,
- if you have a history of liver disease,
- if you are over 70 years old,
- if your doctor has told you that you are intolerant to some sugars, contact them before taking this medicine,
- if you are taking or have taken in the last 7 days a medicine containing fusidic acid (used to treat bacterial infections) by mouth or injection. The combination of fusidic acid and this medicine may cause severe muscle problems (rhabdomyolysis),
- if you have or have had myasthenia (a disease that causes generalised muscle weakness, which in some cases affects the muscles used for breathing) or myasthenic eye disease (a disease that causes weakness of the eye muscles), as statins may sometimes worsen the disease or cause myasthenia (see section 4).
Contact your doctor as soon as possible if you experience unexplained muscle pain, sensitivity, or muscle weakness while taking Ezetimiba/Atorvastatina.This is because, in rare cases, muscle problems can be severe, including muscle rupture causing kidney damage. It is known that atorvastatina causes muscle problems and muscle problems have also been reported with ezetimiba.
Also inform your doctor or pharmacist if you experience persistent muscle weakness. Further tests and additional medicines may be needed to diagnose and treat this problem.
Consult your doctor or pharmacist before starting to take this medicine:
-if you have severe respiratory failure.
If you find yourself in any of the above circumstances (or are unsure), consult your doctor before starting to take ezetimiba/atorvastatina, as your doctor will need to take a blood test before starting your treatment with ezetimiba/atorvastatina, and possibly during it, to predict the risk of you experiencing adverse muscle effects. It is known that the risk of experiencing adverse muscle effects, e.g. rhabdomyolysis, increases when certain medicines are taken simultaneously (see section 2 “Warnings and precautions”).
While you are taking this medicine, your doctor will check if you have diabetes or are at risk of developing diabetes. This risk of diabetes increases if you have high levels of sugar and fat in your blood, are overweight and have high blood pressure.
Inform your doctor of all your medical problems, including allergies.
You should avoid the combined use of ezetimiba/atorvastatina and fibrates (certain medicines to reduce cholesterol), as the combined use of ezetimiba/atorvastatina and fibrates has not been studied.
Children
Ezetimiba/atorvastatina is not recommended for children and adolescents.
Other medicines and Ezetimiba/Atorvastatina pensa
Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medicine, including over-the-counter medicines.
There are some medicines that may modify the effect of ezetimiba/atorvastatina or whose effects may be affected by ezetimiba/atorvastatina (see section 3). This type of interaction may reduce the effectiveness of one or both medicines. On the other hand, it may also increase the risk or severity of adverse effects, including a serious condition in which muscle is destroyed, known as “rhabdomyolysis”, which is described in section 4:
- ciclosporina (a medicine often used in transplant patients),
- erythromycin, clarithromycin, telithromycin, fusidic acid**, rifampicin (medicines used to treat bacterial infections,
- ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole (medicines used to treat fungal infections),
- gemfibrozil, other fibrates, nicotinic acid derivatives, colestipol, cholestyramine (medicines used to regulate lipid levels),
- some calcium channel blockers used to treat angina or high blood pressure, e.g. amlodipine, diltiazem,
- digoxin, verapamil, amiodarone (medicines that regulate heart rhythm),
- medicines used to treat HIV, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, the combination of tipranavir/ritonavir, etc. (used to treat AIDS),
- some medicines used to treat hepatitis C, e.g. telaprevir, boceprevir and the combination of elbasvir/grazoprevir, ledipasvir/sofosbuvir
- letermovir, a medicine that helps you avoid getting citomegalovirus
- daptomycin (a medicine used to treat complicated skin and soft tissue infections and bacteremia).
** If you have to take fusidic acid orally to treat a bacterial infection, you will temporarily have to stop taking this medicine. Your doctor will tell you when you can restart your treatment with ezetimiba/atorvastatina. The use of ezetimiba/atorvastatina with fusidic acid rarely may cause muscle weakness, sensitivity or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.
Other medicines that are known to interact with ezetimiba/atorvastatina
- oral contraceptives (medicines that prevent pregnancy),
- estiripentol (an anticonvulsant medicine used to treat epilepsy),
- cimetidine (a medicine used to treat stomach acid and ulcers),
- phenazone (an analgesic),
- antacids (products used to treat indigestion that contain aluminium or magnesium),
- warfarin, phenprocoumon, acenocoumarol or fluindione (medicines that prevent blood clotting),
- colchicine (used to treat gout),
- St. John's Wort (a medicine used to treat depression).
Taking Ezetimiba/Atorvastatina pensa with food and alcohol
See section 3 for instructions on how to take ezetimiba/atorvastatina. Please note the following:
Orange juice
Do not take more than one or two small glasses of orange juice per day, as large amounts of orange juice may alter the effects of ezetimiba/atorvastatina.
Alcohol
Avoid excessive alcohol consumption while taking this medicine. For more details, see section 2 “Warnings and precautions”.
Pregnancy and breastfeeding
Do not take ezetimiba/atorvastatina if you are pregnant, trying to become pregnant or breastfeeding.
If you become pregnant while taking ezetimiba/atorvastatina, stop taking it immediately and inform your doctor.
Do not take ezetimiba/atorvastatina if you are breastfeeding.
The safety of ezetimiba/atorvastatina during pregnancy and breastfeeding has not been proven.
Consult your doctor or pharmacist before taking this medicine.
Driving and operating machines
Ezetimiba/atorvastatina is not expected to interfere with your ability to drive or use machines. However, some people may experience dizziness after taking ezetimiba/atorvastatina.
Ezetimiba/Atorvastatina pensa contains lactose
The tablets of ezetimiba/atorvastatina contain a sugar called lactose. If your doctor has told you that you are intolerant to certain sugars, consult your doctor before taking this medicine.
Ezetimiba/Atorvastatina pensa contains sodium
This medicine contains less than 23 mg of sodium (1 mmol) per tablet; that is, it is essentially “sodium-free”.
3. How to take Ezetimiba/Atorvastatina pensa
Follow exactly the administration instructions for this medication as indicated by your doctor. Your doctor will determine the appropriate dose per tablet for you, depending on your current treatment and personal risk situation. In case of doubt, consult your doctor or pharmacist again.
- Before starting to takeezetimiba/atorvastatina, you must be following a diet to reduce cholesterol.
- You will need to continue with this cholesterol-reducing diet while takingezetimiba/atorvastatina.
What quantity should you take
The recommended dose is one tablet ofezetimiba/atorvastatinaonce a day taken orally.
Form of administration
Takeezetimiba/atorvastatinaat any time of the day. You can take it with or without food.
If your doctor has prescribedezetimiba/atorvastatinaalong with cholestyramine or any other bile acid sequestrant (medications that reduce cholesterol levels), you should takeezetimiba/atorvastatinaat least 2 hours before or 4 hours after taking the bile acid sequestrant.
If you take more Ezetimiba/Atorvastatina pensa than you should
Consult with your doctor or pharmacist.
In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological Information Service 91 562 04 20, indicating the medication and the amount ingested.
If you forgot to take Ezetimiba/Atorvastatina pensa
Do not take an extra dose; the next day, take your normal dose of ezetimiba/atorvastatina at the usual time. If you have any other questions about the use of this medication, ask your doctor or pharmacist.
4. Possible Adverse Effects
Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If you experience any of the following serious side effects or symptoms, stop taking your tablets and immediately inform your doctor, or go to the nearest hospital emergency service.
- Severe allergic reactions that cause swelling of the face, tongue, and throat and may cause difficulty breathing
- Severe disease whose symptoms are intense peeling and skin inflammation, blistering on the skin, mouth, eyes, genitals, and fever; skin rash with pink or red spots, especially on the palms of the hands or soles of the feet, which may lead to blistering
- Weakness, sensitivity, pain, or muscle rupture or change in urine color to brown-red and especially, if it occurs at the same time, feeling unwell or high temperature that may be caused by abnormal muscle destruction that can be potentially fatal and trigger kidney problems
- Lupus-like syndrome (including rash, joint disorders, and effects on blood cells)
Consult your doctor as soon as possible if you experience problems associated with the unexpected or unusual appearance of bleeding or bruising, as this may be indicative of liver disease.
The following side effects were frequently reported (may affect up to 1 in 10 patients):
- Diarrhea,
- Muscle pain.
The following side effects were infrequently reported (may affect up to 1 in 100 patients):
- Flu,
- Depression; insomnia; sleep disorder,
- Dizziness; headache; tingling sensation,
- Slow heart rate,
- Angina,
- Shortness of breath,
- Digestive problems; abdominal swelling; constipation; indigestion; flatulence; frequent bowel movements; stomach inflammation; nausea; stomach discomfort; stomach upset,
- Acne; hives,
- Muscle pain in the joints; back pain; muscle cramps in the legs; muscle fatigue, spasms, or weakness; pain in the arms and legs,
- Unusual weakness; feeling tired or unwell; inflammation, especially in the ankles (edema),
- Increased levels of some liver or muscle function tests (CK) in blood laboratory tests,
- Weight gain.
In addition, the following side effects have been reported in patients taking ezetimiba/atorvastatina, ezetimiba, or atorvastatina tablets:
- Allergic reactions that include inflammation of the face, lips, tongue, and/or throat that may cause difficulty breathing or swallowing (requiring immediate medical treatment),
- Red, sometimes in the shape of a target, skin rash,
- Liver problems,
- Cough,
- Heartburn,
- Loss of appetite; lack of appetite,
- High blood pressure,
- Itchy skin rash and hives; allergic reactions that include the appearance of skin rash and hives,
- Tendon injury,
- Bile stones or inflammation of the gallbladder (which may cause abdominal pain, nausea, or vomiting),
- Pancreatitis, often accompanied by severe abdominal pain,
- Decreased blood cell count, which may cause bruising or bleeding (thrombocytopenia),
- Nasal congestion; nasal bleeding,
- Neck pain; chest pain; sore throat,
- Increased or decreased blood sugar levels (if you have diabetes, you should closely monitor your blood glucose levels),
- Nightmares,
- Numbness or tingling in the fingers of the hands and feet,
- Decreased sensitivity to pain or touch,
- Altered sense of taste; dry mouth,
- Memory loss,
- Ringing in the ears and/or head; hearing loss,
- Vomiting,
- Belching,
- Hair loss,
- Fever,
- Presence of white blood cells in urine tests,
- Blurred vision; visual disturbances,
- Gynecomastia (breast enlargement in men).
- Myasthenia gravis (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing),
- Myasthenia ocular (a disease that causes weakness of the eye muscles).
Consult your doctor if you experience weakness in your arms or legs that worsens after periods of activity, double vision, eyelid drooping, difficulty swallowing, or difficulty breathing.
Possible side effects reported with some statins
- Sexual dysfunction,
- Depression,
- Respiratory problems, including persistent cough and/or shortness of breath or fever,
- Diabetes. It is more likely if you have high blood sugar and fat levels, obesity, and high blood pressure. Your doctor will monitor you while taking this medication,
- Constant muscle pain, sensitivity, or weakness, and especially if it occurs at the same time, feeling unwell or high temperature that may not disappear after stopping ezetimiba/atorvastatina treatment (unknown frequency).
Reporting side effects
If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medication.
5. Conservation of Ezetimiba/Atorvastatina pensa
Keep this medication out of the sight and reach of children.
Do not use this medication after the expiration date that appears on the packaging or on the container after “CAD” or “EXP”. The expiration date is the last day of the month indicated.
This medication does not require special conditions for conservation.
Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.
6. Content of the packaging and additional information
Composition of Ezetimiba/Atorvastatina pensa
The active principles are ezetimiba and atorvastatina. Each film-coated tablet contains 10 mg of ezetimiba and 20 mg of atorvastatina (as atorvastatina calcium trihydrate).
The other components are: calcium carbonate; anhydrous colloidal silica; sodium croscarmellose; hydroxypropylcellulose; lactose monohydrate; povidone; magnesium stearate; microcrystalline cellulose; polisorbate 80; sodium laurylsulfate (E487).
The tablet coating contains: hypromellose, lactose monohydrate, macrogol titanium dioxide, talc.
Appearance of the product and content of the packaging
Film-coated tablets, capsule-shaped, biconvex, and white to off-white in color, with "2T" engraved on one face.
Packaging sizes:
Packages of 30 film-coated tablets in aluminum/aluminum blisters.
Marketing Authorization Holder
Towa Pharmaceutical, S.A.
C/ de Sant Martí, 75-97
08107 Martorelles (Barcelona)
Spain
Responsible for manufacturing:
Delorbis Pharmaceuticals Ltd.
17 Athinon Street
Ergates Industrial Area
2643 Ergates Lefkosia
Cyprus
This medicine is authorized in the member states of the European Economic Area with the following names:
Spain: Ezetimiba/Atorvastatina pensa 10 mg/20 mg film-coated tablets EFG
Netherlands: Ezetimibe/Atorvastatine Tiefenbacher 10 mg/20 mg filmomhulde tabletten
Revision date of this leaflet: 12/2023
Further information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es
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