Ezetimibe/atorvastatin Stadafarma 10 mg/80 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ezetimibe/Atorvastatin Stadafarma 10 mg/10 mg film-coated tablets

Ezetimibe/Atorvastatin Stadafarma 10 mg/20 mg film-coated tablets

Ezetimibe/Atorvastatin Stadafarma 10 mg/40 mg film-coated tablets

Ezetimibe/Atorvastatin Stadafarma 10 mg/80 mg film-coated tablets

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 you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Package leaflet

1. What Ezetimiba/Atorvastatina Stadafarma is and what it is used for

2. What you need to know before taking Ezetimiba/Atorvastatina Stadafarma

3. How to take Ezetimiba/Atorvastatina Stadafarma

4. Possible side effects

5. How to store Ezetimiba/Atorvastatina Stadafarma

6. Contents of the pack and other information

1. What Ezetimiba/Atorvastatina Stadafarma is and what it is used for

Ezetimiba/Atorvastatina Stadafarma is a medicine that lowers high levels of cholesterol. This medicine contains ezetimibe and atorvastatin.

Ezetimibe/atorvastatin is used in adults to lower total cholesterol levels, "bad" cholesterol (LDL cholesterol), and fatty substances called triglycerides circulating in the blood. In addition, ezetimibe/atorvastatin increases levels of "good" cholesterol (HDL cholesterol).

Ezetimibe/atorvastatin works by reducing cholesterol in two ways. It reduces cholesterol absorbed in the gastrointestinal tract as well as cholesterol produced by your body.

Cholesterol is one of the fatty substances found in the bloodstream. Your total cholesterol is made up mainly of LDL and HDL cholesterol.

LDL cholesterol is often called "bad" cholesterol because it can build up in the walls of your arteries, forming plaques. Over time, this plaque buildup can lead to narrowing of the arteries. This narrowing can slow down or block blood flow to vital organs such as the heart and brain. This interruption in blood flow can trigger a heart attack or stroke.

HDL cholesterol is often called "good" cholesterol because it helps prevent "bad" cholesterol from building up in the arteries and protects against heart disease.

Triglycerides are another type of fat present in your blood that may increase the risk of heart disease.

Your doctor may prescribe ezetimibe/atorvastatin if you are already taking the same doses of atorvastatin and ezetimibe separately, along with your cholesterol-lowering diet, if you have:

• high cholesterol levels in the blood (primary heterozygous and homozygous familial and non-familial hypercholesterolemia) or high levels of fat in the blood (mixed hyperlipidemia)

• heart disease

Ezetimibe/atorvastatin does not help you lose weight.

2. What you need to know before taking Ezetimibe/Atorvastatin Stadafarma

Do not take Ezetimibe/Atorvastatin Stadafarma if:

• you are allergic to atorvastatin, ezetimibe, or any of the other ingredients of this medicine (listed in section 6).
• you have or have ever had a liver disease
• you have had unexplained abnormal results in liver function blood tests
• you are a woman who could become pregnant and are not using reliable contraceptive methods
• you are pregnant, trying to become pregnant, or breastfeeding
• you are taking the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C

Warnings and precautions

Talk to your doctor or pharmacist before taking Ezetimibe/Atorvastatin if:

• you have previously had a stroke with intracranial haemorrhage, or have small accumulations of fluid in the brain due to previous strokes
• you have kidney problems
• your thyroid gland is underactive (hypothyroidism)
• you have had recurrent or unexplained muscle pain or discomfort, or have a personal or family history of muscle disorders
• you have previously experienced muscle problems while being treated with other lipid-lowering medicines (e.g., other medicines containing "statins" or "fibrates")
• you have or have had myasthenia (a disease causing generalized muscle weakness that, in some cases, affects the muscles used for breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), as statins may sometimes worsen the condition or trigger the onset of myasthenia (see section 4).
• you are taking or have taken within the last 7 days an oral or injectable medicine called fusidic acid (used to treat bacterial infection). The combination of fusidic acid and medicines containing ezetimibe/atorvastatin may cause serious muscle problems (rhabdomyolysis)
• you regularly consume large amounts of alcohol
• you have a history of liver disease
• you are over 70 years of age

Contact your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness while taking ezetimibe/atorvastatin. This is because, although rarely, muscle problems can be serious, including muscle breakdown leading to kidney damage. Atorvastatin is known to cause muscle problems, and cases of muscle problems have also been reported with ezetimibe.

Also speak with your doctor or pharmacist if you have persistent muscle weakness. You may need additional tests and treatment.

Talk to your doctor or pharmacist before taking ezetimibe/atorvastatin if:

• you have severe respiratory insufficiency

If any of the above conditions apply to you (or you are unsure), consult your doctor or pharmacist before starting ezetimibe/atorvastatin, as your doctor may need to perform a blood test before starting and possibly during treatment to assess your risk of experiencing muscle-related adverse effects. The risk of muscle-related adverse effects, e.g., rhabdomyolysis (breakdown of damaged skeletal muscle), is known to increase when certain medicines are taken concomitantly (see section 2 “Taking Ezetimibe/Atorvastatin Stadafarma with other medicines”).

While taking this medicine, your doctor will closely monitor you if you have diabetes or are at risk of developing diabetes. This risk is higher if you have high levels of blood sugar and fats, are overweight, or have high blood pressure.

Inform your doctor about all your medical conditions, including allergies.

Children and adolescents

Ezetimibe/atorvastatin is not recommended for use in children and adolescents.

Taking Ezetimibe/Atorvastatin Stadafarma with other medicines

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

Fibrates (medicines used to lower cholesterol) should be avoided while taking ezetimibe/atorvastatin.

There are some medicines that may alter the effect of ezetimibe/atorvastatin or whose effects may be affected by ezetimibe/atorvastatin (see section 3). This type of interaction could reduce the effectiveness of one or both medicines. On the other hand, it could also increase the risk or severity of adverse effects, including a serious condition involving muscle breakdown known as “rhabdomyolysis,” described in section 4:

• cyclosporine (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 and its derivatives, colestipol, cholestyramine (medicines used to regulate lipid levels)

• certain calcium channel blockers used to treat angina or high blood pressure, e.g., amlodipine, diltiazem

• digoxin, verapamil, amiodarone (medicines that regulate heart rhythm)

• letermovir (a medicine that helps prevent cytomegalovirus infection)

• medicines used in the treatment of HIV, e.g., ritonavir, lopinavir, atazanavir, indinavir, darunavir, the combination of tipranavir/ritonavir, etc. (used to treat AIDS)

• certain medicines used in the treatment of hepatitis C, e.g., telaprevir, boceprevir, and the combination of elbasvir/grazoprevir, ledipasvir/sofosbuvir

• daptomycin (a medicine used to treat complicated skin and skin structure infections and bacteremia)

• if you need to take oral fusidic acid to treat a bacterial infection, you will need to temporarily stop taking this medicine. Your doctor will advise you when you can restart treatment with ezetimibe/atorvastatin. Taking this medicine together with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). For further information on rhabdomyolysis, see section 4.

• Other medicines known to interact with the ezetimibe/atorvastatin combination:

  • oral contraceptives (medicines that prevent pregnancy)
  • stiripentol (an anticonvulsant medicine used to treat epilepsy)
  • cimetidine (a medicine used for stomach acidity and peptic ulcers)
  • phenazone (a pain reliever)
  • antacids (medicines for indigestion containing aluminium or magnesium)
  • warfarin, phenprocoumon, acenocoumarol, or fluindione (medicines that prevent blood clots)
  • colchicine (used to treat gout)
  • St. John’s wort (a herbal medicine used to treat depression)

Taking Ezetimibe/Atorvastatin Stadafarma with food, drinks, and alcohol

See section 3 for instructions on how to take ezetimibe/atorvastatin. Please note the following:

Grapefruit juice

Do not drink more than one or two small glasses of grapefruit juice per day, as large amounts of grapefruit juice may alter the effects of ezetimibe/atorvastatin.

Alcohol

Avoid consuming excessive amounts of alcohol while taking this medicine. For further details, see section 2, "Warnings and precautions".

Pregnancy, breastfeeding, and fertility

Do not take ezetimibe/atorvastatin if you are pregnant, think you may be pregnant, or plan to become pregnant.

Do not take ezetimibe/atorvastatin if you are able to become pregnant, unless you are using reliable contraceptive methods. If you become pregnant while taking this medicine, stop taking it immediately and inform your doctor.

Do not take ezetimibe/atorvastatin if you are breastfeeding.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and operating machinery

Ezetimibe/atorvastatin is not expected to impair your ability to drive or operate machinery. However, it should be noted that some individuals may experience dizziness after taking ezetimibe/atorvastatin. If you feel dizzy after taking this medicine, do not drive or operate machinery.

Ezetimibe/Atorvastatin Stadafarma 10 mg/10 mg, 0 mg/20 mg and 10 mg/40 mg contains lactose

If your doctor has informed you that you are intolerant to certain sugars, consult with them before taking this medicine.

Ezetimibe/Atorvastatin Stadafarma contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; essentially, it is "sodium-free".

3. How to take Ezetimiba/Atorvastatina Stadafarma

Follow exactly the instructions for using this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Your doctor will determine the appropriate dose per tablet for you, depending on your current treatment and your individual risk situation.

• Before starting to take ezetimiba/atorvastatina, you should already be following a cholesterol-lowering diet.
• You must continue this cholesterol-lowering diet while taking ezetimiba/atorvastatina.

How much should you take

The recommended dose is one ezetimiba/atorvastatin tablet once daily, preferably always at the same time. The tablet should be taken with a sufficient amount of liquid (e.g., a glass of water).

When to take it

Take ezetimibe/atorvastatin at any time of day. You may take it with or without food.

If your doctor has prescribed ezetimibe/atorvastatin together with cholestyramine or any other bile acid sequestrant (medicines that reduce cholesterol levels), you should take ezetimibe/atorvastatin at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take more Ezetimiba/Atorvastatina Stadafarma than you should

Consult your doctor or pharmacist.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Ezetimibe/Atorvastatin Stadafarma

Do not take a double dose to make up for missed doses. Take your next dose at the usual time on the following day.

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 everybody gets them.

If you experience any of the following serious adverse effects or symptoms, stop taking your tablets immediately and contact your doctor right away, or go to the nearest hospital emergency department and take the tablets with you.

• severe allergic reactions causing swelling of the face, tongue, and throat, which may lead to severe breathing difficulties
• a serious illness characterized by severe skin peeling and inflammation, blistering of 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 progress to blisters
• muscle weakness, tenderness, rupture, or pain, change in urine color to red-brown, and especially if occurring together with a feeling of malaise or high temperature, which may be due to abnormal muscle breakdown that can be potentially life-threatening and lead to kidney problems
• lupus-like syndrome (including skin rash, joint disorders, and effects on blood cells)

Consult your doctor as soon as possible if you experience problems associated with unexpected or unusual bleeding or bruising, as this may indicate liver disease.

Other possible adverse effects with Ezetimibe/Atorvastatin:

Common (may affect up to 1 in 10 people)

• nasal inflammation, sore throat, nosebleeds
• allergic reactions
• increased blood glucose levels; diabetic patients should monitor their blood glucose levels
• headache
• nausea, constipation, flatulence, diarrhea, indigestion, abdominal pain
• pharyngeal and/or laryngeal pain
• joint and/or hand or foot pain, back pain, muscle pain (myalgia), muscle spasms, joint swelling
• elevations in certain blood tests of muscle function (CK)
• abnormal liver function test results, elevations in certain blood tests of liver function (transaminases)
• fatigue

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

• swelling due to an allergic reaction
• reduced blood glucose levels; diabetic patients should monitor their blood glucose levels
• loss of appetite, weight gain
• cough
• muscle weakness, neck pain, chest pain
• hot flushes, high blood pressure
• vomiting
• belching
• inflammation of the pancreas and liver
• acid reflux
• inflammation of the stomach lining
• dry mouth
• skin redness, hives, rash, itching
• hair loss
• nightmares, difficulty sleeping
• dizziness
• numbness
• disturbance of taste sensation
• amnesia
• abnormal local sensations
• blurred vision
• tinnitus (ringing in the ears)
• general malaise, restlessness or pain
• weakness
• increase in the liver enzyme gamma-glutamyl transferase
• positive urine test for white blood cells

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

• reduction in blood platelets
• swelling of the lower layer of skin tissue in the face, tongue, throat, abdomen, arms, or legs (angioedema)
• widespread rash with defined red spots or blistering and peeling rash, particularly around the mouth, nose, eyes, and genitals due to an allergic reaction
• inflammation of skeletal muscle, tendon inflammation sometimes complicated by rupture, muscle weakness due to loss of skeletal muscle fibers
• visual disturbances
• yellowing of the skin and whites of the eyes (jaundice)

Very rare (may affect up to 1 in 10,000 people)

• anaphylactic shock due to allergic reaction
• hearing loss
• liver failure
• enlargement of male breasts

Frequency not known (cannot be estimated from available data)

• allergic reaction, including rash and swelling of the deeper layers of the skin
• shortness of breath, inflammation of the gallbladder, gallstones
• physical weakness and loss of strength, loss of muscle tissue due to autoimmune antibodies
• depression
• myasthenia gravis (a condition causing generalized muscle weakness, which in some cases affects the muscles used for breathing)
• ocular myasthenia (a condition causing weakness of the eye muscles)

Consult your doctor if you experience worsening weakness in the arms or legs after periods of activity, double vision or drooping eyelids, difficulty swallowing, or difficulty breathing.

In addition, the following adverse effects have been reported during post-marketing experience with some statins (medicines used to lower cholesterol):

• difficulty breathing, including persistent cough and/or shortness of breath or fever
• diabetes; this is more likely if you have high levels of sugar and fats in the blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine
• sexual dysfunction

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Ezetimibe/Atorvastatin Stadafarma

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

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

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE point located at your pharmacy. Ask your pharmacist how to properly 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 Ezetimibe/Atorvastatin Stadafarma

• The active substances are ezetimibe and atorvastatin.

10 mg/10 mg: Each tablet contains 10 mg of ezetimibe and 10 mg of atorvastatin (as atorvastatin calcium trihydrate).

10 mg/20 mg: Each tablet contains 10 mg of ezetimibe and 20 mg of atorvastatin (as atorvastatin calcium trihydrate).

10 mg/40 mg: Each tablet contains 10 mg of ezetimibe and 40 mg of atorvastatin (as atorvastatin calcium trihydrate).

10 mg/80 mg: Each tablet contains 10 mg of ezetimibe and 80 mg of atorvastatin (as atorvastatin calcium trihydrate).

• Other components are:

Tablet core

Microcrystalline cellulose 101, mannitol, calcium carbonate, sodium croscarmellose, hydroxypropylcellulose, polysorbate 80, yellow iron oxide (E172), magnesium stearate, povidone K-29/32, sodium lauryl sulfate.

Tablet coating

10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg – Opadry White OY-L-28900 containing: lactose monohydrate, hypromellose 2910 (E464), titanium dioxide (E171), macrogol 4000 (E1521)

10 mg/80 mg – DrCoat FCU containing: hypromellose 2910, titanium dioxide (E171), talc (E553b), macrogol 400, yellow iron oxide (E172)

Appearance of the product and contents of the container

10 mg/10 mg tablet: white, round, biconvex, film-coated tablet with a diameter of approximately 8.1 mm

10 mg/20 mg tablet: white, oval, biconvex, film-coated tablet with dimensions of approximately 11.6 x 7.1 mm

10 mg/40 mg tablet: white, capsule-shaped, biconvex, film-coated tablet with dimensions of approximately 16.1 x 6.1 mm

10 mg/80 mg tablet: yellow, oblong, biconvex, film-coated tablet with dimensions of approximately 19.1 x 7.6 mm

Unit-dose and non-unit-dose blisters made of OPA/AL/PVC//Al, packed in cardboard cartons.

Pack sizes: 30, 30x1 film-coated tablets.

For 10 mg/20 mg and 10 mg/40 mg: also available in packs of 100, 100x1 film-coated tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturing Responsible

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer responsible

ELPEN Pharmaceutical Co. Inc.

Marathonos Ave. 95, Pikermi Attiki, 19009

Greece

or

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

or

ELPEN Pharmaceutical Co. Inc.

Zapani, Block 1048

Keratea 19001

Greece

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

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

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