Ezetimibe/atorvastatin Normogen 10 mg/40 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ezetimibe/Atorvastatin Normogen 10 mg/20 mg tablets EFG

Ezetimibe/Atorvastatin Normogen 10 mg/40 mg tablets EFG

ezetimibe/atorvastatin

Read all of this 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 others, even if they have the same symptoms as you, because it may harm them.
• If you get any side effects, talk to your doctor or pharmacist, even if it is a side effect not listed in this leaflet. See section 4.

Contents of this leaflet

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

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

Ezetimiba/Atorvastatina Normogen is a medicine that lowers high cholesterol levels. 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).

This medicine works by reducing cholesterol in two ways: by decreasing the cholesterol absorbed in the gastrointestinal tract and by reducing the cholesterol produced by the body itself.

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. Such blockage 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, thus protecting against heart disease.

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

Ezetimibe/atorvastatin is used in patients who cannot control their cholesterol levels with diet alone. While taking this medicine, you must continue to follow a cholesterol-lowering diet.

This medicine is used, together with a cholesterol-lowering diet, if you have:

• High blood levels of cholesterol (primary hypercholesterolemia [heterozygous familial and non-familial]) or high blood levels of fatty substances (mixed hyperlipidemia):
  • That are not well controlled with a statin alone.
  • For whom a statin and ezetimibe have previously been used as separate tablets.
• An inherited disease (homozygous familial hypercholesterolemia), which increases cholesterol levels in the blood. You may also receive other treatments.
• Heart disease, as ezetimibe/atorvastatin reduces the risk of heart attack, stroke, surgery to improve blood flow to the heart, or hospitalization due to chest pain.

Ezetimibe/atorvastatin does not help you lose weight.

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

Do not take Ezetimiba/Atorvastatina Normogen

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

Warnings and precautions

Talk to your doctor or pharmacist before starting this medicine:

• If you have previously had a stroke with intracranial bleeding, or have small accumulations of fluid in the brain due to prior strokes.
• If you have kidney problems.
• If your thyroid gland is underactive (hypothyroidism).
• If you have experienced recurrent or unexplained muscle pain or discomfort, or have a personal or family history of muscle disorders.
• If you have previously experienced muscle problems while being treated 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 of age.
• If your doctor has told you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.
• If you are taking or have taken within the last 7 days a medicine containing fusidic acid (used to treat bacterial infection), taken orally or by injection. The combination of fusidic acid and this medicine may cause serious muscle problems (rhabdomyolysis).
• If you have or have had myasthenia (a disease characterized by 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).

Contact your doctor as soon as possible if you experience unexplained muscle pain, tenderness, or weakness while taking ezetimiba/atorvastatina. This is because, although rarely, muscle problems can be serious, including muscle breakdown leading to kidney damage. It is known that atorvastatin may cause muscle problems, and muscle problems have also been reported with ezetimibe.

Also inform your doctor or pharmacist if you experience persistent muscle weakness. Additional tests or treatments may be needed to diagnose and manage this condition.

Talk to your doctor or pharmacist before starting ezetimiba/atorvastatina if you have severe respiratory insufficiency.

If you are in any of the above situations (or are unsure), consult your doctor before starting this medicine, as your doctor may need to perform a blood test before starting and possibly during treatment with ezetimiba/atorvastatina to assess your risk of developing muscle-related side effects. It is known that the risk of muscle-related adverse effects, e.g., rhabdomyolysis, increases when certain medicines are taken concomitantly (see section 2 “Taking Ezetimiba/Atorvastatina Normogen with other medicines”).

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

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

The combined use of this medicine with fibrates (certain medicines used to lower cholesterol) should be avoided, as the combination of ezetimibe/atorvastatin and fibrates has not been studied.

Children and adolescents

This medicine is not recommended for children and adolescents.

Other medicines and Ezetimiba/Atorvastatina Normogen

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including over-the-counter medicines.

Some medicines may alter the effect of ezetimibe/atorvastatin or may be affected by ezetimibe/atorvastatin (see section 3). Such interactions could reduce the effectiveness of one or both medicines. They could also increase the risk or severity of side 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**, and rifampicin (medicines used to treat bacterial infections).
• Ketoconazole, itraconazole, voriconazole, fluconazole, and posaconazole (medicines used to treat fungal infections).
• Gemfibrozil, other fibrates, nicotinic acid, derivatives, colestipol, and cholestyramine (medicines used to regulate lipid levels).
• Certain calcium channel blockers used to treat angina or high blood pressure, e.g., amlodipine and diltiazem.
• Digoxin, verapamil, and 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 combinations elbasvir/grazoprevir and ledipasvir/sofosbuvir.
• Letermovir (a medicine used to help prevent cytomegalovirus disease).
• 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 temporarily, you must stop taking this medicine. Your doctor will advise you when you can restart treatment with ezetimiba/atorvastatina. Using this medicine with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

• Other medicines known to interact with ezetimibe/atorvastatin:
  • Oral contraceptives (medicines that prevent pregnancy).
  • Stiripentol (an anticonvulsant medicine used to treat epilepsy).
  • Cimetidine (a medicine used for stomach acid and peptic ulcers).
  • Phenazone (an analgesic).
  • Antacids (products for treating 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 Ezetimiba/Atorvastatina Normogen with food and alcohol

See section 3 for instructions on how to take this medicine. Please note the following:

Grapefruit juice

Do not drink more than one or two small glasses of grapefruit juice per day, as large quantities of grapefruit juice may alter the effects of this medicine.

Alcohol

Avoid excessive alcohol consumption while taking this medicine. For further details, see section 2 “Warnings and precautions”.

Pregnancy and breastfeeding

Do not take this medicine if you are pregnant, trying to become pregnant, or think you might be pregnant.

Do not take this medicine if you could 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.

The safety of this medicine during pregnancy and breastfeeding has not been established.

Consult your doctor or pharmacist before taking this medicine.

Driving and using machines

This medicine is not expected to affect your ability to drive or use machines. However, bear in mind that some people may experience dizziness after taking this medicine.

Ezetimiba/Atorvastatina Normogen contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

Ezetimiba/Atorvastatina Normogen contains sodium

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

3. How to take Ezetimiba/Atorvastatina Normogen

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. Your doctor will determine the appropriate tablet dose for you, depending on your current treatment and your individual risk situation. If in doubt, please consult your doctor or pharmacist again.

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

The recommended dose is one tablet of ezetimiba/atorvastatina once daily, taken orally.

Method of administration

Take ezetimiba/atorvastatina at any time of day. It may be taken with or without food.

If your doctor has prescribed this medicine together with colestyramine or any other bile acid sequestrant (medicines that reduce cholesterol levels), you must take ezetimiba/atorvastatina at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take more Ezetimiba/Atorvastatina Normogen than you should

Contact 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 Ezetimiba/Atorvastatina Normogen

Do not take a double dose to make up for the missed dose.

The following day, take your usual dose of ezetimiba/atorvastatina at your regular time.

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.

If you experience any of the following serious adverse effects or symptoms, stop taking your tablets immediately and contact your doctor or go to the nearest hospital emergency department without delay.

• Severe allergic reactions causing swelling of the face, tongue, and throat, which may lead to severe breathing difficulties.
• A serious illness characterized by extensive skin peeling and inflammation, blistering of the skin, mouth, eyes, genitals, and fever; skin rash with pink or red spots, particularly on the palms of the hands or soles of the feet, which may progress to blistering.
• Muscle weakness, tenderness, pain, or rupture; or change in urine color to red-brown, especially if accompanied simultaneously by malaise or high temperature, which may be due to abnormal muscle breakdown that could be potentially life-threatening and lead to kidney problems.
• Lupus-like syndrome (including rash, joint disorders, and effects on blood cells).

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

Frequent adverse effects (may affect up to 1 in 10 patients):

• Diarrhea.
• Muscle pain.

Uncommon adverse effects (may affect up to 1 in 100 patients):

• Flu-like illness.
• Depression, difficulty sleeping, sleep disorders.
• Dizziness, headache, tingling sensation.
• Slow heart rate.
• Hot flushes.
• Choking sensations.
• Abdominal pain, bloating, constipation, indigestion, flatulence, frequent bowel movements, stomach inflammation, nausea, stomach discomfort, gastrointestinal upset.
• Acne, pimples.
• Joint pain, back pain, leg cramps, muscle fatigue, muscle spasms or weakness, pain in arms and legs.
• Unusual weakness, feeling tired or unwell, swelling especially in the ankles (edema).
• Increased liver or muscle function tests (CK) in laboratory blood tests.
• Weight gain.

Rare adverse effects (may affect up to 1 in 1000 patients):

• Skin rash or mouth ulcers (drug-induced lichenoid reaction).
• Purple-colored skin lesions (signs of blood vessel inflammation, vasculitis).

Adverse effects with unknown frequency (frequency cannot be estimated from available data):

• Myasthenia gravis (a disease causing generalized muscle weakness, which in some cases affects muscles used for breathing).
• Ocular myasthenia (a disease causing weakness of the eye muscles).

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

Additionally, the following adverse effects have been reported in people taking tablets of this medicine, ezetimibe or atorvastatin:

• Allergic reactions including swelling of the face, lips, tongue, and/or throat, which may cause difficulty breathing or swallowing (requiring immediate medical treatment).
• Red skin rash, sometimes target-shaped.
• Liver problems.
• Cough.
• Heartburn.
• Decreased appetite, loss of appetite.
• High blood pressure.
• Skin rash and itching, allergic reactions including rash and hives.
• Tendon injury.
• Gallstones or inflammation of the gallbladder (which may cause abdominal pain, nausea, or vomiting).
• Inflammation of the pancreas, often accompanied by severe abdominal pain.
• Decreased blood cell count, which may lead to bruising/bleeding (thrombocytopenia).
• Nasal inflammation, nosebleeds.
• 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 fingers and toes.
• Reduced sensitivity to pain or touch.
• Taste disturbances, dry mouth.
• Memory loss.
• Ringing in the ears and/or head, hearing loss.
• Vomiting.
• Belching.
• Hair loss.
• High temperature.
• Presence of white blood cells in urine tests.
• Blurred vision, visual disturbances.
• Gynaecomastia (enlargement of breasts in men).

Possible adverse effects reported with some statins:

• Sexual dysfunction.
• Depression.
• Respiratory problems, including persistent cough and/or choking sensations or fever.
• Diabetes. This is more likely if you have high levels of sugar and fats in your blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine.
• Persistent muscle pain, tenderness, or weakness, especially if accompanied by malaise or high temperature that does not resolve after stopping ezetimibe/atorvastatin treatment (frequency not known).

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, 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 Ezetimibe/Atorvastatin Normogen

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

Do not use this medicine after the expiry date stated on the carton or container after "EXP". The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage temperature.

Store in the original packaging to protect from light and moisture.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE Point at your pharmacy. 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 Ezetimiba/Atorvastatina Normogen

• The active substances are ezetimibe and atorvastatin:
  • Each tablet of Ezetimiba/Atorvastatina Normogen 10 mg/20 mg contains 10 mg of ezetimibe and 20 mg atorvastatin (as atorvastatin calcium trihydrate).
  • Each tablet of Ezetimiba/Atorvastatina Normogen 10 mg/40 mg contains 10 mg of ezetimibe and 40 mg atorvastatin (as atorvastatin calcium trihydrate).
• The other components (excipients) are: lactose monohydrate, sodium croscarmellose, povidone, sodium lauryl sulfate, magnesium stearate, calcium carbonate, polysorbate 80, hydroxypropylcellulose, and microcrystalline cellulose.

Appearance of the medicinal product and contents of the pack

Ezetimiba/Atorvastatina Normogen 10 mg/20 mg film-coated tablets are white or almost white, elliptical, biconvex tablets, engraved with “1020” on one side and smooth on the other.

Ezetimiba/Atorvastatina Normogen 10 mg/40 mg film-coated tablets are white or almost white, elliptical, biconvex tablets, engraved with “1040” on one side and smooth on the other.

Aluminum/Poliamide-Aluminum-PVC blister with perforated unit doses.

Packs containing 30 tablets.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN).

Date of the most recent review of this leaflet: August 2025

Other sources of information

Detailed 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 information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/00000/P_00000.html