Prospect: information for the patient

Ezetimiba/Atorvastatina Normon 10 mg/10 mg tablets

Ezetimiba/Atorvastatina Normon 10 mg/20 mg tablets

Ezetimiba/Atorvastatina Normon 10 mg/40 mg tablets

Ezetimiba/Atorvastatina Normon 10 mg/80 mg tablets

Ezetimiba / Atorvastatina

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

- Keep this prospect, as you may need to read it again.

- If you have any doubts, consult your doctor or pharmacist.

- This medicine has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.

- If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

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

2. What you need to know before starting to take Ezetimiba/Atorvastatina Normon

3. How to take Ezetimiba/Atorvastatina Normon

4. Possible adverse effects

5. Storage of Ezetimiba/Atorvastatina Normon

6. Contents of the package and additional information

Ezetimiba/Atorvastatina Normon is a medication that lowers high levels of cholesterol. Ezetimiba/Atorvastatina Normon contains ezetimiba and atorvastatina.

Ezetimiba/Atorvastatinais used in adults to lower total cholesterol, "bad" cholesterol (LDL cholesterol), and certain types of fat called triglycerides that circulate in the blood. Additionally,Ezetimiba/Atorvastatinaincreases the concentrations of "good" cholesterol (HDL cholesterol).

Ezetimiba/Atorvastatinaacts 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 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 blood flow to vital organs such as the heart and brain slower or interrupted. This interruption of blood flow can trigger a heart attack or stroke.

HDL cholesterol is often referred to as "good" cholesterol because it helps prevent bad cholesterol from accumulating 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 heart disease.

Ezetimiba/Atorvastatina is used in patients who cannot control their cholesterol levels solely with diet. While taking this medication, you should continue to follow a cholesterol-reducing diet.

Your doctor may prescribeEzetimiba/Atorvastatinaif you are already taking both ezetimiba and atorvastatina at the same dose level.

Ezetimiba/Atorvastatina does not help you lose weight.

Do not takeEzetimiba/Atorvastatina Normon

• if you are allergic to ezetimiba, atorvastatina, or any of the other ingredients of this medicine (listed in section 6),
• if you have or have had a liver disease,
• if you have had any unexplained abnormal results in liver function blood tests,
• if you are a woman who may become pregnant and is 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,
• if you need to take oral fusidic acid for a bacterial infection, you should temporarily stop taking this medicine. Your doctor will tell you when it is safe to restart the 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.

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 experienced 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 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 ezetimiba/atorvastatina may cause severe muscle problems (rhabdomyolysis).
• if you have or have had myasthenia (a disease that causes generalized muscle weakness, which in some cases affects the muscles used for breathing) or myasthenia gravis (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.

Consult your doctor or pharmacist before starting to take Ezetimiba/Atorvastatina

• if you have severe respiratory failure.

If you are in any of the above circumstances (or are unsure), consult your doctor before starting to take ezetimiba/atorvastatina, as your doctor will need to perform a blood test before starting your treatment with ezetimiba/atorvastatina, and possibly during it, to predict the risk of experiencing adverse muscle effects. It is known that the risk of experiencing adverse muscle effects, e.g., rhabdomyolysis (rupture of skeletal muscle damaged), increases when certain medicines are taken simultaneously (see section 2 “Taking Ezetimiba/Atorvastatina Normon with other medicines”).

While you are taking this medicine, your doctor will monitor 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, being overweight, and high blood pressure.

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

Children

Ezetimiba/Atorvastatina is not recommended for children and adolescents.

Taking Ezetimiba/Atorvastatina Normon with other medicines

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.

Lipid-lowering fibrates should be avoided while taking Ezetimiba/Atorvastatina.

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 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 in which muscle is destroyed, known as “rhabdomyolysis”, which is described in section 4:

• ciclosporin (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,

• if you need to take oral fusidic acid for a bacterial infection, you should temporarily stop taking this medicine. Your doctor will tell you when it is safe to restart the treatment with Ezetimiba/Atorvastatina. Taking 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 for stomach acid and ulcers),
• phenazone (a painkiller),
• antacids (products used to treat indigestion that contain aluminum 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 Normon 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, breastfeeding, and fertility

Do not take Ezetimiba/Atorvastatina if you are pregnant, trying to become pregnant, or think you may be pregnant.

Do not take Ezetimiba/Atorvastatina if you may become pregnant, unless you are using reliable contraceptive methods. 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.

If you are pregnant, breastfeeding, trying to become pregnant, or think you may be pregnant, 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. If you feel dizzy after taking this medicine, do not drive or use machines.

Ezetimiba/Atorvastatina Normon contains lactose

The Ezetimiba/Atorvastatina Normon tablets contain a sugar called lactose. If your doctor has told you that you have a certain sugar intolerance, consult your doctor before taking this medicine.

Ezetimiba/Atorvastatina Normon contains sodium

Ezetimiba/Atorvastatina Normon contains less than 1 mmol of sodium (23 mg) per tablet, which is essentially “sodium-free”.

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 take Ezetimiba/Atorvastatina, you must be following a diet to reduce cholesterol.
• You will need to continue with this cholesterol-reducing diet while taking Ezetimiba/Atorvastatina.

What quantity should you take

The recommended dose is one Ezetimiba/Atorvastatina tablet once a day taken orally, always at the same time.

The tablets should be swallowed with a sufficient amount of liquid (e.g., a glass of water).

Administration form

Take Ezetimiba/Atorvastatina at any time of the day. You can take it with or without food.

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

If you take more Ezetimiba/Atorvastatina Normon than you should

Consult your doctor or pharmacist.

In case of overdose, consult your doctor or pharmacist or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Ezetimiba/Atorvastatina Normon

Do not take a double dose to compensate for the missed doses, take your normal amount of Ezetimiba/Atorvastatina at the usual time.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

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, stop taking your tablets and immediately inform your doctor, or go to the nearest hospital emergency department.

• Severe allergic reactions that cause swelling of the face, tongue, and throat and may cause difficulty breathing.
• Severe disease with symptoms of 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.
• Muscle weakness, sensitivity, pain, rupture, or brownish-red discoloration of the urine, and particularly if you feel unwell or have a high temperature, which may be caused by an abnormal muscle collapse that can be life-threatening and cause kidney problems.
• Lupus-like disease syndrome (including skin 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.

Other possible side effects with Ezetimiba/Atorvastatina:

Frequent side effects (may affect up to 1 in 10 people):

• Nasal congestion, sore throat, nasal bleeding.
• Allergic reactions.
• Increased blood glucose levels, diabetic patients should control their blood glucose levels.
• Headache.
• Nausea, constipation, flatulence, diarrhea, indigestion, abdominal pain.
• Throat and/or laryngeal pain.
• Joint and/or hand and foot pain, back pain, muscle pain (myalgia), muscle spasms, joint swelling.
• Increased blood creatine kinase levels.
• Increased liver enzymes ALT and/or AST.
• Feeling tired.
• Abnormal liver function test.

Rare side effects (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.
• High blood pressure, hot flushes.
• Vomiting, belching, pancreatitis and liver inflammation, stomach acid, inflammation of the stomach membranes, dry mouth.
• Skin redness, urticaria, skin rash, itching, hair loss.
• Nightmares, difficulty sleeping.
• Dizziness, numbness, altered sense of taste, amnesia, abnormal local sensations.
• Blurred vision.
• Tinnitus.
• General feeling of discomfort, restlessness, or pain.
• Weakness.
• Increased gamma-glutamyltransferase liver enzyme levels.
• Positive urine test for white blood cells.

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

• Anaphylactic shock due to an allergic reaction.
• Loss of hearing.
• Liver failure.
• Increased breast size in men.

Side effects of unknown frequency (frequency cannot be estimated from available data):

• Allergic reaction including skin redness and swelling.
• Shortness of breath, inflammation of the gallbladder, gallstones.
• Physical weakness and loss of strength, muscle tissue loss due to autoimmune antibodies.
• Depression.
• Myasthenia gravis (a disease that causes generalized muscle weakness, which 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.

In addition, the following side effects have been reported post-commercialization for some statins (medicines used to lower cholesterol):

• Respiratory problems, including persistent cough and/or shortness of breath or fever.
• Diabetes: frequency will depend on the presence or absence of risk factors (fasting blood glucose ≥ 5.6 mmol/L, BMI > 20 kg/m, increased triglycerides, high blood pressure).
• Depression.
• Sexual dysfunction.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the 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 medicine.

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

Do not use this medication after the expiration date that appears on the box after CAD. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from light.

Medications should not be disposed of through drains or trash. Dispose of the containers and medications you no longer need at theSIGREpoint of the pharmacy.Ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.

Composition of Ezetimiba/Atorvastatina Normon

- The active principles are ezetimiba and atorvastatina. Each tablet contains 10 mg of ezetimiba and 10 mg, 20 mg, 40 mg or 80 mg of atorvastatina (as atorvastatina calcium).

- The other components are: lactose monohydrate, calcium carbonate, microcrystalline cellulose, sodium lauryl sulfate (E487), sodium croscarmellose, povidone K30, hydroxypropylcellulose, magnesium stearate and polisorbate 80.

Appearance of the product and content of the container

Ezetimiba/Atorvastatina Normon 10 mg/10 mg tablets: white to off-white tablets, in capsule shape (12.7 mm x 5.1 mm), marked with “1” on one face.

Ezetimiba/Atorvastatina Normon 10 mg/20 mg tablets: white to off-white tablets, in capsule shape (14.5 mm x 6.8 mm), marked with “2” on one face.

Ezetimiba/Atorvastatina Normon 10 mg/40 mg tablets: white to off-white tablets, in capsule shape (16.4 mm x 6.3 mm), marked with “3” on one face.

Ezetimiba/Atorvastatina Normon 10 mg/80 mg tablets: white to off-white tablets, in capsule shape (17.0 mm x 8.0 mm), marked with “4” on one face.

Ezetimiba/Atorvastatina Normon is presented in PVC/Aluminum/OPA blisters. There are containers of 10, 30, 90 and 100 tablets.

Only some sizes of containers may be commercially marketed.

Marketing Authorization Holder

Normon Laboratories, S.A.

Ronda de Valdecarrizo, 6

28760 Tres Cantos, Madrid

Spain

Responsible for Manufacturing

Normon Laboratories, S.A.

Ronda de Valdecarrizo, 6

28760 Tres Cantos, Madrid

Spain

Hennig Arzneimittel Gmbh & Co. KG

Liebigstraße. 1-2

D-65439 Flörsheim

Germany

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

Netherlands: Ezetimibe/Atorvastatine Normon 10 mg/10 mg, 20 mg, 40 mg, 80 mg, tablets

Spain: Ezetimiba/Atorvastatina Normon 10 mg/10 mg, 20 mg, 40 mg, 80 mg tablets

Last review date of this leaflet: March 2023

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.es/