EZETIMIBE/ATORVASTATIN NORMON 10 mg/80 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Ezetimibe/Atorvastatin Normon 10 mg/10 mg tablets

Ezetimibe/Atorvastatin Normon 10 mg/20 mg tablets

Ezetimibe/Atorvastatin Normon 10 mg/40 mg tablets

Ezetimibe/Atorvastatin Normon 10 mg/80 mg tablets

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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Ezetimibe/Atorvastatin Normon and what is it used for

Ezetimibe/Atorvastatin Normon is a medicine that lowers high cholesterol levels. Ezetimibe/Atorvastatin Normon contains ezetimibe and atorvastatin.

Ezetimibe/Atorvastatin is used in adults to lower the levels of total cholesterol, “bad” cholesterol (LDL cholesterol) and a type of fat called triglycerides in the blood. It also raises the levels of “good” cholesterol (HDL cholesterol).

Ezetimibe/Atorvastatin works by reducing cholesterol in two ways. It reduces the amount of cholesterol absorbed in the gut and also the amount of cholesterol made by the body.

Cholesterol is one of the fats 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 can lead to a narrowing of the arteries. This narrowing can reduce or completely block the flow of blood to vital organs such as the heart and brain. This blockage can cause 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 found in the blood. High levels of triglycerides can increase the risk of heart disease.

Ezetimibe/Atorvastatin is used in patients who cannot control their cholesterol levels by diet alone. While you are taking this medicine, you should also follow a low-cholesterol diet.

Your doctor may prescribe Ezetimibe/Atorvastatin for you if you are already taking both ezetimibe and atorvastatin at the same dose level.

Ezetimibe/Atorvastatin does not help you lose weight.

2. What you need to know before you take Ezetimibe/Atorvastatin Normon

Do not takeEzetimibe/Atorvastatin Normon

• 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 a liver disease,
• if you have had any unexplained abnormal blood test results indicating liver problems,
• if you are a woman who can become pregnant and are not using reliable contraceptive methods,

• if you are pregnant, trying to become pregnant or are breast-feeding,

• if you are taking the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C,
• if you need to take oral fusidic acid to treat a bacterial infection, you must temporarily stop taking this medicine. Your doctor will tell you when it is safe to restart the treatment with ezetimibe/atorvastatin. Taking ezetimibe/atorvastatin with fusidic acid can rarely cause muscle weakness, tenderness or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

Warnings and precautions

Consult your doctor or pharmacist before taking Ezetimibe/Atorvastatin Normon

• if you have had a previous stroke with bleeding in the brain, or have small amounts of fluid in the brain caused by previous strokes,
• if you have kidney problems,
• if your thyroid gland does not produce enough hormones (hypothyroidism),
• if you have had muscle pain or weakness or have a history of muscle problems,
• if you have had previous muscle problems while taking other lipid-lowering medicines (e.g. other medicines containing “statins” or “fibrates”),
• if you regularly drink 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 by injection. The combination of fusidic acid and ezetimibe/atorvastatin can cause serious muscle problems (rhabdomyolysis).
• if you have or have had myasthenia (a disease characterized by muscle weakness that can affect the muscles used for breathing) or ocular myasthenia (a disease that causes weakness of the eye muscles), as statins can sometimes worsen the disease 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 Ezetimibe/Atorvastatin Normon.This is because muscle problems can be serious, including muscle breakdown causing kidney damage.

Consult your doctor or pharmacist before taking Ezetimibe/Atorvastatin Normon

• if you have severe respiratory failure.

If you are in any of the above situations (or are unsure), consult your doctor before taking ezetimibe/atorvastatin, as your doctor will need to perform a blood test before starting your treatment with ezetimibe/atorvastatin, and possibly during treatment, to predict the risk of muscle side effects. It is known that the risk of muscle side effects, e.g. rhabdomyolysis (skeletal muscle damage), increases when certain medicines are taken at the same time (see section 2 “Taking Ezetimibe/Atorvastatin Normon with other medicines”).

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 the blood, are overweight and have high blood pressure.

Tell your doctor about all your medical problems, including allergies.

Children

Ezetimibe/Atorvastatin is not recommended for children and adolescents.

Taking Ezetimibe/Atorvastatin Normon with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription.

Fibrates (cholesterol-lowering medicines) should be avoided while taking Ezetimibe/Atorvastatin Normon.

There are some medicines that can affect the way Ezetimibe/Atorvastatin Normon works, or their effects can be altered by Ezetimibe/Atorvastatin Normon (see section 3). This type of interaction could decrease the effectiveness of one or both medicines. On the other hand, it could also increase the risk or severity of side effects, including a serious disorder in which muscle tissue is destroyed, known as “rhabdomyolysis”, which is described in section 4:

• cyclosporin (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),
• certain 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),
• certain medicines used to treat hepatitis C, e.g. telaprevir, boceprevir and the combination of elbasvir/grazoprevir,

• if you need to take oral fusidic acid to treat a bacterial infection, you must temporarily stop taking this medicine. Your doctor will tell you when it is safe to restart the treatment with Ezetimibe/Atorvastatin Normon. Taking Ezetimibe/Atorvastatin Normon with fusidic acid can rarely cause muscle weakness, tenderness or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

• Other medicines that are known to interact with Ezetimibe/Atorvastatin Normon:

• oral contraceptives (medicines that prevent pregnancy),
• stiripentol (an anticonvulsant medicine used to treat epilepsy),
• cimetidine (a medicine used to treat stomach acid and peptic ulcers),
• phenazone (a pain reliever),
• 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 Ezetimibe/Atorvastatin Normon with food and drink

See section 3 for instructions on how to take Ezetimibe/Atorvastatin Normon. 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 can affect the way Ezetimibe/Atorvastatin Normon works.

Alcohol

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

Pregnancy, breast-feeding and fertility

Do not take Ezetimibe/Atorvastatin Normon if you are pregnant, trying to become pregnant or think you may be pregnant.

Do not take Ezetimibe/Atorvastatin Normon if you can become pregnant, unless you use reliable contraceptive methods. If you become pregnant while taking Ezetimibe/Atorvastatin Normon, stop taking it immediately and inform your doctor.

Do not take Ezetimibe/Atorvastatin Normon if you are breast-feeding.

If you are pregnant, breast-feeding, trying to become pregnant or think you may be pregnant, consult your doctor or pharmacist before taking this medicine.

Driving and using machines

Ezetimibe/Atorvastatin Normon is unlikely to affect your ability to drive or use machines. However, it should be taken into account that some people experience dizziness after taking Ezetimibe/Atorvastatin Normon. If you feel dizzy after taking this medicine, do not drive or use machines.

Ezetimibe/Atorvastatin Normon contains lactose

Ezetimibe/Atorvastatin Normon tablets contain a sugar called lactose. If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

Ezetimibe/Atorvastatin Normon contains sodium

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

3. How to take Ezetimibe/Atorvastatin Normon

Take this medicine exactly as your doctor has told you. Your doctor will determine the appropriate dose of Ezetimibe/Atorvastatin Normon for you, depending on your current treatment and personal risk situation. If in doubt, consult your doctor or pharmacist again.

• Before starting to take Ezetimibe/Atorvastatin Normon, you should be following a cholesterol-lowering diet.
• You should continue with this cholesterol-lowering diet while taking Ezetimibe/Atorvastatin Normon.

How much to take

The recommended dose is one Ezetimibe/Atorvastatin Normon tablet once a day by mouth, always at the same time.

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

Method of administration

Take Ezetimibe/Atorvastatin Normon at any time of the day. You can take it with or without food.

If your doctor has prescribed Ezetimibe/Atorvastatin Normon with colestyramine or any other bile acid sequestrant (medicines that lower cholesterol levels), you should take Ezetimibe/Atorvastatin Normon at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take more Ezetimibe/Atorvastatin Normon than you should

Consult your doctor or pharmacist.

In case of overdoseconsult your doctor or pharmacist or call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Ezetimibe/Atorvastatin Normon

Do not take a double dose to make up for forgotten doses, take your normal dose of Ezetimibe/Atorvastatin Normon at the usual time.

If you have any further questions on 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 all people suffer from them.

If you experience any of the following serious adverse effects, stop taking your tablets and immediately inform your doctor, or go to the emergency department of the nearest hospital.

• Severe allergic reactions that cause swelling of the face, tongue, and throat and can cause great difficulty in breathing.
• Severe disease whose symptoms are intense exfoliation and skin inflammation, blister formation on the skin, mouth, eyes, genitals, and fever; skin rash with pink or red spots, especially on the palms of the hands or the soles of the feet, which can lead to blisters.
• Muscle weakness, sensitivity, pain, rupture, or brown discoloration of the urine, and in particular, if at the same time, you feel unwell or have a high temperature, which may be caused by abnormal muscle breakdown 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 fact may indicate a liver condition.

Other Possible Adverse Effects with Ezetimibe/Atorvastatin:

Common adverse effects (may affect up to 1 in 10 people):

• Nasal passage 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.
• Pain in the pharynx and/or larynx.
• Pain in the joints and/or hands and feet, back pain, muscle pain (myalgia), muscle spasms, joint swelling.
• Increased blood creatine kinase.
• Increased liver enzymes ALT and/or AST.
• Feeling of fatigue.
• Abnormal liver function test.

Uncommon adverse 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.
• Lack of appetite, weight gain.
• Cough.
• Muscle weakness, neck pain, chest pain.
• High blood pressure, hot flashes.
• Vomiting, belching, pancreas and liver inflammation, stomach acid, stomach lining inflammation, dry mouth.
• Redness of the skin, hives, skin rash, itching, hair loss.
• Nightmares, sleep problems.
• Dizziness, numbness, altered sense of taste, amnesia, abnormal local sensations.
• Blurred vision.
• Ringing in the ears.
• Feeling of general malaise, restlessness, or pain.
• Weakness.
• Increased liver enzyme gamma-glutamyltransferase.
• Positive urine test for white blood cells.

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

• Decrease in blood platelets.
• Inflammation of the lower layers of the skin tissue of the face, tongue, throat, abdomen, arms, or legs (angioneurotic edema).
• Generalized skin rash that forms red spots or demarcated skin rashes with blisters and skin peeling, particularly around the mouth, nose, eyes, and genitals due to an allergic reaction.
• Inflammation of the skeletal muscle, tendon inflammation, sometimes complicated by rupture, muscle weakness due to skeletal muscle fibers.
• Visual disturbances.
• Yellowing of the skin and the whites of the eyes.

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

• Anaphylactic shock due to an allergic reaction.
• Hearing loss.
• Liver failure.
• Increased breast size in men.

Adverse effects of unknown frequency (their frequency cannot be estimated from the available data):

• Allergic reaction that includes redness and swelling of the lower layers of the skin.
• Shortness of breath, gallbladder inflammation, gallstones.
• Physical weakness and loss of strength, loss of muscle tissue due to auto-immune antibodies.
• Depression.
• Severe myasthenia (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing).
• Ocular myasthenia (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, or drooping eyelids, difficulty swallowing, or difficulty breathing.

Additionally, the following adverse effects have been reported post-marketing for some statins (medicines used to lower cholesterol):

• Respiratory problems, including persistent cough and/or shortness of breath or fever.
• Diabetes: the 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 Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Ezetimibe/Atorvastatin Normon

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

Do not use this medicine 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.

Medicines should not be thrown away through the sewers or in the trash. Deposit the packaging and medicines that you no longer need in the SIGRE point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Ezetimibe/Atorvastatin Normon

• The active ingredients are ezetimibe and atorvastatin. Each tablet contains 10 mg of ezetimibe and 10 mg, 20 mg, 40 mg, or 80 mg of atorvastatin (as atorvastatin calcium).

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

Appearance of the Product and Package Contents

Ezetimibe/Atorvastatin Normon 10 mg/10 mg tablets: white to off-white, capsule-shaped tablets (12.7 mm x 5.1 mm), marked with "1" on one face.

Ezetimibe/Atorvastatin Normon 10 mg/20 mg tablets: white to off-white, capsule-shaped tablets (14.5 mm x 6.8 mm), marked with "2" on one face.

Ezetimibe/Atorvastatin Normon 10 mg/40 mg tablets: white to off-white, capsule-shaped tablets (16.4 mm x 6.3 mm), marked with "3" on one face.

Ezetimibe/Atorvastatin Normon 10 mg/80 mg tablets: white to off-white, capsule-shaped tablets (17.0 mm x 8.0 mm), marked with "4" on one face.

Ezetimibe/Atorvastatin Normon is presented in PVC/Aluminum/OPA blisters. There are packages of 10, 30, 90, and 100 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder

Laboratorios Normon, S.A.

Ronda de Valdecarrizo, 6

28760 Tres Cantos, Madrid

Spain

Manufacturer

Laboratorios Normon, 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 under 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

Date of the last revision of this prospectus: March 2023

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