EZETIMIBE/ATORVASTATIN NORMON 10 mg/40 mg TABLETS

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

Do not takeEzetimibe/Atorvastatin Normon

• if you are allergic to ezetimibe, atorvastatin, or any of the other ingredients of this medication (listed in section 6),
• if you have or have ever had a disease that affects the liver,
• if you have had any unexplained abnormal results in blood tests for liver function,
• 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 breastfeeding,

• 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 should temporarily stop using this medication. Your doctor will tell you when it is safe to restart treatment with ezetimibe/atorvastatin. The use of ezetimibe/atorvastatin with fusidic acid can rarely 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 Ezetimibe/Atorvastatin

• if you have had a previous stroke with intracranial hemorrhage or have small accumulations of fluid in the brain derived from previous strokes,
• if you have kidney problems,
• if your thyroid gland has low activity (hypothyroidism),
• if you have had recurring or unexplained muscle pain or a history of muscle problems,
• if you have experienced muscle problems while taking other lipid-lowering medications (e.g., other medications 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 medication containing fusidic acid (used to treat bacterial infections) orally 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 generalized 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 cause myasthenia (see section 4).

Contact your doctor as soon as possible if you experience unexplained muscle pain, sensitivity, or weakness while taking Ezetimibe/Atorvastatina.This is because muscle problems can be serious, including muscle breakdown causing kidney damage.

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

• if you have severe respiratory failure.

If you are in any of the above situations (or are unsure), consult your doctor before starting to take ezetimibe/atorvastatina, as your doctor will need to perform a blood test before starting your treatment with ezetimibe/atorvastatina, and possibly during treatment, to assess the risk of muscle side effects. It is known that the risk of muscle side effects, e.g., rhabdomyolysis (skeletal muscle breakdown), increases when certain medications are taken simultaneously (see section 2 "Taking Ezetimibe/Atorvastatina Normon with other medications").

While you are taking this medication, your doctor will monitor you for diabetes or the 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/Atorvastatina is not recommended for children and adolescents.

Taking Ezetimibe/Atorvastatina Normon with other medications

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

Fibrates (cholesterol-lowering medications) should be avoided while taking Ezetimibe/Atorvastatina.

There are some medications that can modify the effect of Ezetimibe/Atorvastatina or whose effects can be affected by Ezetimibe/Atorvastatina (see section 3). This type of interaction could decrease the effectiveness of one or both medications. On the other hand, it could also increase the risk or severity of side effects, including a serious disorder in which muscle destruction occurs, known as "rhabdomyolysis", which is described in section 4:

• cyclosporine (a medication often used in transplant patients),
• erythromycin, clarithromycin, telithromycin, fusidic acid, rifampicin (medications used to treat bacterial infections),
• ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole (medications used to treat fungal infections),
• gemfibrozil, other fibrates, nicotinic acid, derivatives, colestipol, cholestyramine (medications used to regulate lipid levels),
• certain calcium channel blockers used to treat angina or high blood pressure, e.g., amlodipine, diltiazem,
• digoxin, verapamil, amiodarone (medications that regulate heart rhythm),
• medications used to treat HIV, e.g., ritonavir, lopinavir, atazanavir, indinavir, darunavir, the combination of tipranavir/ritonavir, etc. (used to treat AIDS),
• certain medications 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 should temporarily stop using this medication. Your doctor will tell you when it is safe to restart treatment with Ezetimibe/Atorvastatina. Taking Ezetimibe/Atorvastatina with fusidic acid can rarely cause muscle weakness, sensitivity, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

• Other medications that are known to interact with Ezetimibe/Atorvastatina:

• oral contraceptives (medications that prevent pregnancy),
• stiripentol (an anticonvulsant medication used to treat epilepsy),
• cimetidine (a medication used for stomach acid and peptic ulcers),
• phenazone (a pain reliever),
• antacids (products for the treatment of indigestion that contain aluminum or magnesium),
• warfarin, phenprocoumon, acenocoumarol, or fluindione (medications that prevent blood clot formation),
• colchicine (used to treat gout),
• St. John's Wort (a medication used to treat depression).

Taking Ezetimibe/Atorvastatina Normon with food and alcohol

See section 3 for instructions on how to take Ezetimibe/Atorvastatina. 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 alter the effects of Ezetimibe/Atorvastatina.

Alcohol

Avoid excessive alcohol consumption while taking this medication. For more details, see section 2 "Warnings and precautions".

Pregnancy, breastfeeding, and fertility

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

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

Do not take Ezetimibe/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 medication.

Driving and using machines

Ezetimibe/Atorvastatina is not expected to interfere with your ability to drive or use machines. However, you should be aware that some people experience dizziness after taking Ezetimibe/Atorvastatina. If you feel dizzy after taking this medication, do not drive or use machines.

Ezetimibe/Atorvastatina Normon contains lactose

The tablets of Ezetimibe/Atorvastatina Normon contain a sugar called lactose. If your doctor has told you that you have an intolerance to certain sugars, consult your doctor before taking this medication.

Ezetimibe/Atorvastatina Normon contains sodium

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

3. How to take Ezetimibe/Atorvastatina Normon

Follow the instructions for administration of this medication 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 Ezetimibe/Atorvastatina, you should be following a cholesterol-reducing diet.
• You should continue with this cholesterol-reducing diet while taking Ezetimibe/Atorvastatina.

How much to take

The recommended dose is one tablet of Ezetimibe/Atorvastatina once a day, orally, 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/Atorvastatina at any time of the day. You can take it with or without food.

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

If you take more Ezetimibe/Atorvastatina Normon than you should

Consult your doctor or pharmacist.

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

If you forget to take Ezetimibe/Atorvastatina Normon

Do not take a double dose to make up for forgotten doses, take your normal dose of Ezetimibe/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 adverse effects, although not all people suffer from them.

If you experience any of the following serious adverse effects, stop taking your tablets and inform your doctor immediately, 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 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 disease.

Other Possible Adverse Effects with Ezetimibe/Atorvastatin:

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

• Nasal passage inflammation, sore throat, nasal bleeding.
• Allergic reactions.
• Increased blood glucose level, 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).
• Widespread 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 into 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 tablets, capsule-shaped (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 tablets, capsule-shaped (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 tablets, capsule-shaped (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 tablets, capsule-shaped (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 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

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/