EZETIMIBE/ATORVASTATIN NORMOGEN 10 mg/40 mg TABLETS

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

Do not take Ezetimibe/Atorvastatin 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, a liver disease.
• If you have had any unexplained abnormal blood test results showing 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 breast-feeding.
• If you are taking the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C.

Warnings and precautions

Consult your doctor or pharmacist before taking this medicine:

• If you have had a 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 that repeats or is unexplained, or a personal or family history of muscle problems.
• If you have had muscle problems while taking other medicines to lower cholesterol (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 your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.
• If you are taking, or have taken in the last 7 days, a medicine called fusidic acid (used to treat bacterial infections) by mouth or by injection. The combination of fusidic acid and this medicine can cause muscle problems (rhabdomyolysis).
• If you have, or have had, a muscle disease called myasthenia gravis, which can lead to muscle weakness, or myasthenic syndrome, which can cause eye muscle weakness, as statins can sometimes make these conditions worse (see section 4).

Contact your doctor as soon as possible if you experience unexplained muscle pain, tenderness, or weakness while taking ezetimibe/atorvastatin.This is because, on rare occasions, muscle problems can be serious, including muscle breakdown, which can cause kidney damage. Atorvastatin can cause muscle problems, and muscle problems have also been reported with ezetimibe.

Also, inform your doctor or pharmacist if you experience persistent muscle weakness. You may need further tests and additional medicines to diagnose and treat this condition.

Consult your doctor or pharmacist before taking ezetimibe/atorvastatin if you have severe respiratory problems.

If you are in any of the above situations (or are unsure), consult your doctor before taking this medicine, as your doctor will need to perform a blood test before starting your treatment with ezetimibe/atorvastatin, and possibly during treatment, to check for the risk of muscle side effects. The risk of muscle side effects, e.g. rhabdomyolysis, increases when certain medicines are taken at the same time (see section 2 "Taking Ezetimibe/Atorvastatin Normogen with other medicines").

While 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 conditions, including allergies.

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

Children and adolescents

This medicine is not recommended for children and adolescents.

Other medicines and Ezetimibe/Atorvastatin Normogen

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

There are some medicines that can affect the way ezetimibe/atorvastatin works, or their effects can be altered 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 side effects, including a serious condition called "rhabdomyolysis", which is described in section 4:

• Ciclosporin (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 colestyramine (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).
• Certain medicines used to treat hepatitis C, e.g. telaprevir, boceprevir, and the combination of elbasvir/grazoprevir and ledipasvir/sofosbuvir.
• Letermovir (a medicine that helps prevent cytomegalovirus disease).
• Daptomycin (a medicine used to treat skin and skin structure infections and bacteremia).

**If you need to take fusidic acid by mouth to treat a bacterial infection, you will need to stop using this medicine temporarily. Your doctor will tell you when you can restart the treatment with ezetimibe/atorvastatin. The use of this medicine 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:
• • Oral contraceptives (medicines that prevent pregnancy).
  • Stiripentol (an anticonvulsant medicine used to treat epilepsy).
  • Cimetidine (a medicine used for stomach acidity and peptic ulcers).
  • Phenazon (a pain reliever).
  • Antacids (products for the treatment of 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 Ezetimibe/Atorvastatin Normogen with food and drink

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 amounts of grapefruit juice can affect the way this medicine works.

Alcohol

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

Pregnancy and breast-feeding

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

Do not take this medicine if you can become pregnant, unless you use 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 breast-feeding.

The safety of this medicine during pregnancy and breast-feeding 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, it should be noted that some people experience dizziness after taking this medicine.

Ezetimibe/Atorvastatin Normogen contains lactose

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

Ezetimibe/Atorvastatin Normogen contains sodium

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

3. How to take Ezetimibe/Atorvastatin Normogen

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

• Before starting to take ezetimibe/atorvastatin, you should be following a cholesterol-lowering diet.
• You should continue with this cholesterol-lowering diet while taking this medicine.

The recommended dose is one ezetimibe/atorvastatin tablet once a day by mouth.

Method of administration

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

If your doctor has prescribed this medicine along with colestyramine or any other bile acid sequestrant (medicines that lower 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 Ezetimibe/Atorvastatin Normogen than you should

Consult your doctor or pharmacist.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately 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 Normogen

Do not take a double dose to make up for forgotten doses.

The next day, take your normal dose of ezetimibe/atorvastatin 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 or symptoms, 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 in breathing.
• Serious illness 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.
• Weakness, sensitivity, pain, or muscle rupture or change in urine color to reddish-brown and especially, if it occurs at the same time, a feeling of discomfort or high temperature that may be caused by abnormal muscle destruction that can be potentially fatal and trigger kidney problems.
• Lupus-like syndrome (including 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 be indicative of 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.
• Depression, sleep problems, sleep disorder.
• Dizziness, headache, tingling sensation.
• Slow heart rate.
• Hot flashes.
• Shortness of breath.
• Abdominal pain, abdominal swelling, constipation, indigestion, flatulence, frequent bowel movements, stomach inflammation, nausea, stomach discomfort, stomach upset.
• Acne, hives.
• Joint pain, back pain, muscle cramps in the legs, muscle fatigue, muscle spasms or weakness, pain in the arms and legs.
• Unusual weakness, feeling of tiredness or discomfort, inflammation especially in the ankles (edema).
• Increased levels of some 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 ulcers in the mouth (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):

• Severe myasthenia (disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing).
• Ocular myasthenia (disease that causes weakness of the eye muscles).

Consult your doctor if you experience weakness in the 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 in people taking tablets of this medicine, ezetimibe, or atorvastatin:

• Allergic reactions that include inflammation of the face, lips, tongue, and/or throat that can cause difficulty breathing or swallowing (which require immediate medical treatment).
• Reddened skin rash, and sometimes, in a target-like shape.
• Liver problems.
• Cough.
• Acidity.
• Decreased appetite, lack of appetite.
• High blood pressure.
• Skin rash and itching, allergic reactions that include the appearance of skin rash and hives.
• Tendon injury.
• Gallstones or gallbladder inflammation (which can cause abdominal pain, nausea, or vomiting).
• Pancreatitis, often accompanied by severe abdominal pain.
• Decreased blood cell count, which can produce bruising/bleeding (thrombocytopenia).
• Inflammation of the nasal passages, nosebleeds.
• Neck pain, chest pain, throat pain.
• Increased or decreased blood sugar levels (if you have diabetes, you should closely monitor your blood glucose levels).
• Nightmares.
• Numbness or tingling in the fingers and toes.
• Decreased sensitivity to pain or touch.
• Altered sense of taste, 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.
• Gynecomastia (breast enlargement in men).

Possible adverse effects reported with some statins:

• Sexual dysfunction.
• Depression.
• Respiratory problems, including persistent cough and/or shortness of breath or fever.
• Diabetes. It is more likely if you have high levels of sugars and fats in the blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine.
• Persistent muscle pain, sensitivity, or weakness, and especially, if it occurs at the same time, a feeling of discomfort or high temperature that may not disappear after stopping treatment with ezetimibe/atorvastatin (unknown frequency).

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 leaflet.

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 Ezetimiba/Atorvastatina Normogen

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

Do not use this medicine after the expiration date that appears on the carton or packaging after "EXP". The expiration date is the last day of the month indicated.

This medicine does not require any special storage temperature.

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

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Ezetimiba/Atorvastatina Normogen

• The active ingredients are ezetimibe and atorvastatin:
• • Each Ezetimiba/Atorvastatina Normogen 10 mg/20 mg tablet contains 10 mg of ezetimibe and 20 mg of atorvastatin (as atorvastatin calcium trihydrate).
  • Each Ezetimiba/Atorvastatina Normogen 10 mg/40 mg tablet contains 10 mg of ezetimibe and 40 mg of 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 Product and Package Contents

Ezetimiba/Atorvastatina Normogen 10 mg/20 mg EFG tablets are presented in the form of white or almost white, elliptical, biconvex tablets, engraved with "1020" on one face and smooth on the other.

Ezetimiba/Atorvastatina Normogen 10 mg/40 mg EFG tablets are presented in the form of white or almost white, elliptical, biconvex tablets, engraved with "1040" on one face and smooth on the other.

Aluminum/Polyamide-Aluminum-PVC blister pack with perforated unit doses.

Packaging with 30 tablets.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

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

Date of the Last Revision of this Leaflet:August 2025

Other Sources of Information

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

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