Package Leaflet: Information for the User

Atorvastatina Normogen 10 mg Film-Coated Tablets

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others even if their symptoms are the same as yours. It may harm them.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

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

2.What you need to know beforetaking Atorvastatina Normogen

3. How to take Atorvastatina Normogen

4. Possible side effects

5. Storage of Atorvastatina Normogen

6.Contents of the pack and additional information

Atorvastatina Normogen belongs to a group of medications known as statins, which are medications that regulate lipids (fats).

This medication is used to reduce lipids such as cholesterol and triglycerides in the blood when a low-fat diet and lifestyle changes on their own have failed. If you present a high risk of heart disease, this medication may also be used to reduce this risk even if your cholesterol levels are normal. During treatment, a standard low-cholesterol diet must be followed.

Do not take Atorvastatina Normogen

• If you are allergic to atorvastatin or any of the other ingredients of this medication (listed in section 6).
• If you have or have had any liver disease.
• If you have or have had abnormal liver function test results.
• If you are a fertile woman and do not use adequate contraceptive measures.
• If you are pregnant or trying to become pregnant.
• If you are breastfeeding.
• If you are taking the combination of glecaprevir/pibrentasvir for hepatitis C treatment.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take this medication:

• If you have severe respiratory insufficiency.
• If you are taking or have taken in the last 7 days a medication called fusidic acid (a medication used to treat bacterial infections) by mouth or injection. The combination of fusidic acid and atorvastatin may cause severe muscle problems (rhabdomyolysis).
• If you have had a previous stroke with brain bleeding, or have small fluid embolisms in the brain due to previous strokes.
• If you have kidney problems.
• If you have a thyroid gland with low activity (hypothyroidism).
• If you have repeated or unjustified muscle pain, personal or family history of muscle problems.
• If you have had muscle problems during previous treatment with other medications to reduce lipids (e.g., with another statin or fibrates).
• 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).
• If you regularly drink large amounts of alcohol.
• If you have a history of liver problems.
• If you are over 70 years old.

In any of these cases, your doctor may instruct you to have blood tests before and possibly during treatment with this medication to predict the risk of adverse effects related to muscle. It is known that the risk of adverse effects related to muscle (e.g., rhabdomyolysis) increases when certain medications are taken at the same time (see section 2 “Use of Atorvastatina Normogen with other medications”).

Also inform your doctor or pharmacist if you experience persistent muscle weakness. Additional tests and medications may be necessary to diagnose and treat this problem.

While taking this medication, your doctor will monitor if you have diabetes or a risk of developing diabetes. This risk of diabetes increases if you have high blood sugar and lipid levels, overweight, and high blood pressure.

Other medications and Atorvastatina Normogen

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

There are some medications that may affect the proper functioning of atorvastatin or the effects of these medications may be modified by atorvastatin. This type of interaction may reduce the effect of one or both medications. Alternatively, this concomitant use may increase the risk or severity of adverse effects, including the important muscle deterioration, known as rhabdomyolysis described in section 4:

• Medications used to modify the functioning of your immune system, for example, cyclosporine.
• Certain antibiotics or antifungal medications, for example, erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid.
• Other medications to regulate lipid levels, for example, gemfibrozil, other fibrates, cholestyramine.
• Some calcium channel blockers used in the treatment of angina or hypertension, for example, amlodipine, diltiazem; medications to regulate your heart rhythm, for example, digoxin, verapamil, amiodarone.
• Letermovir, a medication that helps prevent diseases caused by cytomegalovirus.
• Medications used in the treatment of HIV/AIDS, for example, ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir combined with ritonavir, etc.
• Some medications used in the treatment of hepatitis C, such as telaprevir, boceprevir, and the combination of elbasvir/grazoprevir, ledipasvir/sofosbuvir.
• Other medications that are known to interact with atorvastatin include ezetimibe (which reduces cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant for treating epilepsy), cimetidine (used for heartburn and peptic ulcers), phenazone (a pain reliever), colchicine (used for treating gout) and antacids (products for indigestion containing aluminum or magnesium).
• Over-the-counter medications: St. John's Wort.
• If you need to take oral fusidic acid to treat a bacterial infection, you will need to temporarily stop taking this medication. Your doctor will instruct you when it is safe to restart treatment with this medication. Taking atorvastatin in combination with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.
• Daptomycin (a medication used to treat skin and soft tissue infections and bacteria present in the blood).

Taking Atorvastatina Normogen with food, drinks, and alcohol

See section 3 for instructions on how to take this medication.. 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 this medication..

Alcohol

Avoid drinking large amounts of alcohol while taking this medication. See details in section 2 “Warnings and precautions”.

Pregnancy, breastfeeding, and fertility

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

Do not take atorvastatin if you are fertile unless you take adequate contraceptive measures.

Do not take this medication if you are breastfeeding your child.

The safety of atorvastatin during pregnancy and breastfeeding has not been demonstrated.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

Normally, this medication does not affect your ability to drive or operate machinery. However, do not drive if this medication affects your ability to drive. Do not operate tools or machinery if this medication affects your ability to handle them.

Atorvastatina Normogen contains lactose

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with him before taking this medication.

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again..

Before starting treatment, your doctor will put you on a low-cholesterol diet, which you must also follow during treatment with this medication.

The usual initial dose of atorvastatin is 10 mg once a day in adults and children aged 10 years and older. Your doctor may increase it if necessary to reach the dose you need. Your doctor will adjust the dose at intervals of 4 weeks or more. The maximum dose of atorvastatin is 80 mg once a day.

The tablets of this medication should be swallowed whole with a glass of water and can be taken at any time of the day with or without food. However, try to take your tablet every day at the same time.

Your doctor will decide the duration of treatment withAtorvastatina Normogen

Ask your doctor if you think the effect ofthis medicationis too strong or too weak.

If you take more Atorvastatina Normogen than you should

If you accidentally take too many tablets ofatorvastatin(more than your usual daily dose),consult with your doctor or the nearest hospital or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken. Bring the remaining tablets, the packaging, and the complete box so that the hospital staff can easily identify the medication you have taken.

If you forget to take Atorvastatina Normogen

If you forget to take a dose, take the next scheduled dose at the correct time. Do not take a double dose to make up for the missed doses.

If you interrupt treatment with Atorvastatina Normogen

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If you notice any of the following side effects or severe symptoms, stop taking these tablets and inform your doctor immediately or visit the nearest hospital emergency service.

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

• Severe allergic reaction causing swelling of the face, tongue, and throat that may cause severe difficulty breathing.
• Severe disease with severe peeling and inflammation of the skin; blisters on the skin, mouth, genitals, and eyes, and fever. Skin rash with pink-red spots, especially on the palms of the hands or soles of the feet that may form blisters.
• Muscle weakness, pain on palpation, pain, urine discoloration, or brownish-red color, and especially if you have discomfort or high fever, it may be due to abnormal muscle rupture (rhabdomyolysis). Abnormal muscle rupture does not always disappear, even after stopping atorvastatin, and may be fatal and cause kidney problems.

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

• If you experience unexpected or unusual bleeding or bruising, this may suggest liver problems. You should consult your doctor as soon as possible.
• Lupus-like syndrome (including rash, joint disorders, and effects on blood cells).

Other possible side effects with Atorvastatina Normogen

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

• Swelling of the nasal passages, sore throat, nasal bleeding.
• Allergic reactions.
• Increases in blood sugar levels (if you are diabetic, monitor your blood sugar levels), increased creatine kinase in the blood.
• Headache.
• Nausea, constipation, gas, indigestion, diarrhea.
• Joint pain, muscle pain, and back pain.
• Abnormal blood test results that may show abnormal liver function.

Occasional (may affect up to 1 in 100 people):

• Anorexia (loss of appetite), weight gain, decreased blood sugar levels (if you are diabetic, continue to closely monitor your blood sugar levels).
• Nightmares, insomnia.
• Dizziness, numbness or tingling in the fingers of the hands and feet, reduced sensitivity to pain or touch, changes in taste, memory loss.
• Blurred vision.
• Tinnitus in the ears and/or head.
• Vomiting, belching, upper and lower abdominal pain, pancreatitis (inflammation of the pancreas that causes stomach pain).
• Hepatitis (inflammation of the liver).
• Rash, skin rash, and itching, hives, hair loss.
• Neck pain, muscle fatigue.
• Fatigue, feeling unwell, weakness, chest pain, inflammation, especially in the ankles (edema), increased temperature.
• Positive urine tests for white blood cells.

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

• Visual disturbances.
• Unexpected or unusual bleeding or bruising.
• Jaundice (yellowing of the skin and eyes).
• Tendon damage.
• Skin rash or ulcers in the mouth (drug-induced lichenoid reaction).
• Skin lesions of purple color (signs of inflammation of blood vessels, vasculitis).

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

• Allergic reaction - symptoms may include sudden hissing while breathing and chest pain or pressure, swelling of the eyelids, face, lips, mouth, tongue, or throat, difficulty breathing, collapse.
• Loss of hearing.
• Gynecomastia (breast enlargement in men).

Frequency not known: cannot be estimated from available data:

• Constant muscle weakness.
• Myasthenia gravis (a disease that causes generalized muscle weakness that, 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 the arms or legs that worsens after periods of activity, double vision or eyelid drooping, difficulty swallowing or difficulty breathing.

Possible side effects of some statins (medicines of the same type):

• Sexual difficulties.
• Depression.
• Respiratory problems such as persistent cough and/or difficulty breathing or fever.
• Diabetes: It is more likely if you have high blood sugar and fat levels, obesity, and high blood pressure. Your doctor will monitor you while taking this medication.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, 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 blister pack and on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conservation conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Atorvastatina Normogen

The active ingredient is atorvastatina.

Each film-coated tablet contains 10 mg of atorvastatina (as atorvastatina calcium trihydrate).

The other components are: Calcium carbonate, microcrystalline cellulose, lactose monohydrate, polisorbate 80, hydroxypropylcellulose, sodium croscarmellose, and magnesium stearate.

The tablet coating contains: Opadry II White OYL-28900 (containing lactose monohydrate, hypromellose, titanium dioxide, and macrogol) and talc.

Appearance of the product and contents of the packaging

Atorvastatina Normogen 10 mg film-coated tablets are white or almost white, elliptical, and biconvex, with a breaking bar and marked with “AT10” on one face and smooth on the other, with a diameter of 8.2 x 4.7 mm ± 10%.

Atorvastatina Normogen 10 mg is presented in a box with blisters containing 28 film-coated tablets and in a clinical pack containing 500 film-coated tablets.

Atorvastatina Normogen 10 mg is also presented in a bottle containing 28 film-coated tablets.

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON, S.A.

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

Last review date of this leaflet: September 2024

Other sources of information

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

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/86796/P_86796.html