Package Insert: Information for the User

AtorvastatinaVir Pharma 10 mg Film-Coated Tablets

Read this package insert carefully before starting to take this medicine because it contains important information for you.

• Keep this package insert, as you may need to read it again.
  If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed only for you, and you should not give it to others, 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 package insert. See section 4.

1. What is Atorvastatina Vir Pharma and what it is used for

2. What you need to know before starting to take Atorvastatina Vir Pharma

3. How to take Atorvastatina Vir Pharma

4. Possible adverse effects

5. Storage of Atorvastatina Vir Pharma

6. Contents of the pack and additional information

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

Atorvastatina 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 have a high risk of heart disease, atorvastatina 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 Vir Pharma

• 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 using the combination of glecaprevir/pibrentasvir for hepatitis C treatment.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Atorvastatina Vir Pharma:

• If you have severe respiratory insufficiency.
• If you are taking or have taken within the last 7 days a medication called fusidic acid (a medication used to treat bacterial infections) orally or by injection. The combination of fusidic acid and Atorvastatina may cause severe muscle problems (rhabdomyolysis).
• if you have had a previous stroke with cerebral bleeding, or have small fluid embolisms in the brain due to previous strokes
• If you have kidney problems.
• If you have hypothyroidism (a thyroid gland with low activity).
• 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 lipid-lowering medications (e.g., 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 ocular myasthenia (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 Atorvastatina Vir Pharma 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 Vir Pharma 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 you are taking this medication, your doctor will monitor if you have diabetes or are at risk of developing diabetes. This risk of diabetes increases if you have high blood sugar and fat levels, obesity, and high blood pressure.

Use of Atorvastatina Vir Pharma with other medications

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 Atorvastatina Vir Pharma or the effects of these medications may be modified by Atorvastatina Vir Pharma. This type of interaction may reduce the effect of one or both medications. Alternatively, this combined 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 AIDS, for example, ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir combined with ritonavir, etc.
• Some medications used to treat hepatitis C, such as telaprevir, boceprevir, and the combination of elbasvir/grazoprevir.
• Other medications that are known to interact with Atorvastatina Vir Pharma, including ezetimibe (which reduces cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant for epilepsy), cimetidine (used for heartburn and peptic ulcers), phenazone (a pain reliever), colchicine (used for gout treatment) 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 Atorvastatina Vir Pharma. Taking Atorvastatina Vir Pharma 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).

Inform your doctor or pharmacist if you are using or may need to use any other medication.

Taking Atorvastatina Vir Pharma with food, drinks, and alcohol

See Section 3 for instructions on how to take Atorvastatina Vir Pharma. 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 Atorvastatina Vir Pharma.

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 Atorvastatina Vir Pharma if you are pregnant, think you may be pregnant, or are trying to become pregnant.

Do not take Atorvastatina Vir Pharma if you are fertile and do not use adequate contraceptive measures.

Do not take Atorvastatina Vir Pharma if you are breastfeeding your child.

The safety of Atorvastatina Vir Pharma 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 Vir Pharma contains sodium

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

Before starting treatment, your doctor will put you on a low-cholesterol diet, which you should also follow during atorvastatina treatment.

The usual initial dose of atorvastatina 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 atorvastatina is 80 mg once a day.

Atorvastatina tablets 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.

Follow exactly the administration instructions for this medication indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Your doctor will decide the duration of treatment with atorvastatina.

Ask your doctor if you think the effect of atorvastatina is too strong or too weak.

If you take more Atorvastatina Vir Pharma than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested. Bring the remaining tablets, the packaging, and the complete box so that hospital staff can easily identify the medication taken.

If you forgot to take Atorvastatina Vir Pharma

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

If you interrupt treatment with Atorvastatina Vir Pharma

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 that causes swelling of the face, tongue, and throat, which can make breathing difficult.

• 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 can 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 breakdown (rhabdomyolysis). Abnormal muscle breakdown may not always disappear, even after stopping atorvastatin and can be fatal and cause kidney problems.

• Skin rash or mouth ulcers (drug-induced lichenoid reaction)
• Purple skin lesions (signs of blood vessel inflammation, vasculitis)

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.
• Syndrome similar to lupus (including rash, joint disorders, and effects on blood cells).

Other possible side effects of AtorvastatinVir Pharma:

Frequent may affect up to 1 in 10 people:

• Inflammation 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 liver function test results.

Infrequent: may affect up to 1 in 100 people:

• Loss of appetite, weight gain, decreased blood sugar levels (if you are diabetic, continue to monitor your blood sugar levels carefully)
• 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
• Ringing in the ears and/or head
• Vomiting, belching, upper and lower abdominal pain, pancreatitis (inflammation of the pancreas that causes stomach pain)
• Heptatitis (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 bleeding or bruising
• Colestasis (yellowing of the skin and white of the eyes)
• Tendon injury.

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

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

Frequency unknown: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).

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

• Sexual difficulties.
• Depression.
• Respiratory problems including 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 medicine.

Reporting 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 leaflet. 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.

Store below30°C.

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.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Atorvastatina Vir Pharma

- The active ingredient is atorvastatina.

Cada comprimido recubierto con película contains 10 mg of atorvastatina (as atorvastatina cálcica).

The other components (excipients) are: microcrystalline cellulose, anhydrous sodium carbonate, maltose, sodium croscarmellose, magnesium stearate.

The coating of Atorvastatina Vir Pharma contains hypromelosa, hydroxypropylcellulose, triethylcitrate, polysorbate 80, titanium dioxide (E-171).

Appearance of the product and content of the container

The film-coated tablets of Atorvastatina Vir Pharma 10 mg are elliptical, concave, and white.

Atorvastatina Vir Pharma 10 mg is presented in boxes with blisters containing 28 film-coated tablets and in clinical containers containing 500 film-coated tablets.

Only some sizes of containers may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.

C/Laguna 66-70. Polígono Industrial Urtinsa II

28923 Alcorcón (Madrid)

Spain

Responsible for manufacturing:

TEVA PHARMA, S.L.U.

C/ C nº 4 Polígono Industrial Malpica

50016 Zaragoza

Spain

Last review date of this leaflet:October 2024

The detailed information of this medicine is available on the webpage of the Spanish Agency of Medicaments and Health Products (AEMPS)http://www.aemps.gob.es/