Patient Information Leaflet: Product Information

Atorvastatina Vir 80 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 or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet.

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

2. What you need to know before taking Atorvastatina Vir

3. How to take Atorvastatina Vir

4. Possible side effects

5. Storage of Atorvastatina Vir

6. Contents of the pack and additional information

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

Atorvastatina Vir 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, Atorvastatina Vir may also be

used to reduce this risk even though your cholesterol levels are normal. During treatment, a standard low-cholesterol diet must be followed.

Do not take Atorvastatina Vir

-If you are allergic to atorvastatin or to any other medication used to reduce blood lipids or to any of the other components 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 the treatment of hepatitis C.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Atorvastatina Vir.

For the following reasons, Atorvastatina Vir may not be suitable for you:

-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 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.

Also inform your doctor or pharmacist if you experience persistent muscle weakness. You may need further tests and additional medications to diagnose and treat the problem.

Consult your doctor or pharmacist before taking Atorvastatina Vir if you:

• Present severe respiratory insufficiency

• If you are taking or have taken within the last 7 days a medication containing fusidic acid (used to treat bacterial infections) by mouth or injection. The combination of fusidic acid and atorvastatin may cause severe muscle problems (rhabdomyolysis).

While you are taking this medication, your doctor will monitor whether you have diabetes or are at risk of developing diabetes. This risk of diabetes increases if you have high levels of sugar and fats in your blood, obesity, and high blood pressure.

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

Use of Atorvastatina Vir 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 or the effects of these medications may be modified by Atorvastatina Vir. This type of interaction may reduce the effect of one or both medications. Alternatively, this concurrent use may increase the risk or severity of side 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 ciclosporin

−Certain antibiotics or antifungal medications, for example, erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid. If you need to take oral fusidic acid to treat a bacterial infection, you will need to stop taking this medication. Your doctor will instruct you when you can restart the treatment with atorvastatin. The use of atorvastatin with fusidic acid may cause muscle weakness, sensitivity, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

−Other medications to regulate lipid levels, for example, gemfibrozil, other fibrates, colestipol.

−Some calcium channel blockers used in the treatment of angina or high blood pressure, for example, amlodipine, diltiazem; medications to regulate your heart rhythm, for example, digoxin, verapamil, amiodarone

−Some medications used to treat hepatitis C, such as telaprevir, boceprevir, and the combination of elbasvir/grazoprevir.

−Medications used in the treatment of AIDS, for example, ritonavir, lopinavir, atazanavir, indinavir, darunavir, etc.

−Other medications that are known to interact with Atorvastatina Vir, including ezetimiba (which reduces cholesterol), warfarin (which reduces blood coagulation), oral contraceptives, estiripentol (anticonvulsant for treating epilepsy), cimetidine (used for heartburn and peptic ulcers), phenazone (an analgesic), and antacids (products for indigestion containing aluminum or magnesium)

−Over-the-counter medications: St. John's Wort

• Daptomycin (a medication used to treat skin and skin structure infections and bacteremia).

Take Atorvastatina Vir with food, drinks, and alcohol

See section 3 for instructions on how to take Atorvastatina Vir. 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.

Alcohol

Avoid drinking large amounts of alcohol while taking this medication. See details in Section 2 “Be careful with Atorvastatina Vir”.

Pregnancy, breastfeeding, and fertility

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

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

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

Atorvastatina Vir has not been shown to be safe during pregnancy and breastfeeding.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

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 contains lactose and saccharose

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication contains saccharose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubts, 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 Atorvastatina Vir.

The initial normal dose of Atorvastatina Vir is 10 mg once a day in adults and children from 10 years old. 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 Vir is 80 mg once a day for adults and 20 mg once a day for children.

Atorvastatina Vir 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.

Your doctor will decide the duration of treatment with Atorvastatina Vir

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

If you take more Atorvastatina Vir than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Atorvastatina Vir

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

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, Atorvastatina Vir can cause side effects, although not everyone will experience them.

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

Rare: may affect between 1 and 10 in 10,000 patients:

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

−Severe skin disease with severe peeling and inflammation; blisters on the skin, mouth, genitals, and eyes, and fever. Erythema with pink-red patches, especially on the palms of the hands or soles of the feet that can form blisters.

−Muscle weakness, pain on palpation or muscle pain or muscle rupture or change in urine color to brown andespecially, if at the same time you have discomfort or have high fever, it may be due to an abnormal muscle rupture that can be fatal and cause kidney problems.

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

Very rare: may affect fewer than 1 in 10,000 patients:

−If you experience unexpected or unusual bleeding or bruising, this may suggest a liver problem. 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 Atorvastatina Vir:

Frequent side effects (may affect between 1 and 10 in 100 patients) include:

•Nasal congestion, sore throat, nosebleeds

•Allergic reactions

•Increases in blood sugar levels (if you are diabetic, monitor your blood sugar levels), increased creatine kinase in blood

•Headache

•Nausea, constipation, gas, indigestion, diarrhea

•Joint pain, muscle pain, and back pain

•Abnormal blood test results that may show liver dysfunction

Less frequent side effects (may affect between 1 and 10 in 1,000 patients) include:

•Loss of appetite, weight gain, decreased blood sugar levels (if you are diabetic, continue to monitor your blood sugar levels carefully)

•Insomnia, nightmares

•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 side effects (may affect between 1 and 10 in 10,000 patients) include:

•Visual disturbances

•Unexpected bleeding or bruising

•Bile duct obstruction (yellowing of the skin and eyes)

•Tendon damage

Very rare side effects (may affect fewer than 1 in 10,000 patients) include:

•Allergic reaction - symptoms may include sudden hissing sounds when breathing and chest pain or pressure, swelling of the eyelids, face, lips, mouth, tongue, or throat, difficulty breathing, collapse

•Loss of hearing

•Gynecomastia (enlargement of the breasts in men and women).

Unknown frequency:

• Muscle weakness.
• Severe myasthenia (a disease that causes generalized muscle weakness, which in some cases affects the muscles used for breathing).
• Myasthenia gravis (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 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

Possible side effects

•Sleep disorders, including insomnia and nightmares

•Memory loss

•Sexual dysfunction

•Depression

•Respiratory problems including persistent cough and/or difficulty breathing or fever.

Severe side effects

Lupus-like disease (including skin rash, joint disorders, and effects on blood cells).

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, pharmacist, or nurse, even if it is a possible side effect that does not appearin thisprospect.You can alsocomunicarlosdirectamentea travésdel SistemaEspañoldeFarmacovigilancia de Medicamentos deUsoHumano:www.notificaram.es.Mediantelacomunicación deefectos adversosusted puedecontribuiraproporcionar másinformaciónesobrela seguridad de estemedicamento.

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

Do not use Atorvastatina Vir after the expiration date that appears on theblister andon the packaging after CAD. The expiration date is the last day of the month indicated.

Store in the original packaging.

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 point of 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

- The active ingredient is atorvastatina.

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

The other components (excipients) are:

• Lactose monohydrate
• Magnesium stearate
• Laurilsulfate of sodium
• Microcrystalline cellulose (E-460)
• Anhydrous colloidal silica
• Butilhydroxyanisole (E-320)
• Crospovidone
• Sodium hydrogen carbonate
• Saccharose
• Triesterate of sorbitan (E-436)
• Macrogol 40 stearate
• Dimethicone
• 2, Bromo-2-Nitropropano-1,3-diol
• Hypromellose (E-464)
• Titanium dioxide (E-171)
• Macrogol 4000.

The coating of Atorvastatina Vir contains:

• Lactose monohydrate
• Hypromellose (E-464)
• Titanium dioxide (E-171)
• Macrogol 4000

Appearance of the product and contents of the package

Atorvastatina Vir 10 mg tablets are film-coated, cylindrical, biconvex, scored, and frangible tablets, white in color.

Atorvastatina Vir 10 mg is presented in packs containing 28 film-coated tablets.

Marketing Authorization Holder:

Industria Quimica Y Farmaceutica Vir, S.A.

Laguna, 66-68-70. Poligono Industrial Urtinsa II

28923- Alcorcón (Madrid) España

Responsible for manufacturing:

INDUSTRIA QUIMICA Y FARMACEUTICA VIR, S.A. Laguna, 66-68-70. Poligono Industrial Urtinsa II

Alcorcón (Madrid) 28923 España

Last review date of this leaflet: October 2024

The detailed and updated information of this medicine is available on the webpage of the

Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/