ATORVASTATIN VIR 80 mg FILM-COATED TABLETS

Introduction

Patient Information Leaflet

Atorvastatin Vir 80 mg film-coated tablets EFG

Read the entire leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.

Contents of the Leaflet

1. What is Atorvastatin Vir and what is it used for
2. What you need to know before taking Atorvastatin Vir
3. How to take Atorvastatin Vir
4. Possible side effects
5. Storage of Atorvastatin Vir
6. Package contents and additional information

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

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

Atorvastatin Vir is used to reduce lipids such as cholesterol and triglycerides in the blood when a low-fat diet and lifestyle changes have not worked on their own. If you are at high risk of heart disease, Atorvastatin Vir may also be used to reduce this risk even if your cholesterol levels are normal. During treatment, you should follow a standard low-cholesterol diet.

2. What you need to know before taking Atorvastatin Vir

Do not take Atorvastatin Vir

• If you are allergic to atorvastatin or any other similar 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 unexplained abnormal results in blood tests for liver function.
• If you are a woman of childbearing age and do not use adequate contraceptive measures.
• If you are pregnant or trying to become pregnant.
• If you are breastfeeding.
• If you use the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C.

Warnings and precautions

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

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

Tell your doctor or pharmacist if you experience constant muscle weakness. You may need additional tests and medications to diagnose and treat this problem.

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

• have severe respiratory failure.

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 your blood, are overweight, and have high blood pressure.

In any of these cases, your doctor may indicate that you should have blood tests before and possibly during treatment with Atorvastatin Vir to predict the risk of suffering from muscle-related side effects. It is known that the risk of suffering from 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 Atorvastatin Vir with other medications

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

There are some medications that can affect the proper functioning of Atorvastatin Vir or whose effects may be altered by Atorvastatin Vir. This type of interaction can decrease the effect of one or both medications. Alternatively, this combined use can increase the risk or severity of side effects, including serious muscle damage, known as rhabdomyolysis, described in Section 4:

• medications used to modify the functioning of your immune system, such as cyclosporine.
• certain antibiotics or antifungal medications, such as 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 using this medication. Your doctor will tell you when you can restart treatment with atorvastatin. The use of atorvastatin with fusidic acid can cause muscle weakness, sensitivity, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

• other medications for regulating lipid levels, such as gemfibrozil, other fibrates, colestipol.
• certain calcium channel blockers used to treat angina or high blood pressure, such as amlodipine, diltiazem; medications to regulate your heart rate, such as digoxin, verapamil, amiodarone.

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

• medications used to treat HIV, such as ritonavir, lopinavir, atazanavir, indinavir, darunavir, etc.
• other medications that are known to interact with Atorvastatin Vir include ezetimibe (which reduces cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant used to treat epilepsy), cimetidine (used for heartburn and peptic ulcers), phenazone (a pain reliever), and antacids (products for indigestion that contain aluminum or magnesium).

• over-the-counter medications: St. John's Wort.
• Daptomycin (a medication used to treat skin and skin structure infections with complications and bacteria present in the blood).

Taking Atorvastatin Vir with food, drinks, and alcohol

See section 3 for instructions on how to take Atorvastatin Vir. Please note the following:

Grapefruit juice

Do not drink more than one or two small glasses of grapefruit juice per day, as large quantities of grapefruit juice can alter the effects of Atorvastatin Vir.

Alcohol

Avoid drinking large amounts of alcohol while taking this medication. See the details in Section 2 "Be careful with Atorvastatin Vir".

Pregnancy, breastfeeding, and fertility

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

Do not take Atorvastatin Vir if you are of childbearing age unless you use adequate contraceptive measures.

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

The safety of Atorvastatin Vir during pregnancy and breastfeeding has not been established.

Consult your doctor or pharmacist before using any medication.

Driving and using machines

Do not drive if this medication affects your ability to drive. Do not operate tools or machines if this medication affects your ability to use them.

Atorvastatin Vir contains lactose and sucrose

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

3. How to take Atorvastatin Vir

Follow your doctor's instructions for taking this medication exactly. If you are unsure, consult your doctor or pharmacist again.

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

The usual initial dose of Atorvastatin Vir is 10 mg once a day in adults and children from 10 years old. Your doctor may increase it if necessary until you reach the dose you need. Your doctor will adjust the dose at intervals of 4 weeks or more. The maximum dose of Atorvastatin Vir is 80 mg once a day for adults and 20 mg once a day for children.

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

Your doctor will decide the duration of treatment with Atorvastatin Vir

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

If you take more Atorvastatin Vir 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.

If you forget to take Atorvastatin Vir

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 missed doses.

If you stop treatment with Atorvastatin Vir

If you have any other questions about using this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, Atorvastatin Vir can cause side effects, although not everyone gets them.

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

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 cause great difficulty breathing.

• Severe disease with severe scaling and inflammation of the skin; blisters on the skin, mouth, genitals, and eyes, and fever. Rash with pink-red spots, especially on the palms of the hands or soles of the feet, which can form blisters.

• Muscle weakness, pain on palpation, or muscle pain or change in urine color to reddish-brown, and especially if you also have discomfort or have a high fever, may be due to abnormal muscle breakdown, which can be fatal and cause kidney problems.
• Skin rash or mouth ulcers (drug-induced lichenoid reaction).
• Purple-colored skin lesions (signs of blood vessel inflammation, vasculitis).

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

• If you experience unexpected bleeding or bruising, this may suggest a liver problem. 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 Atorvastatin Vir:

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

• nasal congestion, sore throat, nosebleeds.
• allergic reactions.
• increased 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.
• blood test results that may show abnormal liver function.

Uncommon 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, you should continue to carefully 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.
• ringing 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).
• skin 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:

• vision changes.
• unexpected bleeding or bruising.
• jaundice (yellowing of the skin and whites of the eyes).
• tendon injury.

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

• allergic reaction - symptoms may include sudden wheezing and chest pain or tightness, swelling of the eyelids, face, lips, mouth, tongue, or throat, difficulty breathing, collapse.
• hearing loss.
• gynecomastia (breast enlargement in men and women).

Frequency not known:

• constant muscle weakness.
• severe myasthenia (a disease that causes generalized muscle weakness, which in some cases affects the muscles used for breathing).
• ocular myasthenia (a disease that causes weakness of the eye muscles).

Tell 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.

Possible side effects of some statins (medications 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 syndrome (including skin rash, joint disorders, and effects on blood cells).

Diabetes. This is more likely if you have high levels of sugar and fat in your blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medication.

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Atorvastatin Vir

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

Do not use Atorvastatin Vir after the expiration date shown on the blister pack and on the outer packaging after CAD. The expiration date is the last day of the month indicated.

Store in the original packaging.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Container Content and Additional Information

Composition of Atorvastatina Vir

• The active ingredient is atorvastatin.

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

The other components (excipients) are:

• Lactose monohydrate
• Magnesium stearate
• Sodium lauryl sulfate
• Microcrystalline cellulose (E-460)
• Anhydrous colloidal silica
• Butylhydroxyanisole (E-320)
• Crospovidone
• Sodium hydrogen carbonate
• Sucrose
• Sorbitan triester (E-436)
• Macrogol 40 stearate
• Dimethicone
• 2-Bromo-2-nitropropane-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 Container Content

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

Atorvastatina Vir 10 mg is presented in boxes 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) Spain

Manufacturer:

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

Alcorcón (Madrid) 28923 Spain

Date of the Last Revision of this Leaflet: October 2024

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