ATORVASTATIN VIR 40 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Atorvastatin Vir 40 mg Film-Coated Tablets EFG

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

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

Contents of the pack

1. What is Atorvastatin Vir and what is it used for
2. What you need to know before you take Atorvastatin Vir
3. How to take Atorvastatin Vir
4. Possible side effects
5. Storing Atorvastatin Vir
6. Contents of the pack and other information

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

Atorvastatin Vir belongs to a group of medicines known as statins, which are medicines 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 on their own have not worked. 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 you take Atorvastatin Vir

Do not take Atorvastatin Vir

• If you are allergic to atorvastatin or to any other similar medicine used to lower blood lipids or to any of the other ingredients of this medicine (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 are not using adequate contraceptive measures.
• If you are pregnant or trying to become pregnant.
• If you are breast-feeding.
• If you are using 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:

• if you have had a previous stroke with bleeding in the brain, or have small fluid-filled sacs in the brain due to previous strokes.
• if you have kidney problems.
• if you have an underactive thyroid gland (hypothyroidism).
• if you have repeated or unexplained muscle pain, personal or family history of muscle problems.
• if you have previously had muscle problems during treatment with other medicines to lower lipids (e.g. with another statin or fibrates).
• if you have or have had myasthenia (a disease that causes generalized muscle weakness that can affect the muscles used for breathing) or ocular myasthenia (a disease that causes weakness of the eye muscles), as statins can sometimes worsen the disease or cause myasthenia to appear (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.

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

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

• have severe respiratory failure.

• if you are taking or have taken in the last 7 days a medicine that contains fusidic acid (used to treat bacterial infections) orally or by injection. The combination of fusidic acid and atorvastatin can cause serious muscle problems (rhabdomyolysis).

While you are 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.

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 medicines are taken at the same time (see section 2 "Using other medicines").

Using Atorvastatin Vir with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

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

• Medicines used to modify the functioning of your immune system, for example, cyclosporin.
• Certain antibiotics or antifungal medicines, for example, erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid. If you have to take oral fusidic acid to treat a bacterial infection, you will have to stop using this medicine. 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 medicines to regulate lipid levels, for example, gemfibrozil, other fibrates, colestipol.
• Certain calcium channel blockers used to treat angina or high blood pressure, for example, amlodipine, diltiazem; medicines to regulate your heart rate, for example, digoxin, verapamil, amiodarone.

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

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

• Medicines obtained without a prescription: St. John's Wort.
• Daptomycin (a medicine 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 too much alcohol while taking this medicine. See the details in Section 2 "Be careful with Atorvastatin Vir".

Pregnancy, breast-feeding, and fertility

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

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

Do not take Atorvastatin Vir if you are breast-feeding your child.

The safety of Atorvastatin Vir during pregnancy and breast-feeding has not been established.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

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

Atorvastatin Vir contains lactose and sucrose

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

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

3. How to take Atorvastatin Vir

Follow exactly the administration instructions of this medicine indicated by your doctor. 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 should also follow during treatment with Atorvastatin Vir.

The initial dose of Atorvastatin Vir is 10 mg once a day in adults and children from 10 years of age. 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 tablets of Atorvastatin Vir 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 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 medicine 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 forgotten doses.

If you stop treatment with Atorvastatin Vir

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

4. Possible side effects

Like all medicines, Atorvastatin Vir can cause side effects, although not everybody 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 every 10,000 patients:

• Severe allergic reaction that causes swelling of the face, tongue, and throat, which can cause great difficulty in 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 brown and especially if you have discomfort or have a high fever, it 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 inflammation of the blood vessels, vasculitis).

Very rare: may affect less than 1 in every 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 every 100 patients) include:

• nasal inflammation, sore throat, nosebleeds.
• allergic reactions.
• increases in blood sugar levels (if you are diabetic, monitor your blood sugar levels), increase in 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 every 1,000 patients) include:

• loss of appetite, weight gain, decrease in 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.
• 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 every 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 every 10,000 patients) include:

• allergic reaction - symptoms can include sudden wheezing and pain or tightness in the chest, 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 that can affect 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 (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.

Serious side effects.

Lupus-like syndrome (including skin rash, joint disorders, and effects on blood cells). Diabetes. It is more likely if you have high levels of sugar and fat in the blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine.

Reporting side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects that 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 medicine.

5. Storing Atorvastatin Vir

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

Do not use Atorvastatin Vir after the expiration date that appears on the blister pack and on the carton after EXP. The expiration date is the last day of the month indicated.

Store in the original packaging.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. 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 available 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 Prospectus: 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/