Atorvastatin Vir Pharma 80 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Atorvastatina Vir Pharma 80 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 as you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could be harmful to them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of this leaflet:

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

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

Atorvastatin belongs to a group of medicines known as statins, which are lipid-regulating (fat-regulating) medicines.

Atorvastatin is used to reduce lipids such as cholesterol and triglycerides in the blood when a low-fat diet and lifestyle changes alone have failed. If you are at high risk of heart disease, atorvastatin may also be used to reduce this risk, even if your cholesterol levels are normal. A standard cholesterol-lowering diet should be followed during treatment.

2. What you need to know before taking Atorvastatina Vir Pharma

Do not take Atorvastatina Vir Pharma

• If you are allergic to atorvastatin 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 liver function blood tests.
• 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 breastfeeding.
• If you are using the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C.

Warnings and precautions

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

• If you have severe respiratory failure.
• If you are taking or have taken within the last 7 days an oral or injectable medicine called fusidic acid (a medicine used to treat bacterial infections). The combination of fusidic acid and Atorvastatina may cause serious muscle problems (rhabdomyolysis).
• If you have previously had a stroke with bleeding in the brain, or have small accumulations of fluid in the brain due to previous strokes.
• If you have kidney problems.
• If you have an underactive thyroid gland (hypothyroidism).
• If you have had repeated or unexplained muscle pain, or personal or family history of muscle disorders.
• If you have previously experienced muscle problems while being treated with other lipid-lowering medicines (e.g., with another statin or fibrates).
• If you have or have had myasthenia (a disease causing generalized muscle weakness which, in some cases, affects the muscles used for breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), as statins may sometimes worsen the condition or trigger the onset of 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 of age.

In any of these cases, your doctor may recommend blood tests before and possibly during treatment with Atorvastatina Vir Pharma to assess the risk of muscle-related adverse effects. The risk of muscle-related adverse effects (e.g., rhabdomyolysis) is known to increase when certain medicines are taken concomitantly (see section 2 “Use of Atorvastatina Vir Pharma with other medicines”).

Also inform your doctor or pharmacist if you experience persistent muscle weakness. Additional tests and treatments may be needed to diagnose and manage this condition.

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

Use of Atorvastatina Vir Pharma with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Some medicines may interfere with the proper functioning of Atorvastatina Vir Pharma or the effects of these medicines may be altered by Atorvastatina Vir Pharma. Such interactions may reduce the effectiveness of one or both medicines. Alternatively, concomitant use may increase the risk or severity of adverse effects, including serious muscle damage known as rhabdomyolysis described in section 4:

• Medicines used to modify the function of your immune system, for example, cyclosporine.
• Certain antibiotics or antifungal medicines, for example, erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid.
• Other medicines used 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 used to regulate your heart rhythm, for example, digoxin, verapamil, amiodarone.
• Letermovir, a medicine used to prevent cytomegalovirus infections.
• Medicines used in the treatment of HIV/AIDS, for example, ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir combined with ritonavir, etc.
• Some medicines used for the treatment of hepatitis C, such as telaprevir, boceprevir, and the combination of elbasvir/grazoprevir.
• Other medicines known to interact with Atorvastatina Vir Pharma include ezetimibe (which lowers cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant used to treat epilepsy), cimetidine (used for heartburn and peptic ulcer), phenazone (an analgesic), colchicine (used to treat gout), and antacids (indigestion remedies containing aluminium or magnesium).
• Over-the-counter medicines: 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 medicine. Your doctor will advise you when it is safe to restart treatment with Atorvastatina Vir Pharma. Taking Atorvastatina Vir Pharma together with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.
• Daptomycin (a medicine used to treat complicated skin and skin structure infections and bloodstream infections caused by bacteria).

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

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:

Grapefruit juice

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

Alcohol

Avoid drinking large amounts of alcohol while taking this medicine. 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 of childbearing age unless you are using adequate contraceptive measures.

Do not take Atorvastatina Vir Pharma if you are breastfeeding.

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

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

This medicine usually does not affect your ability to drive or operate machinery. However, do not drive if this medicine impairs your ability to do so. Do not operate tools or machines if this medicine affects your ability to handle them safely.

Atorvastatina Vir Pharma contains sodium

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

3. How to take Atorvastatin Vir Pharma

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

The usual starting dose of atorvastatin is 10 mg once daily in adults and children aged 10 years and older. Your doctor may increase this dose if necessary to reach the dose appropriate for you. Your doctor will adjust the dose at intervals of 4 weeks or more. The maximum dose of atorvastatin is 80 mg once daily.

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

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Your doctor will decide the duration of treatment with atorvastatin

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

If you take more Atorvastatin Vir Pharma than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount ingested. Bring any remaining tablets, as well as the outer carton and full packaging, so that hospital staff can easily identify the medicine you have taken.

If you forget to take Atorvastatin Vir Pharma

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

If you interrupt treatment with Atorvastatin Vir Pharma

If you have any further questions about using this medicine or wish to discontinue treatment, consult your doctor or pharmacist.

4. Possible adverse effects

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

If you notice any of the following adverse effects or serious symptoms, stop taking these tablets immediately and contact your doctor or go to the nearest hospital emergency department straight away.

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

• Severe allergic reaction causing swelling of the face, tongue, and throat, which may cause severe difficulty breathing.

• Serious illness with severe skin peeling and inflammation; skin blisters, mouth, genitals, and eyes, and fever. Skin rash with pink-red spots, especially on the palms of the hands or soles of the feet, which may develop into blisters.

• Muscle weakness, tenderness, pain, rupture, or brownish-red discoloration of the urine, and especially if accompanied by malaise or high fever, may be due to abnormal muscle breakdown (rhabdomyolysis). Abnormal muscle breakdown does not always resolve, even after stopping atorvastatin, and may 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 up to 1 in 10,000 people:

• If you experience problems with unexpected or unusual bleeding or bruising, this may indicate 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 adverse effects with AtorvastatinaVir Pharma:

Common: may affect up to 1 in 10 people:

• Nasal inflammation, sore throat, nosebleeds
• Allergic reactions
• Increased 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
• Blood test results that may show abnormal liver function.

Uncommon: may affect up to 1 in 100 people:

• Anorexia (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 fingers and toes, reduced sensitivity to pain or touch, changes in taste sensation, memory loss
• Blurred vision
• Ringing in the ears and/or head
• Vomiting, belching, upper and lower abdominal pain, pancreatitis (inflammation of the pancreas causing 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, swelling, especially in the ankles (edema), increased body temperature
• Urine tests positive for white blood cells.

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

• Visual disturbances
• Unexpected bleeding or bruising
• Cholestasis (yellowing of the skin and whites of the eyes)
• Tendon injury.

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

• Allergic reaction – symptoms may include sudden wheezing and chest pain or tightness, eyelid swelling, facial swelling, lip, mouth, tongue or throat swelling, difficulty breathing, collapse
• Hearing loss
• Gynaecomastia (breast enlargement in men and women).

Frequency not known: cannot be estimated from available data:

• Persistent muscle weakness.
• Myasthenia gravis (a disease causing generalized muscle weakness, which in some cases affects the muscles used for breathing).
• Ocular myasthenia (a disease causing weakness of the eye muscles).

Possible adverse effects reported with some statins (medicines of the same type):

• Sexual difficulties.
• Depression.
• Respiratory problems including persistent cough and/or difficulty breathing or fever.
• Diabetes. This is more likely if you have high levels of sugar and fats in the blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Conservation of Atorvastatin Vir Pharma

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

Store below 30°C.

Do not use this medicine after the expiry date stated on the blister and on the outer packaging following EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be returned to the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of AtorvastatinaVir Pharma

• The active substance is atorvastatin.

Each film-coated tablet contains 80 mg of atorvastatin (as atorvastatin calcium).

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

The coating of AtorvastatinaVir Pharma contains hypromellose, hydroxypropylcellulose, triethyl citrate, polysorbate 80, titanium dioxide (E-171).

Appearance of the product and contents of the pack

The film-coated tablets of AtorvastatinaVir Pharma 80 mg are elliptical, concave, and white in color.

AtorvastatinaVir Pharma 80 mg is available in boxes with blisters containing 28 film-coated tablets and in clinical packs containing 500 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.

C/Laguna 66-70. Polígono Industrial Urtinsa II

28923 Alcorcón (Madrid)

Spain

Manufacturer:

TEVA PHARMA, S.L.U.

C/ C nº 4 Polígono Industrial Malpica

50016 Zaragoza

Spain

Date of the most recent revision of this leaflet: October 2024

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