Atorvastatin Vir Pharma 20 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

AtorvastatinaVir Pharma 20 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, 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, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

1. What AtorvastatinaVir Pharma is and what it is used for
2. What you need to know before taking AtorvastatinaVir Pharma
3. How to take AtorvastatinaVir Pharma
4. Possible side effects
5. How to store AtorvastatinaVir 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 low-cholesterol diet should be followed during treatment.

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

Do not take Atorvastatine Vir Pharma

• If you are allergic to atorvastatin or 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 taking the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Atorvastatine 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 Atorvastatine may cause serious muscle problems (rhabdomyolysis).
• if you have previously had a stroke with bleeding in the brain, or have small fluid-filled pockets in the brain due to prior strokes
• if you have kidney problems
• if you have an underactive thyroid gland (hypothyroidism)
• if you have repeated or unexplained muscle pain, or personal or family history of muscle disorders
• if you have previously experienced muscle problems during treatment 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 condition 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 old.

In any of these cases, your doctor may advise you to have blood tests before and possibly during treatment with Atorvastatine Vir Pharma to assess the risk of muscle-related adverse effects. It is known that the risk of muscle-related adverse effects (e.g., rhabdomyolysis) increases when certain medicines are taken concomitantly (see section 2 “Use of Atorvastatine 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 Atorvastatine 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 Atorvastatine Vir Pharma, or their effects may be altered by Atorvastatine Vir Pharma. Such interactions may reduce the effectiveness of one or both medicines. Alternatively, combining them may increase the risk or severity of adverse effects, including the 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 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 rhythm, for example, digoxin, verapamil, amiodarone.

• Letermovir, a medicine that helps prevent diseases caused by cytomegalovirus.

• Medicines used in the treatment of 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 Atorvastatine 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 (a painkiller), 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 must temporarily stop taking this medicine. Your doctor will advise you when it is safe to restart treatment with Atorvastatine Vir Pharma. Taking Atorvastatine 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 medicine used to treat skin and skin structure infections with complications and bacteria in the blood).

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

Taking Atorvastatine Vir Pharma with food, drinks, and alcohol

See section 3 for instructions on how to take Atorvastatine 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 Atorvastatine 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 Atorvastatine Vir Pharma if you are pregnant, think you may be pregnant, or are trying to become pregnant.

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

Do not take Atorvastatine Vir Pharma if you are breastfeeding.

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

Consult your doctor or pharmacist before using any medicine.

Driving and use of machines

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

Atorvastatine 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 cholesterol-lowering diet, which you must continue to 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. If in doubt, consult your doctor or pharmacist again.

Your doctor will decide the duration of treatment with atorvastatin

Ask your doctor if you think 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. Take any remaining tablets, the carton, and the complete packaging so that hospital staff can easily identify the medication you have taken.

If you forget to take Atorvastatin Vir Pharma 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 Pharma If you have any further questions about using this medicine or wish to discontinue treatment, ask 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, blisters in the 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, muscle rupture, or red-brown discoloration of the urine, particularly if accompanied by malaise or high fever—this may be due to abnormal muscle breakdown (rhabdomyolysis). Abnormal muscle breakdown does not always resolve, even after stopping atorvastatin, and can be fatal and lead to 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 closely), increased blood creatine kinase
• Headache
• Nausea, constipation, gas, indigestion, diarrhea
• Joint pain, muscle pain, and back pain
• Blood test results that may indicate 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 the 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:

• Vision 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, swelling of the eyelids, face, lips, mouth, tongue, or throat, difficulty breathing, collapse
• Hearing loss
• Gynecomastia (enlargement of the breasts 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. The risk is higher if you have high levels of blood sugar and fats, 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. Storage 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 outer packaging following EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at a SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. 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 20 mg of atorvastatin (as atorvastatin calcium).

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

The coating of Atorvastatina Vir 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 Atorvastatina Vir Pharma 20 mg are elliptical, concave, and white in colour.

Atorvastatina Vir Pharma 20 mg is available in cartons with blisters containing 28 film-coated tablets and in clinical packs containing 500 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 review 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/