ATORVASTATIN VIR PHARMA 40 mg FILM-COATED TABLETS

2. What you need to know before you take Atorvastatin Vir Pharma

Do not take Atorvastatin 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 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 breast-feeding.
• 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 Atorvastatin Vir Pharma:

• If you have severe respiratory failure
• If you are taking or have taken in the last 7 days a medicine called fusidic acid (a medicine used to treat bacterial infections) orally or by injection. The combination of fusidic acid and Atorvastatin can cause serious muscle problems (rhabdomyolysis).

In any of these cases, your doctor may indicate that you should have blood tests before and possibly during treatment with Atorvastatin Vir Pharma to predict the risk of muscle-related side effects. It is known that the risk of muscle-related side effects (e.g. rhabdomyolysis) increases when certain medicines are taken at the same time (see section 2 "Using Atorvastatin Vir Pharma with other medicines").

Also, inform your doctor or pharmacist if you experience constant muscle weakness. Additional tests and medications may be necessary to diagnose and treat this problem.

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.

Using Atorvastatin Vir Pharma 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 Pharma or the effects of these medicines may be altered by Atorvastatin Vir Pharma. 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 serious 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.
• Other medicines for regulating 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.
• Certain medicines used to treat hepatitis C, such as telaprevir, boceprevir, and the combination of elbasvir/grazoprevir.
• Other medicines that are known to interact with Atorvastatin Vir Pharma include ezetimibe (which reduces cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant for treating epilepsy), cimetidine (used for heartburn and peptic ulcer), phenazone (a pain reliever), colchicine (used for gout), and antacids (products for indigestion that contain aluminum or magnesium).

• Medicines obtained without a prescription: St. John's Wort.
• If you need to take oral fusidic acid to treat a bacterial infection, you will have to stop using this medicine temporarily. Your doctor will tell you when it is safe to restart treatment with Atorvastatin Vir Pharma. Taking Atorvastatin Vir Pharma in combination with fusidic acid can rarely cause muscle weakness, pain on palpation, 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 present in the blood).

Tell your doctor or pharmacist if you are using or could be using any other medicine.

Taking Atorvastatin Vir Pharma with food, drinks, and alcohol

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

Grapefruit juice

Do not take more than one or two small glasses of grapefruit juice per day because large quantities of grapefruit juice can alter the effects of Atorvastatin Vir Pharma.

Alcohol

Avoid drinking too much alcohol while taking this medicine. See the details in Section 2 "Warnings and precautions".

Pregnancy, breast-feeding, and fertility

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

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

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

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

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Normally, this medicine does not affect your ability to drive or use machines. However, 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 Pharma contains sodium

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

3. How to take Atorvastatin Vir Pharma

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

The initial dose of atorvastatin is usually 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 is 80 mg once a day.

The atorvastatin 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.

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If you are 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, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount ingested. Bring the remaining tablets, the box, and the complete 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 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 Pharma

If you have any further questions about the use of this medicine or want to stop treatment, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

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

• Severe allergic reaction that causes swelling of the face, tongue, and throat, which can cause great difficulty in breathing.

• Severe skin 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, pain, rupture, or brownish discoloration of the urine, and especially if you also have discomfort or have a high fever, may be due to abnormal muscle breakdown (rhabdomyolysis). Abnormal muscle breakdown does not always disappear, even after stopping atorvastatin, and 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 up to 1 in 10,000 people:

• If you experience bleeding or bruising problems or unexpected or unusual bleeding, 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 Pharma:

Frequent: may affect up to 1 in 10 people:

• 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: may affect up to 1 in 100 people:

• loss of appetite (anorexia), 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, 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: may affect up to 1 in 1,000 people:

• vision changes
• 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 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: cannot be estimated from the available data

• 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).

Possible side effects of 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 fat in the blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side 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 which is stated on the blister and carton after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package Contents and Additional Information

Composition of AtorvastatinaVir Pharma

• The active ingredient is atorvastatin.

Each film-coated tablet contains 40 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 Package Contents

The film-coated tablets of Atorvastatina Vir Pharma 40 mg are elliptical, concave, and white in color.

Atorvastatina Vir Pharma 40 mg is available in packs with blisters containing 28 film-coated tablets and in clinical packs containing 500 film-coated tablets.

Only some 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 Last Revision of this Prospectus:October 2024

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