ATORVASTATIN Aurovitas Pharma 10 mg FILM-COATED TABLETS

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

Do not take AtorvastatinAurovitas 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 had any unexplained abnormal blood test results indicating liver function.
• If you are a woman able to have children and are not using 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 or pharmacist before starting to take Atorvastatin Aurovitas Pharma:

• If you have severe respiratory failure.
• If you have had a previous stroke with bleeding in the brain, or have small fluid-filled areas 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, personal or family history of muscle problems.
• If you have or have had myasthenia (a disease that causes general muscle weakness that, in some cases, affects 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 have had muscle problems while taking other medicines to lower lipid levels (e.g., another statin or fibrates).
• If you are taking or have taken in the last 7 days a medicine containing fusidic acid (used to treat bacterial infection) orally or by injection. The combination of fusidic acid and atorvastatin can cause serious muscle problems (rhabdomyolysis).
• 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 decide to perform blood tests before and possibly during treatment with atorvastatin to predict the risk of muscle-related side effects. It is known that the risk of muscle-related side effects, such as rhabdomyolysis, increases when certain medicines are taken at the same time (see section 2 "Other medicines and Atorvastatin Aurovitas Pharma").

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

While 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.

Other medicines and AtorvastatinAurovitas Pharma

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 or the effects of these medicines may be altered by atorvastatin. 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 significant muscle damage, known as rhabdomyolysis described in section 4:

• Medicines used to modify the functioning of your immune system, e.g., cyclosporin.
• Certain antibiotics or antifungal medicines, e.g., erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid.
• Other medicines to regulate lipid levels, e.g., gemfibrozil, other fibrates, colestipol.
• Certain calcium channel blockers used to treat angina or high blood pressure, e.g., amlodipine, diltiazem; medicines to regulate your heart rhythm, e.g., digoxin, verapamil, amiodarone.
• Medicines used in the treatment of AIDS, e.g., ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir combined with ritonavir, etc.
• Certain medicines used in the treatment of hepatitis C, e.g., telaprevir, boceprevir, and the combination elbasvir/grazoprevir, ledipasvir/sofosbuvir.
• Letermovir, a medicine that helps prevent diseases caused by cytomegalovirus.
• Other medicines that are known to interact with atorvastatin include ezetimibe (which reduces cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant to treat epilepsy), cimetidine (used for heartburn and peptic ulcer), phenazon (a pain reliever), colchicine (used to treat gout), and antacids (products for indigestion that contain aluminum or magnesium).
• Medicines obtained without a prescription: St. John's Wort.
• If you have 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 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.
• 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 have recently used any other medicines, including those obtained without a prescription.

Taking AtorvastatinAurovitas Pharmawith food, drinks, and alcohol

See section 3 for instructions on how to take Atorvastatin Aurovitas 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 can alter the effects of atorvastatin.

Alcohol

Avoid drinking large amounts of alcohol while taking this medicine. See the details in section 2 "Warnings and precautions".

Pregnancy, breast-feeding, and fertility

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

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

Do not take atorvastatin if you are breast-feeding.

The safety of atorvastatin 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.

AtorvastatinAurovitas Pharmacontains lactose monohydrate and soy lecithin

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

AtorvastatinAurovitas Pharmacontainssoy lecithin

If you are allergic to peanuts or soy, do not take this medicine.

AtorvastatinAurovitas Pharmacontainssodium

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

3. How to take Atorvastatin Aurovitas Pharma

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

The recommended starting dose of atorvastatin 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 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 the tablet at the same time every day.

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Your doctor will decide the duration of treatment with AtorvastatinAurovitas Pharma

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

If you take more AtorvastatinAurovitas Pharmathan you should

If you accidentally take too many atorvastatin tablets (more than your usual daily dose), consult your doctor or the nearest hospital or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take AtorvastatinAurovitas 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 the forgotten dose.

If you stop taking AtorvastatinAurovitas Pharma

If you have any other 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 breathing.

• Severe disease with severe peeling 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, sensitivity, pain, or rupture, urine discoloration brown-red and especially if you 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.

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

• If you experience unexpected or unusual bleeding or bruising, this may suggest a liver problem. You should consult your doctor as soon as possible.
• Syndrome similar to lupus (which includes rash, joint disorders, and effects on blood cells).

Other possible side effects with AtorvastatinAurovitas Pharma:

Common(may affect up to 1 in 10 people):

• Nasal passage inflammation, 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.
• Pain in the joints, pain in the muscles, 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, 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).
• 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 problems.
• Unexpected or unusual bleeding or bruising.
• Jaundice (yellowing of the skin and whites of the eyes).
• Tendon injury.
• Skin rash or ulcers in the mouth (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):

• 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).

Frequency not known:cannot be estimated from the available data:

• Constant muscle weakness.

• Severe myasthenia (a disease that causes general muscle weakness that, in some cases, affects the muscles used for breathing).
• Ocular myasthenia (a disease that causes weakness of the eye muscles).
• Consult 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.
• 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 of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects 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 Aurovitas Pharma

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

This medicine does not require special storage conditions (PA/Al/PVC/Al).

This medicine does not require special storage conditions (PVC/PE/PVdC-Al).

Do not use this medicine after the expiry date which is stated on the packaging and blister 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 the pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Container Content and Additional Information

Composition of Atorvastatina Aurovitas Pharma

• The active ingredient is atorvastatin.

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

• The other components are:

Core of the tablet:mannitol, copovidone, sodium carbonate, sodium croscarmellose, silicified microcrystalline cellulose (contains anhydrous colloidal silica and microcrystalline cellulose), lactose monohydrate, sodium lauryl sulfate, anhydrous colloidal silica, magnesium stearate.

Coating:polyvinyl alcohol – hydrolyzed part, titanium dioxide (E171), talc, soy lecithin, xanthan gum.

Appearance of the Product and Container Content

White, elliptical (9.8 mm x 5.2 mm) film-coated tablets, marked with an "AS" on one face and "10" on the other face of the tablet.

Atorvastatina Aurovitas Pharma film-coated tablets are available in polyamide/aluminum foil/PVC – aluminum foil blister packs.

Atorvastatina Aurovitas Pharma is also available in PVC/PE/PVdC-aluminum foil blister packs as an alternative packaging.

Container Sizes:

Blister packs: 14, 20, 28, 30, 50, 56, 84, 90, 98, and 100 film-coated tablets.

Only some container sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

This Medicinal Product is Authorized in the Member States of the European Economic Area under the following Names:

Belgium: Atorvastatin AB 10 mg film-coated tablets

Spain: Atorvastatina Aurovitas Pharma 10 mg film-coated tablets EFG

Poland: Atorvastatin Aurovitas

Portugal: Atorvastatina Aurovitas

Date of the Last Revision of this Leaflet:December 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)