Package Leaflet: Information for the User

AtorvastatinaAurovitas Pharma10 mg Film-Coated TabletsEFG

Read 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if they have similar symptoms, as it may harm 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.

1. What isAtorvastatinaAurovitas Pharmaand what it is used for

2. What you need to know before takingAtorvastatinaAurovitas Pharma

3. How to takeAtorvastatinaAurovitas Pharma

4. Possible side effects

5. Storage ofAtorvastatinaAurovitas Pharma

6. Contents of the pack and additional information

AtorvastatinaAurovitas Pharmabelongs to a group of medications known as statins, which are medications that regulate lipids (fats).

Atorvastatina 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 have a high risk of heart disease, atorvastatina may also be used to reduce this risk even if your cholesterol levels are normal. During treatment, a standard low-cholesterol diet must be followed.

Do not take AtorvastatinaAurovitas Pharma

• If you are allergic to atorvastatina or any of the other components of this medication (listed in section 6).
• If you have or have had any liver disease.
• If you have or have had abnormal liver function test results.
• If you are a fertile woman and do not use 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 or pharmacist before starting to takeAtorvastatinaAurovitas Pharma:

• If you have severe respiratory insufficiency.
• If you have had a previous stroke with brain bleeding, or have small fluid embolisms in the brain due to previous strokes.
• If you have kidney problems.
• If you have a thyroid gland with low activity (hypothyroidism).
• If you have had repeated or unjustified muscle pain, personal or family history of muscle problems.
• If you have or have had myasthenia (a disease that causes generalized muscle weakness, which in some cases affects the muscles used for breathing) or myasthenia gravis (a disease that causes weakness of the eye muscles), as statins can sometimes worsen the disease or cause myasthenia (see section 4).
• If you have had muscle problems during previous treatment with other lipid-lowering medications (e.g., another statin or fibrate).
• If you are taking or have taken within the last 7 days a medication containing fusidic acid (used for bacterial infections), orally or by injection. The combination of fusidic acid and atorvastatina can cause severe 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 instruct you to have blood tests before and possibly during treatment with atorvastatina to predict the risk of adverse effects related to muscle. It is known that the risk of adverse effects related to muscle, for example, rhabdomyolysis, increases when certain medications are taken at the same time (see section 2 “Other medications and Atorvastatina Aurovitas Pharma”).

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

While taking this medication, your doctor will monitor if you have diabetes or are at risk of developing diabetes. This risk of diabetes increases if you have high blood sugar and lipid levels, obesity, and high blood pressure.

Other medications and Atorvastatina Aurovitas Pharma

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

There are some medications that can affect the proper functioning of atorvastatina or the effects of these medications may be modified by atorvastatina. This type of interaction can reduce the effect of one or both medications. Alternatively, this combined use can increase the risk or severity of adverse effects, including severe muscle deterioration, known as rhabdomyolysis described in section 4:

• Medications used to modify the functioning of your immune system, for example, cyclosporine.
• Certain antibiotics or antifungal medications, for example, erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid.
• Other medications to regulate lipid levels, for example, gemfibrozil, other fibrates, cholestyramine.
• Some calcium channel blockers used in the treatment of angina or high blood pressure, for example, amlodipine, diltiazem; medications to regulate your heart rhythm, for example, digoxin, verapamil, amiodarone.
• Medications used in the treatment of AIDS, for example, ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir combined with ritonavir, etc.
• Some medications used in the treatment of hepatitis C, for example, telaprevir, boceprevir, and the combination elbasvir/grazoprevir,ledipasvir/sofosbuvir.
• Letermovir, a medication that helps prevent diseases caused by cytomegalovirus.
• Other medications that are known to interact with atorvastatina, including ezetimibe (which reduces cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant for treating epilepsy), cimetidine (used for heartburn and peptic ulcers), phenazone (a pain reliever), colchicine (used to treat gout), and antacids (products for indigestion containing aluminum or magnesium).
• Over-the-counter medications: 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 medication. Your doctor will instruct you when you can resume treatment with atorvastatina. The use of atorvastatina with fusidic acid can cause muscle weakness, sensitivity, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.
• Daptomycin (a medication used to treat skin and soft tissue infections and bacteremia).

Inform your doctor or pharmacist if you are using or have used recently any other medication, including those obtained without a prescription.

Taking Atorvastatina Aurovitas Pharma with food, drinks, and alcohol

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

Orange juice

Do not take more than one or two small glasses of orange juice per day, as large amounts of orange juice can alter the effects of atorvastatina.

Alcohol

Avoid drinking large amounts of alcohol while taking this medication. See the details in section 2 “Warnings and precautions”.

Pregnancy, breastfeeding, and fertility

Do not take atorvastatina if you are pregnant, think you may be pregnant, or are trying to become pregnant.

Do not take atorvastatina if you are fertile and do not use adequate contraceptive measures.

Do not take atorvastatina if you are breastfeeding.

Atorvastatina has not been shown to be safe during pregnancy and breastfeeding. Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

This medication usually does not affect your ability to drive or operate machinery. However, do not drive if this medication affects your ability to drive. Do not operate tools or machinery if this medication affects your ability to operate them.

Atorvastatina Aurovitas Pharma contains lactose monohydrate and soy lecithin

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

Atorvastatina Aurovitas Pharma containssoy lecithin

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

Atorvastatina Aurovitas Pharma containssodium

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

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

The recommended starting dose of atorvastatina is 10 mg once a day for adults and children aged 10 years and above. Your doctor may increase it if necessary to reach the dose you need. Your doctor will adjust the dose at intervals of 4 weeks or more. The maximum dose of atorvastatina is 80 mg once a day.

Atorvastatina tablets 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 the tablet every day at the same time.

Follow exactly the administration instructions for this medication indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Your doctor will decide the duration of treatment with Atorvastatina Aurovitas Pharma

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

If you take more Atorvastatina Aurovitas Pharma than you should

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

If you forgot to take Atorvastatina Aurovitas Pharma

If you forgot to take a dose, take the next scheduled dose at the correct time. Do not take a double dose to make up for the missed dose.

If you interrupt treatment with Atorvastatina Aurovitas Pharma

If you have any other questions about using this medication, or if you want to stop treatment, ask your doctor or pharmacist.

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

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

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

• Severe allergic reaction that causes swelling of the face, tongue, and throat, which can make it difficult to breathe.

• Severe disease with severe peeling and inflammation of the skin, blisters on the skin, mouth, genitals, and eyes, and fever. Skin rash with pink-red spots, especially on the palms of the hands or soles of the feet that can form blisters.
• Muscle weakness, sensitivity, pain, or rupture, brownish-red urine discoloration, and especially if you also have discomfort or high fever, it may be due to an abnormal muscle rupture (rhabdomyolysis). Abnormal muscle rupture 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 AtorvastatinaAurovitas Pharma:

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

• Swelling of the nasal passages, sore throat, nasal bleeding.
• 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.
• Joint pain, muscle pain, and back pain.
• Abnormal blood test results that may show abnormal liver function.

Occasional(may affect up to 1 in 100 people):

• 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 of the hands and feet, reduced sensitivity to pain or touch, changes in taste, memory loss.
• Blurred vision.
• Tinnitus 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):

• Visual disturbances.
• Unexpected or unusual bleeding or bruising.
• Bile duct obstruction (yellowish discoloration of the skin and white of the eyes).
• Tendon damage.
• skin eruption or ulcers in the mouth (drug-induced lichenoid reaction).
• Lesions on the skin or purple skin lesions (signs of inflammation of blood vessels, vasculitis).

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

• Allergic reaction - symptoms may include sudden hissing when breathing and chest pain or tightness, swelling of the eyelids, face, lips, mouth, tongue, or throat, difficulty breathing, collapse.
• Loss of hearing.
• Gynecomastia (breast enlargement in men).

Frequency not known:cannot be estimated from available data:

• Constant muscle weakness.

• Myasthenia gravis (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing).
• Myasthenia ocular (a disease that causes weakness of the eye muscles).
• Consult your doctor if you experience weakness in the arms or legs that worsens after periods of activity, double vision, or eyelid drooping, difficulty swallowing, or difficulty breathing.

Some 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 blood sugar and fat levels, obesity, and high blood pressure. Your doctor will monitor you while taking this medicine.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

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

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

Do not use this medication after the expiration date that appears on the packaging and blister after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point of the pharmacy.Ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

Composition of Atorvastatina Aurovitas Pharma

• The active ingredient is atorvastatina.

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

• The other components are:

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

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

Appearance of the product and contents of the package

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

AtorvastatinaAurovitas Pharmafilm-coated tablets are available in blister packsof polyamide/aluminum foil/PVC – aluminum foil.

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

Packaging sizes:

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

Only some packaging sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

O

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 with the following names:

Bélgica:Atorvastatin AB 10 mg filmomhulde tabletten

España:AtorvastatinaAurovitas Pharma10 mg comprimidos recubiertos con película EFG

Polonia:Atorvastatin Aurovitas

Portugal:Atorvastatina Aurovitas

Last review date of this leaflet:December 2024

The detailed information of this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es)