ATORVASTATIN Aurovitas Pharma 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

AtorvastatinAurovitas Pharma20 mg film-coated tabletsEFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What Atorvastatin Aurovitas Pharma is and what it is used for

Atorvastatin Aurovitas Pharma belongs to a group of medicines known as statins, which are lipid-modifying medicines.

Atorvastatin is used to lower lipid levels such as cholesterol and triglycerides in the blood when a low-fat diet and lifestyle changes on their own have not worked. If you are at high risk of heart disease, atorvastatin can also be used to reduce this risk even if your cholesterol levels are normal. You should maintain a standard cholesterol-lowering diet during treatment.

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 for liver function.
• If you are a woman able to have children and are not using reliable contraception.
• 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 taking 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 from previous strokes.
• If you have kidney problems.
• If you have an underactive thyroid gland (hypothyroidism).
• If you have had repeated or unexplained muscle pains or a family history of muscle problems.
• If you have or have had muscle diseases (e.g. muscular dystrophy).
• If you have previously had muscle problems during treatment with other lipid-lowering medicines (e.g. other statins or fibrates).
• If you are taking or have taken in the last 7 days a medicine called fusidic acid (used to treat bacterial infections) by mouth 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 these cases, your doctor may decide to carry out a blood test 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, tell your doctor or pharmacist if you have constant muscle weakness. Further tests and additional medicines may be needed to diagnose and treat this condition.

While you are on this medicine your doctor will monitor you for signs of diabetes, such as increased thirst or frequency of passing urine, or if you are already diabetic he will monitor your blood sugar levels. Your risk of developing diabetes may increase with atorvastatin, especially if you have high levels of sugars and fats in your blood, are overweight, or 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 may affect the way Atorvastatin Aurovitas Pharma works, or their effect may be altered by Atorvastatin Aurovitas Pharma. This type of interaction can diminish the effect of one or both medicines or 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, such as ciclosporin.
• Certain antibiotics or antifungal medicines, such as erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid.
• Other medicines for lowering lipid levels, such as gemfibrozil, other fibrates, colestipol.
• Certain calcium channel blockers used for the treatment of high blood pressure or angina, such as amlodipine, diltiazem; medicines for regulating heart rhythm, such as digoxin, verapamil, amiodarone.
• Medicines used in the treatment of HIV, such as ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir combined with ritonavir, etc.
• Certain medicines used in the treatment of hepatitis C, such as 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 lowers cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant for treating epilepsy), cimetidine (used for heartburn and peptic ulcers), 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 need to take fusidic acid by mouth to treat a bacterial infection, you will have to stop using this medicine temporarily. Your doctor will tell you when you can restart the 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 and bacteremia).

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 take more than one or two small glasses of grapefruit juice per day because large quantities of grapefruit juice can affect the efficacy of atorvastatin.

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 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 reliable contraception.

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 soya, 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 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 the dose if necessary up to the dose you need. Your doctor will adapt the dose at intervals of 4 weeks or more. The maximum dose of atorvastatin is 80 mg once a day.

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 given 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, telephone: 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 further questions on the use of this medicine or wish 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, stop taking these tablets and inform your doctor immediately or go to the casualty department of your 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 lead to great difficulty in breathing.

• Severe skin disease with severe skin peeling, 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, brownish discoloration of the urine, and especially if you have discomfort or have a high fever, it 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 bleeding or bruising that is not expected or unusual, this may suggest a liver problem. You should consult your doctor as soon as possible.
• Lupus-like syndrome (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.
• Neck pain, muscle fatigue.
• Fatigue, feeling unwell, weakness, chest pain, inflammation, especially in the ankles (edema), increased body temperature.
• Positive urine tests for white blood cells.

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

• Vision disturbances.
• Unexpected bleeding or bruising.
• Jaundice (yellowing of the skin and the 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 may include sudden wheezing, coughing, shortness of breath, 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 generalized muscle weakness that, in some cases, affects the muscles used for breathing).
• Myasthenic syndrome (a disease that causes weakness of the eye muscles).
• Tell 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 coughing and/or difficulty breathing or fever.
• Diabetes. It is more likely if you have high levels of sugars and fats in your 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. This includes any possible side effects not listed in this leaflet. You can also report side effects 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 any special storage conditions (PA/Al/PVC/Al).

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

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Atorvastatina Aurovitas Pharma

• The active ingredient is atorvastatin.

Each film-coated tablet contains 20 mg of atorvastatin (as atorvastatin calcium trihydrate).

• The other components are:

Tablet core: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 Package Contents

White, elliptical (12.3 mm x 6.5 mm) film-coated tablets, marked with an "AS" on one face and "20" 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.

Package Sizes:

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

Not all package 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 20 mg film-coated tablets

Spain: Atorvastatina Aurovitas Pharma 20 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)