Atorvastatin Aurovitas Pharma 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Atorvastatina Aurovitas Pharma 10 mg film-coated tablets EFG

Read the entire 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

1. What Atorvastatina Aurovitas Pharma is and what it is used for
2. What you need to know before taking Atorvastatina Aurovitas Pharma
3. How to take Atorvastatina Aurovitas Pharma
4. Possible adverse reactions
5. How to store Atorvastatina Aurovitas Pharma
6. Contents of the pack and other information

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

Atorvastatina Aurovitas Pharma 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 starting to take Atorvastatin Aurovitas Pharma

Do not take Atorvastatin Aurovitas Pharma

• If you are allergic to atorvastatin or to 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

Talk to your doctor or pharmacist before starting to take Atorvastatin Aurovitas Pharma:

• If you have severe respiratory failure.
• If you have previously had a stroke with bleeding into the brain, or have small accumulations of fluid 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, or personal or family history of muscle disorders.
• 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 disease causing weakness of the eye muscles), as statins may sometimes worsen the condition or trigger the onset of myasthenia (see section 4).
• If you have previously experienced muscle problems during treatment with other lipid-lowering medicines (e.g., with another statin or fibrates).
• If you are taking or have taken within the last 7 days a medicine containing fusidic acid (used to treat bacterial infection), taken 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 whether you should have blood tests before and possibly during treatment with atorvastatin to assess your risk of developing muscle-related adverse effects. It is known that the risk of muscle-related adverse 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 persistent muscle weakness. Additional tests or treatments may be needed to diagnose and manage this condition.

While taking this medicine, your doctor will monitor you for diabetes or risk of developing diabetes. This risk increases if you have high levels of sugar and fats in the blood, are overweight, or have high blood pressure.

Other medicines and Atorvastatin Aurovitas Pharma

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Some medicines may affect how atorvastatin works, or the effects of these medicines may be altered by atorvastatin. This type of interaction may reduce the effect of one or both medicines. Alternatively, taking them together may increase the risk or severity of adverse effects, including 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.
• Some 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.
• Medicines used in the treatment of HIV/AIDS, for example, ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir combined with ritonavir, etc.
• Some medicines used in the treatment of hepatitis C, for example, telaprevir, boceprevir, and the combinations elbasvir/grazoprevir, ledipasvir/sofosbuvir.
• Letermovir, a medicine that helps prevent diseases caused by cytomegalovirus.
• Other medicines known to interact with atorvastatin 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 will need to temporarily stop taking this medicine. Your doctor will advise you when you can restart treatment with atorvastatin. Using atorvastatin with fusidic acid may cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.
• Daptomycin (a medicine used to treat complicated skin and skin structure infections and bloodstream infections caused by bacteria).

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

Taking Atorvastatin Aurovitas Pharma with 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 may alter the effects of atorvastatin.

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 atorvastatin if you are pregnant, think you may be pregnant, or are trying 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 breastfeeding.

The safety of atorvastatin during pregnancy and breastfeeding has not been established. Consult your doctor or pharmacist before using any medicine.

Driving and using machines

This medicine normally 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 affects your ability to use them safely.

Atorvastatin Aurovitas Pharma contains lactose monohydrate and soya lecithin

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

Atorvastatin Aurovitas Pharma contains soya lecithin

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

Atorvastatin Aurovitas Pharma contains sodium

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 place you on a cholesterol-lowering diet, which you must continue to follow during treatment with atorvastatin.

The recommended 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 you require. 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 the tablet at the same time each day.

Always follow exactly the instructions provided by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

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

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

If you take more Atorvastatin Aurovitas Pharma than 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 at telephone number: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Atorvastatin Aurovitas 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 missed dose.

If you stop taking Atorvastatin Aurovitas Pharma

If you have any further questions about using this medicine, or if you wish to stop 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 serious adverse effects or 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 lead to severe difficulty breathing.

• Serious illness with severe skin peeling and inflammation, skin blisters, and sores in the mouth, genitals, and eyes, accompanied by 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, or muscle breakdown, brownish-red discoloration of the urine, and especially if associated with malaise or high fever, may be due to abnormal muscle breakdown (rhabdomyolysis). Abnormal muscle breakdown does not always resolve, even after stopping atorvastatin, and may be fatal and cause kidney problems.

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 AtorvastatinaAurovitas Pharma:

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

• Nasal inflammation, sore throat, nosebleeds.
• Allergic reactions.
• Increased blood glucose levels (if you are diabetic, monitor your blood glucose levels), increased creatine kinase in the blood.
• 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 glucose levels (if you are diabetic, continue to monitor your blood glucose 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.
• 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):

• 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.
• Gynaecomastia (enlargement of the breasts in men).

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).

• Consult your doctor if you experience arm or leg weakness that worsens after periods of activity, double vision or drooping eyelids, difficulty swallowing, or difficulty breathing.

Possible adverse 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. This is more likely if you have high levels of sugar and fats in the blood, 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 or pharmacist, 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 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 stated on the container and blister after EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. 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 Atorvastatin Aurovitas Pharma

• The active substance is atorvastatin.

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

• The other components are:

Tablet core: manitol, 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: partially hydrolysed polyvinyl alcohol, titanium dioxide (E171), talc, soya lecithin, xanthan gum.

Appearance of the product and contents of the pack

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

Atorvastatin Aurovitas Pharma film-coated tablets are available in blisters made of polyamide/aluminium foil/PVC – aluminium foil.

Atorvastatin Aurovitas Pharma is also available in PVC/PE/PVdC – aluminium foil blisters as an alternative pack.

Pack sizes:

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

Only some pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 authorised in the European Economic Area member states under the following names:

Belgium: Atorvastatin AB 10 mg filmomhulde tabletten

Spain: Atorvastatina Aurovitas Pharma 10 mg comprimidos recubiertos con película EFG

Poland: Atorvastatin Aurovitas

Portugal: Atorvastatina Aurovitas

Date of the most recent revision of this leaflet: December 2024

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