Atorvastatin Abex 80 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Atorvastatina abex 80 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as 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 must not be given to other people, even if they have the same symptoms as you, since it could 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.

Contents of the leaflet

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

1. What Atorvastatina abex is and what it is used for

Atorvastatin 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 taking Atorvastatine abex

Do not take atorvastatine

• If you are allergic to atorvastatine or to any other similar medicine used to lower blood lipids, 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 you are not using adequate contraceptive measures.
• If you are pregnant or trying to become pregnant.
• If you are breastfeeding.

Warnings and precautions

Talk to your doctor or pharmacist before taking atorvastatine:

• if you have or have had myasthenia (a disease characterized by generalized muscle weakness, which in some cases affects the muscles used for breathing) or ocular myasthenia (a condition 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 severe respiratory insufficiency.
• if you are taking or have taken within the last 7 days an oral or injectable medicine called fusidic acid (a medicine used to treat bacterial infections). The combination of fusidic acid and atorvastatine may cause serious muscle problems (rhabdomyolysis).
• if you have previously had a stroke with bleeding in the brain, or have small fluid-filled pockets in the brain due to prior strokes.
• if you have kidney problems.
• if you have an underactive thyroid gland (hypothyroidism).
• if you have repeated or unexplained muscle pain, or a personal or family history of muscle disorders.
• if you have previously experienced muscle problems while being treated with other lipid-lowering medicines (e.g. with another statin or fibrates).
• if you regularly drink large amounts of alcohol.
• if you have a history of liver problems.
• if you are over 70 years of age.

In any of these cases, your doctor may recommend blood tests before starting and possibly during treatment with atorvastatine to assess your risk of muscle-related adverse effects. It is known that the risk of muscle-related adverse effects (e.g. rhabdomyolysis) increases when certain medicines are taken concomitantly (see section 2 “Other medicines and atorvastatine”).

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 factors for developing diabetes. This risk increases if you have high levels of sugar and fats in your blood, are overweight, or have high blood pressure.

Other medicines and atorvastatine

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Some medicines may interfere with the proper functioning of atorvastatine, or the effects of these medicines may be altered by atorvastatine. Such interactions may reduce the effectiveness 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 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 to treat hepatitis C, such as telaprevir.
• Other medicines known to interact with atorvastatine include ezetimibe (a cholesterol-lowering agent), warfarin (an anticoagulant), oral contraceptives, stiripentol (an anticonvulsant used to treat epilepsy), cimetidine (used for heartburn and peptic ulcer), phenazone (an analgesic), colchicine (used to treat gout), antacids (indigestion remedies containing aluminium or magnesium), and boceprevir (used to treat liver diseases such as hepatitis C).
• Over-the-counter medicines: St. John’s wort.
  • If you need to take oral fusidic acid to treat a bacterial infection, you must temporarily stop taking this medicine. Your doctor will advise you when it is safe to restart atorvastatine treatment. Taking atorvastatine together with fusidic acid may rarely 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).

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

Taking atorvastatine with food, drinks, and alcohol

See section 3 for instructions on how to take atorvastatine. 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 atorvastatine.

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 atorvastatine if you are pregnant, think you may be pregnant, or are trying to become pregnant.

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

Do not take atorvastatine if you are breastfeeding.

The safety of atorvastatine 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 safely. Do not operate tools or machinery if this medicine impairs your ability to use them safely.

Atorvastatine abex contains lactose and sodium.

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

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which is essentially “sodium-free”.

3. How to take Atorvastatin abex

Before starting treatment, your doctor will place you on a low-cholesterol diet, which you must continue to follow during treatment with atorvastatin.

The usual 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 appropriate for you. Your doctor will adjust the dose at intervals of 4 weeks or more. The maximum dose of atorvastatin is 80 mg once daily for adults and 20 mg once daily for children.

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 your tablet at the same time every day.

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If 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 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 amount taken. Bring any remaining tablets, the outer carton, and the full pack so that hospital staff can easily identify the medication you have taken.

If you forget to take atorvastatin

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 missed doses.

If you stop taking atorvastatin

If you have any further questions about using this medicine or wish to discontinue treatment, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, atorvastatin may produce adverse effects, although not everyone experiences them.

If you notice any of the following serious adverse effects, stop taking these tablets immediately and contact your doctor or go to the nearest hospital emergency department without delay.

Rare: may affect between 1 and 10 out of every 10,000 patients:

• Severe allergic reaction causing swelling of the face, tongue, and throat, which may cause severe difficulty breathing.

• Serious illness 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, which may develop into blisters.

• Muscle weakness, tenderness or pain, and especially if accompanied by malaise or high fever, may be due to abnormal muscle breakdown. Abnormal muscle breakdown does not always resolve, even after stopping atorvastatin, and can be fatal and cause kidney problems.

Very rare: may affect fewer than 1 in every 10,000 patients:

• 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.

Other possible adverse effects with atorvastatin:

Frequent (may affect up to 1 in 10 patients) include:

• Inflammation of the nasal passages, sore throat, nosebleeds
• Allergic reactions
• Increased blood sugar levels (if you are diabetic, monitor your blood sugar levels), increased blood creatine kinase
• 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 patients) include:

• Anorexia (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 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 (oedema), increased body temperature
• Urine tests positive for white blood cells

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

• Changes in vision
• 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 inflammation of blood vessels, vasculitis)

Very rare (may affect fewer than 1 in 10,000 patients) include:

• 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)

Adverse effects of unknown frequency:

• 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 worsening weakness in the arms or legs after periods of activity, double vision or drooping eyelids, difficulty swallowing, or difficulty breathing.

Possible side effects reported with some statins (medicines of the same type):

• Sleep disorders, including insomnia and nightmares
• Memory loss
• Sexual dysfunction
• 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.

If you experience any adverse effects, consult your doctor or pharmacist, even if they are 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 abex

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

Do not use this medicine after the expiry date which is stated on the blister and outer packaging after {EXP}. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Unused medicines and waste materials, including packaging, should be returned to the SIGRE point at your pharmacy. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Additional Information

Composition of Atorvastatin abex

• The active substance is atorvastatin.

Each film-coated tablet contains 80 mg of atorvastatin (as atorvastatin calcium trihydrate).

• The other components (excipients) of Atorvastatin abex are:

Monohydrate lactose, magnesium stearate, microcrystalline cellulose, silicified microcrystalline cellulose (anhydrous colloidal silica and microcrystalline cellulose), sodium croscarmellose, calcium carbonate. Coating material: monohydrate lactose, hypromellose, titanium dioxide (E-171), and macrogol 4000.

Appearance of the product and contents of the container

The 80 mg tablets are white, oval-shaped, biconvex, and marked with “VT80” on one side.

Aluminum-Aluminum blisters.

Atorvastatin abex 80 mg is available in boxes containing blister packs with 28 and 100 tablets (hospital pack).

Only certain pack sizes may be commercially available.

Marketing Authorization Holder:

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa – Barcelona

Spain

Manufacturer:

Galenicum Health, S.L.U.

Sant Gabriel, 50

Esplugues de Llobregat, 08950 Barcelona

Spain

SAG Manufacturing SLU

Crta N-I, Km 36

28750 San Agustín de Guadalix (Madrid)

Spain

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

Detailed and up-to-date 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/