Atorvastatin Mabo 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Atorvastatina Mabo 10mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine.

• 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; do not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you consider any of the side effects you experience to be serious, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents

1. What Atorvastatina Mabo is and what it is used for
2. Before you take Atorvastatina Mabo
3. How to take Atorvastatina Mabo
4. Possible side effects
5. How to store Atorvastatina Mabo
6. Further information

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

Atorvastatina MABO belongs to a group of medicines known as statins, which are lipid-regulating (fat-regulating) medicines.

Atorvastatina MABO 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, Atorvastatina MABO 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. Before taking Atorvastatatin MABO

Do not take Atorvastatin MABO

• If you are allergic (hypersensitive) to atorvastatin or to any other similar medicine used to lower blood lipids, or to any of the other ingredients of this medicine – see more details in Section 6.
• if you are using the combination glecaprevir/pibrentasvir for the treatment of hepatitis C.
• 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.

Take special care with Atorvastatin MABO

Atorvastatin MABO may not be suitable for you for the following reasons:

• if you have previously had a stroke with bleeding in the brain, or have small collections 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 repeated or unexplained muscle pain, or personal or family history of muscle disorders,
• if you have previously had muscle problems during treatment 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.

Also inform your doctor or pharmacist if you experience persistent muscle weakness. Additional tests and treatments may be needed to diagnose and manage this condition.

Talk to your doctor or pharmacist before taking Atorvastatin MABO

• If you have severe respiratory failure.
• 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 MABO can cause serious muscle problems (rhabdomyolysis).
• 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 disease or trigger the onset of myasthenia (see Section 4).

While you are taking this medicine, your doctor will monitor whether you have diabetes or are at 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.

In any of these cases, your doctor may advise you to have blood tests before starting and possibly during treatment with Atorvastatin MABO to assess the 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 at the same time (see Section 2 “ Use with other medicines”).

Use with other medicines

Some medicines may affect how Atorvastatin MABO works, or the effects of these medicines may be altered by Atorvastatin MABO. Such interactions 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 lipid-regulating medicines, 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 AIDS, for example, ritonavir, lopinavir, atazanavir, indinavir, darunavir, etc.
• Some medicines used to treat hepatitis C, such as telaprevir, boceprevir, and the combination of elbasvir/grazoprevir.
• Other medicines known to interact with Atorvastatin MABO include ezetimibe (cholesterol-lowering agent), warfarin (reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant used to treat epilepsy), cimetidine (used for heartburn and peptic ulcer), phenazone (an analgesic), and antacids (indigestion remedies containing aluminium or magnesium).
• Over-the-counter medicines: St. John’s wort.
• 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.

If you need to take oral fusidic acid to treat a bacterial infection, you must stop using this medicine. Your doctor will advise you when you can restart treatment with Atorvastatin MABO. Using Atorvastatin MABO with fusidic acid may cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see Section 4.

Taking Atorvastatin MABO with food and drink

See Section 3 for instructions on how to take Atorvastatin MABO. Please note the following:

Grapefruit juice

Do not drink more than one or two small glasses of grapefruit juice per day, as large amounts of grapefruit juice may alter the effects of Atorvastatin MABO.

Alcohol

Avoid drinking large amounts of alcohol while taking this medicine. See details in Section 2 “Take special care with Atorvastatin MABO”.

Pregnancy and breastfeeding

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

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

Do not take Atorvastatin MABO if you are breastfeeding.

The safety of Atorvastatin MABO during pregnancy and breastfeeding has not been established.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Do not drive if this medicine affects your ability to drive. Do not operate tools or machinery if this medicine affects your ability to operate them.

Atorvastatin MABO contains sodium

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

3. How to take Atorvastatin MABO

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

The usual initial dose of Atorvastatin MABO 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 MABO is 80 mg once daily for adults and 20 mg once daily for children.

Atorvastatin MABO 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 each day.

Follow your doctor's instructions for taking Atorvastatin MABO exactly. If you have any doubts, consult your doctor or pharmacist.

Your doctor will decide the duration of treatment with Atorvastatin MABO

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

If you take more Atorvastatin MABO than you should

If you accidentally take too many Atorvastatin MABO tablets (more than your usual daily dose), consult your doctor or the nearest hospital, or call the Toxicology Information Service at 91 562 04 20.

If you forget to take Atorvastatin MABO

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 MABO

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

4. Possible adverse effects

Like all medicines, Atorvastatine Mabo may cause 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 straight away.

Rare: affects between 1 and 10 in 10,000 patients:

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

• Serious illness with severe skin peeling and inflammation; skin blisters, 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, pain, or injury, change in urine color to red-brown, and especially if you also feel unwell or have high fever—this may be due to abnormal breakdown of muscle tissue, which can be life-threatening and cause kidney problems.

Very rare: affects fewer than 1 in 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.

• Lupus-like disease syndrome (including rash, joint disorders, and effects on blood cells).

Other possible adverse effects with Atorvastatine Mabo:

Common adverse effects (affect between 1 and 10 in 100 patients) include:

• Nasal inflammation, sore throat, nosebleeds,
• Allergic reactions,
• Increased blood sugar levels (if you are diabetic, monitor your blood sugar levels closely), increased creatine kinase in blood,
• Headache,
• Nausea, constipation, flatulence, indigestion, diarrhea,
• Joint pain, muscle pain, and back pain,
• Blood test results that may show abnormal liver function.

Uncommon adverse effects (affect between 1 and 10 in 1,000 patients) include:

• Anorexia (loss of appetite), weight gain, decreased blood sugar levels (if you are diabetic, continue to monitor your blood sugar levels carefully),
• Sleep disorders, including insomnia and nightmares,
• 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 adverse effects (affect between 1 and 10 in 10,000 patients) include:

• 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 adverse effects (affect fewer than 1 in 10,000 patients) include:

• Allergic reaction—symptoms may include sudden wheezing, 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 and women).

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

• 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.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, 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 at website: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Atorvastatin MABO

Keep out of the reach and sight of children.

Store below 30°C.

Do not use Atorvastatin MABO after the expiry date stated on the blister and on the outer packaging following EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point in your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Additional Information

Composition of Atorvastatina Mabo

• The active substance is atorvastatin. Each film-coated tablet contains 10 mg of atorvastatin (as atorvastatin calcium trihydrate).
• The other components (excipients) are: microcrystalline cellulose, anhydrous sodium carbonate, maltose, sodium croscarmellose, and magnesium stearate.
• The coating of Atorvastatina Mabo contains hypromellose (pharmacoat gr. 606), hydroxypropylcellulose, triethyl citrate, polysorbate 80, and titanium dioxide (E-171).

Appearance of Atorvastatina Mabo and contents of the pack

Film-coated tablets of Atorvastatina Mabo 10 mg are elliptical, biconvex, and white in colour.

Atorvastatina Mabo 10 mg is available in carton packs containing blisters with 28 film-coated tablets and in hospital packs containing 500 film-coated tablets.

Marketing Authorization Holder

MABO-FARMA, S.A.

Calle Vía de los Poblados, 3, Edificio 6

28033 Madrid,

Spain.

Manufacturer

TEVA PHARMA, S.L.U.

Polígono Industrial Malpica, Calle C nº 4.

50016 Zaragoza, Spain

Date of the most recent revision of this leaflet: October 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/