Atorvastatin Mabo 40 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Atorvastatin Mabo 40 mg 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 only. Do not give it to other people, even if they have the same symptoms, as 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 Atorvastatin Mabo is and what it is used for
2. Before you take Atorvastatin Mabo
3. How to take Atorvastatin Mabo
4. Possible side effects
5. How to store Atorvastatin 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 Atorvastatina MABO

Do not take Atorvastatina 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 of 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 you are not using adequate contraceptive measures.
• If you are pregnant or trying to become pregnant.
• If you are breastfeeding.

Take special care with Atorvastatina Mabo

Atorvastatina 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 prior 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 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.

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 Atorvastatina Mabo

• If you have severe respiratory failure.
• If you are taking or have taken within the last 7 days an oral or injectable medicine containing fusidic acid (used to treat bacterial infection). The combination of fusidic acid and Atorvastatina 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 disease causing weakness of the eye muscles), as statins may sometimes worsen the condition 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 sugars and fats in your blood, are overweight, or have high blood pressure.

In any of these cases, your doctor may recommend blood tests before and possibly during treatment with Atorvastatina 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 concomitantly (see section 2 “ Use with other medicines”).

Use of other medicines

Some medicines may interfere with the proper function of Atorvastatina Mabo, or the effects of these medicines may be altered by Atorvastatina 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 Atorvastatina 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 bacteremia).

Inform your doctor or pharmacist if you are currently taking or have recently taken 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 taking this medicine. Your doctor will advise you when you can restart treatment with Atorvastatina Mabo. Using Atorvastatina Mabo with fusidic acid may cause muscle weakness, tenderness, or pain (rhabdomyolysis). For further information on rhabdomyolysis, see section 4.

Taking Atorvastatina Mabo with food and drinks

See section 3 for instructions on how to take Atorvastatina Mabo. 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 Atorvastatina Mabo.

Alcohol

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

Pregnancy and breastfeeding

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

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

Do not take Atorvastatina Mabo if you are breastfeeding your child.

The safety of Atorvastatina 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.

Atorvastatina 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 Atorvastatine MABO

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

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

Atorvastatine 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 every day.

Follow exactly the dosing instructions for Atorvastatine MABO provided by your doctor. If you have any doubts, consult your doctor or pharmacist.

Your doctor will decide the duration of treatment with Atorvastatine MABO.

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

If you take more Atorvastatine MABO than you should

If you accidentally take too many Atorvastatine MABO 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.

If you forget to take Atorvastatine MABO

If you forget to take a dose, take the next dose at the scheduled time. Do not take a double dose to make up for forgotten doses.

If you stop taking Atorvastatine MABO

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

4. Possible adverse effects

Like all medicines, Atorvastatin Mabo may cause adverse effects, although not everyone gets them.

If you notice any of the following serious adverse effects, stop taking these tablets immediately and contact your doctor right away or go to the nearest hospital emergency department.

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 difficulty breathing.

• Severe skin disease with extensive peeling and inflammation of the skin; skin blisters, in the 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 rupture, change in urine color to red-brown, and especially if accompanied by malaise or high fever, may be due to abnormal muscle breakdown which can be fatal 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 illness syndrome (including rash, joint disorders, and effects on blood cells).

Other possible adverse effects with Atorvastatin Mabo:

Frequent 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), increased blood creatine kinase,
• 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,
• Positive urine tests for white blood cells.

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

• Changes in vision,
• Unexplained 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 worsening arm or leg weakness 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. More likely if you have high levels of blood sugar and fats, 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, 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 must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and packaging. This will help protect the environment.

6. Information for the user

Composition of Atorvastatin Mabo

• The active substance is atorvastatin. Each film-coated tablet contains 40 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 Atorvastatin Mabo contains hypromellose (pharmacoat gr. 606), hydroxypropylcellulose, triethyl citrate, polysorbate 80, and titanium dioxide (E-171).

Appearance of Atorvastatin Mabo and contents of the pack

Film-coated tablets of Atorvastatin Mabo 40 mg are elliptical, biconvex, and white in colour.

Atorvastatin Mabo 40 mg is available in boxes with blisters containing 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 review of this leaflet: October 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es/