Package Leaflet: Information for the User

Atorvastatina Mabo 40mg Film-Coated Tablets

Read this 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 pass it on to others even if their symptoms are the same.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

1. What isAtorvastatina Maboand what it is used for

2. Before taking Atorvastatina Mabo

3. How to take Atorvastatina Mabo

4. Possible side effects

5. Storage of Atorvastatina Mabo

6. Information for additional use

Atorvastatina Mabo belongs to a group of medications known as statins, which are medications that regulate lipids (fats).

Atorvastatina Mabo is used to reduce lipids such as cholesterol and triglycerides in the blood when a low-fat diet and lifestyle changes on their own have failed.If you present a high risk of heart disease,Atorvastatina Mabomay also be used to reduce this risk even though your cholesterol levels are normal. During treatment, a standard low-cholesterol diet must be followed.

Do not take Atorvastatina Mabo

• If you are allergic (hypersensitive) to atorvastatin or to any other medicine used to reduce blood lipids or to any of the other components 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 abnormal results in blood tests for liver function.
• If you are a fertile woman and do not use adequate contraceptive measures.
• If you are pregnant or trying to become pregnant
• If you are breastfeeding

Be especially careful with Atorvastatina Mabo

For the following reasonsAtorvastatina Mabomay not be suitable for you:

• If you have had a previous stroke with bleeding in the brain, or have small fluid embolisms in the brain due to previous strokes,
• If you have kidney problems,
• If you have a thyroid gland with low activity (hypothyroidism),
• If you have repeated or unjustified muscle pain, personal or family history of muscle problems,
• If you have had muscle problems during previous treatment with other medicines to reduce lipids (for example, 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 old.

Also inform your doctor or pharmacist if you experience persistent muscle weakness. Further tests and additional medicines may be necessary to diagnose and treat this problem.

Talk to your doctor or pharmacist before taking Atorvastatina Mabo

• If you have severe respiratory failure.
• If you are taking or have taken in the last 7 days a medicine that contains fusidic acid (used for bacterial infection treatment), by oral or injection route. The combination of fusidic acid and Atorvastatina Mabo may cause severe muscle problems (rhabdomyolysis).
• If you have or have had myasthenia (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing) or myasthenia gravis (a disease that causes weakness of the eye muscles), as statins can sometimes worsen the disease or cause myasthenia (see section 4).

While you are taking this medicine, your doctor will check if you have diabetes or are at risk of developing diabetes. This risk of diabetes increases if you have high blood sugar and lipid levels, overweight, and high blood pressure.

In any of these cases, your doctormay instruct you to have blood tests before and possibly during treatment with Atorvastatina Maboto predict the risk of adverse effects related to muscle. It is known that the risk of adverse effects related to muscle (for example, rhabdomyolysis) increases when certain medicines are taken at the same time (see section 2“Use of other medicines”).

Use of other medicines

There are some medicines that can affect the proper functioning ofAtorvastatina Maboor the effects of these medicines may be modified byAtorvastatina Mabo.This type of interaction may reduce the effect of one or both medicines. Alternatively, this combined use may increase the risk or severity of adverse effects, including the important muscle deterioration, known as rhabdomyolysis described in Section 4:

• Medicines used to modify the functioning of your immune system, for example ciclosporin
• 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, cholestyramine.
• Some calcium channel blockers used in the treatment of 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.
• Other medicines that are known to interact withAtorvastatina Mabo include ezetimibe (which reduces cholesterol),warfarin (which reduces blood clotting), oral contraceptives, andstiripentol(an anticonvulsant for treating epilepsy), cimetidine (used for heartburn and stomach ulcers), phenazone (a painkiller) and antacids (products for indigestion containing aluminum or magnesium)
• Over-the-counter medicines: St. John's Wort
• daptomycin (a medicine used to treat skin and soft tissue infections and bacteremia).

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

If you need to take fusidic acid orally to treat a bacterial infection, you will need to stop taking this medicine. Your doctor will instruct you when you can restart treatment with Atorvastatina Mabo. The use of Atorvastatina Mabo with fusidic acid may cause muscle weakness, sensitivity, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see Section 4.

TakingAtorvastatina Mabowith food and drinks

See Section 3 for instructions on how to takeAtorvastatina Mabo.Please note the following:

Orange juice

Do not take more than one or two small glasses of orange juice per day, as large amounts of orange juice can alter the effects ofAtorvastatina Mabo.

Alcohol

Avoid drinking large amounts of alcohol while taking this medicine. See details in Section 2 “Be especially careful withAtorvastatina 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 fertile and do not use 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 demonstrated.

Consult your doctor or pharmacist before using any medicine.

Driving and operating machinery

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

Atorvastatina MABO contains sodium

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

Before starting treatment, your doctor will put you on a low-cholesterol diet, which you must also follow during treatment with Atorvastatina Mabo.

The usual initial dose of Atorvastatina Mabo is 10 mg once a day in adults and children aged 10 years and above. Your doctor may increase it if necessary to reach the dose you need. Your doctor will adjust the dose at intervals of 4 weeks or more. The maximum dose of Atorvastatina Mabo is 80 mg once a day for adults and 20 mg once a day for children.

Atorvastatina Mabo tablets should be swallowed whole with a glass of water and can be taken at any time of the day with or without food. However, try to take your tablet every day at the same time.

Follow exactly the administration instructions for Atorvastatina Mabo given by your doctor. Consult your doctor or pharmacist if you have any doubts.

Your doctor will decide the duration of treatment with Atorvastatina Mabo

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

If you take more Atorvastatina Mabo than you should

If you accidentally take too many Atorvastatina Mabo tablets (more than your usual daily dose), consult your doctor or the nearest hospital or call the Toxicological Information Service, phone 91 562 04 20.

If you forget to take Atorvastatina 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 doses.

If you interrupt treatment with Atorvastatina Mabo

If you have any other questions about the use of this medication or wish to discontinue treatment, ask your doctor or pharmacist.

Like all medicines, Atorvastatina Mabo can cause side effects, although not everyone will experience them.

If you notice any of the following serious side effects, stop taking these tablets and inform your doctor immediately or visit the nearest hospital emergency department.

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

• Severe allergic reaction that causes swelling of the face, tongue, and throat, which can make breathing difficult.

• Severe disease 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 that can form blisters.

• Muscle weakness, pain on palpation, pain or rupture, change in urine color to brown-red, and especially if you have discomfort or high fever, it may be due to an abnormal muscle rupture that can be fatal and cause kidney problems.

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

• If you experience problems with unexpected or unusual bleeding or bruising, this may suggest 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 side effects with Atorvastatina Mabo:

Frequent side effects (affect between 1 and 10 of every 100 patients) include:

• inflammationof the nasal passages, sore throat, nosebleeds,
• allergic reactions,
• increases in blood sugar levels (if you are diabetic, monitor your blood sugar levels), increase increatine kinasein blood,
• headache,
• nausea, constipation, gas, indigestion, diarrhea,
• joint pain, muscle pain, and back pain,
• blood test results that may show abnormal liver function.

Infrequent side effects (affect between 1 and 10 of every 1,000 patients) include:

• anorexia (loss of appetite), weight gain, decrease in 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 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, hair loss,
• neck pain, muscle fatigue,
• fatigue, feeling unwell, weakness, chest pain, inflammation, especially in the ankles (edema), increased temperature,
• positive urine tests for white blood cells.

Rare side effects (affect between 1 and 10 of every 10,000 patients) include:

• vision changes,
• unexpected bleeding or bruising,
• cholestasis (yellowing of the skin and eyes),
• tendon injury
• skin rash or ulcers in the mouth (drug-induced lichenoid reaction),
• skin lesions of purple color (signs of inflammation of blood vessels, vasculitis)

Very rare side effects (affect fewer than 1 of every 10,000 patients) include:

• allergic reaction - symptoms may include sudden hissing while breathing and chest pain or tightness, swelling of the eyelids, face, lips, mouth, tongue, or throat, difficulty breathing, collapse,
• hearing loss,
• gynecomastia (enlargement of breasts in men and women).

Unknown frequency: (cannot be estimated from available data):

• Constant muscle weakness.
• Severe myasthenia (a disease that causes generalized muscle weakness, which, in some cases, affects the muscles used for breathing).

Myasthenia gravis (a disease that causes weakness of the eye muscles).

Consult your doctor if you experience weakness in your arms or legs that worsens after periods of activity, double vision, or eyelid drooping, difficulty swallowing, or difficulty breathing

The possible side effects of some statins (medicines of the same type):

• Sexual dysfunction.
• Depression.
• Respiratory problems such as persistent cough and/or difficulty breathing or fever.

Diabetes. It is more likely if you have high blood sugar and fat levels, obesity, and high blood pressure. Your doctor will monitor you while taking this medication.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use, website:www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep out of reach and sight of children.

Store below30°C.

Do not use Atorvastatina Mabo after the expiration date that appears on the blister and on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Atorvastatina Mabo Composition

• The active ingredient is atorvastatina. Each film-coated tablet contains 40 mg of atorvastatina (as atorvastatina 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 packaging contents

The film-coated tablets of Atorvastatina Mabo 40 mg are elliptical, biconvex, and white.

Atorvastatina Mabo 40 mg is presented in boxes with blisters containing 28 film-coated tablets and in clinical packs containing 500 film-coated tablets.

Marketing Authorization Holder

MABO-FARMA, S.A.

Calle Vía de los Poblados, 3, Edificio 6

28033 Madrid,

Spain.

Responsible for manufacturing

TEVA PHARMA, S.L.U.

Polígono Industrial Malpica, Calle C nº 4.

50016 Zaragoza, Spain

Last review date of this leaflet: October 2024

The detailed and updated information of this medicine is available on the webpage of the Spanish Agency of Medicaments and Health Products (AEMPS) http://www.aemps.gob.es/