ATORVASTATIN MABO 40 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Atorvastatin Mabo 40mg Film-Coated Tablets EFG

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you, do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the Package Leaflet

1. What is Atorvastatin Mabo and what is it used for
2. Before taking Atorvastatin Mabo
3. How to take Atorvastatin Mabo
4. Possible side effects
5. Storage of Atorvastatin Mabo
6. Further information

1. What is Atorvastatin Mabo and what is it used for

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

Atorvastatin 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 not worked. If you are at high risk of heart disease, Atorvastatin Mabo can also be used to reduce this risk even if your cholesterol levels are normal. During treatment, you should follow a standard low-cholesterol diet.

2. Before taking Atorvastatin 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 taking 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 blood tests for liver function.
• 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 breast-feeding.

Be especially careful with Atorvastatin Mabo

For the following reasons, Atorvastatin Mabo may not be suitable for you:

• If you have had a previous stroke with bleeding in the brain, or have small fluid-filled sacs 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, personal or family history of muscle problems,
• If you have had muscle problems in the past while taking other medicines to lower lipids (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 old.

Tell your doctor or pharmacist if you experience constant muscle weakness. You may need tests and additional medications to diagnose and treat this problem.

Talk to your doctor or pharmacist before taking Atorvastatin 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 to treat bacterial infections), by mouth 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 that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing) or ocular myasthenia (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 levels of sugar and fat in the blood, are overweight, and have high blood pressure.

In any of these cases, your doctor may indicate that you should have blood tests before and, possibly, during treatment with Atorvastatin Mabo to predict the risk of muscle-related side effects. It is known that the risk of muscle-related side effects (e.g. 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 of Atorvastatin Mabo or the effects of these medicines may be modified by Atorvastatin Mabo. This type of interaction can decrease the effect of one or both medicines. Alternatively, this combined use can increase the risk or severity of side effects, including important muscle damage, known as rhabdomyolysis described in Section 4:

• Medicines used to modify the functioning of your immune system, for example, cyclosporin.
• 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.
• Certain 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 to treat AIDS, for example, ritonavir, lopinavir, atazanavir, indinavir, darunavir, etc.
• Certain medicines used to treat hepatitis C, such as telaprevir, boceprevir, and the combination of elbasvir/grazoprevir.
• Other medicines that are known to interact with Atorvastatin Mabo include ezetimibe (which reduces cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant to treat epilepsy), cimetidine (used for heartburn and peptic ulcers), phenazone (a pain reliever), and antacids (products for indigestion that contain aluminum or magnesium).
• Medicines obtained without a medical prescription: St. John's Wort.
• Daptomycin (a medicine used to treat skin and skin structure infections with complications and bacteria present in the blood).

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

If you have to take oral fusidic acid to treat a bacterial infection, you will have to stop using this medicine. Your doctor will tell you when you can restart treatment with Atorvastatin Mabo. The use of Atorvastatin Mabo with fusidic acid can cause muscle weakness, sensitivity, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

Taking Atorvastatin Mabo with food and drinks

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 quantities of grapefruit juice can alter the effects of Atorvastatin Mabo.

Alcohol

Avoid drinking large amounts of alcohol while taking this medicine. See the details in Section 2 "Be especially careful with Atorvastatin Mabo".

Pregnancy and breast-feeding

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 breast-feeding your child.

The safety of Atorvastatin Mabo during pregnancy and breast-feeding 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 use tools or machines if this medicine affects your ability to use them.

Atorvastatin Mabo contains sodium

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

3. How to take Atorvastatin Mabo

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

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

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

Follow your doctor's instructions for taking Atorvastatin Mabo exactly. Consult your doctor or pharmacist if you have any doubts.

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 tablets of Atorvastatin Mabo (more than your usual daily dose), consult your doctor or the nearest hospital or call the Toxicology Information Service, telephone 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 forgotten doses.

If you stop taking Atorvastatin Mabo

If you have any further questions about the use of this medicine or want to stop treatment, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Atorvastatin Mabo can cause side effects, although not everybody gets them.

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

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

• Severe allergic reaction that causes swelling of the face, tongue, and throat, which can cause great difficulty breathing.

• Severe skin disease with severe peeling and inflammation of the skin; blisters on the skin, mouth, genitals, and eyes, and fever. Rash with pink-red spots, especially on the palms of the hands or soles of the feet, which can form blisters.

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

Very rare: affects less than 1 in every 10,000 patients:

• If you experience bleeding or bruising problems or unexpected or unusual bleeding, this may suggest a liver problem. You should consult your doctor as soon as possible.
• SLE-like syndrome (including rash, joint disorders, and effects on blood cells).

Other possible side effects with Atorvastatin Mabo:

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

• nasal inflammation, sore throat, nosebleeds,
• allergic reactions,
• increased blood sugar levels (if you are diabetic, monitor your blood sugar 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 show abnormal liver function.

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

• loss of appetite, weight gain, decreased blood sugar levels (if you are diabetic, you should continue to carefully monitor your blood sugar levels),
• 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,
• 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 in every 10,000 patients) include:

• vision changes,
• unexpected bleeding or bruising,
• jaundice (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 the blood vessels, vasculitis).

Very rare side effects (affect less than 1 in every 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,
• gynecomastia (breast enlargement in men and women).

Frequency not known: (cannot be estimated from available data):

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

Myasthenic syndrome (a disease that causes weakness of the eye muscles).

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

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 levels of sugar and fat in the blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines Agency's website: www.notificaram.es. By reporting side 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 expiration date that appears on the blister pack and on the carton after EXP. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Further information

Composition of Atorvastatin Mabo

• The active substance is atorvastatin. Each film-coated tablet contains 40 mg of atorvastatin (as atorvastatin calcium trihydrate).
• The other ingredients (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 package contents

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

Atorvastatin Mabo 40 mg is available in packs with blisters containing 28 film-coated tablets and in clinical packs containing 500 film-coated tablets.

Marketing Authorization Holder

MABO-FARMA, S.A.

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 last revision of this leaflet: October 2024

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