Atorvastatin Farma-Mabo 80 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Atorvastatin FARMA-MABO 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, consult your doctor, pharmacist, or nurse.

• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Package leaflet contents

1. What Atorvastatin FARMA-MABO is and what it is used for
2. What you need to know before starting to take Atorvastatin FARMA-MABO
3. How to take Atorvastatin FARMA-MABO
4. Possible side effects
5. Storage of Atorvastatin FARMA-MABO
6. Contents of the pack and other information

1. What Atorvastatine FARMA-MABO is and what it is used for

This medicine contains an active substance called atorvastatin, which belongs to a group of medicines known as statins, drugs that regulate lipids (fats).

Atorvastatin is used to reduce lipid levels 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 starting to take Atorvastatin FARMA-MABO

Do not take atorvastatin:

• if you are allergic to atorvastatin or to any of the other ingredients of this medicine
  (listed in section 6).

• if you have or have had a 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.

• if you are taking the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take atorvastatin:

• if you have severe respiratory failure.
• 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 atorvastatin may cause serious muscle problems (rhabdomyolysis).
• if you have previously had a 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 recurrent 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 have or have previously had myasthenia (a disease causing 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).
• 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 advise you to have blood tests before and possibly during treatment with atorvastatin to assess your risk of developing 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 of atorvastatin with other medicines”).

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

While you are taking this medicine, your doctor will monitor you for diabetes or risk of developing diabetes. This risk is higher if you have high levels of blood sugar and fats, are overweight, and have high blood pressure.

Other medicines and atorvastatine

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Some medicines may affect how atorvastatin works, or the effects of these medicines may be altered by atorvastatin. This type of interaction can reduce the effect of one or both medicines. Alternatively, taking them together may increase the risk or severity of adverse effects, including the 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 used to regulate lipid levels, for example, gemfibrozil, other fibrates, colestipol.
• 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.
• Letermovir, a medicine used to help prevent diseases caused by cytomegalovirus.
• Medicines used in the treatment of HIV/AIDS, for example, ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir combined with ritonavir, etc.
• Some medicines used for the treatment of hepatitis C, such as telaprevir, boceprevir, and the combinations elbasvir/grazoprevir, ledipasvir/sofosbuvir.
• Other medicines known to interact with atorvastatin include ezetimibe (which lowers cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant used to treat epilepsy), cimetidine (used for stomach burning and peptic ulcer), phenazone (an analgesic), colchicine (used to treat gout), and antacids (indigestion remedies containing aluminium or magnesium).
• Medicines obtained without a prescription: St. John's wort.
• If you need to take oral fusidic acid to treat a bacterial infection, you will need to temporarily stop taking this medicine. Your doctor will advise you when it is safe to restart treatment with atorvastatin. Taking atorvastatin together with fusidic acid may rarely cause muscle weakness, tenderness or pain (rhabdomyolysis). For more information about rhabdomyolysis, see section 4.
• Daptomycin (a medicine used to treat complicated skin and skin structure infections and bacteria in the blood)

Taking atorvastatatin with food, drinks, and alcohol

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

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 atorvastatin if you are pregnant, think you may be pregnant, or plan to become pregnant.

Do not take atorvastatin if you are of childbearing age unless you are using appropriate contraceptive measures. Do not take atorvastatin if you are breastfeeding.

The safety of atorvastatin during pregnancy and breastfeeding has not been established. Consult your doctor or pharmacist before using any medicine.

Driving and operating machinery

This medicine usually does not affect the ability to drive or operate machinery. However, 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 FARMA-MABO contains lactose

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.

Atorvastatin FARMA-MABO contains sodium

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

Atorvastatin FARMA-MABO contains soya

This medicine contains soya oil. It must not be used in patients with peanut or soya allergy.

3. How to take Atorvastatina FARMA-MABO

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 you require. Your doctor will adjust the dose at intervals of 4 weeks or more. The maximum dose of atorvastatin is 80 mg once daily.

Atorvastatina FARMA-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 instructions for use of this medicine provided by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Your doctor will decide the duration of treatment with Atorvastatin FARMA-MABO

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 medicine and the amount taken. Bring any remaining tablets, as well as the outer carton and the complete pack, so that hospital staff can easily identify the medicine 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 interrupt treatment with 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, this medicine can cause adverse effects, although not everyone will experience them.

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

Rare: may affect up to 1 in 1,000 people:

• Severe allergic reaction causing swelling of the face, tongue, and throat, which may lead to severe difficulty breathing.
• 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, muscle rupture, or brownish-red discoloration of the urine, particularly if accompanied by malaise or high fever—this may be due to abnormal breakdown of muscle (rhabdomyolysis). Abnormal muscle breakdown does not always resolve even after stopping atorvastatin, and may be fatal and lead to kidney problems.

Very rare: may affect up to 1 in 10,000 people:

• 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 syndrome (including rash, joint disorders, and effects on blood cells).

Other possible adverse effects with atorvastatin:

Common: may affect up to 1 in 10 people

• inflammation of the nasal passages, sore throat, nosebleeds
• allergic reactions
• increases in blood sugar levels (if you are diabetic, monitor your blood sugar levels), increased creatine kinase in blood
• headache
• nausea, constipation, gas, indigestion, diarrhea
• joint pain, muscle pain, and back pain
• blood test results showing abnormal liver function

Uncommon: may affect up to 1 in 100 people

• anorexia (loss of appetite), weight gain, decrease in blood sugar levels (if you are diabetic, continue to monitor your blood sugar levels carefully)
• nightmares, insomnia
• 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, burping, 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: may affect up to 1 in 1,000 people

• 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: may affect up to 1 in 10,000 people

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

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 of some statins (medicines of the same type):

• sexual difficulties
• depression
• respiratory problems such as persistent cough and/or difficulty breathing or fever
• diabetes. This is more likely if you have high levels of sugars 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 reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Atorvastatin FARMA-MABO

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the blister and 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 containers at the SIGRE Point in your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Atorvastatin FARMA-MABO

• The active substance is atorvastatin.

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

• The other components (excipients) are:

Tablet core: lactose monohydrate, microcrystalline cellulose (E460), sodium croscarmellose, Sepitrap 80 (polysorbate 80 (E443) and magnesium aluminometasilicate), calcium carbonate (E170), hydroxypropylcellulose (E463), magnesium stearate (E572).

Film coating: (Opadry II White 85G68918): polyvinyl alcohol (partially hydrolysed) (E1203), titanium dioxide (E171), talc (E553b), macrogol 3350 (E1521), soya lecithin (E322).

Appearance of the Product and Contents of the Package

Atorvastatina FARMA-MABO 80 mg film-coated tablets are white, oval-shaped (approximately 19 mm x 10 mm x 6 mm), biconvex, with "MA" engraved on one side and "4" on the other.

OPA//PVC//Al blisters:

28, 30, 50, 90, and 100 film-coated tablets.

Only certain package sizes may be marketed.

Marketing Authorization Holder and Manufacturing Responsible Party

Marketing Authorization Holder

MABO-FARMA, S.A.

Calle Vía de los Poblados, 3, Edificio 6

28033 Madrid,

Spain.

Manufacturer

Pharmadox Healthcare Ltd,
KW20A Kordin Industrial Park, Paola, PLA3000,
Malta

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/