Atorvastatin Combix 80 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Atorvastatina Combix 80 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine because it contains important information for you.

• 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 and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

1. What Atorvastatina Combix tablets are and what they are used for
2. What you need to know before taking Atorvastatina Combix
3. How to take Atorvastatina Combix
4. Possible side effects
5. How to store Atorvastatina Combix
6. Contents of the pack and other information

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

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

Atorvastatina Combix 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 Combix may also be used to reduce this risk even if your cholesterol levels are normal. A standard low-cholesterol diet should be maintained during treatment.

2. What you need to know before taking Atorvastatina Combix

Do not take Atorvastatina Combix

• 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 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.
• If you are using the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Atorvastatina Combix:

• 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 pockets 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 problems.
• if you have previously experienced muscle problems during treatment with other lipid-lowering medicines (for example, with another statin or fibrates).
• if you have or have 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 old.

In any of these cases, your doctor may recommend blood tests before and possibly during treatment with Atorvastatina Combix to assess your risk of experiencing 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 Atorvastatina Combix with other medicines").

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

While taking this medicine, your doctor will monitor you for diabetes or risk factors for developing diabetes. Your risk of diabetes increases if you have high levels of sugar and fats in the blood, are overweight, or have high blood pressure.

Other medicines and Atorvastatina Combix

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Some medicines may affect how Atorvastatina Combix works, or Atorvastatina Combix may affect how other medicines work. These 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, tipranavir combined with ritonavir, 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 Combix include: ezetimibe (cholesterol-lowering), warfarin (blood thinner), oral contraceptives, stiripentol (an anticonvulsant used to treat epilepsy), cimetidine (used for heartburn and peptic ulcer), phenazone (an analgesic), colchicine (used to treat gout), and antacids (indigestion remedies containing aluminium or magnesium).
• Over-the-counter medicines: St. John’s wort.
• If you need to take oral fusidic acid to treat a bacterial infection, you must temporarily stop taking this medicine. Your doctor will advise you when it is safe to restart Atorvastatina Combix. Taking Atorvastatina Combix together with fusidic acid may rarely cause muscle weakness or pain (rhabdomyolysis). For further information on rhabdomyolysis, see section 4.
• Daptomycin (a medicine used to treat complicated skin and skin structure infections and bloodstream infections caused by bacteria).

Taking Atorvastatina Combix with food, drinks, and alcohol

See section 3 for instructions on how to take Atorvastatina Combix. Please note the following:

Grapefruit juice

Do not drink more than one or two small glasses of grapefruit juice per day, as large amounts may interfere with the effects of Atorvastatina Combix.

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 Atorvastatina Combix if you are pregnant, think you may be pregnant, or are trying to become pregnant.

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

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

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

Driving and using machines

This medicine usually does not affect your ability to drive or operate machinery. However, do not drive if this medicine affects your ability to do so. Do not operate tools or machinery if this medicine impairs your ability to use them safely.

3. How to take Atorvastatina Combix

Before starting treatment, your doctor will prescribe a cholesterol-lowering diet, which you must continue to follow during treatment with Atorvastatina Combix.

The usual starting dose of Atorvastatina Combix 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 Atorvastatina Combix is 80 mg once daily.

Atorvastatina Combix 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 provided by your doctor or pharmacist for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

Your doctor will decide the duration of treatment with Atorvastatina Combix.

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

If you take more Atorvastatina Combix than you should

If you accidentally take too many Atorvastatina Combix tablets (more than your usual daily dose), contact your doctor or the nearest hospital, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount taken. Bring any remaining tablets, the packaging, and the full box so that hospital staff can easily identify the medication you have taken.

If you forget to take Atorvastatina Combix

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 Atorvastatina Combix

If you have any further questions about using this medicine, or if you wish to stop 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 serious adverse effects, stop taking these tablets immediately and contact your doctor 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 cause 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 change in urine color to red-brown, especially if accompanied by general malaise or high fever, may be due to abnormal muscle breakdown (rhabdomyolysis). Abnormal muscle breakdown does not always resolve even after stopping atorvastatin and can be fatal and cause kidney problems.

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

• If you experience 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 Atorvastatina Combix:

Common (may affect up to 1 in 10 people):

• Nasal inflammation, sore throat, nosebleeds
• Allergic reactions
• Increased 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 that may show abnormal liver function

Uncommon (may affect up to 1 in 100 people):

• Anorexia (loss of appetite), weight gain, decreased blood sugar levels (if you are diabetic, continue to monitor your blood sugar levels carefully)
• Nightmares, insomnia
• Dizziness, numbness or tingling in 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 (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 and 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)

Frequency not known: cannot be estimated from available data:

• Persistent muscle weakness
• Myasthenia gravis (a condition causing generalized muscle weakness which, in some cases, affects the muscles used for breathing).
• Ocular myasthenia (a condition causing 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 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. 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, consult your doctor or pharmacist, even if it is an adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Atorvastatine Combix

Keep this medicine out of sight and reach of children.

Do not store above 30°C.

Do not use Atorvastatine Combix after the expiry date stated on the blister and 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. Unused medicines and waste materials should be returned to the SIGRE point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Atorvastatin Combix 80 mg tablets

The active substance is atorvastatin. Each tablet contains 80 mg of atorvastatin as atorvastatin calcium.

The other components are microcrystalline cellulose, anhydrous sodium carbonate, maltose, sodium croscarmellose, magnesium stearate, hypromellose, hydroxypropylcellulose, triethyl citrate, polysorbate 80, titanium dioxide (E171).

Appearance of the medicine and contents of the pack

White to off-white, elliptical, biconvex, smooth, film-coated tablets, measuring 18.8 mm x 10.3 mm.

Each pack contains 28 tablets, packaged in aluminum/aluminum blisters.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

Teva Pharma, S.L.U.

Polígono Malpica, Calle C nº 4

50016 Zaragoza

Date of the most recent revision of this leaflet: October 2024

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