Atorvastatin Combix Pharma 40 mg film-coated tablets EFG

Package leaflet: Information for the patient

Introduction

Package leaflet: information for the patient

Atorvastatin Combix Pharma 10 mg film-coated tablets EFG

Atorvastatin Combix Pharma 20 mg film-coated tablets EFG

Atorvastatin Combix Pharma 30 mg film-coated tablets

Atorvastatin Combix Pharma 40 mg film-coated tablets EFG

Atorvastatin Combix Pharma 60 mg film-coated tablets

Atorvastatin Combix Pharma 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. 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 pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, including any adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Atorvastatin Combix Pharma is and what it is used for
2. What you need to know before taking Atorvastatin Combix Pharma
3. How to take Atorvastatin Combix Pharma
4. Possible side effects
5. How to store Atorvastatin Combix Pharma
6. Contents of the pack and other information

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

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

Atorvastatin is used to lower 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, 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 taking Atorvastatina Combix Pharma

Do not take Atorvastatina Combix Pharma

• 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 this medicine:

• if you have severe respiratory insufficiency.
• if you are taking or have taken within the last 7 days an oral or injectable medicine containing 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 or have had repeated or unexplained muscle pain, or personal or family history of muscle disorders.
• if you have previously experienced muscle problems during treatment with other lipid-lowering medicines (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.
• if you have or have had myasthenia (a disease characterized by generalized muscle weakness that, 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).

In any of these cases, your doctor may decide whether you need blood tests before and possibly during treatment with atorvastatin 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 at the same time (see section 2 “Other medicines and Atorvastatina Combix Pharma”).

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.

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

Other medicines and Atorvastatina Combix Pharma

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Some medicines may interfere with the proper function of atorvastatin or their effects may be altered by atorvastatin. Such interactions may reduce the effectiveness 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 medicines to regulate lipid levels, 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.
• Letermovir, a medicine that helps prevent diseases caused by cytomegalovirus.
• Medicines used in the treatment of 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 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 will need to temporarily stop using 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 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 Pharma with food, drinks and alcohol

See section 3 for instructions on how to take this medicine. 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

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

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

Do not take atorvastatin if you are breastfeeding your child.

Do not take atorvastatin if you are of childbearing age unless you are using adequate contraceptive measures. The safety of atorvastatin 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 machines if this medicine affects your ability to handle them.

Atorvastatina Combix Pharma contains sodium

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

3. How to take Atorvastatina Combix Pharma

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Before starting treatment, your doctor will prescribe a cholesterol-lowering diet, which you must also follow during treatment with this medicine.

The usual recommended initial 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 appropriate for you. Your doctor will adjust the dose at intervals of 4 weeks or more. The maximum dose of atorvastatin is 80 mg once daily.

Atorvastatin 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.

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

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

If you take more Atorvastatina Combix Pharma 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 ingested. Bring any remaining tablets, the outer carton, and the full packaging so that hospital staff can easily identify the medicine you have taken.

If you forget to take Atorvastatina Combix Pharma

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 treatment with Atorvastatina Combix Pharma

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 experiences them.

If you notice any of the following adverse effects or serious symptoms, 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 brownish-red discoloration of the urine, especially if accompanied by 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 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

• Nasal congestion, 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: 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 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
• 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
• Hearing loss
• Gynaecomastia (enlargement of breast tissue 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 the 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. This is 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 effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can 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 Pharma

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

Do not use this medicine 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.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Atorvastatin Combix Pharma

• The active substance is atorvastatin.

Atorvastatin Combix Pharma 10 mg: each film-coated tablet contains 10 mg of atorvastatin (as atorvastatin calcium).

Atorvastatin Combix Pharma 20 mg: each film-coated tablet contains 20 mg of atorvastatin (as atorvastatin calcium).

Atorvastatin Combix Pharma 30 mg: each film-coated tablet contains 30 mg of atorvastatin (as atorvastatin calcium).

Atorvastatin Combix Pharma 40 mg: each film-coated tablet contains 40 mg of atorvastatin (as atorvastatin calcium).

Atorvastatin Combix Pharma 60 mg: each film-coated tablet contains 60 mg of atorvastatin (as atorvastatin calcium).

Atorvastatin Combix Pharma 80 mg: each film-coated tablet contains 80 mg of atorvastatin (as atorvastatin calcium).

• The other components (excipients) are:

Core: microcrystalline cellulose, calcium carbonate, maltose, sodium croscarmellose, a mixture of polysorbate 80 and magnesium aluminum metasilicate, magnesium stearate.

Coating: hypromellose, hydroxypropylcellulose, triethyl citrate, polysorbate 80, titanium dioxide (E171).

Appearance of the product and pack contents

Atorvastatin Combix Pharma 10 mg:

Film-coated tablets, white to off-white, elliptical, biconvex, marked with "10" on one side and plain on the other. The tablet length is approximately 8 mm and the width is approximately 4.4 mm.

Atorvastatin Combix Pharma 20 mg:

Film-coated tablets, white to off-white, elliptical, biconvex, marked with "20" on one side and a score line on the other. The tablet length is approximately 10 mm and the width is approximately 5.5 mm.

The tablet can be divided into equal doses.

Atorvastatin Combix Pharma 30 mg:

Film-coated tablets, white to off-white, elliptical, biconvex, marked with "30" on one side and plain on the other. The tablet length is approximately 11.5 mm and the width is approximately 6.3 mm.

Atorvastatin Combix Pharma 40 mg:

Film-coated tablets, white to off-white, elliptical, biconvex, marked with "40" on one side and a score line on the other. The tablet length is approximately 12.8 mm and the width is approximately 6.9 mm.

The tablet can be divided into equal doses.

Atorvastatin Combix Pharma 60 mg:

Film-coated tablets, white to off-white, elliptical, biconvex, marked with "60" on one side and plain on the other. The tablet length is approximately 14.2 mm and the width is approximately 7.8 mm.

Atorvastatin Combix Pharma 80 mg:

Film-coated tablets, white to off-white, elliptical, biconvex, marked with "80" on one side and a score line on the other. The tablet length is approximately 16 mm and the width is approximately 8.7 mm.

The tablet can be divided into equal doses.

Atorvastatin Combix Pharma is available in standard blisters or pre-cut single-dose blisters, in packs of 28 and 30 tablets for the 10 mg and 20 mg strengths, and in packs of 28 tablets for the 30 mg, 40 mg, 60 mg, and 80 mg strengths.

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.,

C/C, n. 4, Polígono Industrial Malpica,

50016 Zaragoza, Spain

OR

Teva Operations Poland Sp. z.o.o, ul.

Mogilska 80.

31-546, Krakow, Poland

Date of latest revision of this package leaflet: February 2025

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