Package Leaflet: Information for the User

Atorvastatina Combix 20 mg Film-Coated Tablets

Read this 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. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before taking Atorvastatina Combix

3. How to take Atorvastatina Combix

4. Possible side effects

5. Storage of Atorvastatina Combix

6. Contents of the pack and additional information

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

Atorvastatina Combix 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 Combix may 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 AtorvastatinaCombix

• If you are allergic to atorvastatin or any of the other components of this medication (listed in section 6).
• If you have or have had any liver disease.
• If you have or have had abnormal results in liver function tests.
• 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.
• If you are using the combination of glecaprevir/pibrentasvir for hepatitis C treatment.

Warnings and precautions

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

• if you have severe respiratory insufficiency.
• if you are taking or have taken in the last 7 days a medication called fusidic acid (a medication used to treat bacterial infections) orally or by injection. The combination of fusidic acid and atorvastatin may cause severe muscle problems (rhabdomyolysis).
• if you have had a previous stroke with cerebral bleeding, 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 lipid-lowering medications (e.g., with another statin or fibrates).
• 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 may sometimes worsen the disease or cause 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 instruct you to have blood tests before and possibly during treatment with Atorvastatina Combix to predict the risk of adverse effects related to muscle. It is known that the risk of adverse effects related to muscle (e.g., rhabdomyolysis) increases when certain medications are taken at the same time (see section 2 "Use of Atorvastatina Combix with other medications").

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

While taking this medication, your doctor will monitor if you have diabetes or a risk of developing diabetes. This risk of diabetes increases if you have high blood sugar and fat levels, obesity, and high blood pressure.

Other medications and Atorvastatina Combix

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.There are some medications that may affect the proper functioning of Atorvastatina Combix or the effects of these medications may be modified by Atorvastatina Combix. This type of interaction may reduce the effect of one or both medications. 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:

• Medications used to modify the functioning of your immune system, for example, cyclosporine.
• Certain antibiotics or antifungal medications, for example, erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid.
• Other medications to regulate lipid levels, for example, gemfibrozil, other fibrates, cholestyramine.
• Some calcium channel blockers used in the treatment of angina or hypertension, for example, amlodipine, diltiazem, medications to regulate your heart rhythm, for example, digoxin verapamil, amiodarone.
• Medications used in the treatment of AIDS, for example, ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir combined with ritonavir, etc.
• Some medications used for the treatment of hepatitis C, such as telaprevir, boceprevir, and the combination of elbasvir/grazoprevir.
• Other medications that are known to interact with Atorvastatina Combix include: ezetimibe (which reduces cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (anticonvulsant for treating epilepsy), cimetidine (used for heartburn and peptic ulcers),fenazone (a pain reliever), colchicine (used for treating gout) andantacids (products for indigestion containing aluminum or magnesium).
• Over-the-counter medications: 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 medication. Your doctor will instruct you when it is safe to restart treatment with Atorvastatina Combix. Taking Atorvastatina Combix in combination with fusidic acid may rarely cause muscle weakness, pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.
• Daptomycin (a medication used to treat skin and skin structure infections and bacteremia).

Taking Atorvastatina Combix with food, drinks, and alcohol

See section 3 for instructions on how to take Atorvastatina Combix. 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 may alter the effects of Atorvastatina Combix.

Alcohol

Avoid drinking large amounts of alcohol while taking this medication. 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 fertile and do not use 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 demonstrated. Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

This medication usually does not affect your ability to drive or operate machinery. However, do not drive if this medication affects your ability to drive. Do not operate tools or machinery if this medication affects your ability to operate them.

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

The usual initial dose of Atorvastatina Combix is 10 mg once a day in adults and in children aged 10 years or older. 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 Combix is 80 mg once a day.

Atorvastatina Combix 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 this medication indicated by your doctor or pharmacist. If in doubt, 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 moreAtorvastatina Combix than you should

If you accidentally take too many Atorvastatina Combix 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, indicating the medication and the amount taken. Bring the remaining tablets, the packaging, and the complete box so that the 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 doses.

If you interrupt treatment with Atorvastatina Combix

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.This medicine

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

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

• Severe allergic reaction that causes swelling of the face, tongue, and throat, which may make it difficult to breathe.
• 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 may form blisters.
• Muscle weakness, pain on palpation, pain, urine discoloration to brown-red, and especially if you have discomfort or high fever, it may be due to abnormal muscle rupture (rhabdomyolysis). Abnormal muscle rupture does not always disappear, even after stopping atorvastatin, and may 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 suggest liver problems. You should consult your doctor as soon as possible.
• Lupus-like syndrome (including rash, joint disorders, and effects on blood cells).

Other possible side effects with Atorvastatina Combix:

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

• nasal congestion, sore throat, nasal bleeding
• 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
• Abnormal blood test results that may show abnormal liver function

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

• Anorexia (loss of appetite), weight gain, decreased blood sugar levels (if you are diabetic, continue to carefully monitor your blood sugar levels)
• Nightmares, insomnia
• 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)
• Heptatitis (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 (may affect up to 1 in 1,000 people):

• Vision changes
• Unexpected or unusual bleeding or bruising
• Bile duct obstruction (yellowing of the skin and white of the eyes)
• Tendon damage
• Skin rash or ulcers in the mouth (drug reaction)
• Lesions on the skin or purple spots (signs of inflammation of blood vessels, vasculitis)

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

• Allergic reaction - symptoms may include sudden hissing while breathing and chest pain or pressure, swelling of the eyelids, face, lips, mouth, tongue, or throat, difficulty breathing, collapse
• Loss of hearing
• Gynecomastia (breast enlargement in men)

Frequency unknown: cannot be estimated from available data:

• Constant muscle weakness
• Myasthenia gravis (a disease that causes generalized muscle weakness, which in some cases affects the muscles used for breathing).
• Myasthenia ocular (a disease that causes 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 eyelid drooping, 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. 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 or pharmacist, even if it is a 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: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not store at a temperature above30°C.

Do not use Atorvastatina Combix after the expiration date that appears on the blister pack 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 at the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Atorvastatina Combix 20 mg tablets

The active ingredient is atorvastatina. Each tablet contains 20 mg of atorvastatina as atorvastatina calcium.

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

Appearance of the product and content of the packaging

White, elliptical, biconvex, smooth, film-coated tablets, with dimensions of 12.5 mm x 6.6 mm.

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

Holder of the marketing authorization and Responsible for the manufacturing

Holder of the marketing authorization

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Responsible for the manufacturing

Teva Pharma, S.L.U.

Polígono Malpica, Calle C nº 4

50016 Zaragoza

Last review date of this leaflet:October2024

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/