Label:information for the patient

AtorvastatinaPharmaCombix40mgcomprimidos recubiertosconpelícula EFG

Please read all the information in this leaflet carefully before you start using Atorvastatina Pharma Combix 40 mg, because it contains important information for you.

• Read this leaflet carefully, and keep it for future reference.
• Consult your doctor or pharmacist if you have any doubts.
• This medicine has been prescribed for you only; do not pass it on to others, even if their symptoms are the same as yours.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What is Atorvastatina Pharma Combix and how is it used?
2. What you need to know before you start taking Atorvastatina Pharma Combix.
3. How to take Atorvastatina Pharma Combix.
4. Possible side effects.
5. Advice on the use of Atorvastatina Pharma Combix.
6. Contents of the pack and additional information.

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

AtorvastatinaPharmaCombixis 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 have a high risk of heart disease, AtorvastatinaPharmaCombixmay also be used to reduce this risk even if your cholesterol levels are normal. During treatment, a standard low-cholesterol diet must be followed.

Do not take AtorvastatinaPharmaCombix

• if you are allergic to atorvastatina, any other medication used to reduce blood lipids, 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 liver function test results.
• 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 taking the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C.

Warnings and precautions

Consult your doctor or pharmacist before starting to take AtorvastatinaPharmaCombix.

For the following reasons, AtorvastatinaPharmaCombixmay not be suitable for you:

• if you have had a previous stroke with brain bleeding, or have small fluid-filled cysts 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 recurring 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., another statin or fibrate).
• if you have or have had myasthenia (a disease that causes generalized muscle weakness, which in some cases affects the muscles used for breathing) or myasthenia gravis (a disease that causes weakness of the eye muscles), as statins can 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.
• If you are takingor have taken in the last 7days any medication that contains fusidic acid.

Inform your doctor or pharmacist before taking AtorvastatinaPharmaCombix

• if you have severe respiratory failure.
• if you have persistent muscle weakness. You may need further tests and additional medications to diagnose and treat this problem.

In any of these cases, your doctor may instruct you to have blood tests before and possibly during treatment with AtorvastatinaPharmaCombixto predict the risk of experiencing muscle-related adverse effects. It is known that the risk of experiencing muscle-related adverse effects (e.g., rhabdomyolysis) increases when certain medications are taken at the same time (see section 2 “Taking AtorvastatinaPharmaCombixwith other medications”).

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

Taking AtorvastatinaPharmaCombixwith other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to use any other medication.

There are some medications that can affect the proper functioning of AtorvastatinaPharma Combixor the effects of these medications may be modified by AtorvastatinaPharmaCombix. This type of interaction may reduce the effect of one or both medications. Alternatively, this concurrent 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, ciclosporina.
• 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, etc.
• Some medications used to treat hepatitis C, such as telaprevir, boceprevir, and the combination of elbasvir/grazoprevir.
• Other medications that are known to interact with atorvastatina include ezetimibe (which reduces cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant for treating epilepsy), cimetidine (used for heartburn and peptic ulcers), phenazone (a pain reliever), colchicine (used for treating gout) and antacids (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 stop taking this medication.Your doctor will instruct you when you can resume treatment with AtorvastatinaPharma Combix. The use of Atorvastatina Pharma Combixwith fusidic acid may produce muscle weakness, sensitivity, or pain (rhabdomyolysis). For more informationon rhabdomyolysis, see section 4.
• Daptomycin (a medication used to treat skin and soft tissue infections and bacteria present in the blood).

Taking AtorvastatinaPharmaCombixwith foods, beverages, and alcohol

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

Alcohol

Avoid drinking large amounts of alcohol while taking this medication. See details in section 2 “Warnings and precautions”.

Pregnancy, breastfeeding, and fertility

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

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

Do not take AtorvastatinaPharmaCombixif you are fertile and do not use adequate contraceptive measures.

Do not take AtorvastatinaPharmaCombixif you are breastfeeding your child.

The safety of AtorvastatinaPharmaCombixhas not been demonstrated during pregnancy and breastfeeding.

Driving and operating machinery

Do not drive if this medication affects your ability to drive. Do not operate tools or machinery if this medication affects your ability to handle them.

AtorvastatinaPharmaCombixcontains lactose. This medication contains lactose. If your doctor has told you that you have a lactose intolerance, consult with him before taking this medication.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.

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

The usual initial dose is 10 mg once a day in adults and children over 10 years old. 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 is 80 mg once a day for adults and 20 mg once a day for children.

The 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.

Your doctor will decide the duration of treatment with atorvastatina.

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

If you take more Atorvastatina Pharma Combix than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately for medical assistance at 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Atorvastatina Pharma Combix

If you forgot to take a dose, take the next scheduled dose at the correct time. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Atorvastatina Pharma Combix

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

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

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: affect between 1 and 10 of every 10,000 patients:

• Severe allergic reaction that causes swelling of the face, tongue, and throat, which can make breathing very difficult.
• Severe skin peeling and inflammation disease; 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 can form blisters.
• Muscle weakness, sensitivity, pain, urine color change to brown-red, and particularly, if at the same time, you have discomfort or have high fiber, it may be due to an abnormal muscle rupture (rhabdomyolysis). The abnormal muscle rupture does not always disappear, even after stopping atorvastatin, and can be potentially fatal and cause kidney problems.

Very rare: affect fewer than 1 of every 10,000 patients:

• If you experience unexpected or unusual bleeding or bruising problems, 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 atorvastatin:

Frequent side effects (affect between 1 and 10 of every 100 patients) include:

• nasal inflammation, sore throat, nosebleed
• 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

Rare side effects (affect between 1 and 10 of every 1,000 patients) include:

• 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 side effects (affect between 1 and 10 of every 10,000 patients) include:

• Vision changes
• Unexpected or unusual bleeding or bruising
• Cholestasis (yellowing of the skin and white of the eyes)
• Tendon damage
• Skin rash or ulcers in the mouth (drug reaction)
• Skin lesions of purple color (signs of inflammation of blood vessels, vasculitis)

Very rare side effects (affect fewer than 1 of every 10,000 patients) include:

• 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 and women).

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 medicine.

Side effects of unknown frequency:

• Constant muscle weakness.
• Myasthenia gravis (a disease that causes generalized muscle weakness that, 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, eyelid drooping, difficulty swallowing, or difficulty breathing.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System of 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.

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