Leaflet: information for the user

Atorvastatina Davur 60 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, and you must not give it 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.

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

2. What you need to know before starting to take Atorvastatina Davur

3. How to take Atorvastatina Davur

4. Possible side effects

5. Storage of Atorvastatina Davur

6. Contents of the pack and additional information

Atorvastatina Davur belongs to a group of medicines called statins, it is a medicine to reduce the lipids (fats) in the blood.

Atorvastatina Davur is used as a complement to a change in diet to reduce the amount of lipids in the blood such as cholesterol and triglycerides, when a low-fat diet and other treatments such as physical exercise and lifestyle changes have not been sufficient.

Atorvastatina Davur is also used as a complement to other treatments that reduce lipids (e.g.: LDL apheresis: procedure to reduce LDL cholesterol in the blood) or when these treatments are not available.

If you have a high risk of cardiovascular disease, Atorvastatina Davur may also be used to reduce this risk even though your cholesterol levels are normal.

Cholesterol is a substance that is found naturally in the body necessary for normal growth. However, if there is too much cholesterol in the blood it can deposit in the walls of blood vessels, which can become blocked. This is one of the most common causes of heart disease. It is accepted that high cholesterol levels increase the risk of heart disease. Other factors that increase the risk of heart disease are high blood pressure, diabetes, weight gain, sedentary lifestyle, smoking or family history of heart disease.

Do not take Atorvastatina Davur

• if you are allergic to atorvastatin, to any other medication used to reduce blood lipids or to 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 using the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C.
• if you have a muscle disorder called myopathy
• if you are pregnant or breastfeeding.
• if you are a fertile woman and do not use adequate contraceptive measures

Warnings and precautions

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

-if you are taking or have taken in the last 7 days a medication that contains fusidic acid (used for the treatment of bacterial infection) by oral or injection route. The combination of fusidic acid and Atorvastatina Davur may produce severe muscle problems (rhabdomyolysis)

-if you have a history of liver problems or if you consume large amounts of alcohol

-if you have impaired renal function

-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 previously had muscle problems during treatment with other lipid-lowering medications (e.g. with another statin or fibrates).

• if you are over 70 years old.

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 myasthenic eye (a disease that causes weakness of the eye muscles), as statins may sometimes worsen the disease or cause myasthenia (see section 4)

If you experience unexplained muscle pain (myalgia), cramps, pain or fatigue, especially if accompanied by discomfort or fever, contact your doctor immediately, as treatment with Atorvastatina Davur may need to be interrupted or the dose reduced.

In any of these cases, your doctor may instruct you to have blood tests before and during treatment to measure your cholesterol, blood levels and monitor your liver function.

Consult your doctor or pharmacist before taking Atorvastatina Davur if you:

− Present severe respiratory insufficiency

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

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

Use of Atorvastatina Davur with other medications

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

There are some medications that may change the effect of Atorvastatina Davur, or the effects of these medications may be modified by Atorvastatina Davur. This type of interaction may reduce the effect of one or both medications. Your doctor will take this into account when deciding the dose of Atorvastatina Davur.

Inform your doctor if you are taking any of the following medications:

• if you need to take fusidic acid orally to treat a bacterial infection, you will need to stop using this medication. Your doctor will instruct you when you can restart treatment with Atorvastatina Davur. The use of Atorvastatina Davur with fusidic acid may produce muscle weakness, sensitivity or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.
• Medications used to modify the functioning of your immune system, for example ciclosporina.
• Certain antibiotics or antifungal medications, for example erythromycin, clarithromycin, ketoconazole, itraconazole, rifampicin, fusidic acid.
• Other medications to regulate lipid levels, for example gemfibrozil, other fibrates, nicotinic acid derivatives and cholestyramine.
• Some calcium channel blockers used in the treatment of angina or high blood pressure, for example nifedipine, diltiazem, amlodipine.
• Medications to regulate your heart rhythm, for example digoxin, amiodarone.

-Inhibitors of protease used in the treatment of HIV infection (medications for the treatment of AIDS), for example nelfinavir, efavirenz.

-Some benzodiazepines used for anxiety and other diseases, for example nefazodone.

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 Davur 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 that contain aluminum or magnesium).

• daptomycin (a medication used to treat skin and soft tissue infections and bacteremia).

Atorvastatina Davur with food, drinks and alcohol

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

This medication can be taken with or without food.

Alcohol:

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

Pregnancy

Do not takeAtorvastatina Davur if you are pregnant or ifyou are trying to become pregnant. If you are fertile, you should use safe contraceptives during treatment with Atorvastatina Davur.

Breastfeeding

Do not take Atorvastatina Davur if you are breastfeeding.

Driving and operating machinery

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

Excipients

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

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor again.

Atorvastatina Davur is taken once a day. The medication can be taken at any time of the day, with or without food. Remember to follow a special diet and change your lifestyle during treatment with Atorvastatina Davur.

The initial dose is based on the level of cholesterol and the treatment goal. The initial normal dose is 10 mg per day. Your doctor may increase this dose after 4 weeks or more if necessary.

The maximum dose is 80 mg once a day.

The daily dose should be taken in a single dose.

Your doctor will determine the duration of treatment with Atorvastatina Davur. Ask your doctor if you think the effect of atorvastatina is too strong or too weak.

Liver Insufficiency

Atorvastatina Davur should be used with caution in patients with liver insufficiency and is contraindicated in patients with active liver disease.

Children and Adolescents (4-17 years)

The use of Atorvastatina Davur in children should be carried out under strict supervision of a specialist.

If You Take More Atorvastatina Davur Than You Should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If You Forget to Take Atorvastatina Davur

If you have forgotten to take a dose, take it as soon as possible. However, if it is almost time to take the next dose, omit the missed dose and take the next one when it is due.

Do not take a double dose to compensate for the missed doses.

If You Interrupt Treatment with Atorvastatina Davur

If you have any other doubts about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, Atorvastatina Davur can cause side effects, although not everyone will experience them.

The following side effects are serious and if you experience any of them, you will need to take immediate action. Stop taking Atorvastatina Davur and see your doctor immediately if you experience the following symptoms:

• swelling of the face, tongue, and throat that can cause difficulty breathing (angioedema). This is a very rare reaction that can be serious if it occurs. Stop taking atorvastatin and inform your doctor immediately if it occurs.
• In some cases, patients have presented muscle destruction or inflammation, and very rarely this has led to a potentially life-threatening serious disease (called rhabdomyolysis). If you have muscle weakness, pain on palpation, pain or rupture, a change in the color of your urine to brown-red and especially if you feel unwell or have a fever, stop taking atorvastatin and inform your doctor.

Very rare side effects (may affect fewer than 1 in 10,000 patients):

- if you experience unexpected or unusual bleeding or bruising, this may suggest a liver problem. You should consult your doctor as soon as possible.

• lupus-like syndrome (which includes skin rash, joint disorders, and effects on blood cells).

The following side effects have also been reported:

Frequent side effects (may affect between 1 and 10 in 100 patients): abdominal pain, constipation, gas, indigestion, nausea, diarrhea, allergic reactions, difficulty sleeping, headache, dizziness, numbness or tingling in the hands and feet, reduced sensitivity to touch or pain, rash, itching, muscle and joint pain, weakness, chest pain, back pain, and inflammation of the hands and feet.

Rare side effects (may affect between 1 and 10 in 1,000 patients):loss of appetite, vomiting, muscle cramps, unexpected bleeding or bruising due to low platelet count, hair loss, pancreatitis (inflammation of the pancreas causing stomach pain), urticaria, skin rash, memory loss, ringing or buzzing in the ears, discomfort, weight gain, impotence, increased and decreased blood sugar levels (if you have diabetes, you should have strict control of your blood sugar levels).

Rare side effects (may affect between 1 and 10 in 10,000 patients):muscle pain on palpation, liver inflammation (hepatitis), yellowing of the skin and white of the eyes (jaundice), rhabdomyolysis (severe muscle pain and weakness often associated with fever):

Very rare side effects (may affect fewer than 1 in 10,000 patients):

angioneurotic edema (swelling of the face, tongue, and throat that can cause great difficulty breathing), Stevens-Johnson syndrome (a serious disease with blisters on the skin, mouth, eyes, and genitals), erythema multiforme (irregular rash with red spots),vision and taste disorders, hearing loss, breast enlargement in men (gynecomastia), tendon fractures, liver failure.

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).

Myasthenic eye (a disease that causes 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 eyelid drooping, difficulty swallowing or difficulty breathing

Other possible side effects:

•Sleep disorders, including insomnia and nightmares

•Memory loss

•Sexual dysfunction

•Depression

•Respiratory problems, including 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 you are taking this medication.

• skin rash or ulcers in the mouth (drug reaction)
• purple skin lesions (signs of inflammation of blood vessels, vasculitis)

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, 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 for the Pharmacovigilance of Medicines for Human Use:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Store below30°C.

Do not use Atorvastatina Davur after the expiration date that appears 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 packaging and unused medicines at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Atorvastatina Davur

The active ingredient is atorvastatina. Each tablet contains 30 mg of atorvastatina as atorvastatina calcium.

The other components are:

• Microcrystalline cellulose
• Anhydrous sodium carbonate
• Maltose
• Sodium croscarmellose
• Magnesium stearate
• Hipromelose (Pharmacoat Gr. 606)
• Hydroxypropylcellulose
• Triethyl citrate
• Polysorbate 80
• Titanium dioxide (E-171)

Appearance of the product and contents of the packaging

Film-coated tablets.

The tablets are white or almost white, elliptical, biconvex, and marked with “30” on one side.

The packaging contains 28 tablets.

Holder of the marketing authorization

Teva Pharma, S.L.U.

C/ Anabel Segura, 11 - Edificio Albatros B, 1st floor.

28108 – Alcobendas (Madrid)

Responsible for manufacturing

Teva Pharma, S.L.U.

Polígono Malpica, Calle C nº 4.

50016 Zaragoza. Spain.

Date of the last review of this leaflet:November 2024

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/