Atorvastatina davur 80 mg comprimidos recubiertos con pelicula efg

PATIENT INFORMATION LEAFLET

Atorvastatina Davur 80 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 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. See section 4.

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

2. What you need to know before taking 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 medications known as statins, which are medications that regulate lipids (fats).

Atorvastatina Davur 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 Davurmay 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 Atorvastatina Davur

• If you are allergic to atorvastatin or any of the other ingredients 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 using the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C.

Warnings and precautions

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

For the following reasons, Atorvastatina Davur may not be suitable for you:

• If you are taking or have taken within the last 7 days a medication containing fusidic acid (used for bacterial infections) by mouth or injection. The combination of fusidic acid and Atorvastatina Davur may cause severe muscle problems (rhabdomyolysis).
• If you have had a previous stroke with brain bleeding, or have small fluid-filled 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 previous muscle problems during treatment with other lipid-lowering medications (e.g., 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 that causes generalized muscle weakness, which 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).

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

• Have severe respiratory failure.

While you are 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.

In any of these cases, your doctor may instruct you to have blood tests before and possibly during treatment with Atorvastatina Davur 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 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.

Use of Atorvastatina Davur with other medications

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 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:

• If you need to take oral fusidic acid 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 cause muscle weakness, sensitivity, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.
• Medications used to modify the functioning of your immune system, e.g., ciclosporin.
• Certain antibiotics or antifungal medications, e.g., erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid.
• Other medications to regulate lipid levels, e.g., gemfibrozil, other fibrates, colestipol.
• Some calcium channel blockers used in the treatment of angina or high blood pressure, e.g., amlodipine, diltiazem; medications to regulate your heart rhythm, e.g., digoxin, verapamil, amiodarone.
• Medications used in the treatment of AIDS, e.g., 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 Davur, including ezetimibe (which reduces cholesterol), warfarin (which reduces blood clotting), oral contraceptives, and stiripentol (an anticonvulsant for treating epilepsy), cimetidine (used for heartburn and stomach ulcers), colchicine (used for treating gout), phenazone (a pain reliever), and antacids (products for indigestion containing aluminum or magnesium).

• Over-the-counter medications: St. John's Wort.
• Daptomycin (a medication used to treat skin and soft tissue infections and bacteria present in the blood).

Inform your doctor or pharmacist if you are using or have used recently other medications, including those obtained without a prescription.

Taking Atorvastatina Davur with food, drinks, and alcohol

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

Alcohol

Avoid drinking large amounts of alcohol while taking this medication. See details in section 2 “Be especially careful with Atorvastatina Davur”.

Pregnancy and breastfeeding

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

Pregnancy

Do not take Atorvastatina Davur if you are pregnant, think you may be pregnant, or 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 your child.

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.

Excipients

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

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

The usual initial dose of Atorvastatina Davur is 10 mg once a day in adults and children aged 10 years and 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 Davur is 80 mg once a day for adults and 20 mg once a day for children.

Atorvastatina Davur 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 Atorvastatina Davur given by your doctor. Consult your doctor or pharmacist if you have any doubts.

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

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

If you take more Atorvastatina Davur than you should.

If you accidentally take too many Atorvastatina Davur 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.

If you forget to take Atorvastatina Davur.

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 Davur.

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

Like all medicines, Atorvastatina Davur 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 visit the nearest hospital emergency department.

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 difficult.

• 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 can form blisters.

• Muscle weakness, pain on palpation, pain or rupture, change in urine color to brown-red, and especially if you have discomfort or high fever, it may be due to an abnormal muscle rupture that can be fatal and cause kidney problems.

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

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

Other possible side effects with Atorvastatina Davur:

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

• nasal congestion, sore throat, nosebleeds
• 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 results from blood tests that may show abnormal liver function
• 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.

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

• loss of appetite, weight gain, decrease in blood sugar levels (if you are diabetic, continue to monitor your blood sugar levels carefully)
• 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)
• hepatitis (inflammation of the liver)
• skin 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 bleeding or bruising
• bile duct obstruction (yellowing of the skin and eyes)
• tendon damage
• skin rash or ulcers in the mouth (drug-induced lichenoid reaction)
• skin lesions of purple color (signs of inflammation of blood vessels, vasculitis)

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

• allergic reaction - symptoms may include sudden hissing while breathing and chest pain or tightness, swelling of the eyelids, face, lips, mouth, tongue, or throat, difficulty breathing, collapse
• hearing loss
• gynecomastia (breast enlargement in men and women).

Side effects of unknown frequency:

Constant muscle weakness.

Severe myasthenia (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing).

Myasthenia gravis (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

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

Reporting 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 leaflet. You can also report them directly through the Spanish System for 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 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 blister 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 of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Atorvastatina Davur

- The active ingredient is atorvastatina.

Cada comprimido contains 80 mg of atorvastatina as atorvastatina calcium.

The other components (excipients) are:Microcrystalline cellulose, Anhydrous sodium carbonate, Maltose, Sodium croscarmellose, Magnesium stearate, Hypromellose (Pharmacoat Gr. 606), Hydroxypropylcellulose, Triethyl citrate, Polysorbate 80, and Titanium dioxide (E-171).

Appearance of Atorvastatina Davur and contents of the packaging

Coated tablets.

The tablets are white or almost white, elliptical, biconvex, and smooth.

Each package contains 28 tablets.

Holder of the marketing authorization and responsible for manufacturing

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.

Malpica Industrial Estate, Street C, number 4.

50016 Zaragoza. Spain.

Last review date 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/