ATORVASTATIN DAVUR 80 mg FILM-COATED TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Atorvastatina Davur 80 mg film-coated tablets EFG

Read all of this 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What is Atorvastatina Davur and what is it used for
2. What you need to know before you take Atorvastatina Davur
3. How to take Atorvastatina Davur
4. Possible side effects
5. Storing Atorvastatina Davur
6. Contents of the pack and other information

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

Atorvastatina Davur belongs to a group of medicines known as statins, which are medicines 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 not worked. If you are at high risk of heart disease, Atorvastatina Davur can also be used to reduce this risk even if your cholesterol levels are normal. During treatment, you should follow a standard low-cholesterol diet.

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

Do not take Atorvastatina Davur

• If you are allergic to atorvastatin or 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 blood test results for liver function.
• 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 breast-feeding.
• If you are taking the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C.

Warnings and precautions

Consult your doctor or pharmacist before taking Atorvastatina Davur.

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

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

• have severe respiratory failure.

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

In any of these cases, your doctor may indicate that you should have blood tests before and possibly during treatment with Atorvastatina Davur to predict the risk of muscle-related side effects. It is known that the risk of muscle-related side effects (e.g. rhabdomyolysis) increases when certain medicines are taken at the same time (see section 2 "Use with other medicines").

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.

Using Atorvastatina Davur with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

There are some medicines that can affect the proper functioning of Atorvastatina Davur or the effects of these medicines may be modified by Atorvastatina Davur. This type of interaction can decrease the effect of one or both medicines:

• medicines used to modify the functioning of your immune system, such as cyclosporin.
• certain antibiotics or antifungal medicines, such as erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid.
• other medicines to regulate lipid levels, such as gemfibrozil, other fibrates, colestipol.
• certain calcium channel blockers used to treat angina or high blood pressure, such as amlodipine, diltiazem; medicines to regulate your heart rate, such as digoxin, verapamil, amiodarone.
• medicines used to treat AIDS, such as ritonavir, lopinavir, atazanavir, indinavir, darunavir, etc.
• certain medicines used to treat hepatitis C, such as telaprevir, boceprevir, and the combination of elbasvir/grazoprevir.
• other medicines that are known to interact with Atorvastatina Davur include ezetimibe (which reduces cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant to treat epilepsy), cimetidine (used for heartburn and peptic ulcers), colchicine (used to treat gout), fenazon (a pain reliever), and antacids (products for indigestion that contain aluminum or magnesium).

• medicines obtained without a prescription: St. John's Wort.
• daptomycin (a medicine used to treat skin and skin structure infections with complications and bacteria present in the blood).

Tell your doctor or pharmacist if you are using or have recently used other medicines, even 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:

Grapefruit juice

Do not drink more than one or two small glasses of grapefruit juice per day, as large quantities of grapefruit juice can alter the effects of Atorvastatina Davur.

Alcohol

Avoid drinking too much alcohol while taking this medicine. See the details in Section 2 "Be careful with Atorvastatina Davur".

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Do not take Atorvastatina Davur if you are pregnant, think you may be pregnant, or are planning to become pregnant. If you are of childbearing age, you should use reliable contraceptive methods during treatment with Atorvastatina Davur.

Breast-feeding

Do not take Atorvastatina Davur if you are breast-feeding.

Driving and using machines

Do not drive if this medicine affects your ability to drive. Do not use tools or machines if this medicine affects your ability to use them.

Excipients

This medicine contains less than 1mmol of sodium (23 mg) per tablet; this is essentially "sodium-free".

3. How to take Atorvastatina Davur

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

The usual initial dose of Atorvastatina Davur is 10 mg once a day in adults and children from 10 years of age. Your doctor may increase it if necessary until you 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.

The tablets of Atorvastatina Davur should be swallowed whole with a glass of water and can be taken at any time of day with or without food. However, try to take your tablet at the same time every day.

Follow your doctor's instructions for taking Atorvastatina Davur exactly. Ask 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), talk to your doctor or go to the nearest hospital or call the Toxicology 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 forgotten doses.

If you stop taking Atorvastatina Davur

If you have any further questions on the use of this medicine or want to stop treatment, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Atorvastatina Davur can cause side effects, although not everybody gets them.

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

Rare: affects between 1 and 10 in every 10,000 patients:

• severe allergic reaction that causes swelling of the face, tongue, and throat, which can cause great difficulty breathing.

• severe disease with severe peeling and inflammation of the skin; blisters on the skin, mouth, genitals, and eyes, and fever. Rash with pink-red spots, especially on the palms of the hands or soles of the feet, which can form blisters.

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

Very rare: affects less than 1 in every 10,000 patients:

Other possible side effects of Atorvastatina Davur:

Common side effects (affect between 1 and 10 in every 100 patients) include:

• nasal inflammation, 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.
• diabetes. It is more likely if you have high levels of sugars and fats in the blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine.

Uncommon side effects (affect between 1 and 10 in every 1,000 patients) include:

• loss of appetite, weight gain, decreased blood sugar levels (if you are diabetic, you should 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).
• hepatitis (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 in every 10,000 patients) include:

• vision changes.
• unexpected bleeding or bruising.
• jaundice (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 inflammation of the blood vessels, vasculitis).

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

• allergic reaction - symptoms may include sudden wheezing, coughing, 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 general muscle weakness that can affect the muscles used for breathing).

ocular myasthenia (a disease that causes weakness of the eye muscles).

Tell your doctor if you experience weakness in your 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.

Reporting side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Atorvastatina Davur

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

Store below 30°C.

Do not use Atorvastatina Davur after the expiry date which is stated on the blister and on the carton after EXP. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Atorvastatina Davur

• The active substance is atorvastatin.

Each tablet contains 80 mg of atorvastatin as atorvastatin calcium.

The other ingredients (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 pack

Film-coated tablets.

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

Each pack contains 28 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Teva Pharma, S.L.U.

C/ Anabel Segura, 11 - Edificio Albatros B, 1ª planta.

28108 – Alcobendas (Madrid)

Manufacturer

Teva Pharma, S.L.U.

Polígono Malpica, Calle C nº 4.

50016 Zaragoza. Spain.

Date of last revision of this leaflet: November 2024

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