ATORVASTATIN DAVUR 40 mg FILM-COATED TABLETS

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 results in blood tests for liver function.
• If you are a woman of childbearing age and do not use 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 starting to take Atorvastatina Davur.

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

• If you are taking or have taken in the last 7 days a medicine that contains fusidic acid (used to treat bacterial infections) orally or by injection. The combination of fusidic acid and Atorvastatina Davur can cause serious muscle problems (rhabdomyolysis).
• If you have had a previous stroke with bleeding in the brain, or have small fluid-filled sacs in the brain due to previous strokes.
• If you have kidney problems.
• If you have an underactive thyroid gland (hypothyroidism).
• If you have repeated or unexplained muscle pain, personal or family history of muscle problems.
• If you have had muscle problems before while taking other medicines to lower lipid levels (e.g. with 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 that can affect the muscles used for breathing) or ocular myasthenia (a disease that causes weakness of the eye muscles), as statins can sometimes worsen the disease or cause myasthenia to appear (see section 4).

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 "Using other medicines").

Also, inform your doctor or pharmacist if you experience constant muscle weakness. Tests and additional medication 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:

• If you need to take oral fusidic acid to treat a bacterial infection, you will need to stop using this medicine. Your doctor will tell you when you can restart treatment with Atorvastatina Davur. The use of Atorvastatina Davur with fusidic acid can cause muscle weakness, sensitivity, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.
• Medicines used to modify the functioning of your immune system, such as cyclosporine.
• 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 HIV, 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), phenazone (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 large amounts of 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

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

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Breast-feeding

Do not take Atorvastatina Davur if you are breast-feeding your child. If you are of childbearing age, you should use safe contraceptives during treatment with Atorvastatina Davur.

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 1 mmol of sodium (23 mg) per tablet, i.e., it 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 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. 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 tablets of Atorvastatina Davur (more than your usual daily dose), consult your doctor or the nearest hospital or call the Toxicology Information Service, telephone 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 missed 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 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 10,000 patients:

• If you experience bleeding or bruising problems, 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).

Other possible side effects with Atorvastatina Davur:

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

• nose 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 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 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 10,000 patients) include:

• allergic reaction - symptoms may include sudden wheezing 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 can affect the muscles used for breathing).

Ocular myasthenia (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 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, even if it is possible side effects that are not listed in this leaflet. You can also report them 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 expiration date that appears on the blister pack and carton after EXP. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition of Atorvastatina Davur

• The active substance is atorvastatin.

Each tablet contains 40 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.

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

28108 – Alcobendas (Madrid)

Manufacturer

Teva Pharma, S.L.U.

Malpica Industrial Estate, Calle C nº 4.

50016 Zaragoza, Spain.

Date of the last revision of this leaflet: November 2024

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