ATORVASTATIN TARBIS 20 mg FILM-COATED TABLETS

Introduction

Patient Information Leaflet

Atorvastatina Tarbis20mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine.

• 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, do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack

1. What Atorvastatina Tarbis is and what it is used for
2. Before taking Atorvastatina Tarbis
3. How to take Atorvastatina Tarbis
4. Possible side effects
5. Storing Atorvastatina Tarbis
6. Further information

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

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

Atorvastatina Tarbis 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 Tarbis 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. Before taking Atorvastatina Tarbis

Do not take Atorvastatina Tarbis

• If you are allergic (hypersensitive) to atorvastatin or to any other similar medicine used to reduce blood lipids or to any of the other ingredients of this medicine – see more details 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 are not using adequate contraceptive measures.
• If you are pregnant or trying to become pregnant.
• If you are breast-feeding.
• If you are using the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C.

Be especially careful with Atorvastatina Tarbis

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

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

• 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 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).
• 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 previously had muscle problems during treatment with other lipid-lowering medicines (e.g., with another statin or fibrates).
• 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 Tarbis can cause serious muscle problems (rhabdomyolysis).
• if you regularly drink large amounts of alcohol.
• if you have a history of liver problems.
• if you are over 70 years old.

Talk to your doctor or pharmacist before taking Atorvastatina Tarbis

• if you have severe respiratory failure.

In any of these cases, your doctor may indicate that you should have blood tests before and possibly during treatment with Atorvastatina Tarbis 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. You may need additional tests and medicines to diagnose and treat this problem.

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 sugar and fat in the blood, are overweight, and have high blood pressure.

Using Atorvastatina with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicine.

There are some medicines that can affect the proper functioning of Atorvastatina Tarbis or the effects of these medicines may be modified by Atorvastatina Tarbis. This type of interaction can decrease the effect of one or both medicines. Alternatively, this combined use can increase the risk or severity of side effects, including important muscle damage, known as rhabdomyolysis described in Section 4:

• Medicines used to modify the functioning of your immune system, e.g., cyclosporine.
• Certain antibiotics or antifungal medicines, e.g., erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin.
• If you need to take oral fusidic acid to treat a bacterial infection, you will have to stop using this medicine. Your doctor will tell you when you can restart treatment with Atorvastatina Tarbis. The use of Atorvastatina Tarbis with fusidic acid can cause serious muscle problems (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.
• Other medicines for regulating lipid levels, e.g., gemfibrozil, other fibrates, colestipol.
• Certain calcium channel blockers used to treat angina or high blood pressure, e.g., amlodipine, diltiazem; medicines to regulate your heart rhythm, e.g., digoxin, verapamil, amiodarone.
• Medicines used to treat AIDS, e.g., 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 Tarbis 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), phenazone (a pain reliever), colchicine (used to treat gout), and antacids (indigestion products containing aluminum or magnesium).

• Medicines obtained without a prescription: St. John's Wort.

Taking Atorvastatina Tarbis with food and drinks

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

Alcohol

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

Pregnancy and breast-feeding

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

Do not take Atorvastatina Tarbis if you are of childbearing age and are not using adequate contraceptive measures.

Do not take Atorvastatina Tarbis if you are breast-feeding your child.

The safety of Atorvastatina Tarbis during pregnancy and breast-feeding has not been established.

Consult your doctor or pharmacist before using any medicine.

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.

3. How to take Atorvastatina Tarbis

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

The usual initial dose of Atorvastatina Tarbis 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 Tarbis is 80 mg once a day for adults and 20 mg once a day for children.

The tablets of Atorvastatina Tarbis 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 at the same time every day.

Follow your doctor's instructions for taking Atorvastatina Tarbis exactly. Consult your doctor or pharmacist if you have any doubts.

Your doctor will decide the duration of treatment with Atorvastatina Tarbis

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

If you take more Atorvastatina Tarbis than you should

If you accidentally take too many tablets of Atorvastatina Tarbis (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 Tarbis

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 Tarbis

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

4. Possible side effects

Like all medicines, Atorvastatina Tarbis 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, muscle rupture, or 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 or unexpected or unusual bleeding, this may suggest a liver problem. You should consult your doctor as soon as possible.

Other possible side effects with Atorvastatina Tarbis:

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

• nose inflammation, sore throat, nosebleeds.
• allergic reactions.
• increases in 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.

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 or unusual bleeding or bruising.
• jaundice (yellowing of the skin and whites of the eyes).
• tendon injury.

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

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

Lupus-like disease (including rash, joint disorders, and effects on blood cells).

Frequency not known: 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 levels of sugar and fat in the blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine.
• constant muscle weakness.
• severe myasthenia (a disease that causes generalized muscle weakness, which in some cases affects 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 speaking.

Reporting side effects

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

5. Storing Atorvastatina Tarbis

Keep out of the reach and sight of children.

Do not store above 30°C.

Do not use Atorvastatina Tarbis after the expiration date stated 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. Further information

Composition of Atorvastatina Tarbis

• The active substance is atorvastatin.

Each film-coated tablet contains 20 mg of atorvastatin (as atorvastatin calcium trihydrate).

The other ingredients (excipients) are: microcrystalline cellulose, sodium carbonate, anhydrous maltose, sodium croscarmellose, magnesium stearate.

The coating of Atorvastatina Tarbis contains hypromellose, hydroxypropylcellulose, triethyl citrate, polysorbate 80, titanium dioxide (E-171).

Appearance of Atorvastatina Tarbis and package contents

The film-coated tablets of Atorvastatina Tarbis 20 mg are elliptical, concave, and white.

Atorvastatina Tarbis 20 mg is available in packs with blisters containing 28 film-coated tablets and in clinical packs containing 500 film-coated tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:

TARBIS FARMA, S.L.

Gran Vía Carlos III, 94.

08028 Barcelona, Spain.

Manufacturer:

TEVA PHARMA, S.L.U.

Polígono Malpica, Calle C nº 4.

50016 Zaragoza, Spain.

Date of last revision of this leaflet: April 2023

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/.