ATORVASTATIN TARBIS 80 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Atorvastatin Tarbis80mg 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, as 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 package leaflet

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

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

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

Atorvastatin 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 failed. If you have a high risk of heart disease, Atorvastatin 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 Atorvastatin Tarbis

Do not take Atorvastatin 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 components 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 do not use adequate contraceptive measures.
• If you are pregnant or trying to become pregnant.
• If you are breastfeeding.
• If you use the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C.

Be especially careful with Atorvastatin Tarbis

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

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

• 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 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 medications (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 Atorvastatin 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 Atorvastatin 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 Atorvastatin 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 medications 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 medications 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 sugars and fats in the blood, are overweight, and have high blood pressure.

Using Atorvastatin with other medicines

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

There are some medicines that can affect the proper functioning of Atorvastatin Tarbis or the effects of these medicines may be modified by Atorvastatin 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 medications, 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 need to stop using this medicine. Your doctor will tell you when you can restart treatment with Atorvastatin Tarbis. The use of Atorvastatin 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 Atorvastatin Tarbis 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 to treat gout), and antacids (indigestion products containing aluminum or magnesium).

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

Taking Atorvastatin Tarbis with food and drinks

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

Alcohol

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

Pregnancy and breastfeeding

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

Do not take Atorvastatin Tarbis if you are of childbearing age unless you are using adequate contraceptive measures.

Do not take Atorvastatin Tarbis if you are breastfeeding.

The safety of Atorvastatin Tarbis during pregnancy and breastfeeding 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 Atorvastatin Tarbis

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

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

The tablets of Atorvastatin 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 Atorvastatin Tarbis exactly. Consult your doctor or pharmacist if you have any doubts.

Your doctor will decide the duration of treatment with Atorvastatin Tarbis

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

If you take more Atorvastatin Tarbis than you should

If you accidentally take too many Atorvastatin Tarbis tablets (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 Atorvastatin 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 missed doses.

If you stop taking Atorvastatin 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, Atorvastatin 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 out of 10,000 patients:

• Severe allergic reaction that causes swelling of the face, tongue, and throat, which can cause great difficulty in 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 unexpected or unusual bleeding or bruising, this may suggest a liver problem. You should consult your doctor as soon as possible.

Other possible side effects with Atorvastatin Tarbis:

Common side effects (affect between 1 and 10 out of 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.

Uncommon side effects (affect between 1 and 10 out of 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 out of 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 sugars and fats 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 that, 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 breathing.

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: http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Atorvastatin Tarbis

Keep out of the reach and sight of children.

Do not store above 30°C.

Do not use Atorvastatin 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 medicines you no longer need 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 Atorvastatin Tarbis

• The active substance is atorvastatin.

Each film-coated tablet contains 80 mg of atorvastatin (as atorvastatin calcium trihydrate).

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

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

Appearance of Atorvastatin Tarbis and package contents

The film-coated tablets of Atorvastatin Tarbis 80 mg are elliptical, concave, and white.

Atorvastatin Tarbis 80 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 the 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/.