Atorvastatin Tarbis 40 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Atorvastatine Tarbis 40 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine.

• 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, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you consider any of the side effects you experience to be severe, or if you notice any side effects not mentioned in this leaflet, inform your doctor or pharmacist.

Leaflet contents

1. What Atorvastatine Tarbis is and what it is used for
2. Before you take Atorvastatine Tarbis
3. How to take Atorvastatine Tarbis
4. Possible side effects
5. How to store Atorvastatine 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 lipid-regulating (fatty) medicines.

Atorvastatina Tarbis is used to lower lipids such as cholesterol and triglycerides in the blood when a low-fat diet and lifestyle changes alone have failed. If you are at high risk of heart disease, Atorvastatina Tarbis may also be used to reduce this risk, even if your cholesterol levels are normal. A standard low-cholesterol diet should be followed during treatment.

2. Before taking Atorvastatatin Tarbis

Do not take Atorvastatin Tarbis

• If you are allergic (hypersensitive) to atorvastatin or to any other similar medicine used to lower 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 liver function blood tests.
• 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 breastfeeding.
• If you are taking the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C.

Take special care with Atorvastatin Tarbis

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

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

• If you have or have had myasthenia (a disease characterized by generalized muscle weakness, which in some cases affects the muscles used for breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), as statins may sometimes worsen the condition or trigger the onset of myasthenia (see section 4).
• If you have previously had a stroke with bleeding in the brain, or have small fluid-filled pockets in the brain due to prior strokes.
• If you have kidney problems.
• If you have an underactive thyroid gland (hypothyroidism).
• If you have repeated or unexplained muscle pain, or personal or family history of muscle disorders.
• If you have previously experienced muscle problems during treatment with other lipid-lowering medicines (e.g., with another statin or fibrates).
• If you are taking or have taken within the last 7 days an oral or injectable medicine containing fusidic acid (used to treat bacterial infection). The combination of fusidic acid and Atorvastatin Tarbis may 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 of age.

Talk to your doctor or pharmacist before taking Atorvastatin Tarbis

• If you have severe respiratory failure.

In any of these cases, your doctor may recommend blood tests before and possibly during treatment with Atorvastatin Tarbis to assess the risk of muscle-related adverse effects. It is known that the risk of muscle-related adverse effects (e.g., rhabdomyolysis) increases when certain medicines are taken concomitantly (see section 2 “ Use of other medicines”).

Also inform your doctor or pharmacist if you experience persistent muscle weakness. Additional tests and treatments may be needed to diagnose and manage this condition.

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

Use of Atorvastatin with other medicines

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

Some medicines may interfere with the proper function of Atorvastatin Tarbis, or the effects of these medicines may be altered by Atorvastatin Tarbis. Such interactions may reduce the effect of one or both medicines. Alternatively, taking them together may increase the risk or severity of adverse effects, including severe muscle damage known as rhabdomyolysis, described in Section 4:

• Medicines used to modify the function 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 must stop using this medicine. Your doctor will advise you when you can restart treatment with Atorvastatin Tarbis. The use of Atorvastatin Tarbis with fusidic acid may cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

• Other medicines used to regulate 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 heart rhythm, e.g., digoxin, verapamil, amiodarone.

• Medicines used in the treatment of HIV/AIDS, e.g., ritonavir, lopinavir, atazanavir, indinavir, darunavir, etc.

• Some medicines used to treat hepatitis C, such as telaprevir, boceprevir, and the combination of elbasvir/grazoprevir.

• Other medicines known to interact with Atorvastatin Tarbis include ezetimibe (cholesterol-lowering), warfarin (reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant for epilepsy), cimetidine (used for stomach burning and peptic ulcer), phenazone (a painkiller), colchicine (used to treat gout), and antacids (indigestion remedies containing aluminium or magnesium).

• Over-the-counter medicines: 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 may alter the effects of Atorvastatin Tarbis.

Alcohol

Avoid drinking large amounts of alcohol while taking this medicine. See details in Section 2 “Take special care with Atorvastatin Tarbis”.

Pregnancy and breastfeeding

Do not take Atorvastatin Tarbis if you are pregnant, think you may be pregnant, or are trying 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 your child.

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 operate tools or machinery if this medicine affects your ability to handle them.

3. How to take Atorvastatina Tarbis

Before starting treatment, your doctor will place you on a low-cholesterol diet, which you must continue to follow during treatment with Atorvastatina Tarbis.

The usual starting dose of Atorvastatina Tarbis is 10 mg once daily in adults and children aged 10 years and older. Your doctor may increase this dose if necessary to reach the dose appropriate for you. Your doctor will adjust the dose at intervals of 4 weeks or more. The maximum dose of Atorvastatina Tarbis is 80 mg once daily for adults and 20 mg once daily for children.

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

Always follow your doctor's instructions exactly for taking Atorvastatina Tarbis. If you have any doubts, consult your doctor or pharmacist.

Your doctor will decide the duration of treatment with Atorvastatina Tarbis

If you think the effect of Atorvastatina Tarbis is too strong or too weak, speak to your doctor.

If you take more Atorvastatina Tarbis than you should

If you accidentally take too many Atorvastatina Tarbis tablets (more than your usual daily dose), consult your doctor or the nearest hospital, or call the Toxicology Information Service at telephone number 91 562 04 20.

If you forget to take Atorvastatina Tarbis

If you forget to take a dose, take your next dose at the usual time. Do not take a double dose to make up for forgotten doses.

If you stop taking Atorvastatina Tarbis

If you have any further questions about using this medicine or wish to stop treatment, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Atorvastatina Tarbis may cause adverse effects, although not everyone experiences them.

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

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

• Severe allergic reaction causing swelling of the face, tongue, and throat, which may cause severe difficulty breathing.

• Serious illness with severe skin peeling and inflammation; 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, which may develop into blisters.

• Muscle weakness, tenderness, pain, muscle breakdown, or change in urine color to red-brown, particularly if accompanied by malaise or high fever—this may be due to abnormal muscle breakdown, which can be life-threatening and cause kidney problems.

Very rare: affects fewer than 1 in 10,000 patients:

• If you experience problems with unexpected or unusual bleeding or bruising, this may indicate a liver problem. You should consult your doctor as soon as possible.

Other possible adverse effects with Atorvastatina Tarbis:

Common adverse effects (affect between 1 and 10 in 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 blood
• Headache
• Nausea, constipation, flatulence, indigestion, diarrhea
• Joint pain, muscle pain, and back pain
• Blood test results that may indicate abnormal liver function

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

• Anorexia (loss of appetite), weight gain, decreased blood sugar levels (if you are diabetic, continue to monitor your blood sugar levels carefully)
• Nightmares, insomnia
• Dizziness, numbness or tingling in the fingers and toes, reduced sensitivity to pain or touch, changes in taste sensation, memory loss
• Blurred vision
• Ringing in the ears and/or head
• Vomiting, belching, upper and lower abdominal pain, pancreatitis (inflammation of the pancreas causing 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, swelling, especially in the ankles (edema), increased body temperature
• Urine tests positive for white blood cells

Rare adverse effects (affect between 1 and 10 in 10,000 patients) include:

• Vision disturbances
• Unexpected bleeding or bruising
• Cholestasis (yellowing of the skin and whites of the eyes)
• Tendon injury

Very rare adverse effects (affect fewer 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)
• Lupus-like disease (including rash, joint disorders, and effects on blood cells)

Frequency not known: Possible side effects reported with some statins (medicines of the same type):

• Sexual difficulties
• Depression
• Respiratory problems such as persistent cough and/or difficulty breathing or fever
• Diabetes. This is more likely if you have high levels of sugar and fats in the blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine.
• Persistent muscle weakness
• Myasthenia gravis (a disease causing generalized muscle weakness, which in some cases affects the muscles used for breathing)
• Ocular myasthenia (a disease causing weakness of the eye muscles)
• Consult your doctor if you experience worsening weakness in the arms or legs after periods of activity, double vision or drooping eyelids, difficulty swallowing, or difficulty breathing.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: http://www.notificaram.es. By reporting adverse 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 expiry date stated on the blister and packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Additional Information

Composition of Atorvastatin Tarbis

• The active substance is atorvastatin.

Each film-coated tablet contains 40 mg of atorvastatin (as atorvastatin calcium trihydrate).

The other components (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 contents of the container

The film-coated tablets of Atorvastatin Tarbis 40 mg are elliptical, concave, and white in colour.

Atorvastatin Tarbis 40 mg is available in boxes 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 most recent revision of this leaflet: April 2023

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