Atorvastatin Tarbis 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Atorvastatine Tarbis 10 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 should not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you think any of the side effects you experience are serious, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents

1. What Atorvastatine Tarbis is and what it is used for
2. Before taking 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 (fat-regulating) medicines.

Atorvastatina Tarbis is used to reduce 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 Atorvastatin 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 you 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

Talk to 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 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 previous 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 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 advise you to have 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 at the same time (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 is higher if you have high levels of sugars and fats in the blood, are overweight, and have high blood pressure.

Use of Atorvastatin with other medicines

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

Some medicines may affect how Atorvastatin Tarbis works, or the effects of these medicines may be altered by Atorvastatin Tarbis. This type of interaction may reduce the effect of one or both medicines. Alternatively, taking them together may increase the risk or severity of adverse effects, including serious muscle damage known as rhabdomyolysis described in Section 4:

• Medicines used to modify the function of your immune system, for example, cyclosporine.

• Certain antibiotics or antifungal medicines, for example, 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 taking this medicine. Your doctor will advise you when you can restart treatment with Atorvastatin Tarbis. Using Atorvastatin Tarbis with fusidic acid may cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

• Other medicines to regulate lipid levels, for example, gemfibrozil, other fibrates, colestipol.

• Some calcium channel blockers used to treat angina or high blood pressure, for example, amlodipine, diltiazem; medicines to regulate your heart rhythm, for example, digoxin, verapamil, amiodarone.

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

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

• Other medicines known to interact with Atorvastatin Tarbis include ezetimibe (which lowers cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant used to treat epilepsy), cimetidine (used for heartburn and peptic ulcer), phenazone (an analgesic), colchicine (used for the treatment of 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 amounts of grapefruit juice 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 operate them.

3. How to take Atorvastatina Tarbis

Before starting treatment, your doctor will prescribe a cholesterol-lowering 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 you require. 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. 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 Atorvastatina Tarbis tablets (more than your usual daily dose), contact your doctor or the nearest hospital, or call the Toxicology Information Service at 91 562 04 20.

If you forget to take Atorvastatina Tarbis

If you miss a dose, take the next scheduled dose at the correct time. Do not take a double dose to make up for a missed dose.

If you stop taking Atorvastatina Tarbis

If you have any further questions about using this medicine or if you wish to stop treatment, consult 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 without delay.

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

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

• Serious illness with severe skin peeling and inflammation; skin blisters, 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, muscle pain, muscle breakdown, or change in urine color to red-brown, especially if accompanied by malaise or high fever, which may be due to abnormal muscle breakdown that 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:

Frequent adverse effects (affect between 1 and 10 in 100 patients) include:

• Nasal inflammation, sore throat, nosebleeds
• Allergic reactions
• Increased blood glucose levels (if you are diabetic, monitor your blood glucose 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 glucose levels (if you are diabetic, continue to monitor your blood glucose levels carefully)
• Nightmares, insomnia
• Dizziness, numbness or tingling in 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:

• Visual 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, chest pain or tightness, swelling of the eyelids, face, lips, mouth, tongue or throat, difficulty breathing, collapse
• Hearing loss
• Gynaecomastia (enlargement of the breasts in men and women)

Lupus-like illness (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 blood sugar and fats, 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 through the Spanish Pharmacovigilance System for Human Medicines: a. 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 should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This way, you will help protect the environment.

6. Additional Information

Composition of Atorvastatin Tarbis

• The active substance is atorvastatin.

Each film-coated tablet contains 10 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 pack

The film-coated tablets of Atorvastatin Tarbis 10 mg are elliptical, concave, and white in colour.

Atorvastatin Tarbis 10 mg is available in boxes with blisters containing 28 film-coated tablets and in hospital 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.

Malpica Industrial Estate, Block 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 of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/