Atorvastatin Tarbis Farma 80 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Atorvastatina Tarbis Farma 80 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet as you may need to read it again.

• If you have any questions, ask your doctor, pharmacist or nurse.

• This medicine has been prescribed for you only, 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 experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Atorvastatina Tarbis Farma is and what it is used for
2. What you need to know before taking Atorvastatina Tarbis Farma
3. How to take Atorvastatina Tarbis Farma
4. Possible side effects
5. How to store Atorvastatina Tarbis Farma
6. Contents of the pack and other information

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

Atorvastatin belongs to a group of medicines known as statins, which are lipid-regulating (fat-regulating) medicines.

This medicine 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, atorvastatin 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. What you need to know before starting to take Atorvastatin Tarbis Farma

Do not take Atorvastatin Tarbis Farma

• if you are allergic to atorvastatin or to 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 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 using the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to take this medicine

• if you have or have had myasthenia (a disease characterized by generalized muscle weakness that, 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 severe respiratory failure.

• if you are taking or have taken within the last 7 days an oral or injectable medicine called fusidic acid (a medicine used to treat bacterial infections). The combination of fusidic acid and atorvastatin may cause serious muscle problems (rhabdomyolysis).

• 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 previously experienced muscle problems during treatment with other lipid-lowering medicines (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.

In any of these cases, your doctor may decide whether you need blood tests before and possibly during treatment with Atorvastatin Tarbis Farma to assess your 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 “Other medicines and Atorvastatin Tarbis Farma”).

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

Other medicines and Atorvastatin Tarbis Farma

Tell 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 functioning of atorvastatin, or the effects of these medicines may be altered by atorvastatin. Such interactions may reduce the effect of one or both medicines. Alternatively, this combination may increase the risk or severity of adverse effects, including the 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, fusidic acid.

• Other medicines used 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.

• Letermovir, a medicine that helps prevent cytomegalovirus disease.

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

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

• Other medicines known to interact with atorvastatin include: ezetimibe (cholesterol-lowering agent), warfarin (reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant used to treat epilepsy), cimetidine (used for heartburn and peptic ulcer), phenazone (an analgesic), colchicine (used to treat gout), and antacids (indigestion remedies containing aluminium or magnesium).

• Over-the-counter medicines: St. John’s wort.

• If you need to take oral fusidic acid to treat a bacterial infection, you will need to temporarily stop using this medicine. Your doctor will advise you when it is safe to restart treatment with Atorvastatin Tarbis Farma. Taking atorvastatin in combination with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

• Daptomycin (a medicine used to treat complicated skin and skin structure infections, as well as bloodstream infections caused by bacteria).

Taking Atorvastatin Tarbis Farma with food, drinks, and alcohol

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

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 this medicine.

Alcohol

Avoid drinking large amounts of alcohol while taking this medicine. See details in section 2 “Warnings and precautions”.

Pregnancy, breastfeeding, and fertility

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

Do not take this medicine if you are of childbearing age unless you are using adequate contraceptive measures.

Do not take this medicine if you are breastfeeding your child.

The safety of atorvastatin during pregnancy and breastfeeding has not been established. Consult your doctor or pharmacist before using any medicine.

Driving and using machines

This medicine usually does not affect your ability to drive or operate machinery. However, do not drive if this medicine affects your ability to do so. Do not operate tools or machinery if this medicine impairs your ability to use them safely.

Atorvastatin Tarbis Farma contains sodium

This medicine contains 38.8 mg of sodium per dose, equivalent to 1.9% of the maximum daily intake of 2 g of sodium recommended by the WHO for an adult.

3. How to take Atorvastatin Tarbis Farma

Before starting treatment, your doctor will place you on a low-cholesterol diet, which you must continue during treatment with this medicine.

The usual starting dose of this medicine 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 atorvastatin is 80 mg once daily.

Atorvastatin 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 exactly the instructions for use provided by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Your doctor will decide the duration of treatment with Atorvastatin Tarbis Farma

Ask your doctor if you think that the effect of this medicine is too strong or too weak.

If you take more Atorvastatin Tarbis Farma than you should

If you accidentally take too many Atorvastatin Tarbis Farma 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, indicating the medicine and the amount taken. Bring any remaining tablets, the carton, and the complete packaging so that hospital staff can easily identify the medicine you have taken.

If you forget to take Atorvastatin Tarbis Farma

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

If you stop taking Atorvastatin Tarbis Farma

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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

Rare: may affect up to 1 in 1,000 people

• 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; skin blisters, in the 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 rupture, or brownish-red discoloration of the urine, especially if accompanied by malaise or high fever, may be due to abnormal muscle breakdown (rhabdomyolysis). Abnormal muscle breakdown does not always resolve, even after stopping atorvastatin, and can be fatal and lead to kidney problems.

Very rare: may affect up to 1 in 10,000 people

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

Other possible adverse effects with Atorvastatina Tarbis Farma

Common: may affect up to 1 in 10 people

• Inflammation of the nasal passages, sore throat, nosebleeds
• Allergic reactions
• Increased blood sugar levels (if you are diabetic, monitor your blood sugar levels), increased blood creatine kinase
• Headache
• Nausea, constipation, gas, indigestion, diarrhea
• Joint pain, muscle pain, and back pain
• Blood test results that may show abnormal liver function

Uncommon: may affect up to 1 in 100 people

• 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: may affect up to 1 in 1,000 people

• Changes in vision
• Unexpected bleeding or bruising
• Cholestasis (yellowing of the skin and whites of the eyes), tendon injury
• Rash that may appear on the skin or mouth sores (drug-induced lichenoid reaction)
• Purple skin lesions (signs of inflammation of blood vessels, vasculitis)

Very rare: may affect up to 1 in 10,000 people

• 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 (enlargement of the breasts in men)

Frequency not known: cannot be estimated from available data:

• Persistent muscle weakness
• Myasthenia gravis (a disease causing generalized muscle weakness that, 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.

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. 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.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, 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 website: www.notificaRAM.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Atorvastatine Tarbis Farma

This medicine does not require special storage conditions.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the blister and on the outer packaging, following “EXP”. The expiry date refers to the last day of the stated month.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a 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. Contents of the pack and other information

Composition of Atorvastatina Tarbis Farma

The active substance is atorvastatin.

Each film-coated tablet contains atorvastatin calcium trihydrate equivalent to 80 mg of atorvastatin.

The other components are:

Tablet core: Mannitol, sodium lauryl sulfate, anhydrous colloidal silica, sodium carbonate (E500), butyl hydroxyanisole, microcrystalline cellulose, sodium croscarmellose (E468), magnesium stearate (E572)

Film coating: Hypromellose, microcrystalline cellulose, stearic acid

Appearance of the product and contents of the pack

Film-coated tablet.

White, oval-shaped (approximately 19.4 mm long and 10.4 mm wide), biconvex film-coated tablets, with "80" engraved on one side and the other side smooth.

Atorvastatina Tarbis Farma is available in Alu-Alu blisters containing 28, 30, 50, 90, 98, 100 and 250 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Tarbis Farma S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Manufacturer

Amarox Pharma B.V.

Rouboslaan 32

Voorschoten, 2252TR

The Netherlands

This medicinal product is authorised in the European Economic Area member states under the following names:

Denmark: Atorvastatin Amarox

Germany: Atorvastatin Amarox 80 mg Filmtabletten

Netherlands: Atorvastatine Amarox 80 mg, filmomhulde tabletten

Spain: Atorvastatina Tarbis Farma 80 mg comprimidos recubiertos con película EFG

Sweden: Atorvastatin Amarox 80 mg filmdragerade tabletter

Date of the most recent revision of this leaflet: September 2024

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/