Atorvastatin Stadagen 80 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Atorvastatin Stadagen 10 mg film-coated tablets EFG

Atorvastatin Stadagen 20 mg film-coated tablets EFG

Atorvastatin Stadagen 40 mg film-coated tablets EFG

Atorvastatin Stadagen 80 mg film-coated tablets EFG

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

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

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

Atorvastatin 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, this medicine may also be used to reduce that risk, even if your cholesterol levels are normal. A standard cholesterol-lowering diet should be followed during treatment.

2. What you need to know before taking Atorvastatine Stadagen

Do not take Atorvastatine Stadagen

• 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 taking the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking Atorvastatine Stadagen:

• if you have severe respiratory insufficiency.
• if you are taking or have taken within the last 7 days a medicine containing fusidic acid (used to treat bacterial infection) by mouth or by injection. The combination of fusidic acid and atorvastatin may cause serious muscle problems (rhabdomyolysis).
• if you have previously had a stroke with bleeding into 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, 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 have or have had myasthenia (a disease causing 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 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 this medicine to assess your risk of developing 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 Atorvastatine Stadagen with other medicines”).

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

While you are being treated with this medicine, your doctor will monitor you closely if you have diabetes or are at risk of developing diabetes. If you have high levels of sugar and fats in your blood, are overweight, and have high blood pressure, you may be at risk of developing diabetes.

Use of Atorvastatine Stadagen 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 works, or the effects of these medicines may be altered by atorvastatin. 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 the serious 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, fusidic acid.
• Other lipid-regulating medicines, e.g., gemfibrozil, other fibrates, colestipol.
• Some 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.
• Letermovir, a medicine used to prevent cytomegalovirus infections.
• Medicines used in the treatment of AIDS, e.g., ritonavir, lopinavir, atazanavir, indinavir, darunavir, the combination of tipranavir/ritonavir, etc.
• Some medicines used to treat hepatitis C, such as telaprevir, boceprevir, and the combinations elbasvir/grazoprevir, ledipasvir/sofosbuvir.
• Daptomycin (a medicine used to treat complicated skin and skin structure infections and bloodstream infections caused by bacteria).
• Other medicines known to interact with this medicine include ezetimibe (which lowers cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant used to treat epilepsy), cimetidine (used for stomach acid 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.
• If you need to take oral fusidic acid to treat a bacterial infection, you must temporarily stop taking this medicine. Your doctor will advise you when it is safe to restart atorvastatin treatment. Using atorvastatin with fusidic acid may very rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

Taking Atorvastatine Stadagen with food and drinks

See section 3 for instructions on how to take Atorvastatine Stadagen. 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 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 and breastfeeding

Do not take atorvastatin if you are pregnant, think you may be pregnant, or are trying 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 baby.

The safety of this medicine during pregnancy and breastfeeding has not been established.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

This medicine normally 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 machines if this medicine affects your ability to use them safely.

Atorvastatine Stadagen contains lactose and sodium

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

This medicine contains less than 23 mg of sodium (1 mmol) per tablet, which is essentially “sodium-free”.

3. How to take Atorvastatina Stadagen

Before starting treatment, your doctor will place you on a low-cholesterol diet, which you must continue to follow 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 you require. Your doctor will adjust the dose at intervals of 4 weeks or more. The maximum dose of this medicine 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 given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

Your doctor will decide the duration of treatment with Atorvastatina Stadagen

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

If you take more Atorvastatina Stadagen than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 915 620 420, indicating the medicine and the amount ingested.

If you forget to take Atorvastatina Stadagen

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

If you stop taking Atorvastatina Stadagen

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

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

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 breathing difficulties.
• A serious illness with severe skin peeling and inflammation; skin blisters, blisters in the mouth, genitals, and eyes, and fever. Skin rash with pink-red spots, particularly on the palms of the hands or soles of the feet, which may develop into blisters.
• Muscle weakness, tenderness, pain, muscle rupture, or change in urine colour to red-brown, especially if accompanied by feeling unwell or high fever, which may be due to abnormal muscle breakdown (rhabdomyolysis). Abnormal muscle breakdown does not always resolve, even after stopping atorvastatin, and may 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 this medicine:

Common: may affect up to 1 in 10 people:

• Nasal inflammation, 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, flatulence, indigestion, diarrhoea
• 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 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 (oedema), increased body temperature
• Urine tests positive for white blood cells

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

• Vision disturbances
• Unexpected bleeding or bruising
• Cholestasis (yellowing of the skin and whites of the eyes)
• Tendon injury
• Skin rash or mouth ulcers (drug-induced lichenoid reaction)
• Purple-coloured skin lesions (signs of blood vessel inflammation, vasculitis)

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

• 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 (breast enlargement in men)

Frequency not known: cannot be estimated from available data:

• 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.

Possible adverse effects reported with the use of some statins (medicines in the same class):

• Sexual problems
• Depression
• Respiratory problems, including persistent cough, difficulty breathing, or fever
• Diabetes. This adverse effect is more common if you have high levels of sugar and fats in the blood, are overweight, and have high blood pressure. Your doctor will monitor you clinically while you are taking this medicine.

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

5. Storage of Atorvastatin Stadagen

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

Do not use this medicine after the expiry date which is stated on the carton and bottle 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 containers and medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

PVC-PE-PVDC/Aluminum blister – Store below 25 °C.

Aluminum/oriented polyamide-aluminum-polyvinyl chloride (PVC) blister – Do not store above 30 °C.

HDPE bottle – No special storage conditions required.

6. Contents of the pack and other information

Composition of Atorvastatin Stadagen

• The active substance is atorvastatin.

Each film-coated tablet contains 10 mg of atorvastatin (as atorvastatin calcium trihydrate).

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

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

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

• The other components are:

Monohydrate lactose, microcrystalline cellulose, calcium carbonate E170, copovidone, crospovidone type A, sodium croscarmellose, sodium lauryl sulfate, anhydrous colloidal silica, talc and magnesium stearate.

Coating composition: mono and dicaprylocaproyl glycerides, poly (vinyl alcohol), talc, titanium dioxide and graft copolymer of macrogol and poly (vinyl alcohol).

Appearance of the product and contents of the pack

Atorvastatin Stadagen 10 mg film-coated tablets: white, round, biconvex tablets with a score line on one side and marked “10” on the other side. The size of each tablet is approximately 7.0 mm.

Atorvastatin Stadagen 20 mg film-coated tablets: white, round, biconvex tablets with a score line on one side and marked “20” on the other side. The size of each tablet is approximately 9.0 mm.

Atorvastatin Stadagen 40 mg film-coated tablets: white, round, biconvex tablets with a score line on one side and marked “40” on the other side. The size of each tablet is approximately 11.0 mm.

Atorvastatin Stadagen 80 mg film-coated tablets: white, round, biconvex tablets with a score line on one side and marked “80” on the other side. The size of each tablet is approximately 13.0 mm.

Atorvastatin Stadagen is available in PVC-PE-PVDC/Aluminum and Aluminum/oriented polyamide-aluminum-polyvinyl chloride (PVC) blisters in pack sizes of 4, 7, 10, 14, 20, 28, 30, 50, 56, 84, 90, 98 and 100 film-coated tablets.

Atorvastatin Stadagen is available in HDPE bottles containing 98 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

Laboratorios Liconsa, S.A.

Polígono Industrial Miralcampo. Avda. Miralcampo, 7

19200 Azuqueca de Henares – Guadalajara

Spain

This medicinal product is authorized in the European Economic Area Member States under the following names:

Date of the last revision of this leaflet: November 2024

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