Package Leaflet: Information for the User

Atorvastatina Stadagen 10 mg Film-Coated Tablets

Atorvastatina Stadagen 20 mg Film-Coated Tablets

Atorvastatina Stadagen 40 mg Film-Coated Tablets

Atorvastatina Stadagen 80 mg Film-Coated Tablets

Read this 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. Do not pass it on to others even if their symptoms are the same as yours. It may harm them.
• If you experience any side effects, talk to your doctor, pharmacist or nurse. See section 4.

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

2. What you need to know before you start using Atorvastatina Stadagen

3. How to use Atorvastatina Stadagen

4. Possible side effects

5. Storage of Atorvastatina Stadagen

6. Contents of the pack and additional information

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

Atorvastatina 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, this medicine may also be used to reduce this risk even if your cholesterol levels are normal. During treatment, a standard low-cholesterol diet must be followed.

Do not take Atorvastatina Stadagen

• if you are allergic to atorvastatin or any of the other ingredients of this medicine (listed in section6).
• if you have or have had any liver disease.
• if you have or have had abnormal results in liver function tests.
• if you are a fertile woman and do not use 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

Consult your doctor, pharmacist or nurse before starting to take Atorvastatina Stadagen:

• if you have severe respiratory failure
• if you are taking or have taken within the last 7 days a medicine that contains fusidic acid (used for the treatment of bacterial infections) by mouth or injection. The combination of fusidic acid and atorvastatin may cause severe muscle problems (rhabdomyolysis)
• if you have had a previous stroke with bleeding in the brain, or have small fluid collections in the brain due to previous strokes
• if you have kidney problems
• if you have a thyroid gland with low activity (hypothyroidism)
• if you have repeated or unjustified muscle pain, personal or family history of muscle problems
• if you have had muscle problems during previous treatment with other medicines to reduce lipids (e.g. with another "statin" or "fibrate")
• 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 myasthenia gravis (a disease that causes weakness of the eye muscles), as statins may sometimes worsen the disease or cause 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

In any of these cases, your doctor may instruct you to have blood tests before and possibly during treatment with this medicine to predict the risk of suffering adverse effects related to muscle. It is known that the risk of suffering adverse effects related to muscle (e.g. rhabdomyolysis) increases when certain medicines are taken at the same time (see section2 “Use of Atorvastatina Stadagen with other medicines”).

Also inform your doctor or pharmacist if you have persistent muscle weakness, as you may need other tests and medicines to diagnose and treat this condition.

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

Use of Atorvastatina Stadagen with other medicines

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

There are some medicines that may affect the proper functioning of atorvastatin or the effects of these medicines may be modified by atorvastatin. This type of interaction may reduce the effect of one or both medicines. Alternatively, this combined use may increase the risk or severity of adverse effects, including the important muscle deterioration, known as rhabdomyolysis, described in section4:

• Medicines used to modify the functioning of your immune system, for example, ciclosporin.
• Certain antibiotics or antifungal medicines, for example, erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid.
• Other medicines to regulate lipid levels, for example, gemfibrozil, other fibrates, cholestyramine.
• Some calcium channel blockers used in the treatment of 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 diseases caused by cytomegalovirus.
• Medicines used in the treatment of HIV/AIDS, for example, ritonavir, lopinavir, atazanavir, indinavir, darunavir, the combination of tipranavir/ritonavir, etc.
• Some medicines used in the treatment of hepatitis C such as telaprevir,boceprevir and the combination of elbasvir/grazoprevir, ledipasvir/sofosbuvir.
• Daptomycin (a medicine used to treat skin and soft tissue infections and bacteria present in the blood).
• Other medicines that are known to interact with this medicine 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 painkiller),colchicine (used to treat gout) andantacids (products for indigestion that contain aluminum 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 taking this medicine. Your doctor will tell you when it is safe for you to restart treatment with atorvastatin. The use of atorvastatin with fusidic acid may cause very rarely muscle weakness, sensitivity or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

Taking Atorvastatina Stadagen with food and drinks

See section 3 for instructions on how to take Atorvastatina Stadagen. Please note the following:

Orange juice

Do not take more than one or two small glasses of orange juice per day, as large amounts of orange 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 if you are trying to become pregnant.

Do not take this medicine if you are fertile and do not use adequate contraceptive measures.

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

This medicine has not been proven to be safe during pregnancy and breastfeeding.

Consult your doctor or pharmacist before using any medicine.

Driving and operating machinery

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

Atorvastatina Stadagen contains lactoseand sodium

This medicine contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with him before taking this medicine.

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

Before starting treatment, your doctor will put you on a low-cholesterol diet, which you must also follow during treatment with this medication.

The usual initial dose of this medication is 10 mg once a day in adults and children aged 10 years or older. Your doctor may increase it if necessary to reach the dose you need. Your doctor will adjust the dose at intervals of 4 weeks or more. The maximum dose of this medication is 80 mg once a day.

Atorvastatina tablets 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 every day at the same time.

Follow exactly the administration instructions for this medication indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Your doctor will decide the duration of treatment with Atorvastatina Stadagen.Atorvastatina Stadagen

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

If you take more Atorvastatina Stadagen than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 915 620 420, indicating the medication and the amount ingested.

If you forget to take Atorvastatina Stadagen

If you forget to take a dose, take the next scheduled dose at the correct time. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Atorvastatina Stadagen

If you have any other questions about the use of this medication or want to interrupt treatment, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

If you notice any of the following serious side effects or symptoms, stop taking these tablets and inform your doctor immediately or go to the nearest hospital emergency service.

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

• Severe allergic reaction that causes swelling of the face, tongue, and throat, which may make it difficult to breathe.
• Severe disease with severe peeling and inflammation of the skin; 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 that may form blisters.

-Muscle weakness, tenderness, pain, rupture, or change in urine color to brown-red, and especially if you have discomfort or high fever, it may be due to abnormal muscle breakdown (rhabdomyolysis). Abnormal muscle breakdown may not always disappear, even after you have stopped taking atorvastatin and may be fatal and cause kidney problems.

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

• If you experience unexpected or unusual bleeding or bruising, this may suggest a liver problem. You should consult your doctor as soon as possible.
• Lupus-like syndrome (which includes rash, joint disorders, and effects on blood cells).

Other possible side effects with this medicine:

Frequent: may affect up to 1 in 10 people:

• nasal inflammation, sore throat, nasal bleeding
• Allergic reactions
• Increases in blood sugar levels (if you are diabetic, monitor your blood sugar levels), increased creatine kinase in blood
• Headache
• Nausea, constipation, gas, indigestion, diarrhea
• Joint pain, muscle pain, and back pain
• Abnormal blood test results that may show abnormal liver function

Infrequent: may affect up to 1 in 100 people:

• Anorexia (loss of appetite), weight gain, decreased blood sugar levels (if you are diabetic, 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)
• Heptatitis (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: may affect up to 1 in 1,000 people:

• Visual disturbances
• Unexpected or unusual bleeding or bruising
• Jaundice (yellowing of the skin and eyes)
• Tendon injury
• Skin rash or ulcers in the mouth (drug-induced lichenoid reaction)
• Lesions on the skin or purple spots (signs of inflammation of blood vessels, vasculitis)

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

• Allergic reaction - symptoms may include sudden hissing while breathing and chest pain or tightness, swelling of the eyelids, face, lips, mouth, tongue, or throat, difficulty breathing, collapse
• Loss of hearing
• Gynecomastia (breast enlargement in men)

Frequency unknown:cannot be estimated from available data:

• Persistent muscle weakness.
• Myasthenia gravis (a disease that causes generalized muscle weakness, which in some cases affects the muscles used for breathing).
• Myasthenia ocular (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 eyelid drooping, difficulty swallowing or difficulty breathing.

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

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

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the box and the bottle after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Deposit the containers and medicines you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

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

Aluminum/polyamide oriented-aluminum-chlorinated vinyl (PVC) blister - Do not store at a temperature above 30 °C.

HDPE bottle – No special storage conditions are required.

Composition of Atorvastatina Stadagen

• The active ingredient is atorvastatina.

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

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

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

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

• The other components are:

Lactose monohydrate, microcrystalline cellulose, calcium carbonate E170, copovidone, crospovidone typeB, croscarmellose sodium, sodium lauryl sulfate, anhydrous colloidal silica, talc, and magnesium stearate.

Coating content: mono and dicaprilocaprato of glycerol, poly (vinyl alcohol), talc, titanium dioxide, and copolymer of grafting of macrogol and poly (vinyl alcohol).

Appearance of the product and content of the package

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

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

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

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

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

Atorvastatina Stadagen is available in HDPE bottles in pack sizes of 98 film-coated tablets.

Only some pack sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

STADA Laboratorio, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for manufacturing

Laboratorios Liconsa, S.A.

Polígono Industrial Miralcampo. Avda. Miralcampo, 7

19200 Azuqueca de Henares – Guadalajara

Spain

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

Last review date of this leaflet:November 2024

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