ATORVASTATIN STADAGEN 20 mg FILM-COATED TABLETS

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 signs of illness 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 pack

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

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

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

Atorvastatin is used to lower lipids such as cholesterol and triglycerides in the blood when a low-fat diet and lifestyle changes on their own have failed. If you are at high risk of heart disease, this medicine may also be used to reduce this risk even if your cholesterol levels are normal. During treatment, you should follow a standard low-cholesterol diet.

2. What you need to know before you take Atorvastatin Stadagen

Do not take Atorvastatin Stadagen

• if you are allergic to atorvastatin or 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 blood test results indicating liver function.
• 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 breast-feeding
• 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 you start taking Atorvastatin Stadagen:

• if you have severe respiratory failure
• if you are taking or have taken in 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 can cause serious muscle problems (rhabdomyolysis)
• if you have had a previous stroke with bleeding in 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, personal or family history of muscle problems
• if you have had muscle problems while taking other medicines to lower lipid levels (e.g. with another 'statin' or 'fibrate')
• if you have or have had myasthenia (a disease that causes generalized muscle weakness that can affect the muscles used for breathing) or ocular myasthenia (a disease that causes weakness of the eye muscles), as statins can sometimes worsen the disease or cause myasthenia to appear (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 indicate that you should have blood tests before and possibly during treatment with this medicine to predict the risk of muscle-related side effects. It is known that the risk of muscle-related side effects (e.g. rhabdomyolysis) increases when certain medicines are taken at the same time (see section 2 "Using Atorvastatin 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 sugar and fat levels in your blood, are overweight, and have high blood pressure, you may be at risk of developing diabetes.

Using Atorvastatin Stadagen with other medicines

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

There are some medicines that can affect the proper functioning of atorvastatin or the effects of these medicines may be altered by atorvastatin. This type of interaction can decrease the effect of one or both medicines. Alternatively, this combined use can increase the risk or severity of side effects, including serious muscle damage, known as rhabdomyolysis, described in section 4:

• Medicines used to modify the functioning of your immune system, e.g. cyclosporin.
• Certain antibiotics or antifungal medicines, e.g. erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid.
• Other medicines 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 your heart rhythm, e.g. digoxin, verapamil, amiodarone.
• Letermovir, a medicine that helps prevent diseases caused by cytomegalovirus.
• Medicines used to treat AIDS, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, the combination of tipranavir/ritonavir, etc.
• Certain medicines used to treat hepatitis C, such as telaprevir, boceprevir, and the combination of elbasvir/grazoprevir, ledipasvir/sofosbuvir.
• Daptomycin (a medicine used to treat skin and skin structure infections with complications and bacteria present in the blood).
• Other medicines that are known to interact with this medicine include ezetimibe (which lowers cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant to treat epilepsy), cimetidine (used for heartburn and peptic ulcer), phenazone (a pain reliever), colchicine (used to treat gout), and antacids (indigestion products containing aluminum or magnesium).
• Medicines obtained without a prescription: 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 tell you when it is safe for you to restart treatment with atorvastatin. The use of atorvastatin with fusidic acid can very rarely cause muscle weakness, sensitivity, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

Taking Atorvastatin Stadagen with food and drinks

See section 3 for instructions on how to take Atorvastatin 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 can alter the effects of this medicine.

Alcohol

Avoid drinking too much alcohol while taking this medicine. See the details in section 2 "Warnings and precautions".

Pregnancy and breast-feeding

Do not take atorvastatin 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 breast-feeding your child.

The safety of this medicine during pregnancy and breast-feeding has not been established.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Normally, this medicine does not affect your ability to drive or use machines. However, do not drive if this medicine affects your ability to drive. Do not use tools or machines if this medicine affects your ability to use them.

Atorvastatin Stadagen contains lactose and sodium

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

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

3. How to take Atorvastatin Stadagen

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

The initial dose of this medicine is usually 10 mg once a day in adults and children from 10 years of age. Your doctor may increase the dose if necessary until you reach the dose you need. Your doctor will adjust the dose at intervals of 4 weeks or more. The maximum dose of this medicine is 80 mg once a day.

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

Follow the instructions for administration of this medicine indicated by your doctor. If you are in doubt, consult your doctor or pharmacist again.

Your doctor will decide the duration of treatment with Atorvastatin Stadagen

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

If you take more Atorvastatin Stadagen than you should

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

If you forget to take Atorvastatin Stadagen

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

If you stop taking Atorvastatin Stadagen

If you have any further questions about the use of this medicine or want to stop treatment, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets 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 emergency department of the nearest hospital.

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

• Severe allergic reaction that causes swelling of the face, tongue, and throat, which can cause great difficulty breathing.
• Severe skin disease with severe scaling and inflammation of the skin; blisters on the skin, mouth, genitals, and eyes, and fever. Rash with pink-red spots, especially on the palms of the hands or soles of the feet, which can form blisters.

• Muscle weakness, pain on palpation, pain, rupture, or change in urine color to reddish-brown, and especially if you have discomfort or have a high fever, may be due to abnormal muscle rupture (rhabdomyolysis). Abnormal muscle rupture does not always disappear, even after you have stopped taking atorvastatin, and can be fatal and cause kidney problems.

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

• If you experience bleeding or bruising problems, 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:

Common: may affect up to 1 in 10 people:

• nasal inflammation, sore throat, nosebleeds
• allergic reactions
• increased sugar levels in the blood (if you are diabetic, monitor your blood sugar levels), increased creatine kinase in the blood
• 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:

• loss of appetite, weight gain, decreased sugar levels in the blood (if you are diabetic, you should 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)
• hepatitis (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:

• vision changes
• unexpected bleeding or bruising
• jaundice (yellowing of the skin and whites of the eyes)
• tendon injury
• skin rash or ulcers in the mouth (drug-induced lichenoid reaction)
• purple-colored skin lesions (signs of inflammation of the blood vessels, vasculitis)

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

• allergic reaction - symptoms may include sudden wheezing and chest pain or tightness, swelling of the eyelids, face, lips, mouth, or tongue, difficulty breathing, collapse
• hearing loss
• gynecomastia (breast enlargement in men)

Frequency not known: cannot be estimated from the available data:

• Persistent muscle weakness.
• Severe myasthenia (a disease that causes generalized muscle weakness that can affect the muscles used for breathing).
• Ocular myasthenia (a disease that causes weakness of the eye muscles).

Tell your doctor if you experience weakness in your arms or legs that worsens after periods of activity, double vision, or drooping eyelids, 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, difficulty breathing, and fever
• Diabetes. This side effect is more common if you have high sugar and fat levels in your blood, 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 side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use www.notificaram.es. By reporting side 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 blister after EXP. The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

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

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

HDPE bottle - No special storage conditions required.

6. Container Content and Additional Information

Composition of Atorvastatina Stadagen

• The active ingredient 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:

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

Coating content: glycerol mono and di-caprylocaprate, poly(vinyl alcohol), talc, titanium dioxide, and macrogol/poly(vinyl alcohol) graft copolymer.

Appearance of the Product and Container Content

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

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

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

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

Atorvastatina Stadagen is available in PVC-PE-PVDC/Aluminum and Aluminum/polyamide-oriented-aluminum-polyvinyl chloride (PVC) blisters in packs 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 packs of 98 film-coated tablets.

Only some 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 Member States of the European Economic Area under the following names:

Date of the Last Revision 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 Health Products (AEMPS) http://www.aemps.gob.es/