Patient Information Leaflet

Atorvastatina abex 10 mg Film-Coated Tablets

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

2. What you need to know before you start taking Atorvastatina abex

3. How to take Atorvastatina abex

4. Possible side effects

5. Storage of Atorvastatina abex

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 present a high risk of heart disease, atorvastatina may also be used to reduce this risk even though your cholesterol levels are normal. During treatment, a standard low-cholesterol diet must be followed.

Do not take atorvastatin

• If you are allergic to atorvastatin or to any other medication used to reduce blood lipids or to any of the other components of this medication (listed in section 6).
• If you have or have had any liver disease.
• If you have or have had abnormal results in liver function blood 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.

Warnings and precautions

Consult your doctor or pharmacist before starting to take atorvastatin:

• 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 ocular myasthenia (a disease that causes weakness of the eye muscles), as statins may sometimes worsen the disease or cause myasthenia (see section 4).
• If you have severe respiratory failure.
• If you are taking or have taken in the last 7 days a medication called fusidic acid (a medication used to treat 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 brain bleeding, or have small fluid embolisms 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 medications to reduce lipids (for example, 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 instruct you to have blood tests before and possibly during treatment with atorvastatin to predict the risk of experiencing muscle-related adverse effects. It is known that the risk of experiencing muscle-related adverse effects (for example, rhabdomyolysis) increases when certain medications are taken at the same time (see section 2 “Other medications and atorvastatin”).

Also inform your doctor or pharmacist if you experience persistent muscle weakness. Additional tests and medications may be necessary to diagnose and treat this problem.

While taking this medication, your doctor will monitor if you have diabetes or are at risk of developing diabetes. This risk of diabetes increases if you have high blood sugar and lipid levels, obesity, and high blood pressure.

Other medications and atorvastatin

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. There are some medications that may affect the proper functioning of atorvastatin or the effects of these medications may be modified by atorvastatin. This type of interaction may reduce the effect of one or both medications. Alternatively, this combined use may increase the risk or severity of adverse effects, including the important muscle deterioration, known as rhabdomyolysis described in Section 4:

−Medications used to modify the functioning of your immune system, for example ciclosporina

−Certain antibiotics or antifungal medications, for example, erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid.

−Other medications 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; medications to regulate your heart rhythm, for example, digoxin, verapamil, amiodarone

−Medications used in the treatment of AIDS, for example, ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir combined with ritonavir, etc.

−Other medications known to interact with atorvastatin include ezetimibe (which reduces cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (anticonvulsant for treating epilepsy), cimetidine (used for heartburn and peptic ulcers), phenazone (a pain reliever), colchicine (used for treating gout), antacids (products for indigestion containing aluminum or magnesium) and boceprevir (used for treating liver diseases such as hepatitis C).

−Over-the-counter medications: St. John's Wort

• If you need to take oral fusidic acid to treat a bacterial infection, you will need to stop taking this medication temporarily. Your doctor will instruct you when it is safe to restart the treatment with atorvastatin. 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 medication used to treat skin and skin structure infections and bacteria present in the blood).

Inform your doctor or pharmacist if you are using or have used recently other medications, even those purchased without a prescription.

Taking atorvastatin with food, drinks, and alcohol

See section 3 for instructions on how to take atorvastatin. 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 atorvastatin.

Alcohol

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

Pregnancy, breastfeeding, and fertility

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

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

Do not take atorvastatin if you are breastfeeding your child.

The safety of atorvastatin during pregnancy and breastfeeding has not been demonstrated.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

Normally, this medication does not affect your ability to drive or operate machinery. However, do not drive if this medication affects your ability to drive. Do not operate tools or machinery if this medication affects your ability to operate them.

Atorvastatin abex contains lactose and sodium.

If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.

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

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

The usual initial dose of atorvastatina is 10 mg once a day for adults and children aged 10 years and 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 atorvastatina is 80 mg once a day for adults and 20 mg once a day for children.

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 or pharmacist. If in doubt, consult your doctor or pharmacist again.

Your doctor will decide the duration of atorvastatina treatment

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

If you take more atorvastatina than you should

If you accidentally take too many atorvastatina tablets (more than your usual daily dose), consult your doctor or the nearest hospital or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken. Bring the remaining tablets, the packaging, and the complete box so that hospital staff can easily identify the medication you have taken.

If you forget to take atorvastatina

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 the missed doses.

If you interrupt atorvastatina treatment

If you have any other questions about using this medication or want to stop treatment, ask your doctor or pharmacist.

Like all medicines, atorvastatin can cause side effects, although not everyone will experience them.

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

Rare: may affect between 1 and 10 of every 10,000 patients:

−Severe allergic reaction causing swelling of the face, tongue, and throat that may make it difficult to breathe.

−Severe skin disease with severe peeling and inflammation; blisters on the skin, mouth, genitals, and eyes, and fever. Red rash with pink-red spots, especially on the palms of the hands or soles of the feet that may form blisters.

−Muscle weakness, pain on palpation, or pain, especially if you also have discomfort or high fever, may be due to an abnormal muscle rupture. Abnormal muscle rupture does not always disappear, even after stopping atorvastatin and may be fatal and cause kidney problems.

Very rare: may affect fewer than 1 of every 10,000 patients:

−If you experience unexpected or unusual bleeding or bruising, this may suggest liver problems. You should consult your doctor as soon as possible.

Other possible side effects with atorvastatin:

Frequent (may affect 1 in 10 patients) include:

•nasal congestion, sore throat, nosebleeds

•allergic reactions

•increased blood sugar levels (if you are diabetic, monitor your blood sugar levels), increased creatine kinase in the blood

•headaches

•nausea, constipation, gas, indigestion, diarrhea

•joint pain, muscle pain, and back pain

•abnormal blood test results that may show liver dysfunction

Possible (may affect 1 in 100 patients) include:

•loss of appetite, weight gain, decreased blood sugar levels (if you are diabetic, continue to closely 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)

•skin 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 1 in 1,000 patients) include:

•vision changes

•unexpected or unusual bleeding or bruising

•jaundice (yellowing of the skin and eyes)

•tendon damage

•skin rash or ulcers in the mouth (drug-induced lichenoid reaction)

•skin lesions of purple color (signs of inflammation of blood vessels, vasculitis)

Very rare (may affect fewer than 1 in 10,000 patients) include:

•allergic reaction - symptoms may include sudden hissing while breathing and chest pain or pressure, swelling of the eyelids, face, lips, mouth, tongue, or throat, difficulty breathing, collapse

•hearing loss

•gynecomastia (breast enlargement in men).

Side effects of unknown frequency:

•Constant muscle weakness

•Severe myasthenia (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing).

•Myasthenia gravis (a disease that causes weakness of the eye muscles).

Consult your doctor if you experience weakness in the arms or legs that worsens after periods of activity, double vision, or eyelid drooping, difficulty swallowing, or difficulty breathing.

The possible side effects of some statins (medicines of the same type):

•Sleep disorders, including insomnia and nightmares.

•Memory loss.

•Sexual difficulties

•Depression

•Respiratory problems such as persistent cough and/or difficulty breathing or fever

•Diabetes. It is more likely if you have high blood sugar and fat levels, obesity, and high blood pressure. Your doctor will monitor you while taking this medication

If you experience side effects, consult your doctor or pharmacist, even if they do not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the blister pack and on the packaging after {CAD}. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Atorvastatina abex

- The active ingredient is atorvastatina.

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

• The other components (excipients) of Atorvastatina abex are:

Lactose monohydrate, magnesium stearate, microcrystalline cellulose, microcrystalline cellulose silicified (anhydrous colloidal silica and microcrystalline cellulose), croscarmellose sodium, calcium carbonate. The coating material: lactose monohydrate, hypromellose, titanium dioxide (E-171) and macrogol 4000.

Appearance of the product and contents of the package

The 10 mg tablets are white, round, biconvex, and marked with “T” on one side.

Aluminum-Aluminum blisters.

Atorvastatina abex 10 mg is presented in boxes with blisters containing 28 and 100 tablets (clinical package)

Only some package sizes may be commercially available.

Marketing Authorization Holder:

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa – Barcelona

Spain

Responsible for Manufacturing:

Galenicum Health, S.L.U.

Sant Gabriel, 50

Esplugues de Llobregat, 08950 Barcelona

Spain

SAG Manufacturing SLU

Crta N-I, Km 36

28750 San Agustín de Guadalix (Madrid)

Spain

Last review date of this leaflet: September 2024

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