ATORVASTATIN ABEX 10 mg FILM-COATED TABLETS

Introduction

Patient Information Leaflet

Atorvastatin Abex 10 mg film-coated tablets EFG

Read 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 or pharmacist.
• 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 experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

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

Atorvastatin 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 not worked. If you are at high risk of heart disease, atorvastatin can 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 Abex

Do not take atorvastatin

• If you are allergic to atorvastatin or to any other medicine used to lower blood lipids or to any of the other ingredients of this medicine (listed in section 6).
• If you have or have had a liver disease.
• If you have or have had unexplained abnormal results in blood tests for 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.

Warnings and precautions

Tell your doctor or pharmacist before you start taking atorvastatin:

• if you have or have had myasthenia (a disease characterized by general 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 (see section 4).
• if you have severe respiratory failure.
• if you are taking or have taken in the last 7 days a medicine called fusidic acid (a medicine used to treat bacterial infections) orally 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. 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 indicate that you should have blood tests before and possibly during treatment with atorvastatin 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 "Other medicines and atorvastatin").

Also, inform your doctor or pharmacist if you experience constant muscle weakness. Tests and additional medication may be necessary to diagnose and treat this problem.

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

Other medicines and atorvastatin

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. ciclosporin.
• 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.
• Medicines used to treat HIV, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir combined with ritonavir, etc.
• Certain medicines used to treat hepatitis C, such as telaprevir.
• Other medicines that are known to interact with atorvastatin include ezetimibe (which lowers cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant used to treat epilepsy), cimetidine (used for heartburn and peptic ulcer), phenazone (a pain reliever), colchicine (used to treat gout), antacids (indigestion products containing aluminum or magnesium), and boceprevir (used to treat liver diseases such as hepatitis C).
• Medicines obtained without a prescription: St. John's Wort.
• If you need to take oral fusidic acid to treat a bacterial infection, you will have to stop using this medicine temporarily. Your doctor will tell you when it is safe to restart treatment with atorvastatin. Taking atorvastatin in combination with fusidic acid can rarely cause muscle weakness, pain, or tenderness (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.
• Daptomycin (a medicine used to treat skin and skin structure infections with complications and bacteria present in the blood).

Tell your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription.

Taking atorvastatin with food, drinks, and alcohol

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

Alcohol

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

Pregnancy, breast-feeding, and fertility

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

Do not take atorvastatin if you are of childbearing age and are not using adequate contraceptive measures.

Do not take atorvastatin if you are breast-feeding.

The safety of atorvastatin 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 Abex contains lactose and sodium.

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

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

3. How to take Atorvastatin Abex

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

The initial dose of atorvastatin is usually 10 mg once a day in adults and children from 10 years of age. Your doctor may increase it 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 atorvastatin is 80 mg once a day for adults and 20 mg once a day for children.

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

Your doctor will decide the duration of treatment with atorvastatin

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

If you take more atorvastatin than you should

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

If you forget to take atorvastatin

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

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

4. Possible side effects

Like all medicines, atorvastatin can cause side effects, although not everybody gets them.

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

Rare: may affect up to 1 in 10,000 people:

• Severe allergic reaction that causes swelling of the face, tongue, and throat, which can cause great difficulty in 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, or tenderness, especially if you also have malaise or have a high fever, may be due to abnormal muscle breakdown. Abnormal muscle breakdown does not always go away, even after stopping 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.

Other possible side effects with atorvastatin:

Common (may affect up to 1 in 10 people) include:

• nose inflammation, sore throat, nosebleeds.
• allergic reactions.
• increased blood sugar levels (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) include:

• loss of appetite, weight gain, decreased blood sugar levels (if you are diabetic, you should continue to carefully monitor your blood sugar levels).
• nightmares, insomnia.
• dizziness, numbness or tingling in the fingers and toes, 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 up to 1 in 1,000 people) include:

• 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 blood vessel inflammation, vasculitis).

Very rare (may affect less than 1 in 10,000 people) include:

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

Frequency not known:

• constant muscle weakness.
• severe myasthenia (a disease that causes general 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 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. This is more likely if you have high levels of sugar and fat in the blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine.

If you experience side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Atorvastatin Abex

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 carton after {CAD}. The expiry date is the last day of the month indicated.

This medicine does not require special storage conditions.

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

6. Additional Information

Composition of Atorvastatina abex

• The active ingredient is atorvastatin.

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

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

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

Appearance of the product and packaging content

The 10 mg tablets are white, round, biconvex, marked with "T" on one face.

Aluminum-Aluminum blisters.

Atorvastatina abex 10 mg is available in packs with blisters containing 28 and 100 tablets (clinical packaging)

Only some pack sizes may be marketed.

Marketing authorization holder:

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa – Barcelona

Spain

Manufacturer:

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

Date of the last revision of this prospectus: September 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/