ATORVASTATIN PENSA 80 mg FILM-COATED TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Atorvastatin Pensa 80mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine.

• 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, do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any of the side effects, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Contents of the pack:

1. What Atorvastatin Pensa is and what it is used for
2. Before taking Atorvastatin Pensa
3. How to take Atorvastatin Pensa
4. Possible side effects
5. Storage of Atorvastatin Pensa
6. Further information

1. What is ATORVASTATIN PENSA and what is it used for

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

Atorvastatin Pensa 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 are at high risk of heart disease, Atorvastatin Pensa 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. Before taking ATORVASTATIN PENSA

Do not takeAtorvastatin Pensa

• If you are allergic (hypersensitive) to atorvastatin or to any other similar medicine used to reduce blood lipids or to any of the other components of this medicine – see more details in Section 6.
• If you have or have had any 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 do not use adequate contraceptive measures.
• If you are pregnant or trying to become pregnant.
• If you are breast-feeding.
• If you use the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Atorvastatin Pensa.

• If you are taking or have taken in the last 7 days a medicine that contains fusidic acid, (used to treat bacterial infections) by mouth or by injection. The combination of fusidic acid and Atorvastatin Pensa can cause serious muscle problems (rhabdomyolysis).
• If you have had a previous stroke with bleeding in the brain, or have small fluid-filled blisters 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 previously during treatment with other medicines to reduce lipids (e.g. 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.
• If you have or have had myasthenia (a disease that causes general 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 can sometimes worsen the disease or cause myasthenia to appear (see section 4).

Tell your doctor or pharmacist if you experience constant muscle weakness. You may need tests and additional medication to diagnose and treat this problem.

Consult your doctor or pharmacist before taking Atorvastatin Pensa if you:

• Have severe respiratory failure.

In any of these cases, your doctor may indicate that you should have blood tests before and, possibly, during treatment with Atorvastatin Pensa 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 other medicines").

While you are 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 Pensa

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

There are some medicines that can affect the proper functioning of Atorvastatin Pensa or the effects of these medicines may be altered by Atorvastatin Pensa. This type of interaction can reduce 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, for example, cyclosporin.
• 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, colestipol.
• Certain calcium channel blockers used to treat angina or high blood pressure, for example, amlodipine, diltiazem; medicines to regulate your heart rhythm, for example, digoxin, verapamil, amiodarone.
• Medicines used to treat AIDS, for example, ritonavir, lopinavir, atazanavir, indinavir, darunavir, etc.
• Certain medicines used to treat hepatitis C, such as telaprevir, boceprevir, and the combination of elbasvir/grazoprevir.
• Other medicines that are known to interact with Atorvastatin Pensa include ezetimibe (which reduces 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 that contain 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 stop using this medicine. Your doctor will tell you when you can restart treatment with Atorvastatin Pensa. The use of Atorvastatin Pensa with fusidic acid can cause muscle weakness, sensitivity, or pain (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 any other medicines, including those obtained without a prescription.

Taking Atorvastatin Pensa with food and drinks

See section 3 for instructions on how to take Atorvastatin Pensa. 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 Pensa.

Alcohol

Avoid drinking large amounts of alcohol while taking this medicine. See the details in Section 2 "Be careful with Atorvastatin Pensa".

Pregnancy and breast-feeding

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

Do not take Atorvastatin Pensa if you are of childbearing age unless you use adequate contraceptive measures.

Do not take Atorvastatin Pensa if you are breast-feeding your child.

The safety of Atorvastatin Pensa during pregnancy and breast-feeding has not been established.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

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.

Important information about some of the ingredients of Atorvastatin Pensa:

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

3. How to take ATORVASTATIN PENSA

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

The initial dose of Atorvastatin Pensa is 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 Pensa is 80 mg once a day for adults and 20 mg once a day for children.

The tablets of Atorvastatin Pensa 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 your doctor's instructions for taking Atorvastatin Pensa exactly. Consult your doctor or pharmacist if you have any doubts.

Your doctor will decide the duration of treatment with Atorvastatin Pensa

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

If you take more Atorvastatin Pensa than you should

If you accidentally take too many tablets of Atorvastatin Pensa (more than your usual daily dose), consult your doctor or the nearest hospital or call the Toxicology Information Service, telephone 91 562 04 20.

If you forget to take Atorvastatin Pensa

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 treatment with Atorvastatin Pensa

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

4. Possible side effects

Like all medicines, Atorvastatin Pensa 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 emergency department of the nearest hospital.

Rare: affects between 1 and 10 in every 10,000 patients:

• Severe allergic reaction that causes swelling of the face, tongue, and throat, which can cause great difficulty breathing.

• Severe skin disease with severe peeling 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 or 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 breakdown, which can be fatal and cause kidney problems.

Very rare: affects less than 1 in every 10,000 patients:

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

Frequency not known:

• Constant muscle weakness.
• Severe myasthenia (a disease that causes general muscle weakness that, in some cases, affects the muscles used for breathing).
• Ocular myasthenia (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 drooping eyelids, difficulty swallowing, or difficulty breathing.

Other possible side effects with Atorvastatin Pensa:

Common side effects (affect between 1 and 10 in every 100 patients) include:

• inflammation of the nasal passages, sore throat, nosebleeds
• allergic reactions
• increases in blood sugar levels (if you are diabetic, monitor your blood sugar levels), increase in 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 side effects (affect between 1 and 10 in every 1,000 patients) include:

• loss of appetite, weight gain, decrease in 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 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 side effects (affect between 1 and 10 in every 10,000 patients) 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 inflammation of the blood vessels, vasculitis)

Very rare side effects (affect less than 1 in every 10,000 patients) include:

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

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

• Sleep disorders, including insomnia and nightmares
• Memory loss
• Sexual dysfunction
• Depression
• Respiratory problems, including persistent cough and/or difficulty breathing or fever
• Diabetes: it 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 any side effects, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting 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 is not listed in this leaflet. You can also report them 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 PENSA

Keep out of the reach and sight of children.

Do not store above 30°C.

Keep in the original packaging.

Do not use Atorvastatin Pensa after the expiration date that appears on the blister pack and on the packaging after EXP. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. ADDITIONAL INFORMATION

Composition of Atorvastatina Pensa

• The active ingredient is atorvastatin.

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

The other components (excipients) are: lactose monohydrate (lactose), magnesium stearate, sodium lauryl sulfate, microcrystalline cellulose (E-460), anhydrous colloidal silica, butylhydroxyanisole (E-320), crospovidone, sodium hydrogen carbonate, sucrose, sorbitan triesterate, macrogol 40 stearate, dimethicone, and 2-Bromo-2-Nitropropano-1,3-diol.

The coating of Atorvastatina Pensa contains lactose monohydrate (lactose), hypromellose (E-464), titanium dioxide (E-171), and macrogol 4000.

Appearance ofAtorvastatina Pensaand package contents

The film-coated tablets of Atorvastatina Pensa 80 mg are oblong, biconvex, scored, fracturable, white in color, and marked with the code “AT8”.

Atorvastatina Pensa 80 mg is presented in boxes with blisters containing 28 film-coated tablets and in clinical containers containing 500 film-coated tablets.

Marketing authorization holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer

Laboratorios Cinfa, S.A.

C/ Olaz-Chipi, 10 – Polígono Industrial Areta

31620 Huarte – Pamplona (Navarra)

Or

Galenicum Health, S.L.U.

Sant Gabriel, 50

Esplugues de Llobregat. 08950 Barcelona

Spain

Or

SAG Manufacturing, S.L.U.

Crta N-I, Km. 36

San Agustin de Guadalix, 28750 Madrid

Spain

Date of the last revision of this prospectus:August 2024

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/