ATORVASTATIN PENSA PHARMA 80 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Atorvastatin Pensa Pharma 80mgfilm-coated tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Atorvastatin Pensa Pharma and what is it used for
2. What you need to know before taking Atorvastatin Pensa Pharma
3. How to take Atorvastatin Pensa Pharma
4. Possible side effects
5. Storage of Atorvastatin Pensa Pharma
6. Package contents and additional information

1. What is Atorvastatin Pensa Pharma and what is it used for

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

Atorvastatin Pensa Pharma is used to reduce lipids such as cholesterol and triglycerides in the blood when a low-fat diet and lifestyle changes have not worked on their own. If you are at high risk of heart disease, Atorvastatin Pensa Pharma 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 taking Atorvastatin Pensa Pharma

Do not take Atorvastatin Pensa Pharma:

• if you are taking the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C.
• if you are allergic to atorvastatin or to any similar medication used to lower blood lipid levels 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 unexplained abnormal liver function test results.
• 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 breastfeeding.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Atorvastatin Pensa Pharma:

• if you have severe respiratory insufficiency.
• if you are taking or have taken in the last 7 days a medication called fusidic acid (an antibiotic used to treat bacterial infections) orally or by injection. The combination of fusidic acid and this medication 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 during treatment with other medications to lower lipid levels (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 generalized muscle weakness, which 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 (see section 4).

In any of these cases, your doctor may indicate that you should have blood tests before and possibly during treatment with this medication 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 medications are taken at the same time (see section 2 "Using Atorvastatin Pensa Pharma with other medications").

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

While taking this medication, your doctor will monitor you for diabetes or the 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.

Using Atorvastatin Pensa Pharma with other medications

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

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

• Medications used to modify the functioning of your immune system, e.g., cyclosporine.
• Certain antibiotics or antifungal medications, e.g., erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid.
• Other medications 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; medications to regulate your heart rhythm, e.g., digoxin, verapamil, amiodarone.
• Medications used to treat HIV, e.g., ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir combined with ritonavir, etc.
• Certain medications used to treat hepatitis C, such as telaprevir, boceprevir, and the combination of elbasvir/grazoprevir.
• Letermovir, a medication that helps prevent diseases caused by cytomegalovirus.
• Other medications 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), and antacids (products for indigestion that contain aluminum or magnesium)
• Medications 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 medication temporarily. Your doctor will indicate when it is safe to restart treatment with this medication. Taking this medication in combination with fusidic acid can rarely cause muscle weakness, pain, or discomfort (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.
• Daptomycin (a medication used to treat skin and skin structure infections with complications and bacteria present in the blood).

Taking Atorvastatin Pensa Pharma with food, drinks, and alcohol

See section 3 for instructions on how to take Atorvastatin Pensa Pharma. 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 large amounts of alcohol while taking this medication. See the details in section 2 "Warnings and precautions".

Pregnancy, breastfeeding, and fertility

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

Do not take this medication if you are of childbearing age unless you are using adequate contraceptive measures.

Do not take this medication if you are breastfeeding.

The safety of atorvastatin during pregnancy and breastfeeding has not been established. Consult your doctor or pharmacist before using any medication.

Driving and using machines

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 Pensa Pharma contains lactose and sodium

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

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

3. How to take Atorvastatin Pensa Pharma

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

The initial dose of atorvastatin is usually 10 mg once a day in adults and children from 10 years old. 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.

The tablets of this medication 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 administration instructions of this medication exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Your doctor will decide the duration of treatment with Atorvastatin Pensa Pharma

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

If you take more Atorvastatin Pensa Pharma than you should

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service Telephone 91.562.04.20, indicating the medication and the amount ingested.

If you forget to take Atorvastatin Pensa Pharma

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 missed doses.

If you interrupt treatment with Atorvastatin Pensa Pharma

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone 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. Skin rash with pink-red spots, especially on the palms of the hands or soles of the feet, which can form blisters.
• Weakness, muscle sensitivity, pain, or change in urine color to reddish-brown, and especially if it occurs at the same time, feeling unwell or fever, which can be caused by abnormal muscle destruction that can be potentially fatal and lead to 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 (including rash, joint disorders, and effects on blood cells).

Other possible side effects of Atorvastatin Pensa Pharma:

Frequent: may affect up to 1 in 10 people

• 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

• 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 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 up to 1 in 1,000 people

• vision changes
• unexpected or unusual 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 people

• 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)

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

• constant muscle weakness
• severe myasthenia (a disease that causes generalized muscle weakness, which 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.

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

• sexual difficulties
• depression
• respiratory problems such as 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 medication

Reporting side effects

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

5. Storage of Atorvastatin Pensa Pharma

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

Do not use this medication after the expiration date stated on the blister pack and carton 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 via wastewater or household waste. Place the packaging and any unused medication in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Container Content and Additional Information

Composition of Atorvastatina pensa pharma

• The active ingredient is atorvastatin calcium trihydrate

Each film-coated tablet contains 80 mg of atorvastatin (as 86.64 mg atorvastatin calcium trihydrate).

• The other components (excipients) are:

Lactose monohydrate, silicified microcrystalline cellulose (anhydrous colloidal silica and microcrystalline cellulose), microcrystalline cellulose PH 102 (E460), sodium croscarmellose (E468), calcium carbonate (E170), magnesium stearate (E470b). The coating material: lactose monohydrate, HPMC 2910/Hypromellose (E464), titanium dioxide (E171), and macrogol/PEG (E1521).

See section 2 Atorvastatina pensa pharma contains lactose and sodium

Appearance of Atorvastatina pensa pharma and Container Content

The 80 mg tablets are white, oval, biconvex, marked with "VT80" on one face. Tablet dimensions: 20.1 x 8.8 ± 0.5 mm.

They are presented in perforated aluminum/aluminum OPA/AL/PVC unit-dose blisters.

Content:

This medication is available in film-coated tablets of 10 mg, 20 mg, 30 mg, 40 mg, 60 mg, and 80 mg

Atorvastatina pensa pharma 80 mg is presented in blister packs containing 28 x 1 and 30 x 1 film-coated tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer

Galenicum Health, S.L.

Sant Gabriel, 50

Esplugues de Llobregat

08950 Barcelona

Spain

or

SAG Manufacturing, S.L.U.

Crta. N-I, Km 36

28750 San Agustin de Guadalix, Madrid

Spain

This medication is authorized in the Member States of the European Economic Area under the following names:

Italy – Atorvastatina Pensa Pharma

Portugal – Atorvastatina toLife

Spain – Atorvastatina pensa pharma

Malta – Atorvastatina Diagonalis

Date of the Last Revision of this ProspectusSeptember 2024.

Other Sources of Information

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