Atorvastatin Pensapharma 30 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Atorvastatina pensa pharma 30 mg film-coated tablets

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

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

What is in this leaflet

1. What Atorvastatina pensa pharma is and what it is used for
2. What you need to know before taking Atorvastatina pensa pharma
3. How to take Atorvastatina pensa pharma
4. Possible side effects
5. How to store Atorvastatina pensa pharma
6. Contents of the pack and other information

1. What Atorvastatina pensa pharma is and what it is used for

Atorvastatina pensa pharma belongs to a group of medicines known as statins, which are drugs that regulate lipids (fats).

Atorvastatina pensa pharma is used to reduce lipid levels such as cholesterol and triglycerides in the blood when a low-fat diet and lifestyle changes alone have failed. If you are at high risk of heart disease, Atorvastatina pensa pharma may also be used to reduce this risk even if your cholesterol levels are normal. A standard low-cholesterol diet should be followed during treatment.

2. What you need to know before taking Atorvastatin pensa pharma

Do not take Atorvastatin pensa pharma:

• if you are using the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C.
• if you are allergic to atorvastatin or to any similar medicine used to lower blood lipids, or to any of the other components of this medicine (listed in section 6).
• if you have or have had any liver disease.
• if you have or have had unexplained abnormal results in liver function blood tests.
• if you are a woman of childbearing age and you are not using adequate contraceptive measures.
• if you are pregnant or trying to become pregnant.
• if you are breastfeeding.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Atorvastatin pensa pharma:

• if you have severe respiratory failure.
• if you are taking or have taken within the last 7 days an oral or injectable medicine called fusidic acid (a medicine used to treat bacterial infections). The combination of fusidic acid and this medicine may cause serious muscle problems (rhabdomyolysis).
• if you have previously had a stroke with bleeding in the brain, or have small fluid-filled pockets 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, or a personal or family history of muscle disorders.
• if you have previously experienced muscle problems during treatment with other lipid-lowering medicines (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 causing generalized muscle weakness, which in some cases affects the muscles used for breathing) or ocular myasthenia (a condition causing weakness of the eye muscles), as statins may sometimes worsen the condition or trigger the onset of myasthenia (see section 4).

In any of these cases, your doctor may decide whether you need blood tests before and possibly during treatment with this medicine to assess your risk of muscle-related adverse effects. It is known that the risk of muscle-related adverse effects (e.g., rhabdomyolysis) increases when certain medicines are taken concomitantly (see section 2 “ Use of Atorvastatin pensa pharma with other medicines”).

Also inform your doctor or pharmacist if you experience persistent muscle weakness. Additional tests and treatments may be needed to diagnose and manage this condition.

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

Use of Atorvastatin pensa pharma with other medicines

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

Some medicines may interfere with the proper function of atorvastatin, or the effects of these medicines may be altered by atorvastatin. Such interactions may reduce the effect of one or both medicines. Alternatively, taking them together may increase the risk or severity of adverse effects, including the serious muscle damage known as rhabdomyolysis described in section 4:

• Medicines used to modify the function of your immune system, for example, cyclosporine.
• Certain antibiotics or antifungal medicines, for example, erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid.
• Other medicines used to regulate lipid levels, for example, gemfibrozil, other fibrates, colestipol.
• Some 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 in the treatment of HIV/AIDS, for example, ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir combined with ritonavir, etc.
• Some medicines used to treat hepatitis C, such as telaprevir, boceprevir, and the combination of elbasvir/grazoprevir.
• Letermovir, a medicine used to prevent cytomegalovirus infections.
• Other medicines known to interact with atorvastatin include ezetimibe (cholesterol-lowering), warfarin (anticoagulant), oral contraceptives, stiripentol (an anticonvulsant used to treat epilepsy), cimetidine (used for heartburn and peptic ulcer), phenazone (a painkiller), colchicine (used to treat gout), and antacids (indigestion remedies containing aluminium or magnesium).
• Herbal products: St. John’s wort.
• If you need to take oral fusidic acid to treat a bacterial infection, you must temporarily stop taking this medicine. Your doctor will advise you when it is safe to restart treatment. Taking this medicine together with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.
• Daptomycin (a medicine used to treat complicated skin and skin structure infections and bloodstream infections caused by bacteria).

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 may alter the effects of atorvastatin.

Alcohol

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

Pregnancy, breastfeeding, and fertility

Do not take this medicine if you are pregnant, think you may be pregnant, or are trying 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 breastfeeding.

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

Driving and using machines

This medicine usually does not affect your ability to drive or operate machinery. However, do not drive if this medicine affects your ability to do so. Do not operate tools or machinery if this medicine impairs your ability to use them safely.

Atorvastatin pensa pharma contains lactose and sodium

If your doctor has informed you that you have an intolerance to certain sugars, consult with him 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 pensa pharma

Before starting treatment, your doctor will place you on a cholesterol-lowering diet, which you must continue to follow during treatment with this medicine.

The usual starting dose of atorvastatin is 10 mg once daily in adults and children aged 10 years and older. Your doctor may increase this dose if necessary to reach the dose appropriate for you. Your doctor will adjust the dose at intervals of 4 weeks or more. The maximum dose of atorvastatin is 80 mg once daily.

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

Always follow exactly the instructions for use of this medicine provided 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 that the effect of this medicine is too strong or too weak.

If you take more Atorvastatin pensa pharma than you should

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service at telephone number 91.562.04.20, indicating the medicine and the amount ingested.

If you forget to take Atorvastatin pensa pharma

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

If you stop taking Atorvastatin pensa pharma

If you have any further questions about using this medicine or wish to discontinue treatment, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

If you notice any of the following adverse effects or serious symptoms, stop taking these tablets immediately and contact your doctor or go to the nearest hospital emergency department without delay.

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

• Severe allergic reaction causing swelling of the face, tongue, and throat, which may lead to severe difficulty breathing.
• Serious illness with severe skin peeling and inflammation; skin blisters, 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 may develop into blisters.
• Muscle weakness, muscle tenderness, muscle pain, or change in urine color to red-brown, especially if accompanied by a feeling of malaise or high temperature. These may be caused by abnormal muscle breakdown, which can be potentially life-threatening and may trigger kidney problems.

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

• If you experience problems with bleeding or unusual or unexpected bruising, this may indicate 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 adverse effects with Atorvastatinapensa pharma:

Common: may affect up to 1 in 10 people

• Nasal inflammation, sore throat, nosebleeds
• Allergic reactions
• Increased blood sugar levels (if you are diabetic, monitor your blood sugar levels closely), increased blood creatine kinase
• Headache
• Nausea, constipation, flatulence, indigestion, diarrhoea
• 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

• Anorexia (loss of appetite), weight gain, decreased blood sugar levels (if you are diabetic, continue to monitor your blood sugar levels carefully)
• Nightmares, insomnia
• Dizziness, numbness or tingling in fingers and toes, reduced sensitivity to pain or touch, changes in taste sensation, memory loss
• Blurred vision
• Ringing in the ears and/or head
• Vomiting, belching, upper and lower abdominal pain, pancreatitis (inflammation of the pancreas causing stomach pain)
• Hepatitis (inflammation of the liver)
• Rash, skin rash and itching, hives, hair loss
• Neck pain, muscle fatigue
• Fatigue, malaise, weakness, chest pain, swelling, especially in the ankles (oedema), increased temperature
• Urine tests positive for white blood cells

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

• Vision disturbances
• Unexplained bleeding or bruising
• Cholestasis (yellowing of the skin and whites of the eyes)
• Tendon injury
• Skin rash or mouth ulcers (drug-induced lichenoid reaction)
• Purple-colored skin lesions (signs of blood vessel inflammation, vasculitis)

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

• Allergic reaction – symptoms may include sudden wheezing, chest pain or tightness, swelling of the eyelids, face, lips, mouth, tongue, or throat, difficulty breathing, collapse
• Hearing loss
• Gynaecomastia (enlargement of the breasts in men)

Frequency not known: cannot be estimated from available data:

• Persistent muscle weakness
• Myasthenia gravis (a condition causing generalized muscle weakness, which in some cases affects the muscles used for breathing).
• Ocular myasthenia (a condition causing 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 drooping eyelids, difficulty swallowing, or difficulty breathing.

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

• 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 fats in the blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is an effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Atorvastatin pensa pharma

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 on the outer packaging following {EXP}. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE point in your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Atorvastatina pensa pharma

• The active substance is atorvastatin calcium trihydrate.

Each film-coated tablet contains 30 mg of atorvastatin (as 32.49 mg atorvastatin calcium trihydrate).

• The other components (excipients) are:

Monohydrate lactose, silicified microcrystalline cellulose (anhydrous colloidal silica and microcrystalline cellulose), microcrystalline cellulose PH 102 (E460), sodium croscarmellose (E468), calcium carbonate (E170), magnesium stearate (E470b). Coating material: monohydrate lactose, 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 contents of the pack

The 30 mg tablets are white, oval-shaped, biconvex, with a score line on one side. Tablet dimensions: 13.0 x 7.5 ± 0.5 mm.

Presented in single-dose aluminum/aluminum OPA/AL/PVC perforated blisters.

Contents:

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

Atorvastatina pensa pharma 30 mg is available in packaging with blisters containing 28 x 1 film-coated tablets.

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 medicinal product 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 most recent revision of this leaflet: September 2024.

Other sources of information

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