Atorvastatin Qualigen Farma 20 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Atorvastatine Qualigen Farma 20 mg film-coated tablets EFG

Read all of 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 questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if the side effects are not listed in this leaflet. See section 4.

What this leaflet contains

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

1. What Atorvastatina Qualigen Farma is and what it is used for

Atorvastatina Qualigen Farma belongs to a group of medicines known as statins, which are lipid-regulating (fat-regulating) medicines.

Atorvastatina Qualigen Farma is used to reduce lipids 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 Qualigen Farma may also be used to reduce this risk, even if your cholesterol levels are normal. During treatment, a standard low-cholesterol diet should be followed.

2. What you need to know before taking Atorvastatina Qualigen Farma

Do not take Atorvastatina Qualigen Farma:

• if you are using the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C.
• if you are allergic to atorvastatin 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 do not use adequate contraceptive measures.
• if you are pregnant or trying to become pregnant.
• if you are breastfeeding.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to take Atorvastatina Qualigen Farma.

The following are reasons why Atorvastatina Qualigen Farma may not be suitable for you:

• 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 Atorvastatina Qualigen Farma may cause serious muscle problems (rhabdomyolysis).
• if you have previously had a stroke with bleeding in the brain, or have small accumulations of fluid 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 personal or family history of muscle disorders.
• if you have previously experienced muscle problems while being treated 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 of age.

Consult your doctor or pharmacist before taking Atorvastatina Qualigen Farma:

• if you have severe respiratory insufficiency.
• if you have or have had myasthenia (a disease characterized by generalized muscle weakness, which in some cases affects the muscles used for breathing) or ocular myasthenia (a disease 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 Atorvastatina Qualigen Farma to assess the 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 Atorvastatina Qualigen Farma 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 of 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 Atorvastatina Qualigen Farma 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 functioning of Atorvastatina Qualigen Farma, or their effects may be altered by Atorvastatina Qualigen Farma. 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 severe 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.

• 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 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.

• Other medicines known to interact with Atorvastatina Qualigen Farma include: ezetimibe (cholesterol-lowering agent), warfarin (reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant used to treat epilepsy), cimetidine (used for heartburn and peptic ulcer), phenazone (an analgesic), colchicine (used to treat gout), antacids (indigestion remedies containing aluminium or magnesium).

• Over-the-counter medicines: 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 atorvastatin treatment. 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 medicine used to treat complicated skin and skin structure infections and bloodstream infections caused by bacteria).

Taking Atorvastatina Qualigen Farma with food, drinks, and alcohol

See section 3 for instructions on how to take Atorvastatina Qualigen Farma. 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 Atorvastatina Qualigen Farma.

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 Atorvastatina Qualigen Farma if you are pregnant, think you may be pregnant, or are trying to become pregnant.

Do not take Atorvastatina Qualigen Farma if you are of childbearing age unless you are using adequate contraceptive measures.

Do not take Atorvastatina Qualigen Farma if you are breastfeeding.

The safety of Atorvastatina Qualigen Farma 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 machines if this medicine impairs your ability to handle them.

Atorvastatina Qualigen Farma contains lactose and sodium.

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

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

3. How to take Atorvastatina Qualigen Farma

Before starting treatment, your doctor will place you on a low-cholesterol diet, which you must continue to follow during treatment with Atorvastatina Qualigen Farma.

The usual starting dose of Atorvastatina Qualigen Farma 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 you require. Your doctor will adjust the dose at intervals of 4 weeks or more. The maximum dose of Atorvastatina Qualigen Farma is 80 mg once daily.

Atorvastatina Qualigen Farma tablets 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.

Follow exactly the instructions for administration provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Your doctor will decide the duration of treatment with Atorvastatina Qualigen Farma

Ask your doctor if you think that the effect of Atorvastatina Qualigen Farma is too strong or too weak.

If you take more Atorvastatina Qualigen Farma than you should

If you accidentally take too many Atorvastatina Qualigen Farma tablets (more than your usual daily dose), consult your doctor or the nearest hospital.

If you forget to take Atorvastatina Qualigen Farma

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 Atorvastatina Qualigen Farma

If you have any further questions about using this medicine or wish to stop treatment, ask 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 serious adverse effects, stop taking these tablets immediately and contact your doctor right away or go to the nearest hospital emergency department.

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, blisters in the 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 muscle rupture, change in urine color to red-brown, and especially if occurring together with a feeling of malaise or high temperature, which may be due to abnormal muscle breakdown (rhabdomyolysis). Abnormal muscle breakdown does not always resolve, even after stopping atorvastatin, and may be fatal and cause kidney problems.

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

• If you experience problems with unexpected or unusual bleeding or bruising, this may indicate a liver problem. You should consult your doctor as soon as possible.

Other possible adverse effects with Atorvastatina Qualigen Farma:

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

• Nasal inflammation, sore throat, nosebleeds
• Allergic reactions
• Increased blood sugar levels (if you have diabetes, monitor your blood sugar levels), increased creatine kinase in 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):

• Anorexia (loss of appetite), weight gain, decreased blood sugar levels (if you have diabetes, 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 (liver inflammation)
• Rash, skin rash and itching, hives, hair loss
• Neck pain, muscle fatigue
• Fatigue, feeling unwell, weakness, chest pain, swelling, 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 disturbances
• Unexpected 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 and chest pain or tightness, swelling of the eyelids, face, lips, mouth, tongue, or throat, difficulty breathing, collapse
• Hearing loss
• Gynaecomastia (enlargement of breasts in men)
• Lupus-like syndrome (including rash, joint disorders, and effects on blood cells)

Frequency not known: cannot be estimated from available data:

• Persistent muscle weakness
• Myasthenia gravis (a disease causing generalized muscle weakness, which in some cases affects muscles used for breathing)
• Ocular myasthenia (a disease causing weakness of the eye muscles)

Consult your doctor if you experience worsening weakness in your arms or legs after periods of activity, double vision or drooping eyelids, difficulty swallowing, or difficulty breathing.

Possible side effects reported with 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 your 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 adverse effect, talk to your doctor or pharmacist, even if it is an effect not listed in this leaflet. You can 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 Qualigen Farma

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the blister pack and 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 should not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Atorvastatin Qualigen Farma

• The active substance is atorvastatin.
• Each film-coated tablet contains 20 mg of atorvastatin (as atorvastatin calcium trihydrate).

The other components (excipients) are:

Tablet core: Microcrystalline cellulose, Monohydrate lactose, Calcium carbonate, Hydroxypropylcellulose, Sodium croscarmellose type A, Hydrophobic colloidal silica, and Magnesium stearate.

Coating: Hypromellose (E464), Macrogol, Titanium dioxide (E171), Talc (E553b).

Appearance of the product and contents of the pack

Atorvastatin Qualigen Farma 20 mg film-coated tablets: white, oblong tablets, marked with "20" on one side and "ATV" on the other side.

PA/Alu/PVC-Alu blisters: 4, 7, 10, 14, 20, 28, 30, 50, 56, 84, 90, 98, 100, 200 (10x20) and 500 film-coated tablets.

PVC/PVDC-Alu blisters: 4, 7, 10, 14, 20, 28, 30, 50, 56, 84, 90, 98, 100, 200 (10x20) and 500 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona – Spain

Manufacturer

Haupt Pharma Latina S.R.L

Borgo San Michele S S 156 KM 47

Latina, 600 04100

Italy

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

Date of the most recent review of this leaflet: October 2024

Detailed and up-to-date information about this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/