Atorvastatina qualigen farma 80 mg comprimidos recubiertos con pelicula efg

Package Leaflet: Information for the User

Atorvastatina Qualigen Farma 80mg Film-Coated Tablets

Read this leaflet carefully before you start taking this medicinebecause 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, pharmacistor nurse.
• This medicine has been prescribed for you only. Do not pass it on to others even if their symptoms are the same. It may harm them.
• If you experience any side effects, talk to your doctor or pharmacist.See section 4.

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

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

3.How to take Atorvastatina Qualigen Farma

4.Possible side effects

5.Storage of Atorvastatina Qualigen Farma

6.Contents of the pack and additional information

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

Atorvastatina Qualigen Farma 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 present a high risk of heart disease, Atorvastatina Qualigen Farma may also be used to reduce this risk even though your cholesterol levels are normal. During treatment, a standard low-cholesterol diet must be followed.

Do not take Atorvastatina Qualigen Farma:

• if you are taking the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C.
• if you are allergic to atorvastatina or to any of the other components of this medication (including those listed in section 6).
• if you have or have had any liver disease.
• if you have or have had abnormal results in liver function blood tests.
• if you are a fertile woman and do not use adequate contraceptive measures.
• if you are pregnant or trying to become pregnant.
• if you are breastfeeding.

Warnings and precautions

Consult 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 in the last 7 days a medication called fusidic acid (a medication used to treat bacterial infections) by mouth or by injection. The combination of fusidic acid and Atorvastatina Qualigen Farma may cause severe muscle problems (rhabdomyolysis).
• if you have had a previous stroke with bleeding in the brain, or have small fluid clots in the brain due to previous strokes.
• if you have kidney problems.
• if you have a thyroid gland with low activity (hypothyroidism).
• if you have repeated or unjustified muscle pain, personal or family history of muscle problems.
• if you have had muscle problems during previous treatment with other medications to reduce lipids (for example, 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.

Consult your doctor or pharmacist before taking Atorvastatina Qualigen Farma

• if you have severe respiratory failure
• if you have or have had myasthenia (a disease that causes generalized 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 may sometimes worsen the disease or cause myasthenia (see section 4).

In any of these cases, your doctor may instruct you to have blood tests before and, possibly, during treatment with Atorvastatina Qualigen Farma to predict the risk of suffering adverse effects related to muscle. It is known that the risk of suffering adverse effects related to muscle (for example, rhabdomyolysis) increases when certain medications are taken at the same time (see section 2 “Use of Atorvastatina Qualigen Farma with other medications”).

Also inform your doctor or pharmacist if you experience persistent muscle weakness. Additional tests and medications may be necessary to diagnose and treat this problem.

While taking this medication, your doctor will monitor if you have diabetes or a risk of developing diabetes. This risk of diabetes increases if you have high levels of sugars and fats in your blood, overweight, and high blood pressure.

Use of Atorvastatina Qualigen Farma with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. There are some medications that may affect the proper functioning of Atorvastatina Qualigen Farma or the effects of these medications may be modified by Atorvastatina Qualigen Farma.

• Medications used to modify the functioning of your immune system, for example, cyclosporine.
• Certain antibiotics or antifungal medications, for example, erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid.
• Other medications to regulate lipid levels, for example, gemfibrozil, other fibrates, cholestyramine.
• Some calcium channel blockers used in the treatment of angina or hypertension, for example, amlodipine, diltiazem; medications to regulate your heart rhythm, for example, digoxin, verapamil, amiodarone.
• Medications used in the treatment of AIDS, for example, ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir combined with ritonavir, etc.
• Other medications known to interact with Atorvastatina Qualigen Farma include: ezetimibe (which reduces cholesterol), warfarin (which reduces blood clotting), oral contraceptives, and stiripentol (an anticonvulsant for treating epilepsy), cimetidine (used for heartburn and peptic ulcers), phenazone (a pain reliever), colchicine (used for treating gout), antacids (products for indigestion that contain aluminum or magnesium).

• Over-the-counter medications: St. John's Wort.
• If you need to take oral fusidic acid to treat a bacterial infection, you will need to stop taking this medication temporarily. Your doctor will instruct you when it is safe to restart the treatment with atorvastatina. Taking atorvastatina in combination with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.
• Daptomycin (a medication used to treat skin and skin structure infections and bacteremia).

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:

Orange juice

Do not take more than one or two small glasses of orange juice per day, as large amounts of orange juice may alter the effects of Atorvastatina Qualigen Farma.

Alcohol

Avoid drinking large amounts of alcohol while taking this medication. 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 fertile and do not use adequate contraceptive measures.

Do not take Atorvastatina Qualigen Farma if you are breastfeeding your child.

The safety of Atorvastatina Qualigen Farma during pregnancy and breastfeeding has not been demonstrated.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

This medication usually 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 handle them.

Atorvastatina Qualigen Farma contains lactose and sodium

This medication contains lactose. If your doctor has told you that you have a intolerance to certain sugars, consult with him before taking this medication.

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially “sodium-free”.

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

The usual initial dose of Atorvastatina Qualigen Farma is 10 mg once a day in adults and children aged 10 years and older. Your doctor may increase it if necessary to reach the dose you need. Your doctor will adjust the dose at intervals of 4 weeks or more. The maximum dose of Atorvastatina Qualigen Farma is 80 mg once a day.

Atorvastatina Qualigen Farma tablets should be swallowed whole with a glass of water and can be taken at any time of the day with or without food. However, try to take your tablet every day at the same time.

Follow exactly the administration instructions for this medication indicated 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 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 tablets of Atorvastatina Qualigen Farma (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 the missed doses.

If you interrupt treatment with Atorvastatina Qualigen Farma

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

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

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

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

• Severe allergic reaction that causes swelling of the face, tongue, and throat, which may make it difficult to breathe.

• Severe disease with severe peeling 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 that may form blisters.

Muscle weakness, muscle sensitivity, muscle pain or muscle rupture, change in urine color to brown-red, and especially if it occurs at the same time, feeling unwell or high temperature, which may be caused by abnormal muscle destruction (rhabdomyolysis). Abnormal muscle rupture may not always disappear, 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 unexpected or unusual bleeding or bruising, this may suggest liver problems. You should consult your doctor as soon as possible.

Other possible side effects with Atorvastatina Qualigen Farma:

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

• nasal congestion, 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
• abnormal liver function test results

Uncommon (may affect up to 1 in 100 people):

• 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 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 bleeding or bruising
• cholestasis (yellowing of the skin and eyes)
• tendon damage
• skin rash or ulcers in the mouth (drug reaction)
• skin lesions of purple color (signs of inflammation of blood vessels, vasculitis)

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

• allergic reaction - symptoms may include sudden hissing while breathing 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)
• systemic lupus-like syndrome (including rash, joint problems, and effects on blood cells).

Frequency not known: cannot be estimated from available data:

• Muscle weakness that persists
• Severe myasthenia (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing).
• Myasthenia gravis (a disease that causes weakness of the eye muscles).

Consult your doctor if you experience muscle weakness in your arms or legs that worsens after periods of activity, double vision, eyelid drooping, 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. It is more likely if you have high blood sugar and fat levels, obesity, and high blood pressure. Your doctor will monitor you while taking this medicine

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is not listed in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reachof children.

Do not usethis medicationafter the expiration date that appears on the blister pack and on the packaging 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 through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need.This will help protect the environment.

Composition of Atorvastatina Qualigen Farma

• The active ingredient is atorvastatina.
• Each film-coated tablet contains 80 mg of atorvastatina (as atorvastatina calcium trihydrate).

The other components (excipients) are:

Tablet core: Microcrystalline cellulose, Lactose monohydrate, Calcium carbonate, Hydroxypropylcellulose, Croscarmellose sodium type A, Hydrophobic colloidal silica, and Magnesium stearate.

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

Appearance of the product and contents of the packaging

Atorvastatina Qualigen Farma 80 mg film-coated tablets: White, oblong, marked with an 80 on one side and with the “ATV” on the other side.

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

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

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona – Spain

Responsible for manufacturing

Haupt Pharma Latina S.R.L

Borgo San Michele S S 156 KM 47

Latina, 600 04100

Italy

This medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet: October 2024

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