ATORVASTATIN QUALIGEN FARMA 60 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Atorvastatina Qualigen Farma 60 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, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Atorvastatina Qualigen Farma and what is it used for
2. What you need to know before you take 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 other information

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

Atorvastatina Qualigen Farma belongs to a group of medicines known as statins, which are lipid-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 on their own have not worked.

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, you should follow a standard low-cholesterol diet.

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

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 atorvastatin or any of the other ingredients of this medicine (listed in section 6).
• if you have or have had any liver disease.
• if you have or have had unexplained abnormal blood test results indicating liver function.
• 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 breast-feeding.

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 medicine called fusidic acid (a medicine used to treat bacterial infections) by mouth or by injection. The combination of fusidic acid and Atorvastatina Qualigen Farma 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 while taking other lipid-lowering medicines (e.g. other statins 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 general muscle weakness that can affect 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).

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

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

While 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.

Using Atorvastatina Qualigen Farma with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. There are some medicines that can affect the proper functioning of Atorvastatina Qualigen Farma or the effects of these medicines may be altered by Atorvastatina Qualigen Farma. 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, e.g. ciclosporin.
• Certain antibiotics or antifungal medicines, e.g. erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid.
• Other medicines for regulating lipid levels, e.g. gemfibrozil, other fibrates, colestipol.
• Certain calcium channel blockers used to treat angina or high blood pressure, e.g. amlodipine, diltiazem; medicines for regulating your heart rhythm, e.g. digoxin, verapamil, amiodarone.
• Medicines used to treat AIDS, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir combined with ritonavir, 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 Atorvastatina Qualigen Farma include: ezetimibe (which reduces cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant for treating epilepsy), cimetidine (used for heartburn and peptic ulcers), phenazone (a pain reliever), colchicine (used to treat gout), antacids (indigestion products containing 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 have to stop using this medicine temporarily. Your doctor will tell you when it is safe to restart treatment with atorvastatin. Taking atorvastatin in combination with fusidic acid can rarely cause muscle weakness, pain, or tenderness (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.
• Daptomycin (a medicine 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:

Grapefruit juice

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

Alcohol

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

Pregnancy, breast-feeding, and fertility

Do not take Atorvastatina Qualigen Farma if you are pregnant, think you may be pregnant, or are planning to become pregnant.

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

Do not take Atorvastatina Qualigen Farma if you are breast-feeding.

The safety of Atorvastatina Qualigen Farma during pregnancy and breast-feeding has not been established.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Normally, this medicine does not affect your ability to drive or use machines. However, 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.

Atorvastatina Qualigen Farma contains lactose and sodium.

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

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

3. How to take Atorvastatina Qualigen Farma

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 initial dose of Atorvastatina Qualigen Farma 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 Atorvastatina Qualigen Farma is 80 mg once a day.

The tablets of Atorvastatina Qualigen Farma 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 exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of 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 forgotten doses.

If you stop treatment with Atorvastatina Qualigen Farma

If you have any further questions on the use of this medicine or wish to stop treatment, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine 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: 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 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, muscle sensitivity, muscle pain, or muscle rupture, change in urine color to reddish-brown, and especially if it occurs at the same time, feeling unwell or high temperature, which can be caused by abnormal muscle destruction (rhabdomyolysis). The abnormal muscle rupture does not always disappear, even after stopping atorvastatin, and can be fatal and cause kidney problems.

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

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

Other possible side effects with Atorvastatina Qualigen Farma:

Frequent (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), 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 and toes, 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 (may affect up to 1 in 1,000 people):

• vision changes
• unexpected bleeding or bruising
• jaundice (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 inflammation of the blood vessels, vasculitis)

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

• allergic reaction - symptoms can include sudden wheezing and chest pain or tightness, swelling of the eyelids, face, lips, mouth, or tongue, difficulty breathing, collapse
• hearing loss
• gynecomastia (breast enlargement in men)
• lupus-like syndrome (including rash, joint disorders, and effects on blood cells).

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

• constant muscle weakness
• severe myasthenia (a disease that causes general muscle weakness that can affect the muscles used for breathing).
• ocular myasthenia (a disease that causes weakness of the eye muscles).

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is not listed in this leaflet. You can also report side effects 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 Atorvastatina Qualigen Farma

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

Do not use this medicine after the expiry date which is stated on the blister and carton after {CAD}. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to the pharmacy. Ask your pharmacist how to dispose of containers and any unused medicines. This will help protect the environment.

6. Container contents and additional information

Composition of Atorvastatina Qualigen Farma

• The active ingredient is atorvastatin.
• Each film-coated tablet contains 60 mg of atorvastatin (as atorvastatin calcium trihydrate).

The other components (excipients) are:

Core of the tablet: Microcrystalline cellulose, Lactose monohydrate, Calcium carbonate, Hydroxypropylcellulose, Sodium croscarmellose type A, Colloidal silicon dioxide, and Magnesium stearate.

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

Appearance of the product and container contents

Atorvastatina Qualigen Farma 60 mg film-coated tablets: white, oblong, marked with a 60 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 some 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 last revision of this leaflet: October 2024

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