Atrox 40

Leaflet accompanying the packaging: information for the user

Atrox 10, 10 mg, coated tablets

Atrox 20, 20 mg, coated tablets

Atrox 40, 40 mg, coated tablets

Atrox, 80 mg, coated tablets

Atorvastatin

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, you should ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. See section 4.

“Medicine absolutely contraindicated in pregnancy”.

Table of contents of the leaflet

• 1. What is Atrox and what is it used for
• 2. Important information before taking Atrox
• 3. How to take Atrox
• 4. Possible side effects
• 5. How to store Atrox
• 6. Contents of the packaging and other information

1. What is Atrox and what is it used for

Atrox belongs to a group of medicines called statins, which regulate lipid metabolism in the body.
Atrox is used to reduce the levels of lipids, such as cholesterol and triglycerides, in the blood, when a low-fat diet and lifestyle changes are not effective. Atrox can also be used to reduce the risk of heart disease, even if the cholesterol level is normal. During treatment, you should continue to follow a standard low-cholesterol diet.

2. Important information before taking Atrox

When not to take Atrox

• 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 liver disease;
• if you have unexplained, abnormal liver function test results;
• if you are taking glecaprevir with pibrentasvir for the treatment of hepatitis C virus infection;
• in women of childbearing age who do not use effective methods of contraception;
• in pregnant or breastfeeding women;
• in nursing mothers.

Warnings and precautions

Before starting treatment with Atrox, you should discuss it with your doctor, pharmacist, or nurse:

• if you have severe respiratory failure,
• if you are taking or have taken fusidic acid (an antibiotic used to treat bacterial infections) orally or by injection within the last 7 days. Concurrent use of fusidic acid with Atrox may lead to serious muscle problems (rhabdomyolysis),
• in case of a stroke with bleeding into the brain, or if there is a small amount of fluid from a previous stroke in the brain,
• in case of kidney problems,
• in case of hypothyroidism,
• in case of recurring or unexplained muscle pain, or muscle problems in the past, or similar problems in relatives,
• in case of muscle problems during previous treatment with other lipid-lowering medicines (e.g., other statins or fibrates),
• in case of regular consumption of large amounts of alcohol,
• in case of a history of liver disease,
• in patients over 70 years of age,
• if you have or have had myasthenia (a disease that causes general muscle weakness, including in some cases muscles involved in breathing) or ocular myasthenia (a disease that causes muscle weakness in the eyes), as statins may sometimes exacerbate symptoms of the disease or lead to the development of myasthenia (see section 4).
  The doctor will order a blood test before starting treatment with Atrox and, if possible, during treatment, to monitor the risk of muscle-related side effects. It is known that the risk of muscle-related side effects, such as rhabdomyolysis, is higher when certain other medicines are taken concurrently (see section 2 "Atrox and other medicines").
  The doctor or pharmacist should also be informed if muscle weakness persists. To diagnose and treat this condition, additional tests and medications may be necessary.
  During treatment with Atrox, the doctor will closely monitor you for the development of diabetes or the risk of developing diabetes. Patients with high blood sugar and lipid levels, patients who are overweight, and patients with high blood pressure may be at risk of developing diabetes.

  Atrox and other medicines

  You should tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about medicines you plan to take, including those that are available without a prescription, as they may interact with Atrox. Some medicines may change the effect of Atrox or the effect of these medicines on the body may be changed by Atrox.
  This type of interaction can lead to reduced efficacy of one or both medicines. At the same time, it can increase the risk of serious side effects, including severe muscle damage, called rhabdomyolysis, described in section 4:

  • immunosuppressants, such as cyclosporine;
  • certain antibiotics or antifungal medicines, such as erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid;
  • other lipid-lowering medicines, such as gemfibrozil, other fibrates, cholestyramine;
  • certain calcium channel blockers used to treat angina or high blood pressure, such as amlodipine, diltiazem, as well as medicines that regulate heart rhythm, such as digoxin, verapamil, amiodarone;
  • medicines used to treat HIV infection, such as ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir in combination with ritonavir, etc.;
  • certain medicines used to treat hepatitis C virus infection, such as telaprevir, boceprevir, and a combination product containing elbasvir with grazoprevir;
  • other medicines known to interact with Atrox, including ezetimibe (a cholesterol-lowering medicine), warfarin (a blood thinner), oral contraceptives, stiripentol (an antiepileptic medicine), cimetidine (used to treat heartburn and stomach ulcers), phenazon (a pain reliever), colchicine (used to treat gout), and antacids (medicines used to treat heartburn, containing aluminum or magnesium);
  • over-the-counter medicines: St. John's Wort;
  • if oral fusidic acid is required for the treatment of a bacterial infection, Atrox should be temporarily discontinued. The doctor will inform you when it is possible to resume taking Atrox. The use of Atrox with fusidic acid can rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis). More information on rhabdomyolysis can be found in section 4;
  • daptomycin (a medicine used to treat complicated skin and soft tissue infections and bloodstream infections caused by bacteria).

  Atrox with food, drink, and alcohol

  Information on the use of Atrox can be found in section 3. However, you should pay attention to the following information:
  Grapefruit juice
  You should not drink more than one or two small glasses of grapefruit juice per day, as larger amounts of grapefruit juice may change the effect of Atrox.
  Alcohol
  While taking Atrox, you should avoid consuming excessive amounts of alcohol.
  Detailed information on this can be found in section 2 "Warnings and precautions".

  Pregnancy, breastfeeding, and fertility

  If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should ask your doctor or pharmacist for advice before taking this medicine.
  Pregnancy
  Taking Atrox during pregnancy or when planning to become pregnant is contraindicated.
  Breastfeeding
  Taking Atrox during breastfeeding is contraindicated.
  Women of childbearing age
  Taking Atrox by women of childbearing age is contraindicated if they do not use effective methods of contraception.

  Driving and using machines

  Normally, the medicine does not affect the ability to drive or use machines.
  However, you should not drive if the medicine affects your ability to drive. You should not use any tools or machines if taking the medicine affects your ability to use them.

  Atrox contains lactose

  If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking this medicine.
  The medicine contains less than 1 mmol (23 mg) of sodiumper recommended dose, which means that the medicine is considered "sodium-free".

  3. How to take Atrox

  This medicine should always be taken exactly as prescribed by your doctor. If you are unsure, you should ask your doctor or pharmacist.
  Before starting treatment, your doctor will recommend a low-cholesterol diet; this diet should be continued during treatment with Atrox.

  Dosage

  The usual starting dose of Atrox for adults and children over 10 years of age is 10 mg once daily. This dose may be increased by your doctor if necessary, up to a dose suitable for you. The doctor will adjust the dose of Atrox at intervals of at least 4 weeks. The maximum dose of Atrox is 80 mg once daily.

  Method of administration

  • The tablet should be swallowed whole, with water.
  • The tablet can be divided into two equal doses.
  • The tablet should be taken once a day, and can be taken at any time of day, with or without food. However, you should try to take the tablet at the same time every day.

  The duration of treatment with Atrox is determined by your doctor.

  If you feel that the effect of Atrox is too strong or too weak, you should consult your doctor.

  Taking a higher dose of Atrox than recommended

  You should not take a higher dose than recommended by your doctor.
  If you have accidentally taken too many Atrox tablets (more than the usual daily dose), you should contact your doctor or the nearest hospital for advice.

  Missing a dose of Atrox

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

  Stopping treatment with Atrox

  If you have any further questions about taking this medicine, you should ask your doctor or pharmacist.

  4. Possible side effects

  Like all medicines, Atrox can cause side effects, although not everybody gets them.

  If you experience any of the following serious side effects or symptoms, you should stop taking Atrox and contact your doctor or go to the emergency department of the nearest hospital immediately.

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

  • Severe allergic reaction causing swelling of the face, tongue, and throat, which can cause severe breathing difficulties.
  • Severe disease characterized by skin peeling and swelling, blisters on the skin, mouth, eyes, genitals, and fever. Skin rash with pink-red spots, especially on the palms or soles, with possible blisters.
  • Weakness, tenderness, muscle pain, muscle rupture, or reddish-brown urine. If you also feel unwell or have a high fever, it may be caused by muscle breakdown (rhabdomyolysis). Muscle breakdown may not always resolve, even if you stop taking atorvastatin, and can be life-threatening and cause kidney problems.

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

  • If you experience unexpected or unusual bleeding or bruising, it may indicate liver problems. 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 Atrox:

  Common: may affect up to 1 in 10 people:

  • nasal congestion, sore throat, nosebleeds
  • allergic reactions
  • increased blood glucose levels (in diabetic patients, blood glucose levels should continue to be closely monitored), increased creatine kinase levels in the blood
  • headaches
  • nausea, constipation, bloating, indigestion, diarrhea
  • joint pain, muscle pain, and back pain
  • blood test results indicating abnormal liver function

  Uncommon: may affect up to 1 in 100 people:

  • loss of appetite, weight gain, decreased blood glucose levels (in diabetic patients, blood glucose levels should continue to be closely monitored)
  • nightmares, insomnia
  • dizziness, numbness or tingling in the fingers and toes, decreased sensitivity to pain and touch, changes in taste, memory loss
  • blurred vision
  • ringing in the ears and (or) head
  • vomiting, belching, abdominal pain, pancreatitis (causing abdominal pain)
  • hepatitis
  • skin rash, skin rash, and itching, hives, hair loss
  • neck pain, muscle fatigue
  • fatigue, malaise, weakness, chest pain, swelling, especially of the ankles, elevated temperature
  • presence of white blood cells in the urine

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

  • vision disturbances
  • unexpected bleeding or bruising (bruises)
  • cholestasis (yellowing of the skin and whites of the eyes)
  • tendon rupture
  • skin rash, which may occur on the skin, or ulcers in the mouth (lupus-like drug reaction)
  • purple skin discolorations (symptoms of vasculitis)

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

  • allergic reactions - 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 (excessive breast tissue growth in men)

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

  • persistent muscle weakness
  • Myasthenia (a disease that causes general muscle weakness, including in some cases muscles involved in breathing).
  • Ocular myasthenia (a disease that causes muscle weakness in the eyes).

  You should talk to your doctor if you experience weakness in your arms or legs, worsening after periods of activity, double vision, or drooping eyelids, difficulty swallowing, or shortness of breath.
  Other possible side effects reported during treatment with some statins (medicines of the same type):

  • sexual disorders
  • depression
  • breathing problems, including persistent cough and (or) shortness of breath or fever
  • diabetes; the risk of developing diabetes is higher in people with high blood sugar and lipid levels, overweight, and high blood pressure. Your doctor will monitor your condition while you are taking this medicine.

  Reporting side effects

  If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, e-mail: ndl@urpl.gov.pl.
  Side effects can also be reported to the marketing authorization holder.
  Reporting side effects will help to gather more information on the safety of this medicine.

  5. How to store Atrox

  Do not store above 25°C.
  The medicine should be stored out of sight and reach of children.
  Do not use this medicine after the expiry date stated on the carton and blister.
  The expiry date refers to the last day of the month.
  Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

  6. Contents of the packaging and other information

  What Atrox contains

  • The active substance of the medicine is atorvastatin.

  Atrox 10:
  One coated tablet contains 10 mg of atorvastatin (in the form of atorvastatin calcium).
  Atrox 20:
  One coated tablet contains 20 mg of atorvastatin (in the form of atorvastatin calcium).
  Atrox 40:
  One coated tablet contains 40 mg of atorvastatin (in the form of atorvastatin calcium).
  Atrox, 80 mg:
  One coated tablet contains 80 mg of atorvastatin (in the form of atorvastatin calcium).

  • The other ingredients of the medicine are: tablet core: microcrystalline cellulose, calcium carbonate, lactose monohydrate, sodium croscarmellose, hydroxypropyl cellulose, polysorbate 80, magnesium stearate. tablet coating (AquaPolish white 014.11): hypromellose, hydroxypropyl cellulose, talc, titanium dioxide (E 171), macrogol 6000.

  What Atrox looks like and contents of the pack

  Atrox 10:
  White, round, biconvex coated tablets, with a dividing line on one side.
  Atrox 20:
  White, oval, biconvex coated tablets, with a dividing line on one side.
  Atrox 40:
  White, oval, biconvex coated tablets, with a dividing line on one side.
  Atrox, 80 mg:
  White, oval, biconvex coated tablets, with a dividing line on one side.
  The coated tablets are packaged in aluminum/aluminum blisters, placed in a cardboard box.
  Available packs:
  Atrox 10, Atrox 20: 30, 60, or 90 coated tablets
  Atrox 40: 10, 30, 60, or 90 coated tablets
  Atrox, 80 mg: 10, 14, 28, 30, 56, or 60 coated tablets
  Not all pack sizes may be marketed.

  Marketing authorization holder and manufacturer

  Biofarm Sp. z o.o.
  ul. Wałbrzyska 13
  60-198 Poznań
  Tel. +48 61 66 51 500
  biofarm@biofarm.pl
  Date of last revision of the leaflet:09.10.2024