Atrox

Leaflet accompanying the packaging: information for the user

Atrox 10, 10 mg, film-coated tablets

Atrox 20, 20 mg, film-coated tablets

Atrox 40, 40 mg, film-coated tablets

Atrox, 80 mg, film-coated tablets

Atorvastatin

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 specifically for you, do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, 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 cholesterol levels are normal. During treatment, a standard low-cholesterol diet should be continued.

2. Important information before taking Atrox

When not to take Atrox

• in women of childbearing age who do not use effective methods of contraception;
• in pregnant or breast-feeding women;
• in nursing mothers.

Warnings and precautions

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

• in case of a stroke with bleeding into the brain, or if there is a small amount of fluid in the brain from a previous stroke,
• 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,
For patients who are in any of the above situations, 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 at the same time (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 the patient for the development of diabetes or the risk of diabetes. Patients with high sugar and fat levels in the blood, patients who are overweight, and patients with high blood pressure may be at risk of developing diabetes.

Atrox and other medicines

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:

• medicines that modify the immune system, such as cyclosporine;
• certain antibiotics or antifungal medicines, such as erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid;
• other medicines that regulate lipid levels, such as gemfibrozil, other fibrates, cholestyramine;
• certain calcium channel blockers used in 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, such as 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 for indigestion, containing aluminum or magnesium);
• over-the-counter medicines: St. John's Wort;
• 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, note the following:

Grapefruit juice
Do not drink more than one or two small glasses of grapefruit juice per day, as larger amounts of grapefruit juice can change the effect of Atrox.
Alcohol
Avoid excessive alcohol consumption while taking Atrox.
Detailed information on this can be found in section 2 "Warnings and precautions".

Pregnancy, breast-feeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Atrox is contraindicated in pregnant women or women who may become pregnant.
Breast-feeding
Atrox is contraindicated during breast-feeding.
Women of childbearing age
Atrox is contraindicated in women of childbearing age who do not use effective methods of contraception.

Driving and using machines

Atrox usually does not affect the ability to drive or use machines.
However, do not drive if the medicine affects your ability to drive. Do not use any tools or machines if the medicine affects your ability to use them.

Atrox contains lactose

If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Atrox contains less than 1 mmol (23 mg) of sodiumper dose, which means that it is essentially "sodium-free".

3. How to take Atrox

Always take this medicine exactly as your doctor has told you.
In case of doubt, consult 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 if necessary by your doctor, 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

• Swallow the tablet whole with water.
• The tablet can be divided into two equal doses.
• Take one tablet a day, the tablet can be taken at any time of day, with or without food. However, 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, talk to your doctor.

Taking a higher dose of Atrox than recommended

Do not take a higher dose than recommended by your doctor.
In case of accidental ingestion of too many Atrox tablets (more than the usual daily dose), contact your doctor or the nearest hospital for advice.

Missing a dose of Atrox

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

Stopping treatment with Atrox

If you have any further questions about taking this medicine, 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, stop taking Atrox and contact your doctor immediately or go to the emergency department of your nearest hospital.

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 hands or feet, with possible blisters.
• Weakness, tenderness, muscle pain, muscle rupture, or brownish discoloration of urine. If accompanied by malaise or high fever, it may be caused by muscle breakdown (rhabdomyolysis). Muscle breakdown may not always resolve, even if the patient stops taking atorvastatin, and may 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. Consult your doctor as soon as possible.
• Systemic lupus erythematosus-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 blood creatine kinase levels
• 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 urine tests

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

• vision disturbances
• unexpected bleeding or bruising (bruises)
• cholestasis (yellowing of the skin and eyes)
• tendon rupture
• skin rash, which may occur on the skin, or ulcers in the mouth (lichenoid 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, 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 muscles involved in breathing).
• Ocular myasthenia (a disease that causes muscle weakness in the eyes).

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 sugar and fat levels in the blood, overweight, and high blood pressure. The doctor will monitor the patient's condition during treatment with this medicine.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Atrox

Do not store above 25°C.
Keep the medicine out of the 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. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Atrox contains

• The active substance of Atrox is atorvastatin.

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

• 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 film-coated tablets with a dividing line on one side.
Atrox 20:
White, oval, biconvex film-coated tablets with a dividing line on one side.
Atrox 40:
White, oval, biconvex film-coated tablets with a dividing line on one side.
Atrox, 80 mg:
White, oval, biconvex film-coated tablets with a dividing line on one side.
Atrox film-coated tablets are packaged in aluminum/aluminum blisters, placed in a cardboard box.
Available packs:
Atrox 10, Atrox 20: 30, 60, or 90 film-coated tablets
Atrox 40: 10, 30, 60, or 90 film-coated tablets
Atrox, 80 mg: 10, 14, 28, 30, 56, or 60 film-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
Phone: +48 61 66 51 500
biofarm@biofarm.pl
Date of last revision of the leaflet:09.10.2024