Atrox 10

Leaflet attached to 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

You should carefully read the contents of the leaflet before taking 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 doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed to a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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 may 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 breastfeeding women;
• in nursing mothers.

Warnings and precautions

Before starting treatment with Atrox, the patient should discuss it with their 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,
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 concomitantly (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 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

The patient should tell their doctor or pharmacist about all medicines they are taking, or have recently taken, and about medicines they 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 may lead to reduced efficacy of one or both medicines. At the same time, it may 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 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, and 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 to treat indigestion, containing aluminum or magnesium);
• over-the-counter medicines: St. John's Wort;
• daptomycin (a medicine used to treat complicated skin and skin structure infections and bacteremia).

Atrox with food, drink, and alcohol

Information on the use of Atrox can be found in section 3. However, the following information should be noted:
Grapefruit juice
Do 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, the patient should avoid consuming excessive amounts of alcohol.
More detailed information on this can be found in section 2 "Warnings and precautions".

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist 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, the patient should not drive if the medicine affects their ability to drive. The patient should not use any tools or machines if taking the medicine affects their ability to use them.

Atrox contains lactose

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their 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 the doctor. If the patient has any doubts, they should consult their doctor or pharmacist.
Before starting treatment, the 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 the doctor if necessary, up to a dose suitable for the patient. 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, the patient should try to take the tablet at the same time every day.

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

If the patient feels that the effect of Atrox is too strong or too weak, they should consult their doctor.

Taking a higher dose of Atrox than recommended

The patient should not take a dose higher than that recommended by their doctor.
If the patient accidentally takes too many Atrox tablets (more than the usual daily dose), they should contact their doctor or the nearest hospital for advice.

Missing a dose of Atrox

If the patient forgets to take a dose, they should simply take the next dose at the scheduled time.
The patient should not take a double dose to make up for a missed dose.

Stopping treatment with Atrox

If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

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

If the patient experiences any of the following serious side effects or symptoms, they should stop taking Atrox and contact their 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 may 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 the patient experiences unexpected or unusual bleeding or bruising, it may indicate liver problems. The patient should consult their 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 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 of the hands and feet, decreased sensitivity to pain and touch, changes in taste, memory loss
• blurred vision
• ringing in the ears and/or head
• vomiting, belching, upper and lower 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 disorders
• 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 (lichenoid drug reaction)
• purple skin changes (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 growth of breast tissue 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).
• Myasthenic syndrome (a disease that causes muscle weakness in the eyes).

The patient should talk to their doctor if they experience weakness in their 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, who are overweight, and who have high blood pressure. The doctor will monitor the patient's condition during treatment with this medicine.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their 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: [email protected]
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the 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. The patient should ask their 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 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).

• The other ingredients of the medicine are: tablet core: microcrystalline cellulose, calcium carbonate, lactose monohydrate, sodium croscarmellose, hydroxypropylcellulose, polysorbate 80, magnesium stearate. tablet coating (AquaPolish white 014.11): hypromellose, hydroxypropylcellulose, 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
[email protected]
Date of last revision of the leaflet:09.10.2024