Atrox 10

Package leaflet: 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
Atorvastatinum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

"This medicine is absolutely contraindicated during pregnancy."
Table of contents of the leaflet

1. What Atrox is and what it is 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 pack and other information

1. What Atrox is and what it is used for

Atrox belongs to a group of medicines called statins, which regulate lipid (fat) metabolism in the
body.
Atrox is used to reduce blood levels of lipids known as cholesterol and triglycerides, when a low-fat diet and lifestyle changes alone are not effective. Atrox may also be used to reduce the risk of heart disease, even when cholesterol levels are within the normal range. During treatment, patients should continue a standard diet low in cholesterol.

2. Important information before using Atrox

When not to use Atrox

• if the patient is allergic to atorvastatin or any of the other ingredients of this medicine (listed in section 6);
• if the patient currently has or has previously had liver disease;
• if the patient has unexplained abnormal liver function test results;
• if the patient is taking glecaprevir with pibrentasvir for the treatment of hepatitis C virus infection;
• in women of childbearing potential who are not using effective methods of contraception;
• in women who are pregnant or planning to become pregnant;
• in women who are breastfeeding.

Warnings and precautions
Before starting treatment with Atrox, discuss the following with your doctor, pharmacist, or nurse:

• if the patient has severe respiratory failure;
• if the patient is taking or has taken, within the last 7 days, oral or injectable fusidic acid (a medicine used to treat bacterial infections). Concomitant use of fusidic acid with Atrox may lead to serious muscle problems (rhabdomyolysis);
• in case of haemorrhagic stroke, 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 (underactive thyroid);
• in case of recurrent or unexplained muscle pain or muscle problems in the past, or similar problems in family members;
• 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 previous liver disease;
• in patients aged 70 years and older;
• if the patient currently has or has previously had myasthenia (a disease causing generalised muscle weakness, including in some cases muscles involved in breathing) or ocular myasthenia (a disease causing weakness of eye muscles), because statins may sometimes worsen symptoms of the disease or lead to the development of myasthenia (see section 4).

For patients with any of the above conditions, the doctor may order blood tests before starting treatment with Atrox and, whenever possible, during treatment, to monitor the risk of muscle-related adverse effects. It is known that the risk of muscle-related adverse effects, such as rhabdomyolysis, is increased when certain other medicines are used concomitantly (see section 2 “Atrox and other medicines”).
Inform your doctor or pharmacist if muscle weakness persists. Additional tests and additional medicines may be necessary to diagnose and treat this condition.
While taking this medicine, your doctor will closely monitor you for the development of diabetes or risk of developing diabetes. Patients with high blood sugar and lipid levels, overweight patients, and those with high blood pressure may be at increased risk of developing diabetes.

Atrox and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including those available without a prescription, as they may interact with Atrox. Some medicines may alter the effect of Atrox, or the effect of these medicines may be altered by Atrox.
This type of interaction may reduce the effectiveness of one or both medicines. It may also increase the risk of serious adverse effects, including severe muscle damage known as rhabdomyolysis, described in section 4:

• medicines that modify the immune system, e.g. cyclosporine;
• certain antibiotics or antifungal medicines, e.g. erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid;
• other lipid-regulating medicines, e.g. gemfibrozil, other fibrates, colestyramine;
• certain calcium channel blockers used for angina or high blood pressure, e.g. amlodipine, diltiazem, and also medicines regulating heart rhythm, e.g. digoxin, verapamil, amiodarone;
• medicines used to treat HIV infection, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir in combination with ritonavir, etc.;
• certain medicines used to treat hepatitis C virus infection, e.g. telaprevir, boceprevir, and the fixed-dose combination containing elbasvir with grazoprevir;
• other medicines known to interact with Atrox include ezetimibe (cholesterol-lowering medicine), warfarin (reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant used in the treatment of epilepsy), cimetidine (used to treat heartburn and stomach ulcers), phenazone (a painkiller), colchicine (a medicine used to treat gout), and antacids (medicines used for indigestion containing aluminium or magnesium);
• over-the-counter medicines: St John's wort (Hypericum perforatum);
• if oral fusidic acid is required for the treatment of a bacterial infection, treatment with Atrox should be temporarily discontinued. Your doctor will inform you when it is safe to restart taking Atrox. Concomitant use of Atrox with fusidic acid may 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 skin tissue infections and bloodstream infections caused by bacteria).

Atrox, food, drink and alcohol
Information on the use of Atrox can be found in section 3. However, please pay attention to the following:

Grapefruit juice
Do not consume more than one or two small glasses of grapefruit juice per day, as larger quantities may alter the effect of Atrox.

Alcohol
While taking this medicine, avoid excessive alcohol consumption.
Further information on this topic is provided in section 2 “Warnings and precautions”.

Pregnancy, breastfeeding and fertility

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before taking this medicine.

Pregnancy
Atrox must not be used by women who are pregnant or planning to become pregnant.

Breastfeeding
Atrox must not be used during breastfeeding.

Women of childbearing potential
Atrox must not be used by women of childbearing potential unless they are using effective methods of contraception.

Driving and using machines
Atrox usually does not affect the ability to drive or operate machinery.
However, patients should not drive or operate machinery if this medicine affects their ability to do so safely.

Atrox contains lactose
If the patient has been previously diagnosed with an intolerance to certain sugars, the patient should consult their doctor before taking this medicine.

The medicine contains less than 1 mmol (23 mg) of sodium per recommended dose unit, meaning the medicine is considered "sodium-free".

3. How to use Atrox

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
Before starting treatment, your doctor will recommend a low-cholesterol diet; this diet should be continued throughout treatment with Atrox.

Dosage
The usual starting dose of Atrox in adults and children aged 10 years or older is 10 mg once daily. If necessary, your doctor may increase this dose gradually to the appropriate level for the patient. Your doctor will adjust the dose 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 may be divided into two equal doses.
• The tablet should be taken once daily. It can be taken at any time of day, with or without food. However, it is advisable to take the tablet at approximately the same time each 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, consult your doctor.

Taking more than the recommended dose of Atrox
Do not take more than the dose prescribed by your doctor.
If you accidentally take too many Atrox tablets (more than the usual daily dose), contact your doctor or the nearest hospital for advice.

Missed 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 the missed dose.

Stopping Atrox
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If the patient experiences any of the following severe adverse reactions or symptoms, they should stop taking the medicine immediately and contact a doctor or go to the emergency department of the nearest hospital without delay.
Rare: may occur in 1 out of 1,000 patients:

• Severe allergic reaction causing swelling of the face, tongue, and throat, which may lead to serious breathing difficulties.
• Severe illness characterized by peeling and swelling of the skin, skin blisters, blisters in the mouth, eyes, genitals, and fever. Skin rash with pink-red spots, particularly on the palms or soles, possibly accompanied by blisters.
• Muscle weakness, tenderness, muscle pain, muscle rupture, or red-brown discoloration of urine. If accompanied by malaise or high fever, this may be due to rhabdomyolysis (breakdown of striated muscles). Rhabdomyolysis may not always resolve even after discontinuation of atorvastatin, and may be life-threatening and lead to kidney problems.

Very rare: may occur in 1 out of 10,000 patients:

• Unexpected or unusual bleeding or bruising, which may indicate liver abnormalities. Medical advice should be sought as soon as possible.
• Lupus-like syndrome (including rash, joint disorders, and effects on blood cells).

Other possible adverse reactions of Atrox:
Common: may occur in 1 out of 10 patients:

• Nasal inflammation, sore throat, nosebleeds
• Allergic reactions
• Increased blood glucose levels (in diabetic patients, blood glucose levels should continue to be carefully monitored), increased blood creatine kinase levels
• Headache
• Nausea, constipation, bloating, indigestion, diarrhoea
• Joint pain, muscle pain, and back pain
• Blood test results indicating abnormal liver function

Uncommon: may occur in 1 out of 100 patients:

• Anorexia (loss of appetite), weight gain, decreased blood glucose levels (in diabetic patients, blood glucose levels should continue to be carefully monitored)
• Nightmares, insomnia
• Dizziness, numbness or tingling in fingers and toes, reduced sensitivity to pain and touch, altered taste, memory loss
• Blurred vision
• Ringing in the ears and (or) in the head
• Vomiting, regurgitation, pain in the upper and lower abdomen, pancreatitis (causing abdominal pain)
• Hepatitis
• Rash, skin eruptions and itching, urticaria, hair loss
• Neck pain, muscle fatigue
• Fatigue, malaise, weakness, chest pain, swelling especially in the ankles, elevated body temperature
• Presence of white blood cells in urine analysis

Rare: may occur in 1 out of 1,000 patients:

• Vision disorders
• Unexpected bleeding or bruising (bruises)
• Cholestasis (yellowing of the skin and whites of the eyes)
• Tendon rupture
• Rash which may appear on the skin or oral ulcers (lichenoid drug reaction)
• Purple skin lesions (symptoms of vasculitis)

Very rare: may occur in 1 out of 10,000 patients:

• Allergic reactions – symptoms may include sudden shortness of breath and chest pain or tightness, eyelid, facial, lip, oral, tongue or throat swelling, breathing difficulties, collapse
• Hearing loss
• Gynaecomastia (excessive development of male breast glandular tissue)

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

• Persistent muscle weakness
• Myasthenia (a disease causing general muscle weakness, including in some cases muscles involved in breathing).
• Ocular myasthenia (a disease causing weakness of eye muscles).

Patients should consult a doctor if they experience weakness in arms or legs worsening after periods of activity, double vision or drooping eyelids, difficulty swallowing, or shortness of breath.
Other possible adverse reactions reported during treatment with certain statins (medicines of the same type):

• Sexual dysfunction
• Depression
• Breathing problems, including persistent cough and (or) shortness of breath or fever
• Diabetes; increased risk of developing diabetes in individuals with high blood sugar and fat levels, overweight, and high blood pressure. The doctor will monitor the patient’s condition during treatment with this medicine.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, patients should inform their doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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: [email protected]
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Atrox

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

6. Contents of the packaging and other information

What Atrox contains

• The active substance is atorvastatin.

Atrox 10:
One coated tablet contains 10 mg of atorvastatin (as atorvastatin calcium).
Atrox 20:
One coated tablet contains 20 mg of atorvastatin (as atorvastatin calcium).
Atrox 40:
One coated tablet contains 40 mg of atorvastatin (as atorvastatin calcium).
Atrox 80 mg:
One coated tablet contains 80 mg of atorvastatin (as atorvastatin calcium).

• Other ingredients are: tablet core: microcrystalline cellulose, calcium carbonate, monohydrate lactose, 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 coated tablets, with a break line on one side.
Atrox 20:
white, elongated, biconvex coated tablets, with a break line on one side.
Atrox 40:
white, elongated, biconvex coated tablets, with a break line on one side.
Atrox 80 mg:
white, elongated, biconvex coated tablets, with a break line on one side.
Atrox coated tablets are packed in aluminium/aluminium foil blisters, placed in a cardboard box.
Available pack sizes:
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 Authorisation Holder and Manufacturer
Biofarm Sp. z o.o.
Wałbrzyska Street 13
60-198 Poznań
Tel. +48 61 66 51 500
[email protected]