Atractin

Package leaflet: information for the patient

Atractin
(Atorvastatinum)
10 mg, film-coated tablets
20 mg, film-coated tablets
40 mg, film-coated tablets
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents:

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

1. What Atractin is and what it is used for

Atractin belongs to a group of medicines known as statins, which are lipid-lowering (fat-lowering) agents.
Atractin is used to lower lipid levels—cholesterol and triglycerides—in the blood when a low-fat diet and lifestyle changes alone have not been effective. In individuals at increased risk of heart disease, Atractin may also be used to reduce this risk, even when cholesterol levels are within the normal range. A cholesterol-lowering diet should be maintained during treatment.

2. Important information before taking Atractin

When not to take Atractin:

• if the patient is allergic to atorvastatin or to any of the other ingredients of this medicine (listed in section 6);
• if the patient currently suffers or has ever suffered from a disease affecting the liver;
• if liver function test results have been abnormal for unknown reasons;
• if the woman is of childbearing age and is not using effective methods of contraception;
• if the woman is pregnant or plans to become pregnant in the near future;
• if the woman is breastfeeding;
• if the patient is taking glecaprevir with pibrentasvir for the treatment of hepatitis C virus infection.

Warnings and precautions
Before starting treatment with Atractin, consult a doctor, pharmacist, or nurse:

• if the patient suffers from severe respiratory insufficiency;
• if the patient is taking or has taken fusidic acid orally or by injection within the last 7 days (a medicine used to treat bacterial infections). Concomitant use of fusidic acid with Atractin may lead to serious muscle problems (rhabdomyolysis);
• if the patient has previously experienced a haemorrhagic stroke or if small fluid-filled pockets have developed in the brain after previous strokes;
• if the patient has kidney problems;
• if the patient has been diagnosed with hypothyroidism;
• if the patient experiences recurrent or unexplained muscle pain or cramps, or if the patient or a family member has a history of muscle disorders;
• if the patient previously experienced muscle problems while being treated with other lipid-lowering medicines (e.g. other statins or fibrates);
• if the patient regularly consumes large amounts of alcohol;
• if the patient has previously been diagnosed with liver disease;
• in patients over 70 years of age.

If any of the above conditions apply to the patient, the doctor may need to perform blood tests before and possibly during treatment with Atractin to assess the risk of muscle-related adverse effects. It is known that the risk of muscle-related adverse effects, such as rhabdomyolysis, increases when certain medicines are taken concomitantly (see section 2 "Other medicines and Atractin").
Inform your doctor or pharmacist also if muscle weakness persists. Additional tests and treatment with other medicines may be necessary to diagnose and treat this condition.
Patients with diabetes or those at risk of developing diabetes will be under close medical supervision while taking this medicine. Patients with high blood sugar and fat levels, overweight, and high blood pressure may be at risk of developing diabetes.

Atractin and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines you plan to take. Some medicines may alter the effect of Atractin or Atractin may alter their effect.
Such interactions may reduce the effectiveness of one or both medicines. Alternatively, they may increase the risk or severity of adverse effects, including significant muscle damage known as rhabdomyolysis, described in section 4:

• Medicines that affect 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, cholestyramine;
• Certain calcium channel blockers used for angina or high blood pressure, e.g. amlodipine, diltiazem; medicines regulating heart rhythm, e.g. digoxin, verapamil, amiodarone;
• Letermovir, a medicine used to prevent cytomegalovirus infection;
• Medicines used in HIV infection, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir in combination with ritonavir, etc.;
• Certain medicines used in the treatment of hepatitis C virus infection, e.g. telaprevir, boceprevir, and the fixed-dose combination containing elbasvir with grazoprevir;
• Other medicines known to interact with Atractin, including ezetimibe (cholesterol-lowering), warfarin (reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant used in epilepsy), cimetidine (used in heartburn and peptic ulcer), phenazone (an analgesic), colchicine (used in gout treatment), and antacids (medicines for indigestion containing aluminium or magnesium);
• Over-the-counter medicines: herbal products containing St. John's wort.
• If the patient needs to take fusidic acid orally for the treatment of a bacterial infection, treatment with Atractin should be temporarily discontinued. The doctor will inform the patient when it is safe to restart Atractin. Taking Atractin together with fusidic acid may rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis). More information on rhabdomyolysis can be found in section 4.

Atractin with food, drink, and alcohol
Instructions on how to take Atractin are provided in section 3. Please pay attention to the following:

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

Alcohol
Avoid consuming excessive amounts of alcohol while taking this medicine.
Further information is provided in section 2 "Warnings and precautions".

Pregnancy and breastfeeding
Women who are pregnant or planning to become pregnant in the near future should not take Atractin.
Women of childbearing age should not take Atractin unless they are using effective methods of contraception.
Women who are breastfeeding should not take Atractin.
The safety of Atractin during pregnancy and breastfeeding has not been established. Consult a doctor or pharmacist before taking any medicine.

Driving and operating machinery
This medicine usually does not affect the ability to drive or operate machinery. However, do not drive if the medicine affects the patient's ability to do so safely.
If the medicine affects the patient's ability to use tools or operate machinery, the patient should not use them.

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine is considered "sodium-free".

3. How to take Atractin

Before starting treatment, your doctor will prescribe a low-cholesterol diet that you must follow both before and during treatment with Atractin.
The usual starting dose of Atractin is 10 mg once daily in adults and children aged 10 years and older.
If necessary, your doctor may increase the dose to the amount appropriate for the individual patient.
Your doctor will adjust the dose approximately every 4 weeks or less frequently. The maximum dose of Atractin is 80 mg once daily.
Tablets should be swallowed whole with water. Atractin can be taken at any time of day, with or without food. However, it is recommended to take the tablets at the same time each day.
This medicine should always be taken according to the instructions given by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The duration of treatment is determined by the treating physician.
If you feel that the effect of Atractin is too strong or too weak, consult your doctor.

Taking more Atractin than prescribed
If you accidentally take too many Atractin tablets (a dose higher than your usual daily dose), contact your doctor or seek advice at the nearest hospital immediately.

Missed dose of Atractin
If you miss a dose, simply take the next scheduled dose at the usual time. Do not take a double dose to make up for the missed dose.

Stopping Atractin
If you have any further questions about using this medicine or if you are considering stopping treatment, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in everyone.
If any of the serious adverse effects or symptoms listed below occur,
you must stop taking the tablets immediately and contact your doctor or go to the
emergency department of the nearest hospital without delay.

Rare: occurs in no more than 1 in 1,000 people:

• severe allergic reactions with swelling of the face, tongue and throat, which may cause serious breathing problems;
• serious conditions associated with skin swelling and peeling, formation of blisters on the skin, inside the mouth, eyes, genital area, and accompanied by fever. Skin rash with pink-red lesions, especially on the palms and soles, which may develop into blisters;
• muscle weakness, tenderness, pain or muscle rupture, or red-brown discoloration of urine, especially if associated with malaise or high fever, may be caused by breakdown of muscle tissue (rhabdomyolysis). Rhabdomyolysis may not resolve even after discontinuation of atorvastatin, may be life-threatening and may lead to kidney problems.

Very rare: occurs in no more than 1 in 10,000 people:

• unexpected or unusual bleeding or bruising, which may indicate liver problems. You should consult your doctor as soon as possible.
• lupus-like syndrome (including rash, joint disorders and blood cell abnormalities).

Other possible adverse effects of Atractin:
Common: (occurs in no more than 1 in 10 people)

• inflammation of the nasal cavity, sore throat, nosebleeds
• allergic reactions
• increased blood glucose levels (patients with diabetes should continue to carefully monitor their blood glucose levels), increased creatine kinase activity in blood
• headache
• nausea, constipation, flatulence, indigestion, diarrhoea
• joint pain, muscle pain and back pain
• blood test results indicating abnormal liver function

Uncommon: (occurs in no more than 1 in 100 people)

• loss of appetite, weight gain, decreased blood glucose levels (patients with diabetes should continue to carefully monitor their blood glucose levels)
• nightmares, insomnia
• dizziness, numbness or tingling in fingers or toes, reduced sensitivity to pain or touch, altered taste, memory impairment
• blurred vision
• ringing in the ears and/or head
• vomiting, belching, upper and lower abdominal pain, pancreatitis causing abdominal pain
• hepatitis
• rash, itchy rash, urticaria, hair loss
• neck pain, muscle fatigue
• fatigue, malaise, weakness, chest pain, oedema, especially around the ankles, elevated body temperature
• presence of white blood cells in urine

Rare: (occurs in no more than 1 in 1,000 people)

• visual disturbances
• unexpected bleeding or appearance of bruises
• congestive jaundice (yellowing of the skin and whites of the eyes)
• tendon damage

Very rare: (occurs in no more than 1 in 10,000 people)

• allergic reaction – symptoms may include sudden onset of wheezing and chest pain or tightness, swelling of the eyelids, face, lips, mouth, tongue or throat, breathing difficulties, collapse
• hearing loss
• gynaecomastia (enlargement of breasts in men and women)

Frequency unknown: (frequency cannot be estimated from available data)

• persistent muscle weakness

Possible adverse effects reported during use of certain statins (medicines of the same type):

• Sexual disorders
• Depression
• Respiratory disorders, including chronic cough and/or shortness of breath or fever
• Diabetes. The risk of developing diabetes is higher in people with elevated blood sugar and fat levels, overweight and high blood pressure. Your doctor will monitor your condition during treatment with this medicine.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the 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
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Atractin

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of the stated month.
Do not store above 25°C.
Medicines must 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 package and other information

What Atractin contains
The active substance is atorvastatin in the form of atorvastatin calcium.
One Atractin 10 mg film-coated tablet contains 10 mg of atorvastatin (Atorvastatinum) in the form of atorvastatin calcium.
One Atractin 20 mg film-coated tablet contains 20 mg of atorvastatin (Atorvastatinum) in the form of atorvastatin calcium.
One Atractin 40 mg film-coated tablet contains 40 mg of atorvastatin (Atorvastatinum) in the form of atorvastatin calcium.

The other ingredients are:
mannitol, microcrystalline cellulose, calcium carbonate, povidone (K-30), sodium croscarmellose, sodium lauryl sulfate, colloidal anhydrous silica, magnesium stearate, hypromellose, titanium dioxide (E171), macrogol 6000.

What Atractin looks like and contents of the pack
Appearance of the tablets:
Atractin 10 mg film-coated tablets: white, round, biconvex, 7 mm in diameter.
Atractin 20 mg film-coated tablets: white, round, biconvex, 9 mm in diameter.
Atractin 40 mg film-coated tablets: white, oval, biconvex, 8.2 mm x 17 mm.

Pack sizes:
30 or 100 film-coated tablets in blister packs contained in a cardboard box.
Not all pack sizes may be marketed.

This medicinal product is available in film-coated tablets of 10 mg, 20 mg, and 40 mg.

Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder
Bausch Health Poland sp. z o.o.
Przemysłowa 2 Street
35-959 Rzeszów
Poland

Manufacturer
Balkanpharma – Dupnitsa AD
3 Samokovsko Shosse Str.
Dupnitsa 2600
Bulgaria

This medicinal product is authorized for marketing in the European Economic Area countries under the following names:
Iceland: Copastatin 10/20/40 mg film-coated tablets
Poland: Atractin
Hungary: DECHOLEST