Atractin

Leaflet attached to the packaging: patient information

Atractin

(Atorvastatin)
10 mg, coated tablets
20 mg, coated tablets
40 mg, coated tablets

Please read carefully the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• Please keep this leaflet, so 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 specifically for you. 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.

Table of contents of the leaflet:

• 1. What is Atractin and what is it 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 packaging and other information

1. What is Atractin and what is it used for

Atractin belongs to a group of medicines known as statins, which are lipid-controlling medicines.
Atractin is used to lower lipid levels - cholesterol and triglycerides - in the blood when a low-fat diet and lifestyle changes have proven ineffective. In people at increased risk of heart disease, Atractin may also be used to reduce this risk even if cholesterol levels are normal. During treatment, a standard cholesterol-lowering diet should be followed.

2. Important information before taking Atractin

When not to take Atractin:

• if the patient is allergic to atorvastatin or any other component of this medicine (listed in section 6);
• if the patient currently or has previously suffered from a disease that affects the liver;
• if liver function tests have been abnormal for unknown reasons;
• if a woman is of childbearing age and does not use effective contraception;
• if a woman is pregnant or plans to become pregnant soon;
• if a woman is breastfeeding;
• if the patient is taking glecaprevir with pibrentasvir for the treatment of hepatitis C virus infection.

Warnings and precautions

Before starting to take Atractin, you should consult a doctor, pharmacist, or nurse:

• if the patient has severe respiratory failure;
• if the patient is taking or has taken fusidic acid (an antibiotic) orally or by injection within the last 7 days. Taking fusidic acid with Atractin may lead to serious muscle problems (rhabdomyolysis);
• if the patient has had a stroke with bleeding in the brain or if small fluid-filled pockets have formed in the brain after strokes;
• if the patient has kidney problems;
• if the patient has been diagnosed with hypothyroidism;
• if the patient experiences recurring or unexplained muscle pain or cramps, or if the patient or their family members have had muscle disorders;
• if the patient has had muscle problems while taking other lipid-lowering medicines (e.g., other statins or fibrates);
• if the patient regularly consumes large amounts of alcohol;
• if the patient has had liver disease in the past;
• in people over 70 years old.

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

Atractin and other medicines

You should tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take. Some medicines may change the effect of Atractin or Atractin may change their effect.
Such interactions may reduce the effectiveness of one or both medicines. Alternatively, they may increase the risk of side effects, including serious muscle tissue damage known as rhabdomyolysis, which is described in section 4:

• Medicines that change the way the immune system works, e.g., cyclosporine;
• Certain antibiotics or antifungal medicines, e.g., erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid;
• Other lipid-controlling medicines, e.g., gemfibrozil, other fibrates, colestyramine;
• Certain calcium channel blockers used for angina or high blood pressure, e.g., amlodipine, diltiazem; heart rhythm-regulating medicines, e.g., digoxin, verapamil, amiodarone;
• Letermowir, a medicine used to prevent cytomegalovirus disease;
• 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 a combination product containing elbasvir with grazoprevir;
• Other medicines that are known to interact with Atractin, including ezetimibe (a cholesterol-lowering medicine), warfarin (a blood-thinning medicine), oral contraceptives, stiripentol (an antiepileptic medicine), cimetidine (used for ulcers and heartburn), fenazon (a pain reliever), colchicine (used to treat gout), and antacids (medicines used for indigestion containing aluminum or magnesium);
• Over-the-counter medicines: preparations containing St. John's Wort.
• If the patient needs to take fusidic acid orally for a bacterial infection, they should temporarily stop taking Atractin. The doctor will inform the patient when it is safe to restart Atractin. Taking Atractin with fusidic acid may rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis). More information about rhabdomyolysis can be found in section 4.

Atractin with food, drink, and alcohol

Instructions for taking Atractin are given in section 3. Please note the following:

Grapefruit juice
You should not drink more than one or two small glasses of grapefruit juice per day, as grapefruit juice in large quantities may change the effect of Atractin.
Alcohol
You should avoid drinking too much alcohol while taking this medicine.
More information is given in section 2 "Warnings and precautions".

Pregnancy and breastfeeding

Women who are pregnant or plan to become pregnant soon should not take Atractin.
Women of childbearing age should not take Atractin unless they use effective contraception.
Women who are breastfeeding should not take Atractin.
The safety of Atractin during pregnancy and breastfeeding has not been established. Before taking any medicine, you should consult a doctor or pharmacist.

Driving and using machines

Normally, this medicine does not affect the ability to drive or use machines. However, you should not drive if you feel that the medicine affects your ability to drive.
If the medicine affects your ability to use tools or machines, you should not use them.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Atractin

Before starting treatment, your doctor will prescribe a low-cholesterol diet, which you should follow during treatment with Atractin.
Usually, the initial dose of Atractin is 10 mg once a day for adults and children from 10 years old.
Your doctor may increase this dose if necessary, tailored to your individual needs.
Your doctor will adjust the dose every 4 weeks or less often. The maximum dose of Atractin is 80 mg once a day.
Swallow the tablets whole with water. You can take the medicine at any time of day, with or without food. However, you should try to take the tablets at the same time every day.
Always take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, you should consult your doctor or pharmacist.
The treatment duration is determined by your doctor.
If you feel that the effect of Atractin is too strong or too weak, you should consult your doctor.

Taking a higher dose of Atractin than recommended

If you have taken too many Atractin tablets (more than the usual daily dose), you should consult your doctor or go to the nearest hospital for advice.

Missing a dose of Atractin

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

Stopping treatment with Atractin

If you have any further doubts about taking this medicine or wish to stop treatment, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Atractin 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 the tablets and immediately consult your doctor or go to the emergency department of your nearest hospital.

Rare: occur in fewer than 1 in 1000 people:

• severe allergic reactions with swelling of the face, tongue, and throat, which may cause serious breathing difficulties;
• serious diseases characterized by swelling and peeling of the skin, blistering of the skin, mouth, eyes, genitals, and fever. A rash on the skin with pink-red spots, especially on the palms of the hands and soles of the feet, which may form blisters;
• muscle weakness, tenderness, pain, or rupture, or brownish discoloration of the urine, especially if accompanied by malaise or high fever, may be caused by muscle tissue breakdown (rhabdomyolysis). Muscle breakdown does not always resolve, even if the patient stops taking atorvastatin, and may be life-threatening and cause kidney problems.

Very rare: occur in fewer than 1 in 10,000 people:

• unexpected or unusual bleeding or bruising may indicate liver problems. You should consult your doctor as soon as possible.
• a condition similar to lupus (including rash, joint disorders, and effects on blood cells).

Other possible side effects of Atractin:

Common: (occur in fewer than 1 in 10 people)

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

Uncommon: (occur in fewer than 1 in 100 people)

• loss of appetite, weight gain, decreased blood sugar levels (people with diabetes should continue to monitor their blood sugar levels closely)
• nightmares, insomnia
• dizziness, numbness or tingling of fingers or toes, decreased sensation of pain or touch, changes in taste, memory loss
• blurred vision
• ringing in the ears and/or head
• vomiting, belching, abdominal pain, pancreatitis causing abdominal pain
• hepatitis
• rash, itchy rash, hives, hair loss
• neck pain, muscle fatigue
• fatigue, malaise, weakness, chest pain, swelling, especially around the ankles, elevated temperature
• presence of white blood cells in the urine

Rare: (occur in fewer than 1 in 1000 people)

• vision disturbances
• unexpected bleeding or bruising
• jaundice (yellowing of the skin and whites of the eyes)
• tendon damage

Very rare: (occur in fewer than 1 in 10,000 people)

• allergic reaction - symptoms may include sudden wheezing, chest pain or tightness, swelling of the eyelids, face, lips, mouth, tongue, or throat, difficulty breathing, collapse
• hearing loss
• gynecomastia (breast enlargement in men and women).

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

• persistent muscle weakness.

Possible side effects reported during the use of some statins (medicines of the same type):

• Sexual disorders
• Depression
• Breathing disorders, including chronic 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 any side effects not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. 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
Website: https://smz.ezdrowie.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 Atractin

Keep this medicine out of the 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 month stated.
Do not store above 25°C.
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 Atractin contains

The active substance of Atractin is atorvastatin in the form of atorvastatin calcium.
One Atractin 10 mg coated tablet contains 10 mg of atorvastatin (Atorvastatinum) in the form of atorvastatin calcium.
One Atractin 20 mg coated tablet contains 20 mg of atorvastatin (Atorvastatinum) in the form of atorvastatin calcium.
One Atractin 40 mg 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, silica colloidal anhydrous, magnesium stearate, hypromellose, titanium dioxide (E171), macrogol 6000.

What Atractin looks like and contents of the pack

Appearance of the tablets:
Atractin, 10 mg coated tablets: white, round, biconvex, 7 mm.
Atractin, 20 mg coated tablets: white, round, biconvex, 9 mm.
Atractin, 40 mg coated tablets: white, oval, biconvex, 8.2 mm x 17 mm.
Available pack sizes:
30 or 100 coated tablets in blisters in a cardboard box.
Not all pack sizes may be marketed.
This medicine is available in the form of 10 mg, 20 mg, and 40 mg coated tablets.

Marketing authorization holder and manufacturer:

Marketing authorization holder

Manufacturer

Balkanpharma – Dupnitsa AD
3 Samokovsko Shosse Str.
Dupnitsa 2600
Bulgaria
Bausch Health Poland sp. z o.o.
ul. Przemysłowa 2
35-959 Rzeszów
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Iceland
Poland
Copastatin 10/20/40 mg film-coated tablets
Atractin
Hungary
DECHOLEST

Date of last revision of the leaflet: