Patient Information Leaflet

Atostat, 10 mg, film-coated tablets
Atostat, 20 mg, film-coated tablets
Atostat, 40 mg, film-coated tablets
Atorvastatin
Please read this leaflet carefully before taking this medicine, because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for you personally. 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 any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Leaflet Contents:

What Atostat is and what it is used for
What you need to know before taking Atostat
How to take Atostat
Possible side effects
How to store Atostat
Contents of the pack and other information

1. What Atostat is and what it is used for

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

2. Important information before using Atostat

When not to use Atostat:

if the patient is allergic to atorvastatin or to any other similar medicine used to lower blood lipid levels, or to 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,
in women of childbearing age 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 taking Atostat, discuss this with your doctor, pharmacist, or nurse.

in case of severe respiratory failure,
if the patient is taking or has taken within the last 7 days fusidic acid orally or by injection (a medicine used for bacterial infections). Concomitant use of fusidic acid and Atostat may lead to serious muscle problems (rhabdomyolysis),
in case of stroke with bleeding into the brain, or when 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 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 over 70 years of age.

In patients with any of the above conditions, the doctor will order a blood test before starting treatment with Atostat 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 higher when certain medicines are used concomitantly (see section 2 "Other medicines and Atostat"). You should also inform your doctor or pharmacist if the patient suffers from chronic muscle weakness. Additional tests and medicines may be needed to diagnose and treat muscle weakness.
While taking this medicine, the patient's health will be closely monitored if the patient has diabetes or is at risk of developing diabetes. The patient is at risk of developing diabetes if they have high blood sugar and fat levels, overweight, and high blood pressure.

Other medicines and Atostat
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.
If the patient needs to take fusidic acid orally to treat a bacterial infection, temporary discontinuation of Atostat is necessary. The doctor will inform the patient when it is safe to resume treatment with Atostat.
Concomitant use of Atostat and fusidic acid may rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis). More information on rhabdomyolysis can be found in section 4.
Some medicines may alter the effect of Atostat, or the effect of these medicines on the body may be altered by Atostat. 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:

immunosuppressive medicines, e.g. cyclosporine,
certain antibiotics and 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 hypertension, e.g. amlodipine, diltiazem; and 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, e.g. telaprevir,
other medicines known to interact with Atostat include ezetimibe (which lowers cholesterol levels), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant used in epilepsy treatment), cimetidine (used to treat heartburn and stomach ulcers), phenazone (a painkiller), colchicine (used to treat gout), antacids (medicines for indigestion containing aluminium or magnesium), and boceprevir (used to treat liver diseases such as hepatitis C),
over-the-counter medicines: St. John's wort (Hypericum perforatum).

Taking Atostat with food and drink
Information on how to take Atostat is provided in section 3. However, please pay attention to the following:

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

Alcohol
Avoid excessive alcohol consumption while taking this medicine. Further details on this are provided in section 2 "Warnings and precautions".

Pregnancy and breastfeeding
Use of Atostat in women who are pregnant or planning to become pregnant is contraindicated.
Use of Atostat in women of childbearing age is contraindicated if they are not using effective methods of contraception.
Use of Atostat during breastfeeding is contraindicated.
The safety of Atostat during pregnancy and breastfeeding has not been established.
Before taking any medicine, consult your doctor or pharmacist.

Driving and using machines
Usually, this medicine does not affect the ability to drive or operate machinery. However, the patient should not drive if the medicine affects their ability to do so. Do not use any tools or machines if taking this medicine affects your ability to operate them.

Atostat contains lactose
Patients who have been informed by their doctor that they have an intolerance to certain sugars should consult their doctor before taking this medicine.

3. How to use Atostat

Atostat should always be taken exactly as directed by the physician. In case of
doubt, consult the physician or pharmacist again.
Before starting treatment, the physician will recommend a low-cholesterol diet;
this diet should be continued throughout treatment with Atostat.
The recommended starting dose of Atostat in adults and children aged 10 years or older is
10 mg once daily. If necessary, the physician may increase this dose up to
the dose appropriate for the individual patient. The physician adjusts the dose at intervals of 4-
weeks or longer. The maximum dose of Atostat is 80 mg once daily for
adults and 20 mg once daily for children.
Atostat tablets should be swallowed whole with water; they may be
taken at any time of day, with or without food. However, it is recommended to
take the tablet at approximately the same time each day.
The duration of treatment with Atostat is determined by the physician.
If you feel that the effect of Atostat is too strong or too weak, consult your
physician.
Taking more Atostat than prescribed
If you accidentally take too many Atostat tablets (more than the usual daily dose),
contact your physician or the nearest hospital for advice.
Missing a dose of Atostat
If you forget to take your dose, simply take the next dose at the scheduled time. Do not take a double
dose to make up for a missed dose.
Stopping Atostat
If you have any doubts about using Atostat, consult your physician or
pharmacist.

4. Possible adverse reactions

Like all medicines, Atostat may cause adverse reactions, although not everyone will experience them.
If any of the following serious adverse reactions occur in a patient, 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 up to 1 in 1,000 people

Severe allergic reaction causing swelling of the face, tongue and throat, which may lead to serious breathing difficulties.
Severe illness characterized by skin peeling and swelling, skin blisters, and sores in the mouth, eyes, genitals, accompanied by fever. Skin rash with pink-red spots, particularly on the palms or soles, possibly with blisters.
Muscle weakness, tenderness or pain. If this occurs together with malaise or high fever, it may be due to abnormal muscle breakdown. Abnormal muscle breakdown does not always resolve after stopping atorvastatin and may be life-threatening and lead to kidney problems.

Very rare: may occur in up to 1 in 10,000 people

If a patient experiences unexpected or unusual bleeding or bruising, this may indicate liver problems. Medical advice should be sought immediately.

Other possible adverse reactions of Atostat:
Common (may occur in up to 1 in 10 people)

Nasopharyngitis, 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,
Headache,
Nausea, constipation, flatulence, indigestion, diarrhoea,
Joint pain, muscle pain and back pain,
Blood test results indicating abnormal liver function.

Uncommon (may occur in up to 1 in 100 people)

Anorexia (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 fingers and toes, reduced sensitivity to pain and touch, taste disturbances, memory loss,
Blurred vision,
Ringing in the ears or head,
Vomiting, belching, 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 of the ankles), elevated body temperature,
Presence of white blood cells in urine.

Rare (may occur in up to 1 in 1,000 people)

Visual disturbances,
Unexpected bleeding or bruising,
Cholestasis (yellowing of the skin and whites of the eyes),
Tendon rupture.

Very rare (may occur in up to 1 in 10,000 people)

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

Adverse reactions with unknown frequency: persistent muscle weakness.
The following adverse reactions have been reported with treatment using other statins:
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; the development of diabetes is more likely if the patient has high levels of blood sugar and lipids, overweight and high blood pressure. Your doctor will monitor your condition during treatment with this medicine.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department for Monitoring 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 Atostat

Keep this medicine out of sight and reach of children.
Do not use Atostat after the expiry date stated on the carton and on the blister after "EXP". The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with medicines no longer required. Proper disposal helps protect the environment.

6. Contents of the packaging and other information

What Atostat contains

The active substance in Atostat is atorvastatin.
o Each coated tablet contains 10 mg of atorvastatin (as atorvastatin calcium).
o Each coated tablet contains 20 mg of atorvastatin (as atorvastatin calcium).
o Each coated tablet contains 40 mg of atorvastatin (as atorvastatin calcium).
o Each coated tablet contains 80 mg of atorvastatin (as atorvastatin calcium).
Other ingredients in Atostat are:
o Tablet core: mannitol, sodium lauryl sulfate, colloidal anhydrous silica, sodium carbonate, butylhydroxyanisole, microcrystalline cellulose, sodium croscarmellose, magnesium stearate.
o Coating: hypromellose 15 cP, microcrystalline cellulose, stearic acid.

What Atostat looks like and contents of the pack
10 mg film-coated tablets
White, oval, biconvex film-coated tablets marked with "10" on one side and smooth on the other side.
20 mg film-coated tablets
White, oval, biconvex film-coated tablets marked with "20" on one side and smooth on the other side.
40 mg film-coated tablets
White, oval, biconvex film-coated tablets marked with "40" on one side and smooth on the other side.
Atostat is packed in an aluminum blister sealed with a heat-sealable aluminum foil.
The pack contains 30 film-coated tablets in a cardboard box.
Marketing Authorisation Holder:
Artespharm Sp. z o.o.
Solec 81 B, lok. A-51,
00-382 Warsaw, Poland
Name and address of the importer responsible for batch release:
Mako Pharma Sp. z o.o.
Wiśniowa 9, 05-092 Kiełpin