Atostat

Package Leaflet: Information for the User

Atostat, 80 mg, Film-Coated Tablets

Atorvastatin

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. 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 those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the Package Leaflet:

• 1. What Atostat is and what it is used for
• 2. Important information before taking Atostat
• 3. How to take Atostat
• 4. Possible side effects
• 5. How to store Atostat
• 6. 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 the levels of lipids, such as cholesterol and triglycerides, in the blood when a low-fat diet and lifestyle changes are not enough.
Atostat can also be used to reduce the risk of heart disease, even if your cholesterol levels are normal. During treatment, you should continue to follow a standard low-cholesterol diet.

2. Important information before taking Atostat

When not to take Atostat:

• if you are allergic to atorvastatin or any other similar medicine used to lower lipid levels in the blood or to any of the other ingredients of this medicine listed in section 6,
• if you have or have had liver disease,
• if you have had unexplained, abnormal liver function tests,
• in women of childbearing age who are not using effective methods of contraception,
• in pregnant or breastfeeding women,
• 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 you are taking or have taken fusidic acid orally or by injection (an antibiotic) in the last 7 days. Taking fusidic acid and Atostat at the same time may lead to serious muscle problems (rhabdomyolysis),
• in case of a stroke with bleeding in 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 underactive thyroid gland,
• in case of repeated 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 liver disease in the past,
• in patients over 70 years old.

In patients with any of the above conditions, your doctor will order a blood test before starting treatment with Atostat 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 medicines are taken at the same time (see section 2 "Other medicines and Atostat").
You should also inform your doctor or pharmacist if you have persistent muscle weakness. Additional tests and medicines may be needed to diagnose and treat muscle weakness.
During treatment with this medicine, your health will be closely monitored if you have diabetes or are at risk of developing diabetes. You are at risk of developing diabetes if you have high levels of sugar and fat in the blood, are overweight, and have high blood pressure.

Other medicines and Atostat

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
If you need to take fusidic acid orally for a bacterial infection, you will need to temporarily stop taking Atostat. Your doctor will tell you when you can safely resume taking Atostat.
Taking Atostat and fusidic acid at the same time can rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis). More information on rhabdomyolysis can be found in section 4.
Some medicines may affect the way Atostat works or may be affected by Atostat. This type of interaction can lead to reduced effectiveness of one or both medicines or increase the risk of serious side effects, including severe muscle damage known as rhabdomyolysis, described in section 4:

• medicines that modify the immune system, such as cyclosporine,
• certain antibiotics and antifungal medicines, such as erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid,
• other medicines that regulate lipid levels, such as gemfibrozil, other fibrates, cholestyramine,
• certain calcium channel blockers used for angina or high blood pressure, such as amlodipine, diltiazem, and certain heart rhythm regulators, 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, such as telaprevir,
• other medicines known to interact with Atostat, such as ezetimibe (which lowers cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an antiepileptic medicine), cimetidine (used to treat heartburn and stomach ulcers), fenazon (a pain reliever), colchicine (used to treat gout), antacids (medicines used for indigestion, containing aluminum or magnesium), and boceprevir (used to treat liver diseases such as hepatitis C),
• over-the-counter medicines: St. John's Wort.

Taking Atostat with food and drink

Information on taking Atostat can be found in section 3. However, pay attention to the following:

Grapefruit juice
Do not drink more than one or two small glasses of grapefruit juice per day, as larger amounts may affect the way Atostat works.
Alcohol
Avoid excessive alcohol consumption while taking Atostat. More information on this can be found in section 2 "Warnings and precautions".

Pregnancy and breastfeeding

Taking Atostat during pregnancy or if you are planning to become pregnant is contraindicated.
Taking Atostat in women of childbearing age is contraindicated if they do not use effective methods of contraception.
Taking 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

Atostat usually does not affect the ability to drive or use machines. However, do not drive if the medicine affects your ability to do so.
Do not use any tools or machines if taking Atostat affects your ability to use them.

ATOSTAT contains lactose

Patients who have been informed by their doctor about intolerance to some sugars should contact their doctor before taking Atostat.

3. How to take Atostat

Always take Atostat exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Before starting treatment, your doctor will recommend a low-cholesterol diet; you should continue this diet during treatment with Atostat.
The recommended initial dose of Atostat for adults and children over 10 years old is 10 mg once daily. This dose may be increased if necessary by your doctor to the dose that is suitable for you. Your doctor will adjust the dose of Atostat at intervals of 4 weeks or more. The maximum dose of Atostat is 80 mg once daily for adults and 20 mg once daily for children.
Swallow the tablets whole with water; they can be taken at any time of day, with or without food. However, try to take your tablet at the same time each day.

The duration of treatment with Atostat is determined by your doctor.

If you feel that the effect of Atostat is too strong or too weak, talk to your doctor.

If you take more Atostat than you should

If you accidentally take too many Atostat tablets (more than the usual daily dose), contact your doctor or the nearest hospital for advice.

Forget to take Atostat

If you forget to take a dose, just take the next dose at the scheduled time. Do not take a double dose to make up for a forgotten dose.

Stopping treatment with Atostat

If you have any questions about your treatment, ask your doctor or pharmacist.

4. Possible side effects

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

If you experience any of the following serious side effects, stop taking Atostat and contact your doctor immediately or go to the emergency department at your nearest hospital.

Rare(may affect up to 1 in 1000 people)

• Severe allergic reaction causing swelling of the face, tongue, and throat, which may lead to severe breathing difficulties.
• Severe skin disease characterized by peeling and swelling of the skin, blisters on the skin, mouth, eyes, genitals, and fever. Skin rash with reddish-purple spots, especially on the palms or soles, with possible blisters.
• Muscle weakness, tenderness, or pain. If you also feel unwell or have a high fever, this could be a sign of muscle breakdown. Muscle breakdown does not always go away, even after stopping atorvastatin, and can be life-threatening and cause kidney problems.

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

• If you experience unexpected or unusual bleeding or bruising, this may indicate liver problems. You should consult your doctor as soon as possible.

Other possible side effects of Atostat:

Common(may affect up to 1 in 10 people)

• nasal congestion, sore throat, nosebleeds,
• allergic reactions,
• increased blood glucose levels (if you have diabetes, you should continue to monitor your blood glucose levels closely), increased levels of creatine kinase 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 (if you have diabetes, you should continue to monitor your blood glucose levels closely),
• nightmares, insomnia,
• dizziness, numbness or tingling in the fingers and toes, decreased sensitivity to pain and touch, changes in taste, memory loss,
• blurred vision,
• ringing in the ears or head,
• vomiting, belching, upper and lower abdominal pain, pancreatitis (causing abdominal pain),
• hepatitis,
• skin rash, skin lesions, 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 1000 people)

• vision disturbances,
• unexpected bleeding or bruising (bruises),
• cholestasis (yellowing of the skin and whites of the eyes),
• tendon rupture.

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

• allergic reactions - 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 (excessive breast tissue growth in men).

Side effects of unknown frequency: persistent muscle weakness.

The following side effects have been reported with other statins:

Possible side effects reported during treatment with some 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 you have high levels of sugar and fat in the blood, are overweight, and have high blood pressure. Your doctor will monitor your condition while taking this medicine.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Poland, tel.: +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 this medicine.

5. How to store Atostat

Keep out of the sight and reach of children.
Do not take Atostat after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of that month.
Medicines should 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 pack and other information

What Atostat contains

• The active substance of Atostat is atorvastatin. Each film-coated tablet contains 80 mg of atorvastatin (as atorvastatin calcium).
• The other ingredients of Atostat are:
  Core: mannitol, sodium lauryl sulfate, colloidal anhydrous silica, sodium carbonate, butylhydroxyanisole, microcrystalline cellulose, sodium croscarmellose, magnesium stearate.
  Coating: hypromellose 15cP, microcrystalline cellulose, stearic acid.

What Atostat looks like and contents of the pack

80 mg film-coated tablets
white, oval, biconvex tablets with "80" engraved on one side and smooth on the other
Atostat is packaged in aluminum blisters sealed with a heat-sealable aluminum foil.
The pack contains 30 film-coated tablets in a cardboard box.

Marketing authorization holder:

Artespharm Sp. z o.o.
Solec 81 B, lok. A-51,
00-382 Warsaw, Poland

Name and address of the importer responsible for the release of the batch:

Mako Pharma Sp z o.o.
Wiśniowa 9, 05-092 Kiełpin

Date of last revision of the leaflet: