ATORVASTATIN 10 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Atorvastatin Medreg, 10 mg, film-coated tablets
3. Atorvastatin Medreg, 20 mg, film-coated tablets
4. Atorvastatin Medreg, 40 mg, film-coated tablets
5. Atorvastatin Medreg, 80 mg, film-coated tablets
   1. You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
6. What is Atorvastatin Medreg and what is it used for
7. Important information before taking Atorvastatin Medreg
   1. When not to take Atorvastatin Medreg
   2. Warnings and precautions
   3. Atorvastatin Medreg and other medicines
   4. Atorvastatin Medreg with food, drink, and alcohol
   5. Pregnancy and breastfeeding
   6. Driving and using machines
   7. Atorvastatin Medreg contains lactose monohydrate
   8. Atorvastatin Medreg contains sodium
8. How to take Atorvastatin Medreg
   1. The duration of treatment with Atorvastatin Medreg is determined by the doctor.
   2. Taking a higher dose of Atorvastatin Medreg than recommended
   3. Missing a dose of Atorvastatin Medreg
   4. Stopping treatment with Atorvastatin Medreg
9. Possible side effects
   1. If the patient experiences any of the following serious side effects, they should stop taking the medicine and contact their doctor or go to the emergency department of the nearest hospital immediately.
   2. Reporting side effects
10. How to store Atorvastatin Medreg
11. Contents of the packaging and other information
    1. What Atorvastatin Medreg contains
    2. What Atorvastatin Medreg looks like and contents of the pack
    3. Marketing authorization holder and manufacturer:
    4. Marketing authorization holder:
    5. Manufacturer:
    6. This medicine is authorized in the Member States of the European Economic Area under the following names:
    7. Date of last revision of the leaflet: 11/2024

Leaflet attached to the packaging: patient information

Atorvastatin Medreg, 10 mg, film-coated tablets

Atorvastatin Medreg, 20 mg, film-coated tablets

Atorvastatin Medreg, 40 mg, film-coated tablets

Atorvastatin Medreg, 80 mg, film-coated tablets

Atorvastatin

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

• -You should keep this leaflet, so that you can read it again if necessary.
• -If you have any doubts, you should consult a doctor or pharmacist.
• -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 as yours.
• -If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Atorvastatin Medreg and what is it used for

Atorvastatin Medreg belongs to a group of medicines called statins, which regulate lipid (fat) metabolism in the body.
Atorvastatin Medreg is used to reduce the levels of lipids known as cholesterol and triglycerides in the blood when a low-fat diet and lifestyle changes are not effective. Atorvastatin Medreg can also be used to reduce the risk of heart disease, even if the cholesterol level is normal. During treatment, a standard low-cholesterol diet should be continued.

2. Important information before taking Atorvastatin Medreg

When not to take Atorvastatin Medreg

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

Warnings and precautions

Before starting treatment with Atorvastatin Medreg, the patient should discuss the following with their doctor or pharmacist:

• in case of severe respiratory insufficiency,
• if the patient is taking or has taken fusidic acid (an antibiotic) orally or by injection in the last 7 days. Concurrent use of fusidic acid and Atorvastatin Medreg may lead to serious muscle problems (rhabdomyolysis).
• in case of a history of stroke with bleeding into 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 hypothyroidism,
• in case of recurring 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),
• if the patient is taking or has taken fusidic acid orally or by injection in the last 7 days. There have been reports of rhabdomyolysis (muscle breakdown) in patients receiving a statin in combination with fusidic acid,
• in case of regular consumption of large amounts of alcohol,
• in case of a history of liver disease,
• in patients over 70 years of age,
• if the patient has or has had myasthenia (a disease causing general muscle weakness, including in some cases muscles involved in breathing) or ocular myasthenia (a disease causing muscle weakness in the eyes), as statins may sometimes exacerbate symptoms of the disease or lead to myasthenia (see section 4).

In patients with any of the above conditions, the doctor will order a blood test before starting treatment with Atorvastatin Medreg 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 concurrently (see section 2 "Atorvastatin Medreg and other medicines").
The doctor or pharmacist should also be informed if muscle weakness persists. To diagnose and treat this condition, additional tests and medications may be necessary.
During treatment with Atorvastatin Medreg, the doctor will closely monitor the patient for the development of diabetes or the risk of developing diabetes. Patients with high blood sugar and fat levels, patients who are overweight, and patients with high blood pressure may be at risk of developing diabetes.

Atorvastatin Medreg and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. Some medicines may change the effect of Atorvastatin Medreg or the effect of these medicines on the body may be changed by Atorvastatin Medreg. This type of interaction can lead to reduced efficacy of one or both medicines. At the same time, it can increase the risk of serious side effects, including severe muscle damage known as rhabdomyolysis, described in section 4:

• immunosuppressive medicines, e.g. cyclosporine,
• certain antibiotics or antifungal medicines, e.g. erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid,
• other lipid-lowering medicines, e.g. gemfibrozil, other fibrates, colestyramine,
• certain calcium channel blockers used for angina or high blood pressure, e.g. amlodipine, diltiazem; as well as medicines that regulate heart rhythm, e.g. digoxin, verapamil, amiodarone,
• letermovir, 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, e.g. telaprevir, boceprevir, and the combination of elbasvir with grazoprevir,
• other medicines that are known to interact with Atorvastatin Medreg include ezetimibe (which lowers cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an antiepileptic medicine), cimetidine (used to treat heartburn and stomach ulcers), phenazon (a pain reliever), colchicine (used to treat gout), and antacids (medicines used to treat indigestion, containing aluminum or magnesium),
• over-the-counter medicines: St. John's wort,
• if the patient needs to take fusidic acid orally to treat a bacterial infection, they should temporarily stop taking Atorvastatin Medreg. The doctor will inform the patient when it is safe to resume taking Atorvastatin Medreg. Concurrent use of Atorvastatin Medreg and fusidic acid may rarely lead to muscle weakness, hypersensitivity, or pain (rhabdomyolysis). More information on rhabdomyolysis can be found in section 4.
• daptomycin (a medicine used to treat complicated skin and soft tissue infections and bloodstream infections caused by bacteria).

Atorvastatin Medreg with food, drink, and alcohol

Information on the use of Atorvastatin Medreg can be found in section 3. However, the following information should be noted:
Grapefruit juice
Do not drink more than one or two small glasses of grapefruit juice per day, as larger amounts of grapefruit juice may change the effect of Atorvastatin Medreg.
Alcohol
Avoid excessive alcohol consumption while taking this medicine.
Detailed information on this can be found in section 2 "Warnings and precautions".

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.
Taking atorvastatin during pregnancy is contraindicated.
Taking Atorvastatin Medreg in women of childbearing age is contraindicated if they do not use effective methods of contraception.
Taking Atorvastatin Medreg during breastfeeding is contraindicated.
The safety of Atorvastatin Medreg during pregnancy or breastfeeding has not been established. The patient should consult their doctor or pharmacist before taking any medicine.

Driving and using machines

This medicine usually does not affect the ability to drive or use machines. However, the patient should not drive if the medicine affects their ability to do so. The patient should not use any tools or machines if taking the medicine affects their ability to use them.

Atorvastatin Medreg contains lactose monohydrate

If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking this medicine.

Atorvastatin Medreg contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Atorvastatin Medreg

Before starting treatment, the doctor will recommend a low-cholesterol diet; this diet should be continued during treatment with Atorvastatin Medreg.
Usually, the recommended initial dose of Atorvastatin Medreg in adults and children over 10 years of age is 10 mg once daily. This dose may be increased by the doctor if necessary, up to a dose suitable for the patient. The doctor will adjust the dose of Atorvastatin Medreg at intervals of at least 4 weeks. The maximum dose of Atorvastatin Medreg is 80 mg once daily.
Atorvastatin Medreg tablets should be swallowed whole with water; they can be taken at any time of day, with or without food. However, the patient should try to take the tablet at the same time every day.
This medicine should always be taken as directed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist.

The duration of treatment with Atorvastatin Medreg is determined by the doctor.

If the patient feels that the effect of Atorvastatin Medreg is too strong or too weak, they should consult their doctor.

Taking a higher dose of Atorvastatin Medreg than recommended

If the patient has accidentally taken more than the recommended dose of Atorvastatin Medreg (more than the usual daily dose), they should contact their doctor or the nearest hospital for advice.

Missing a dose of Atorvastatin Medreg

If the patient forgets to take a dose, they should simply take the next dose at the scheduled time. The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Atorvastatin Medreg

If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

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

If the patient experiences any of the following serious side effects, they should stop taking the medicine and contact their doctor or go to the emergency department of the nearest hospital immediately.

Rarely(may affect up to 1 in 1,000 people):

• Severe allergic reaction causing swelling of the face, tongue, and throat, which can cause severe breathing difficulties.
• Severe disease characterized by skin peeling and swelling, blisters on the skin, mouth, eyes, genitals, and fever. Skin rash with pink-red spots, especially on the palms or soles, with possible blisters.
• Muscle weakness, tenderness, or pain. If this is accompanied by malaise or high fever, it may be caused by muscle breakdown (rhabdomyolysis). Muscle breakdown may not always resolve, even if the patient stops taking atorvastatin, and may be life-threatening and cause kidney problems.

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

• if the patient experiences unexpected or unusual bleeding or bruising, this may indicate liver problems. The patient should consult their doctor as soon as possible.
• lupus-like syndrome (including rash, joint disorders, and effects on blood cells).

Other possible side effects of Atorvastatin Medreg:
Common(may affect up to 1 in 10 people):

• nasal congestion, sore throat, nosebleeds
• allergic reactions
• increased blood glucose levels (in patients with diabetes, blood glucose levels should continue to be closely monitored), increased creatine kinase levels 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 (in patients with diabetes, blood glucose levels should continue to be closely monitored)
• nightmares, insomnia
• dizziness, numbness or tingling in the fingers, decreased sensitivity to pain and touch, changes in taste, memory loss
• blurred vision
• ringing in the ears and/or head
• vomiting, belching, abdominal pain, pancreatitis (causing abdominal pain)
• liver inflammation
• skin rash, skin rash, 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 1,000 people):

• vision disorders
• unexpected bleeding or bruising (bruises)
• cholestasis (yellowing of the skin and whites of the eyes)
• tendon rupture
• skin rash, which may occur on the skin, or ulcers in the mouth (lichenoid drug reaction)
• purple skin changes (symptoms of vasculitis).

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

• allergic reactions - symptoms may include sudden wheezing and 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).

Frequency not known(frequency cannot be estimated from the 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 muscle weakness in the eyes)
• the patient should discuss with their doctor if they experience weakness in their arms or legs, worsening after periods of activity, double vision, or drooping eyelids, difficulty swallowing, or shortness of breath.

Other possible side effects reported during treatment with some statins (medicines of the same type):
of the same type):

• sexual disorders
• depression
• breathing problems, including persistent cough and/or shortness of breath or fever
• diabetes; the risk of developing this disease is higher in patients with high blood sugar and fat levels, patients who are overweight, and patients with high blood pressure. During treatment with this medicine, the doctor will perform the necessary tests on the patient.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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
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 Atorvastatin Medreg

The medicine should be stored out of sight and reach of children.
There are no special storage instructions for this medicine.
Do not use this medicine after the expiry date stated on the carton and blister after: EXP.
The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 Atorvastatin Medreg contains

The active substance of Atorvastatin Medreg is atorvastatin. Each film-coated tablet contains 10 mg, 20 mg, 40 mg, or 80 mg of atorvastatin (as a trihydrate calcium salt).
The other ingredients are:
Tablet core: lactose monohydrate, microcrystalline cellulose (PH 101), sodium croscarmellose, sepitrap 80 (polysorbate 80 (E 443) and magnesium aluminosilicate), calcium carbonate (E 170), hydroxypropylcellulose (E 463), magnesium stearate.
Tablet coating: partially hydrolyzed polyvinyl alcohol, titanium dioxide (E 171), talc, macrogol 3350, soybean lecithin.

What Atorvastatin Medreg looks like and contents of the pack

Atorvastatin Medreg 10 mg:
White, oval [9.2 mm x 4.7 mm x 2.7 mm], biconvex film-coated tablets, with "MA" embossed on one side and "1" on the other side.
Atorvastatin Medreg 20 mg:
White, oval [12.1 mm x 6.5 mm x 3.4 mm], biconvex film-coated tablets, with "MA" embossed on one side and "2" on the other side.
Atorvastatin Medreg 40 mg:
White, oval [15.4 mm x 8.1 mm x 4.4 mm], biconvex film-coated tablets, with "MA" embossed on one side and "3" on the other side.
Atorvastatin Medreg 80 mg:
White, oval [19.4 mm x 10.4 mm x 5.5 mm], biconvex film-coated tablets, with "MA" embossed on one side and "4" on the other side.
Blisters of OPA/PVC/Aluminum foil:
Atorvastatin Medreg 10 mg:28, 30, 60, 90, or 100 film-coated tablets.
Atorvastatin Medreg 20 mg:28, 30, 60, 90, or 100 film-coated tablets.
Atorvastatin Medreg 40 mg:28, 30, 60, 90, or 100 film-coated tablets.
Atorvastatin Medreg 80 mg:14, 28, 30, 90, or 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer:

Marketing authorization holder:

Medreg s.r.o.
Na Florenci 2116/15
Nové Město
110 00 Prague 1
Czech Republic
tel.: (+420) 516 770 199

Manufacturer:

Medis International a.s.
Výrobní závod Bolatice
Průmyslová 961/16
747 23 Bolatice
Czech Republic
Pharmazet Group s.r.o.
Třtinová 260/1
Čakovice
196 00 Prague 9
Czech Republic

This medicine is authorized in the Member States of the European Economic Area under the following names:

Czech Republic:
Atorvastatin Medreg
Poland:
Atorvastatin Medreg
Romania:
Atorvastatin Gemax Pharma 10 mg film-coated tablets
Atorvastatin Gemax Pharma 20 mg film-coated tablets
Atorvastatin Gemax Pharma 40 mg film-coated tablets
Atorvastatin Gemax Pharma 80 mg film-coated tablets
Slovakia:
Atorvastatin Medreg 10 mg
Atorvastatin Medreg 20 mg
Atorvastatin Medreg 40 mg
Atorvastatin Medreg 80 mg

Date of last revision of the leaflet: 11/2024