Atorvastatin Medreg

Leaflet accompanying 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

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

• -Keep this leaflet, so you can read it again if you need to.
• -If you have any doubts, consult your 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 you experience any side effects, including those not listed in this leaflet, tell your 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 on their own are not effective. Atorvastatin Medreg may also be used to reduce the risk of heart disease, even if cholesterol levels are 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 you are allergic to atorvastatin or any other ingredient of this medicine (listed in section 6),
• if you have or have had liver disease,
• if you have unexplained, abnormal liver function test results,
• in women of childbearing age who do not use effective contraception methods,
• in pregnant or breastfeeding women,
• in combination with glecaprevir and pibrentasvir for the treatment of hepatitis C virus infection.

Warnings and precautions

Before starting treatment with Atorvastatin Medreg, discuss with your doctor or pharmacist:

• in case of severe respiratory failure,
• if you are taking or have taken fusidic acid (an antibiotic) orally or by injection in the last 7 days. Taking fusidic acid with Atorvastatin Medreg can lead to serious muscle problems (rhabdomyolysis).
• in case of a 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 you are taking or have taken fusidic acid orally or by injection in the last 7 days. There have been reports of rhabdomyolysis (muscle breakdown) in patients receiving statins 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 you have or have 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 can 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 side effects. It is known that the risk of muscle side effects, such as rhabdomyolysis, is higher when certain medicines are taken at the same time (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, the doctor will closely monitor you 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

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 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:

• immunosuppressants, such as cyclosporine,
• certain antibiotics or antifungal medicines, such as erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid,
• other lipid-lowering medicines, such as gemfibrozil, other fibrates, colestyramine,
• certain calcium channel blockers used for angina or high blood pressure, such as amlodipine, diltiazem; as well as medicines that regulate heart rhythm, such as digoxin, verapamil, amiodarone,
• letermovir, a medicine used to prevent cytomegalovirus disease,
• 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, 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 (a medicine used to treat gout), and antacids (medicines used to treat indigestion, containing aluminum or magnesium),
• over-the-counter medicines: St. John's Wort,
• if you need to take fusidic acid orally to treat a bacterial infection, you should temporarily stop taking this medicine. Your doctor will tell you when you can safely resume taking Atorvastatin Medreg. Taking Atorvastatin Medreg and fusidic acid at the same time can 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, pay attention to the following information:
Grapefruit juice
Do not drink more than one or two small glasses of grapefruit juice per day, as larger amounts of grapefruit juice can 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 you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, consult your 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 contraception methods.
Taking Atorvastatin Medreg during breastfeeding is contraindicated.
The safety of Atorvastatin Medreg during pregnancy or breastfeeding has not been established. Consult your 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, do not drive if the medicine affects your ability to do so. Do not use any tools or machines if taking the medicine affects your ability to use them.

Atorvastatin Medreg contains lactose monohydrate

If you have been diagnosed with intolerance to some sugars, consult your 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 essentially "sodium-free".

3. How to take Atorvastatin Medreg

Before starting treatment, your doctor will recommend a low-cholesterol diet; this diet should be continued during treatment with Atorvastatin Medreg.
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 your doctor if necessary, up to a dose suitable for you. 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, try to take the tablet at the same time every day.
This medicine should always be taken as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

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

If you feel that the effect of Atorvastatin Medreg is too strong or too weak, consult your doctor.

Taking a higher dose of Atorvastatin Medreg than recommended

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

Missing a dose of Atorvastatin Medreg

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

Stopping treatment with Atorvastatin Medreg

If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

If you experience any of the serious side effects, stop taking the medicine and contact your doctor or go to the emergency department of your 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 peeling and swelling of the skin, 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 accompanied by malaise or high fever, it may be caused by muscle breakdown (rhabdomyolysis). Muscle breakdown may not always resolve, even if you stop taking atorvastatin, and can be life-threatening and cause kidney problems.

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

• if you experience unexpected or unusual bleeding or bruising, it may indicate liver problems. Consult your 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 diabetic patients, 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 diabetic patients, blood glucose levels should continue to be closely monitored)
• nightmares, insomnia
• dizziness, numbness or tingling in the fingers of the hands and feet, 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)
• hepatitis
• 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 test.

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
• rash that can 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 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)
• you should discuss with your doctor if you experience weakness in your 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):

• sexual disorders
• depression
• breathing problems, including persistent cough and (or) shortness of breath or fever
• diabetes; the likelihood 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, your doctor will perform the necessary tests.

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, Ministry of Health, or 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

Keep the medicine out of the 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 stated.
Medicines should not be disposed of via wastewater or household waste. 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 Atorvastatin Medreg contains

The active substance of the medicine is atorvastatin. Each film-coated tablet contains 10 mg, 20 mg, 40 mg, or 80 mg of atorvastatin (as a trihydrate calcium salt).
Other ingredients are:
Core: lactose monohydrate, microcrystalline cellulose (PH 101), sodium croscarmellose, Sepitrap 80 (polysorbate 80 (E 443) and magnesium aluminum silicate), calcium carbonate (E 170), hydroxypropyl cellulose (E 463), magnesium stearate.
Coating: partially hydrolyzed polyvinyl alcohol, titanium dioxide (E 171), talc, macrogol 3350, soy 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