Atorvastatin medreg

Package leaflet: Information for the patient

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
Atorvastatinum
Please read carefully all the information in this leaflet before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

1. What Atorvastatin Medreg is and what it is 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 pack and other information

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

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

2. Important information before using Atorvastatin Medreg

When not to use 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 currently has or has previously had liver disease,
• if the patient has unexplained abnormal liver function test results,
• in women of childbearing potential who are not using effective methods of contraception,
• in pregnant women or women planning to become pregnant,
• in breastfeeding women,
• when co-administering glecaprevir with pibrentasvir for the treatment of hepatitis C virus infection.

Warnings and precautions
Before starting treatment with Atorvastatin Medreg, discuss the following with your doctor or
pharmacist:

• in case of severe respiratory insufficiency,
• if the patient is taking or has taken orally or by injection fusidic acid (a medicine used to treat bacterial infections) within the last 7 days. Concomitant use of fusidic acid with Atorvastatin Medreg may lead to serious muscle problems (rhabdomyolysis).
• in case of haemorrhagic stroke, 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 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),
• if the patient is taking or has taken orally or by injection a medicine called fusidic acid (used in bacterial infections) within the last 7 days. Cases of rhabdomyolysis (muscle breakdown) have been reported in patients receiving statins concomitantly with fusidic acid,
• in case of regular consumption of large amounts of alcohol,
• in case of previous liver disease,
• in patients over 70 years of age,
• if the patient currently has or has previously had myasthenia (a disease causing general muscle weakness, including in some cases muscles involved in breathing) or ocular myasthenia (a disease causing weakness of eye muscles), because statins may occasionally worsen symptoms of the disease or lead to the development of myasthenia (see section 4).

In patients affected by any of the above conditions, the doctor will order a blood test before starting treatment with Atorvastatin Medreg and, whenever possible, during treatment to monitor the risk of muscle-related adverse reactions. It is known that the risk of muscle-related adverse reactions, such as rhabdomyolysis, is higher when certain medicines are used concomitantly (see section 2 “Atorvastatin Medreg and other medicines”). Inform your doctor or pharmacist if muscle weakness persists. Additional tests and medications may be necessary to diagnose and treat this condition.
During treatment, the doctor will closely monitor the patient for the development of diabetes or risk of developing diabetes. Patients with high levels of blood sugar and fats, overweight patients, and those with high blood pressure may be at increased risk of developing diabetes.

Atorvastatin Medreg and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take. Some medicines may alter the effect of Atorvastatin Medreg, or the effect of these medicines may be altered by Atorvastatin Medreg. This type of interaction may reduce the effectiveness of one or both medicines. It may also increase the risk of serious adverse reactions, 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-regulating medicines, e.g. gemfibrozil, other fibrates, colestipol,
• certain calcium channel blockers used for angina or high blood pressure, e.g. amlodipine, diltiazem; and also medicines regulating heart rhythm, e.g. digoxin, verapamil, amiodarone,
• letermovir, a medicine used to prevent cytomegalovirus infection,
• 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 known to interact with Atorvastatin Medreg 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 (a medicine used to treat gout), and antacids (medicines used for indigestion containing aluminium or magnesium),
• over-the-counter medicines: St. John’s wort (Hypericum perforatum),
• if the patient needs to take oral fusidic acid to treat a bacterial infection, they should temporarily stop taking Atorvastatin Medreg. The doctor will inform the patient when it is safe to resume treatment with Atorvastatin Medreg. Concomitant use of Atorvastatin Medreg and fusidic acid may rarely lead to muscle weakness, tenderness or pain (rhabdomyolysis). More information on rhabdomyolysis can be found in section 4.
• daptomycin (a medicine used to treat complicated skin and skin tissue infections and bloodstream infections caused by bacteria).

Atorvastatin Medreg with food, drink and alcohol
Information on how to take Atorvastatin Medreg is provided in section 3. However, please note the following:
Grapefruit juice
Do not consume more than one or two small glasses of grapefruit juice per day, as larger quantities may alter the effect of Atorvastatin Medreg.
Alcohol
Avoid excessive alcohol consumption while taking this medicine.
Further details on this are provided in section 2, “Warnings and precautions”.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Use of atorvastatin in women who are pregnant or planning to become pregnant is contraindicated.
Use of Atorvastatin Medreg in women of childbearing potential is contraindicated if they are not using effective methods of contraception.
Use of 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 operate machinery. However, the patient should not drive if this medicine affects their ability to do so. Do not use any tools or machines if taking this medicine affects your ability to operate them.

Atorvastatin Medreg contains lactose monohydrate
If the patient has been previously diagnosed with an intolerance to certain sugars, they should consult their doctor before taking this medicine.

Atorvastatin Medreg contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered “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 usual recommended starting dose of Atorvastatin Medreg in adults and children aged 10 years or older is 10 mg once daily. This dose may be increased by your doctor as needed to achieve the appropriate dose for the patient. Your doctor will adjust the dose 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 and can be taken at any time of day, with or without food. However, it is advisable to take the tablet at the same time each day.
This medicine should always be taken exactly as prescribed 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 more Atorvastatin Medreg than prescribed
If you accidentally take too many Atorvastatin Medreg tablets (more than the usual daily dose), contact your doctor or the nearest hospital for advice immediately.
Missing a dose of Atorvastatin Medreg
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 the missed dose.
Stopping Atorvastatin Medreg
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If the patient experiences any of the serious side effects, they should stop taking the medicine
immediately and contact their doctor or go to the emergency department of the nearest hospital.

Rare (may occur in up to 1 in 1,000 patients):

• Severe allergic reaction causing swelling of the face, tongue and throat, which may lead to severe breathing difficulties.
• Severe illness characterized by peeling and swelling of the skin, skin blisters, and sores in the mouth, eyes, genitals, and fever. Skin rash with pink-red spots, particularly on the palms or soles, possibly with blisters.
• Muscle weakness, tenderness or muscle pain. If accompanied by malaise or high fever, this may be due to breakdown of striated muscles (rhabdomyolysis). Breakdown of striated muscles does not always resolve even after the patient stops taking atorvastatin; it may also be life-threatening and cause kidney problems.

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

• Unexpected or unusual bleeding or bruising, which may indicate liver problems. Medical advice should be sought as soon as possible.
• Lupus-like syndrome (including skin rash, joint disorders and effects on blood cells).

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

• Inflammation of nasal passages, sore throat, nosebleeds
• Allergic reactions
• Increased blood glucose levels (in patients with diabetes, blood glucose levels should continue to be closely monitored), increased blood creatine kinase levels
• Headaches
• Nausea, constipation, bloating, 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 patients):

• Anorexia (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 fingers and toes, reduced sensitivity to pain and touch, altered taste, memory loss
• Blurred vision
• Ringing in the ears and/or head
• Vomiting, regurgitation, pain in the upper and lower abdomen, pancreatitis (causing abdominal pain)
• Hepatitis
• Rash, skin rash and itching, urticaria, hair loss
• Neck pain, muscle fatigue
• Fatigue, malaise, weakness, chest pain, swelling, especially of the ankles, elevated temperature
• Presence of white blood cells in urine tests.

Rare (may occur in up to 1 in 1,000 patients):

• Vision disorders
• Unexpected bleeding or bruising (bruises)
• Cholestasis (yellowing of the skin and whites of the eyes)
• Tendon rupture
• Rash, which may appear on the skin, or oral ulcers (lichenoid drug reaction)
• Purple skin lesions (symptoms of vasculitis).

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

• Allergic reactions – symptoms may include sudden shortness of breath and chest pain or tightness, swelling of the eyelids, face, lips, mouth, tongue or throat, breathing difficulties, collapse
• Hearing loss
• Gynaecomastia (excessive growth of glandular breast tissue 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 weakness of the eye muscles)
• Patients should talk to their doctor if they experience weakness in 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 dysfunction
• Depression
• Breathing problems, including persistent cough and/or shortness of breath or fever
• Diabetes; the likelihood of developing this condition is higher in patients with high levels of blood sugar and fat, overweight patients, and those with high blood pressure. The doctor will perform appropriate tests during treatment with this medicine.

Reporting of side effects
If any side effects occur, including any side effects not listed in this leaflet, patients should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects helps provide more information on the safety of the medicine.

5. How to store Atorvastatin Medreg

Keep this medicine out of the sight and reach of children.
No special storage instructions apply for this medicine.
Do not use this medicine after the expiry date stated on the carton and blister pack 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 how to dispose of medicines you no longer use. Doing so helps protect the environment.

6. Contents of the pack and other information

What Atorvastatin Medreg contains
The active substance is atorvastatin. Each coated tablet contains 10 mg, 20 mg, 40 mg,
or 80 mg of atorvastatin (as calcium trihydrate).
The other ingredients are:
Tablet core: monohydrate lactose, 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 hydrolysed 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 coated tablets, embossed with
“MA” on one side and “1” on the other.
Atorvastatin Medreg 20 mg:
White, oval [12.1 mm x 6.5 mm x 3.4 mm], biconvex coated tablets, embossed with
“MA” on one side and “2” on the other.
Atorvastatin Medreg 40 mg:
White, oval [15.4 mm x 8.1 mm x 4.4 mm], biconvex coated tablets, embossed with
“MA” on one side and “3” on the other.
Atorvastatin Medreg 80 mg:
White, oval [19.4 mm x 10.4 mm x 5.5 mm], biconvex coated tablets, embossed with
“MA” on one side and “4” on the other.

Blister packs made of OPA/PVC/Aluminium containing:
Atorvastatin Medreg 10 mg: 28, 30, 60, 90 or 100 coated tablets.
Atorvastatin Medreg 20 mg: 28, 30, 60, 90 or 100 coated tablets.
Atorvastatin Medreg 40 mg: 28, 30, 60, 90 or 100 coated tablets.
Atorvastatin Medreg 80 mg: 14, 28, 30, 90 or 100 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation 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 medicinal product is authorised in the European Economic Area countries under the following names:
Czech Republic: Atorvastatin Medreg
Poland: Atorvastatin Medreg
Romania: Atorvastatină Gemax Pharma 10 mg comprimate filmate
Atorvastatină Gemax Pharma 20 mg comprimate filmate
Atorvastatină Gemax Pharma 40 mg comprimate filmate
Atorvastatină Gemax Pharma 80 mg comprimate filmate
Slovakia: Atorvastatin Medreg 10 mg
Atorvastatin Medreg 20 mg
Atorvastatin Medreg 40 mg
Atorvastatin Medreg 80 mg