Atorvastatin Genoptim

Leaflet attached to the packaging: information for the user

Atorvastatin Genoptim, 10 mg, film-coated tablets

Atorvastatin Genoptim, 20 mg, film-coated tablets

Atorvastatin Genoptim, 40 mg, film-coated tablets

Atorvastatin Genoptim, 80 mg, film-coated tablets

Atorvastatinum

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

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed to you specifically. 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, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

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

Atorvastatin Genoptim belongs to a group of medicines called statins, which regulate lipid (fat) metabolism in the body.
Atorvastatin Genoptim 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 Genoptim 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 Genoptim

When not to take Atorvastatin Genoptim:

• 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,
• if the patient is taking glecaprevir with pibrentasvir for the treatment of hepatitis C virus infection.

Warnings and precautions

Before starting treatment with Atorvastatin Genoptim, the patient should discuss it with their doctor, pharmacist, or nurse:

• if the patient has severe respiratory failure,
• if the patient is taking or has taken fusidic acid (an antibiotic) orally or by injection in the last 7 days. Taking fusidic acid with Atorvastatin Genoptim 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),
• in case of regular consumption of large amounts of alcohol,
• in case of liver disease in the past,
• in patients over 70 years of age,
• if the patient has or has had myasthenia (a disease that causes general muscle weakness, including in some cases muscles involved in breathing) or ocular myasthenia (a disease that causes muscle weakness in the eyes), as statins can sometimes exacerbate symptoms of the disease or lead to the development of myasthenia (see section 4).

In patients who are in any of these situations, the doctor will order a blood test before starting treatment with Atorvastatin Genoptim 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 "Atorvastatin Genoptim 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 the medicine, 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 Genoptim 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 can change the effect of Atorvastatin Genoptim or their effect may be changed by Atorvastatin Genoptim. 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 disease caused by cytomegalovirus,
• 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 a combination product containing elbasvir with grazoprevir,
• other medicines known to interact with Atorvastatin Genoptim, including 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 (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 (a herbal medicine),
• if the patient needs to take fusidic acid orally to treat a bacterial infection, they should temporarily stop taking Atorvastatin Genoptim. The doctor will inform the patient when it is safe to restart treatment with Atorvastatin Genoptim. Taking Atorvastatin Genoptim with fusidic acid can 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 structure infections and bloodstream infections caused by bacteria).

Atorvastatin Genoptim with food, drink, and alcohol

Information on the use of Atorvastatin Genoptim can be found in section 3. However, the following information should be noted:
Grapefruit juice
The patient should 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 Genoptim.
Alcohol
The patient should avoid excessive alcohol consumption while taking this medicine.
More detailed information on this can be found in section 2 "Warnings and precautions".

Pregnancy and breastfeeding

The use of Atorvastatin Genoptim in women who are pregnant or plan to become pregnant is contraindicated.
The use of Atorvastatin Genoptim in women of childbearing age is contraindicated if they do not use effective methods of contraception.
The use of Atorvastatin Genoptim during breastfeeding is contraindicated.
The safety of Atorvastatin Genoptim during pregnancy and breastfeeding has not been established.
Before taking any medicine, the patient should consult their doctor or pharmacist.

Driving and using machines

Normally, the medicine 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 the use of the medicine affects their ability to use them.

Atorvastatin Genoptim contains sodium

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

3. How to take Atorvastatin Genoptim

Before starting treatment, the doctor will recommend following a low-cholesterol diet, which should also be continued during treatment with Atorvastatin Genoptim.
The usual starting dose of Atorvastatin Genoptim 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 the medicine at intervals of at least 4 weeks. The maximum dose of Atorvastatin Genoptim is 80 mg once daily.
The tablets of Atorvastatin Genoptim should be swallowed whole, with a glass of 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.
The 20 mg, 40 mg, and 80 mg tablets of Atorvastatin Genoptim can be divided into equal doses.
This medicine should always be taken as directed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.

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

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

Taking a higher dose of Atorvastatin Genoptim than recommended

In case of accidental ingestion of more tablets of Atorvastatin Genoptim than the usual daily dose, the patient should contact their doctor or the nearest hospital for advice.

Missing a dose of Atorvastatin Genoptim

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 Genoptim

In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

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

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

Rarely: may occur in less than 1 in 1000 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. Rash with pink-red spots, especially on the palms or soles, with possible blisters.
• Muscle weakness, tenderness, muscle rupture, muscle pain, or reddish-brown urine. If 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 occur in less than 1 in 10,000 people:

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

Frequency not known: cannot be estimated from the available data:

• Myasthenia (a disease that causes general muscle weakness, including in some cases muscles involved in breathing).
• Ocular myasthenia (a disease that causes muscle weakness in the eyes).

The patient should talk to their doctor if they experience muscle weakness in their hands or feet, worsening after periods of activity, double vision, or drooping eyelids, difficulty swallowing, or shortness of breath.

Other possible side effects of Atorvastatin Genoptim:

Common: may occur in less than 1 in 10 people

• nose and throat infections, 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,
• headaches,
• nausea, constipation, bloating, indigestion, diarrhea,
• joint pain, muscle pain, and back pain,
• blood test results indicating abnormal liver function.

Uncommon: may occur in less than 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 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 occur in less than 1 in 1000 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 (signs of vasculitis).

Very rare: may occur in less than 1 in 10,000 people

• allergic reactions - symptoms may include sudden wheezing and chest pain, swelling of the eyelids, face, lips, mouth, tongue, or throat, difficulty breathing, collapse,
• hearing loss,
• gynecomastia (excessive growth of breast tissue in men)

Frequency not known: cannot be estimated from the available data

• persisting muscle weakness.

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

• sexual disorders,
• depression,
• breathing difficulties, 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, 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 the leaflet, they should tell their doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +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 gather more information on the safety of the medicine.

5. How to store Atorvastatin Genoptim

The medicine should be stored out of sight and reach of children.
Store in a temperature below 30°C.
Do not use this medicine after the expiry date stated on the outer packaging after "Expiry date", "EXP". The expiry date refers to the last day of that 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 Genoptim contains

• The active substance is atorvastatin. Each film-coated tablet contains 10 mg of atorvastatin (in the form of atorvastatin calcium). Each film-coated tablet contains 20 mg of atorvastatin (in the form of atorvastatin calcium). Each film-coated tablet contains 40 mg of atorvastatin (in the form of atorvastatin calcium). Each film-coated tablet contains 80 mg of atorvastatin (in the form of atorvastatin calcium).
• Other ingredients of Atorvastatin Genoptim are: microcrystalline cellulose, sodium carbonate, maltose, sodium croscarmellose, and magnesium stearate. The tablet coating contains: hypromellose (E464), hydroxypropylcellulose, triethyl citrate (E1505), polysorbate 80, and titanium dioxide (E171).

This medicine is available as film-coated tablets of 10 mg, 20 mg, 40 mg, and 80 mg.

What Atorvastatin Genoptim looks like and contents of the pack

• Atorvastatin Genoptim 10 mg film-coated tablets are white or almost white, oval, biconvex, with the inscription "10" on one side of the tablet.
• Atorvastatin Genoptim 20 mg film-coated tablets are white or almost white, oval, biconvex, with a score line on one side and the inscription "20" on the other side of the tablet. The tablets can be divided into equal doses.
• Atorvastatin Genoptim 40 mg film-coated tablets are white or almost white, oval, biconvex, with a score line on one side and the inscription "40" on the other side of the tablet. The tablets can be divided into equal doses.
• Atorvastatin Genoptim 80 mg film-coated tablets are white or almost white, oval, biconvex, with a score line on one side and the inscription "80" on the other side of the tablet. The tablets can be divided into equal doses.
• Atorvastatin Genoptim is packaged in PA/Aluminum/PVC//Aluminum blisters containing 7, 10, 14, 15, 28, 30, 50, 56, 60, 84, 90, 98, 100, or 200 tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warsaw

Manufacturer

Teva Pharma S.L.U., C/C, n. 4, Poligono Industrial Malpica, 50016 Zaragoza, Spain
Synoptis Industrial Sp. z o.o., ul. Rabowicka 15, 62-020 Swarzędz
Date of last revision of the leaflet:09.2024