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.
• If you have any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed to you by a doctor and you should not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, you should tell your 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 lower the levels of lipids, such 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 your cholesterol levels are normal. During treatment, you should continue to follow a standard low-cholesterol diet.

2. Important information before taking Atorvastatin Genoptim

When not to take Atorvastatin Genoptim:

• if you are allergic to atorvastatin or 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 test results,
• in women of childbearing age who do not use effective methods of contraception,
• in pregnant or breastfeeding women,
• if you are taking glecaprevir with pibrentasvir for the treatment of hepatitis C virus infection.

Warnings and precautions

Before starting treatment with Atorvastatin Genoptim, you should discuss this with your doctor, pharmacist, or nurse:

• if you have 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 Genoptim can cause serious muscle problems (rhabdomyolysis),
• if you have had a stroke with bleeding in the brain, or if there is a small amount of fluid in the brain from a previous stroke,
• if you have kidney problems,
• if you have hypothyroidism (underactive thyroid),
• if you have had repeated or unexplained muscle pain or muscle problems in the past or similar problems in relatives,
• if you have had muscle problems during previous treatment with other lipid-lowering medicines (e.g., other statins or fibrates),
• if you regularly drink large amounts of alcohol,
• if you have had liver disease in the past,
• in patients over 70 years old,
• if you have or have 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 cause myasthenia (see section 4).

In patients with any of the above conditions, the doctor will order a blood test before starting treatment with Atorvastatin Genoptim 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 Genoptim and other medicines").
Your 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 Genoptim, your 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 Genoptim and other medicines

You should 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 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:

• medicines that modify the immune system, 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, cholestyramine,
• 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 heartburn, containing aluminum or magnesium),
• over-the-counter medicines: St. John's Wort (a herbal medicine),
• if you need to take fusidic acid orally to treat a bacterial infection, you should temporarily stop taking Atorvastatin Genoptim. Your doctor will tell you when you can safely 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 soft tissue 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, you should pay attention to the following information:
Grapefruit juice
You 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
While taking this medicine, you should avoid drinking excessive amounts of alcohol.
Detailed information on this can be found in section 2 "Warnings and precautions".

Pregnancy and breastfeeding

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

Driving and using machines

Normally, the medicine does not affect the ability to drive or use machines. However, you should not drive or use machines if the medicine affects your ability to do so.

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, your doctor will recommend that you follow a low-cholesterol diet, which you should continue to follow during treatment with Atorvastatin Genoptim.
The usual starting dose of Atorvastatin Genoptim in adults and children over 10 years old is 10 mg once a day. This dose may be increased by your doctor if necessary, up to a dose suitable for you. Your doctor will adjust the dose of Atorvastatin Genoptim at intervals of at least 4 weeks. The maximum dose of Atorvastatin Genoptim is 80 mg once a day.
Atorvastatin Genoptim tablets should be swallowed whole, with water; they can be taken at any time of day, with or without food. However, you should try to take the tablet at the same time every day.
Atorvastatin Genoptim 20 mg, 40 mg, and 80 mg tablets can be divided into equal doses.
This medicine should always be taken as directed by your doctor or pharmacist. If you have any doubts, you should consult a doctor or pharmacist.

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

If you feel that the effect of Atorvastatin Genoptim is too strong or too weak, you should consult a doctor.

Taking a higher dose of Atorvastatin Genoptim than recommended

If you accidentally take more Atorvastatin Genoptim tablets than the recommended daily dose, you should contact a doctor or the nearest hospital for advice.

Missing a dose of Atorvastatin Genoptim

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

Stopping treatment with Atorvastatin Genoptim

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

4. Possible side effects

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

If you experience any of the following serious side effects or symptoms, you should stop taking the medicine and contact a 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. Skin rash with reddish-purple spots, especially on the palms or soles, with possible blisters.
• Muscle weakness, tenderness, muscle rupture, muscle pain, or reddish-brown urine. If you also feel unwell or have a high fever, it may be caused by muscle breakdown (rhabdomyolysis). Muscle breakdown may not always resolve, even if you stop taking atorvastatin, and it can be life-threatening and cause kidney problems.

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

• If you experience unexpected or unusual bleeding or bruising, it may indicate liver problems. You should consult a 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).

You should talk to your doctor if you experience muscle weakness in your 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 inflammation, 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,
• 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 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, reduced sensitivity to pain and touch, changes in taste, memory loss,
• blurred vision,
• ringing in the ears and/or head,
• vomiting, belching, upper and lower abdominal pain, pancreatitis (causing abdominal pain),
• hepatitis,
• 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 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,
• skin rash, which can occur on the skin, or ulcers in the mouth (lichenoid drug reaction),
• purple skin changes (signs of vasculitis).

Very rarely: 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 breast tissue growth in men)

Frequency not known: cannot be estimated from the available data

• persistent 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 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, your doctor will perform the necessary tests.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your 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.
By reporting side effects, you can help provide more information on the safety of this 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. You should 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 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 10 mg, 20 mg, 40 mg, and 80 mg film-coated tablets.

What Atorvastatin Genoptim looks like and contents of the pack

• Atorvastatin Genoptim 10 mg film-coated tablets are white or almost white, oval, and biconvex, with the inscription "10" on one side of the tablet.
• Atorvastatin Genoptim 20 mg film-coated tablets are white or almost white, oval, and 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, and 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, and 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