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

Atorvastatin

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please 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 pack 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 changes in lifestyle are not effective on their own.
Atorvastatin Genoptim can also be used to reduce the risk of heart disease, even if 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:

• in women of childbearing age who are not using effective methods of contraception,
• in pregnant or breast-feeding women,

Warnings and precautions

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

If any of the above apply to you, your 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. Additional tests and medications may be needed to diagnose and treat this condition.
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

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about any medicines you plan to take.
Some medicines may affect the way Atorvastatin Genoptim works, or their effect may be altered 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, colestyramine,
• certain calcium channel blockers used for angina or high blood pressure, such as amlodipine, diltiazem; and 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), phenazon (a pain reliever), colchicine (used to treat gout), and antacids (used to treat indigestion, containing aluminum or magnesium),
• over-the-counter medicines: St. John's Wort (a herbal medicine),
• daptomycin (a medicine used to treat complicated skin and skin structure infections and bacteremia).

Atorvastatin Genoptim with food, drink, and alcohol

Information on the use of Atorvastatin Genoptim can be found in section 3. However, please note the following:

Grapefruit juice
Do not drink more than one or two small glasses of grapefruit juice per day, as larger amounts of grapefruit juice may affect the action of Atorvastatin Genoptim.
Alcohol
Avoid excessive alcohol consumption while taking this medicine.
More information on this can be found in section 2 "Warnings and precautions".

Pregnancy and breast-feeding

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

Driving and using machines

Atorvastatin Genoptim is unlikely to affect your ability to drive or use machines. However, do not drive if this medicine affects your ability to drive. Do not use any tools or machines if your ability to use them is affected by this medicine.

Atorvastatin Genoptim contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, which means it is essentially "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 for adults and children over 10 years old is 10 mg once daily. This dose may be increased if necessary by your doctor to the dose that is 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 daily.
Atorvastatin Genoptim tablets should be swallowed whole with water and can be taken at any time of day, with or without food. However, try to take your tablet at the same time each 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 are unsure, consult your 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, talk to your doctor.

Taking more than the recommended dose of Atorvastatin Genoptim

If you accidentally take more than the recommended dose of Atorvastatin Genoptim (more than the usual daily dose), contact your doctor or the nearest hospital for advice.

Forgetting to take a dose of Atorvastatin Genoptim

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 Genoptim

If you have any further questions about taking this medicine, ask your 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, stop taking Atorvastatin Genoptim and contact your doctor or go to the emergency department at your nearest hospital immediately.

Rarely: may affect up to 1 in 1000 people:

• Severe allergic reaction causing swelling of the face, tongue, and throat, which can cause severe breathing difficulties.
• Severe skin disease characterized by peeling and swelling of the skin, blisters on the skin, mouth, eyes, genitals, and fever. Rash on the skin 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 due to muscle breakdown (rhabdomyolysis). Muscle breakdown does not always resolve, even if the patient stops 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, this may indicate liver problems. You should consult your doctor as soon as possible.
• Systemic lupus erythematosus-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 muscles involved in breathing).
• Myasthenic syndrome (a disease that causes muscle weakness in the eyes).

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 affect up to 1 in 10 people

• nose and throat infections, 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 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, upper and lower 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 1000 people

• vision disturbances,
• unexpected bleeding or bruising (bruises),
• jaundice (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 rarely: may affect up to 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 those not listed in this leaflet, please tell your doctor, pharmacist, or nurse.
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
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 to gather more information on the safety of this medicine.

5. How to store Atorvastatin Genoptim

Keep this medicine out of the 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. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Atorvastatin Genoptim contains

• The active substance is atorvastatin. Each film-coated tablet contains 10 mg of atorvastatin (as atorvastatin calcium). Each film-coated tablet contains 20 mg of atorvastatin (as atorvastatin calcium). Each film-coated tablet contains 40 mg of atorvastatin (as atorvastatin calcium). Each film-coated tablet contains 80 mg of atorvastatin (as atorvastatin calcium).
• The 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