Atorvastatin genoptim

Package leaflet: 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
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you personally. Do not give it to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

1. What Atorvastatin Genoptim is and what it is used for
2. What you need to know 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 Atorvastatin Genoptim is and what it is 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 blood levels of lipids known as cholesterol and triglycerides, when a low-fat diet and lifestyle changes alone are not effective.
Atorvastatin Genoptim may also be used to reduce the risk of heart disease, even when cholesterol levels are normal. During treatment, you should continue to follow a standard low-cholesterol diet.

2. Important information before using Atorvastatin Genoptim

When not to use Atorvastatin Genoptim:

• if the patient is allergic to atorvastatin or to 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 age who are not using effective contraceptive methods,
• in pregnant women or women planning to become pregnant,
• in breastfeeding women,
• if the patient is concurrently taking glecaprevir with pibrentasvir for the treatment of hepatitis C virus infection.

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

• if the patient has 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 Genoptim 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),
• 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 has or has 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).

For patients affected by any of the above conditions, the doctor will order a blood test before starting treatment with Atorvastatin Genoptim and, whenever possible, during treatment to monitor the risk of muscle-related adverse effects. It is known that the risk of muscle-related adverse effects, such as rhabdomyolysis, is higher when certain medicines are used concomitantly (see section 2 “Atorvastatin Genoptim and other medicines”). Inform your doctor or pharmacist if muscle weakness persists. Additional tests and additional medicines may be necessary to diagnose and treat this condition.
During treatment, your doctor will closely monitor you for the development of diabetes or risk of developing diabetes. Patients with high levels of blood sugar and lipids, overweight patients, 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 currently taking or have recently taken, as well as any medicines you plan to take.

Some medicines may alter the effect of Atorvastatin Genoptim or their effect may be altered by Atorvastatin Genoptim. This type of interaction may result in reduced effectiveness of one or both medicines. It may also increase the risk of serious adverse effects, 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, cholestyramine,
• certain calcium channel blockers used for angina or hypertension, 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 fixed-dose combination 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 anticonvulsant used in epilepsy treatment), cimetidine (used to treat heartburn and stomach ulcers), phenazone (a pain reliever), 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 (a herbal remedy),
• if, during treatment of a bacterial infection, the patient needs to take oral fusidic acid to treat a bacterial infection, treatment with this medicine should be temporarily discontinued. The doctor will inform the patient when it is safe to restart treatment with Atorvastatin Genoptim. Taking Atorvastatin Genoptim together with 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 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, please pay attention to the following:

Grapefruit juice
Do not consume more than one or two small glasses of grapefruit juice per day, as larger amounts may alter the effect of Atorvastatin Genoptim.

Alcohol
While taking this medicine, avoid consuming excessive amounts of alcohol.
Further information on this topic is provided in section 2 “Warnings and precautions”.

Pregnancy and breastfeeding
Use of Atorvastatin Genoptim in women who are pregnant or planning to become pregnant is contraindicated.
Use of Atorvastatin Genoptim in women of childbearing potential is contraindicated if they are not using effective contraceptive methods.
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, consult your doctor or pharmacist.

Driving and operating machinery
Generally, this medicine does not affect the ability to drive or operate machinery. However, patients should not drive if this medicine affects their ability to do so. Do not use any tools or machinery if taking this medicine affects your ability to operate them.

Atorvastatin Genoptim contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, meaning the medicine is considered "sodium-free".

3. How to use Atorvastatin Genoptim

Before starting treatment, your doctor will advise you to follow a cholesterol-lowering diet.
This diet should be continued during treatment with Atorvastatin Genoptim.
The usual starting dose of Atorvastatin Genoptim in adults and children aged 10 years or older is 10 mg once daily. If necessary, your doctor may increase this dose gradually to the dose appropriate for the patient. Your doctor will adjust the dose 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; they may be taken at any time of day, with or without food. However, you should try to take the tablet at the same time each day.
Atorvastatin Genoptim 20 mg, 40 mg, and 80 mg tablets may be divided into equal doses.
This medicine should always be used according to the instructions given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The duration of treatment with Atorvastatin Genoptim is determined by the doctor.
If you feel that the effect of Atorvastatin Genoptim is too strong or too weak, consult your doctor.
Taking more Atorvastatin Genoptim than prescribed
If you accidentally take too many Atorvastatin Genoptim tablets (more than the usual daily dose), contact your doctor or the nearest hospital for advice.
Missing a dose of Atorvastatin Genoptim
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 Genoptim
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If the patient experiences any of the serious adverse effects or symptoms listed below, they should
stop taking the medicine immediately and contact their doctor or go to the emergency department
at the nearest hospital.

Rare: may occur in no more than 1 in 1,000 people:

• Severe allergic reaction causing swelling of the face, tongue, and throat, which may lead to severe breathing difficulties.
• Severe illness characterized by skin peeling and swelling, skin blisters, sores in the mouth, eyes, genitals, and fever. Skin rash with pink-red spots, especially on the palms or soles, possibly with blisters.
• Weakness, tenderness, muscle rupture, muscle pain, or red-brown discoloration of urine. If accompanied by malaise or high fever, this may be due to rhabdomyolysis (breakdown of striated muscles). Rhabdomyolysis may not resolve even after discontinuation of atorvastatin, and may be life-threatening and lead to kidney problems.

Very rare: may occur in no more than 1 in 10,000 people:

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

Frequency unknown: cannot be estimated from available data:

• 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 speak to their doctor if they experience weakness in hands or legs worsening with activity, double vision or drooping eyelids, difficulty swallowing, or shortness of breath.
Other possible adverse effects of Atorvastatin Genoptim:
Common: may occur in no more than 1 in 10 people

• Nasopharyngitis, 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, flatulence, indigestion, diarrhoea,
• Joint pain, muscle pain, and back pain,
• Blood test results indicating abnormal liver function.

Uncommon: may occur in no more than 1 in 100 people

• 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,
• Tinnitus and (or) ringing in the head,
• Vomiting, regurgitation, pain in the upper and lower abdomen, pancreatitis (causing abdominal pain),
• Hepatitis,
• Rash, skin eruptions 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 analysis.

Rare: may occur in no more than 1 in 1,000 people

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

Very rare: may occur in no more than 1 in 10,000 people

• Allergic reactions – symptoms may include sudden wheezing and chest pain, eyelid, facial, lip, oral cavity, tongue or throat swelling, breathing difficulties, collapse,
• Hearing loss,
• Gynaecomastia (excessive growth of breast glandular tissue in males).

Frequency unknown: cannot be estimated from available data

• Persistent muscle weakness.

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

• Sexual dysfunction,
• Depression,
• Breathing difficulties, including persistent cough and (or) shortness of breath or fever,
• Diabetes – the likelihood of developing this condition is higher in patients with high blood sugar and fat levels, those who are overweight, and those with high blood pressure. The doctor will perform appropriate tests during treatment with this medicine.

Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, patients should inform their doctor, pharmacist, or nurse.
Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Atorvastatin Genoptim

Keep this medicine out of the sight and reach of children.
Store below 30°C.
Do not use this medicine after the expiry date stated on the outer packaging following “Expiry date”, “EXP”. The expiry date refers to the last day of the specified month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Atorvastatin Genoptim contains

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

This medicine is available as 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 coated tablets are white or almost white, oval-shaped, biconvex, with an imprint "10" on one side of the tablet.
• Atorvastatin Genoptim 20 mg coated tablets are white or almost white, oval-shaped, biconvex, with a score line on one side and an imprint "20" on the other side of the tablet. The tablets can be divided into equal doses.
• Atorvastatin Genoptim 40 mg coated tablets are white or almost white, oval-shaped, biconvex, with a score line on one side and an imprint "40" on the other side of the tablet. The tablets can be divided into equal doses.
• Atorvastatin Genoptim 80 mg coated tablets are white or almost white, oval-shaped, biconvex, with a score line on one side and an imprint "80" on the other side of the tablet. The tablets can be divided into equal doses.
• Atorvastatin Genoptim is packed in blisters made of PA/Aluminium/PVC//Aluminium 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 Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warszawa
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