Atorvastatin genoptim med

Package leaflet: Information for the user

Atorvastatin Genoptim MED, 10 mg, film-coated tablets
Atorvastatin Genoptim MED, 20 mg, film-coated tablets
Atorvastatin Genoptim MED, 40 mg, film-coated tablets
Atorvastatin Genoptim MED, 80 mg, film-coated tablets
Atorvastatinum
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. 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 any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Atorvastatin Genoptim MED is and what it is used for
2. What you need to know before taking Atorvastatin Genoptim MED
3. How to take Atorvastatin Genoptim MED
4. Possible side effects
5. How to store Atorvastatin Genoptim MED
6. Contents of the pack and other information

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

Atorvastatin Genoptim MED belongs to a group of medicines called statins, which regulate lipid (fat) metabolism in the body.
Atorvastatin Genoptim MED 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 Genoptim MED may also be used to reduce the risk of heart disease, even when cholesterol levels are normal. A cholesterol-lowering diet should be continued during treatment.

2. Important information before using Atorvastatin Genoptim MED

When not to use Atorvastatin Genoptim MED

• 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 MED, discuss the following with your doctor or
pharmacist:

• 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 MED 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 a history of recurrent or unexplained muscle pain or muscle problems, or similar problems in family members,
• in case of muscle problems experienced during previous treatment with other lipid-lowering medicines (e.g. other statins or fibrates),
• 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 sometimes worsen symptoms of the disease or lead to the development of myasthenia (see section 4),
• in case of regular consumption of large amounts of alcohol,
• in case of previous liver disease,
• in patients aged over 70 years.

In patients affected by any of the above conditions, the doctor will order a blood test before starting treatment with Atorvastatin Genoptim MED 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 Genoptim MED and other medicines”). Inform your doctor or pharmacist if muscle weakness persists. Additional tests and medicines 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 blood sugar and lipid levels, overweight patients, and those with high blood pressure may be at increased risk of developing diabetes.

Atorvastatin Genoptim MED and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Some medicines may alter the effect of atorvastatin or their effect may be altered by atorvastatin. 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 hypertension, e.g. amlodipine, diltiazem; and 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, a combination medicine containing elbasvir with grazoprevir, and ledipasvir with sofosbuvir,
• other medicines known to interact with Atorvastatin Genoptim MED, including ezetimibe (which reduces 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 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 (Hypericum perforatum),
• if 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 Atorvastatin Genoptim MED. Taking Atorvastatin Genoptim MED together with fusidic acid may rarely lead to muscle weakness, tenderness or pain (rhabdomyolysis). More information about 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 MED, food, drink and alcohol
Information on how to take Atorvastatin Genoptim MED 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 MED.
Alcohol
Avoid excessive alcohol consumption while taking this medicine.
Further details on this are provided in section 2 “Warnings and precautions”.

Pregnancy and breastfeeding
Atorvastatin Genoptim MED must not be used by women who are pregnant or planning to become pregnant.
Atorvastatin Genoptim MED must not be used by women of childbearing age unless they are using effective contraceptive methods.
Atorvastatin Genoptim MED must not be used during breastfeeding.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
The safety of atorvastatin during pregnancy and breastfeeding has not been established.
Always consult a 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 Genoptim MED contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. the medicine is considered "sodium-free".

3. How to use Atorvastatin Genoptim MED

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt,
you should consult your doctor or pharmacist.
Before starting treatment, your doctor will recommend that you follow a low-cholesterol diet, which
should be continued during treatment with Atorvastatin Genoptim MED.
The usual starting dose of Atorvastatin Genoptim MED in adults and children aged 10 years and older
is 10 mg once daily. If necessary, your doctor may increase this dose gradually to the dose appropriate
for the individual patient. Your doctor will adjust the dose at intervals of at least 4 weeks. The maximum
dose of Atorvastatin Genoptim MED is 80 mg once daily.
Atorvastatin Genoptim MED tablets should be swallowed whole with water and may 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.
Atorvastatin Genoptim MED 20 mg, 40 mg and 80 mg tablets may be divided into equal doses.
The duration of treatment with Atorvastatin Genoptim MED is determined by the doctor.
If you feel that the effect of Atorvastatin Genoptim MED is too strong or too weak, you should consult
your doctor.
Taking more Atorvastatin Genoptim MED than prescribed
If you accidentally take too many Atorvastatin Genoptim MED tablets (more than the usual daily dose),
you should contact your doctor or the nearest hospital for advice.
Missing a dose of Atorvastatin Genoptim MED
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 a missed dose.
Stopping Atorvastatin Genoptim MED
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If the patient experiences any of the serious adverse reactions or symptoms listed below, 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 no more than 1 in 1,000 people

• Severe allergic reaction causing swelling of the face, tongue, and throat, which may cause severe breathing difficulties.
• Severe illness characterized by skin peeling and swelling, skin blisters, and sores in the mouth, eyes, genitals, accompanied by fever. Skin rash with pink-red spots, particularly on the palms or soles, possibly with blisters.
• Muscle weakness, tenderness, pain, or muscle rupture, or red-brown discoloration of urine. If these symptoms occur together with malaise or high fever, this may indicate rhabdomyolysis (breakdown of skeletal muscle). Rhabdomyolysis does not always resolve even after discontinuation of atorvastatin, may be life-threatening, and may 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).

Other possible adverse reactions of Atorvastatin Genoptim MED
Common: may occur in no more than 1 in 10 people

• Nasal inflammation, 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, 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, taste disturbances, memory loss,
• Blurred vision,
• Ringing in the ears and (or) in the head,
• Vomiting, belching, 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 body temperature,
• Presence of white blood cells in urine analysis.

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

• Visual disturbances,
• 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 ulceration in the mouth (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, 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: 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 eye muscles).

Talk to your doctor if the patient experiences weakness in arms or legs worsening with activity, double vision or drooping eyelids, difficulty swallowing, or shortness of breath.
Other possible adverse reactions 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 diabetes is higher in patients with high levels of blood sugar and fats, overweight patients, and those with high blood pressure. The doctor will perform appropriate tests during treatment with this medicine.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse.
Adverse reactions 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 reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Atorvastatin Genoptim MED

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and carton after "Expiry date", "EXP". The expiry date refers to the last day of the specified month.
This medicine does not require any special storage conditions.
This medicine may pose a risk to the environment. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Atorvastatin Genoptim MED 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 are:
  Tablet core: microcrystalline cellulose (type 102), calcium carbonate, maltose, sodium croscarmellose, polysorbate 80, magnesium aluminometasilicate type 1-A, magnesium stearate
  Coating: hypromellose type 2910, low-substituted hydroxypropylcellulose, triethyl citrate, polysorbate 80, titanium dioxide (E 171)

What Atorvastatin Genoptim MED looks like and contents of the pack
Atorvastatin Genoptim MED 10 mg coated tablets are white or almost white, oval-shaped, biconvex, smooth on one side and engraved with "10" on the other side. Dimensions: approx. 8 mm x 4 mm.
Atorvastatin Genoptim MED 20 mg coated tablets are white or almost white, oval-shaped, biconvex, engraved with "20" on one side and a breakline on the other side. Dimensions: approx. 10 mm x 6 mm.
Atorvastatin Genoptim MED 40 mg coated tablets are white or almost white, oval-shaped, biconvex, engraved with "40" on one side and a breakline on the other side. Dimensions: approx. 13 mm x 7 mm.
Atorvastatin Genoptim MED 80 mg coated tablets are white or almost white, oval-shaped, biconvex, engraved with "80" on one side and a breakline on the other side. Dimensions: approx. 16 mm x 9 mm.

Atorvastatin Genoptim MED 10 mg is available in blisters of 30 tablets and in perforated unit dose blisters of 30x1 tablets.
Atorvastatin Genoptim MED 20 mg is available in blisters of 30, 60 and 90 tablets and in perforated unit dose blisters of 30x1, 60x1 and 90x1 tablets.
Atorvastatin Genoptim MED 40 mg is available in blisters of 30, 60 and 90 tablets and in perforated unit dose blisters of 30x1, 60x1 and 90x1 tablets.
Atorvastatin Genoptim MED 80 mg is available in blisters of 30 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
tel.: 22 32 16 240

Manufacturer
Teva Pharma S.L.U.
Calle Malpica N°4
Poligono Industrial Malpica
50016 Zaragoza
Spain

This medicinal product is authorised for marketing in the Member States of the European Economic Area under the following names:
Austria Tiskrefaren 10 mg, 20 mg, 40 mg, 80 mg Filmtabletten
Poland Atorvastatin Genoptim MED, 10 mg, 20 mg, 40 mg, 80 mg, coated tablets