Torvacard neo

Leaflet attached to the packaging: patient information

Torvacard neo,10 mg, film-coated tablets
Torvacard neo,20 mg, film-coated tablets
Torvacard neo,40 mg, film-coated tablets
Torvacard neo,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.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Torvacard neo and what is it used for

Torvacard neo belongs to a group of medicines called statins, which regulate lipid metabolism in the body.
Torvacard neo is used to reduce the levels of lipids, such as cholesterol and triglycerides, in the blood when a low-fat diet and lifestyle changes are not effective. In people with increased risk of heart disease, Torvacard neo may be used to reduce this risk, even if their cholesterol levels are normal. During treatment, a standard cholesterol-lowering diet should be continued.

2. Important information before taking Torvacard neo

When not to take Torvacard neo

• 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,
• if the patient is taking glecaprevir with pibrentasvir for the treatment of hepatitis C virus infection,
• if the patient is of childbearing age and is not using a reliable method of contraception,
• if the patient is pregnant or plans to become pregnant,
• if the patient is breastfeeding.

Warnings and precautions

Before starting treatment with Torvacard neo, the patient should discuss the following with their doctor or pharmacist:

• in case of severe respiratory failure,
• if the patient is taking or has taken fusidic acid (an antibiotic) orally or by injection in the last 7 days. The combination of fusidic acid and Torvacard neo can lead to serious muscle problems (rhabdomyolysis),
• if the patient has 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 the patient has kidney problems,
• if the patient has hypothyroidism,
• if the patient has had recurring or unexplained muscle pain or muscle problems, or if similar problems have occurred in relatives,
• if the patient has had muscle problems while taking other lipid-lowering medicines (e.g. other statins or fibrates),
• 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 myasthenia (see section 4),
• if the patient regularly consumes large amounts of alcohol,
• if the patient has had liver disease,
• if the patient is over 70 years old.

In patients who are affected by any of the above situations, the doctor will order a blood test before starting treatment with Torvacard neo 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 "Torvacard neo 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 this medicine, the doctor will closely monitor the patient if they have diabetes or are at risk of developing diabetes. If the patient has high levels of sugars and fats in the blood, is overweight, or has high blood pressure, they may also be at risk of developing diabetes.

Torvacard neo and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take.
Some medicines can change the effect of Torvacard neo, or the effect of these medicines on the body can be changed by Torvacard neo. 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 and antifungals, 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 cytomegalovirus disease,
• 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 virus infection, such as telaprevir, boceprevir, and a combination product containing elbasvir with grazoprevir, ledipasvir with sofosbuvir.
• other medicines known to interact with Torvacard neo, 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 (medicines used to treat indigestion, containing aluminum or magnesium),

• over-the-counter medicines: St. John's wort,
• if the patient is taking fusidic acid orally to treat a bacterial infection, they should stop taking Torvacard neo. The doctor will inform the patient when they can restart taking Torvacard neo. Taking Torvacard neo 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).

Torvacard neo with food, drink, and alcohol

Information on taking Torvacard neo can be found in section 3. However, the following information should be noted:
Grapefruit juice
Do 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 Torvacard neo.
Alcohol
Avoid excessive alcohol consumption while taking this medicine. More information on this can be found in section 2 "Warnings and precautions".

Pregnancy, breastfeeding, and fertility

Taking Torvacard neo during pregnancy or planning to become pregnant is contraindicated.
Taking Torvacard neo in women of childbearing age is contraindicated if they do not use reliable methods of contraception.
Taking Torvacard neo during breastfeeding is contraindicated.
The safety of atorvastatin during pregnancy and breastfeeding has not been established.
Before taking any medicine, consult a 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 drive. Do not use any tools or machines if taking the medicine affects the ability to use them.

Torvacard neo contains lactose monohydrate.

If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

3. How to take Torvacard neo

Take this medicine always as directed by your doctor or pharmacist. In case of doubt, consult a doctor or pharmacist.
Before starting treatment, the doctor will recommend a low-cholesterol diet. This diet should be continued during treatment with Torvacard neo.
Usually, the recommended dose of Torvacard neo for adults and children over 10 years old is 10 mg once a day. 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 4 weeks or more. The maximum dose of Torvacard neo is 80 mg once a day.
Tablets of Torvacard neo should be swallowed whole, with a glass of water; they can be taken at any time of day, with or without food. However, try to take the tablet at the same time every day.

The duration of treatment with Torvacard neo is determined by the doctor.

If the patient feels that the effect of Torvacard neo is too strong or too weak, they should consult a doctor.

Taking a higher dose of Torvacard neo than recommended

In case of accidental ingestion of too many Torvacard neo tablets (more than the normal daily dose), consult a doctor or the nearest hospital for advice.

Missing a dose of Torvacard neo

If the patient forgets to take a dose, they should take the next dose at the right time.
Do not take a double dose to make up for a missed dose.

Stopping treatment with Torvacard neo

In case of any further doubts about taking this medicine or if the patient wants to stop treatment, they should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Torvacard neo can cause side effects, although not everybody gets them.

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

Rare (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 disease characterized by peeling and swelling of the skin, blisters on the skin, mouth, eyes, genitals, and fever. Skin rash with pink-red spots, especially on the palms or soles, with possible blisters.
• Muscle weakness, tenderness, pain, or muscle rupture, or brownish discoloration of urine. If accompanied by malaise or high fever, it may be due to abnormal breakdown of muscle cells (rhabdomyolysis) - a life-threatening condition that can lead to kidney problems. This condition can persist after stopping atorvastatin.

Very rare (may affect up to 1 in 10,000 people):

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

Other possible side effects of Torvacard neo:

Common (may affect up to 1 in 10 people):

• nasal congestion, sore throat, nosebleeds
• allergic reactions
• increased blood glucose levels (patients with diabetes should continue to monitor their blood glucose levels), increased creatine kinase activity in the blood
• headache
• nausea, constipation, bloating, indigestion, diarrhea
• joint pain, joint swelling, muscle pain, muscle spasms, pain in the hands and feet, 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 (patients with diabetes should continue to monitor their blood glucose levels)
• nightmares, insomnia
• dizziness, numbness or tingling in the fingers and toes, 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)
• liver inflammation
• skin rash, skin rash and itching, hives
• neck pain, muscle fatigue
• fatigue, malaise, weakness, chest pain, swelling (especially in the ankle area), elevated temperature
• presence of white blood cells in urine

Rare (may affect up to 1 in 1000 people):

• vision disorders
• unexpected bleeding or bruising (bruises)
• bile duct obstruction (yellowing of the skin and whites of the eyes)
• tendon damage
• skin rash, which may occur on the skin, or ulcers in the mouth (lichenoid drug reaction)
• purple skin changes (symptoms of vasculitis

Very rare (may affect up to 1 in 10,000 people):

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

Frequency not known (frequency cannot be estimated from the available data):

• persistent muscle weakness
• 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)

Talk to a doctor if the patient experiences weakness in the hands or feet, worsening after periods of activity, double vision, or drooping eyelids, difficulty swallowing, or shortness of breath.
Other possible side effects reported during treatment with some statins (medicines of the same type):

• sexual disorders
• depression
• breathing problems, including persistent cough and (or) shortness of breath or fever
• diabetes. The development of diabetes is more likely if the patient has high levels of sugars and fats in the blood, is overweight, or has high blood pressure. During treatment with this medicine, the doctor will monitor the patient's condition.

Reporting side effects
If side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products.
Jerozolimskie Avenue 181 C, 02-222 Warsaw, Tel: +48 22 49 21 301, Fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store Torvacard neo

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the outer packaging after "Expiry date". The expiry date refers to the last day of the month.
There are no special precautions for storage.
Do not use this medicine if signs of deterioration are visible.
Medicines should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Torvacard neo contains

The active substance is atorvastatin.
Torvacard neo, 10 mg: Each film-coated tablet contains 10 mg of atorvastatin (as trihydrate calcium salt of atorvastatin).
Torvacard neo, 20 mg: Each film-coated tablet contains 20 mg of atorvastatin (as trihydrate calcium salt of atorvastatin).
Torvacard neo, 40 mg: Each film-coated tablet contains 40 mg of atorvastatin (as trihydrate calcium salt of atorvastatin).
Torvacard neo, 80 mg: Each film-coated tablet contains 80 mg of atorvastatin (as trihydrate calcium salt of atorvastatin).
Other ingredients are:
Core: calcium carbonate, microcrystalline cellulose (E 460), lactose monohydrate, hypromellose with low substitution degree, povidone K12, colloidal anhydrous silica, magnesium stearate (E 572).
Coating: hypromellose (E 464), macrogol 6000, titanium dioxide (E171), talc, yellow iron oxide (E 172),
lactose monohydrate.

What Torvacard neo looks like and contents of the pack

Torvacard neo, 10 mg: White or almost white, round, biconvex film-coated tablets, approximately 6 mm in diameter.
Torvacard neo, 20 mg: Yellowish, round, biconvex film-coated tablets, approximately 8 mm in diameter.
Torvacard neo, 40 mg: Orange-yellow to yellow-orange, round, biconvex film-coated tablets, approximately 10 mm in diameter.
Torvacard neo, 80 mg: Yellow-orange, round, biconvex film-coated tablets, approximately 12 mm in diameter.
Pack sizes:
Torvacard neo 10 mg: 30, 60, or 90 film-coated tablets
Torvacard neo 20 mg: 30, 60, or 90 film-coated tablets
Torvacard neo 40 mg: 30, 60, or 90 film-coated tablets
Torvacard neo 80 mg: 30, 60, or 90 film-coated tablets
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder
Zentiva k.s., U kabelovny 130, Dolní Měcholupy, 102 37 Prague 10, Czech Republic
Manufacturer
Zentiva k.s., U kabelovny 130, Dolní Měcholupy, 102 37 Prague 10, Czech Republic
Uždaroji Akcinė Bendrovė „Oriola Vilnius”, Laisvės pr. 75, LT-06144, Vilnius, Lithuania

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

To obtain more detailed information on the medicine, please contact the representative of the marketing authorization holder in Poland:

Zentiva Polska Sp. z o. o.
Bonifraterska 17 Street
00-203 Warsaw
Phone: +48 22 375 92 00
Date of last revision of the leaflet:October 2024