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

You should carefully read the contents of the leaflet before taking 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 further questions, you should ask your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do 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 those not listed in this leaflet, you should tell your 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 packaging 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
(fats) in the body.
Torvacard neo is used to reduce the levels of lipids known 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, you should continue a standard diet aimed at reducing cholesterol levels.

2. Important information before taking Torvacard neo

When not to take Torvacard neo

• 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 unexplained, abnormal liver function test results,
• if you are taking glecaprevir with pibrentasvir for the treatment of hepatitis C virus infection,
• if you are a woman of childbearing age and do not use a reliable method of contraception,
• if you are pregnant or planning to become pregnant,
• if you are breastfeeding.

Warnings and precautions

Before starting treatment with Torvacard neo, you should discuss it with your doctor or pharmacist:

• in case of severe respiratory failure,
• if you are taking or have taken within the last 7 days a medicine called fusidic acid (an antibiotic) orally or by injection. The combination of fusidic acid and Torvacard neo can lead to serious muscle problems (rhabdomyolysis),
• if you have had a stroke with bleeding into 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,
• if you have had recurring or unexplained muscle pain or muscle problems, or if similar problems have occurred in your relatives,
• if you have had muscle problems while taking other lipid-lowering medicines (e.g. other statins or fibrates),
• if you 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 lead to myasthenia (see section 4),
• if you regularly consume large amounts of alcohol,
• if you have had liver disease,
• if you are 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 you if you have diabetes or are at risk of developing diabetes. If you have high levels of sugars and fats in your blood, are overweight, or have high blood pressure, you may also be at risk of developing diabetes.

Torvacard neo 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 may change the effect of Torvacard neo, or the effect of these medicines on the body may be changed by Torvacard neo. This type of interaction can be the cause of 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 and 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 a 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 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 used to treat epilepsy), 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 you are taking fusidic acid orally to treat a bacterial infection, you should stop taking this medicine. Your doctor will tell you when you can start taking Torvacard neo again. The simultaneous use of Torvacard neo with fusidic acid can 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).

Torvacard neo with food, drink, and alcohol

Information on the use of Torvacard neo 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 Torvacard neo.
Alcohol
While taking this medicine, you should avoid consuming excessive amounts of alcohol. 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 by 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, you should consult your doctor or pharmacist.

Driving and using machines

Normally, the medicine does not affect the ability to drive and use machines. However, you should not drive if the medicine affects your ability to drive. You should not use any tools or machines if taking the medicine affects your ability to use them.

Torvacard neo contains lactose monohydrate.

If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.

3. How to take Torvacard neo

This medicine should always be taken as directed by your doctor or pharmacist. If you are unsure, you should ask your doctor or pharmacist.
Before starting treatment, your doctor will recommend a low-cholesterol diet. You should continue this diet 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 your doctor if necessary, up to a dose suitable for you. Your 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.
The 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, you should try to take the tablet at the same time every day.

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

If you feel that the effect of Torvacard neo is too strong or too weak, you should consult your doctor.

Taking a higher dose of Torvacard neo than recommended

If you have accidentally taken too many Torvacard neo tablets (more than the normal daily dose), you should contact your doctor or the nearest hospital for advice.

Missing a dose of Torvacard neo

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

Stopping treatment with Torvacard neo

If you have any further questions about taking this medicine or if you want to stop treatment, you should consult your doctor or pharmacist.

4. Possible side effects

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

If you experience any of the serious side effects or symptoms listed below, you should stop taking the medicine and contact your doctor or go to the emergency department of the nearest hospital immediately.

Rare (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 pink-red spots, especially on the palms or soles of the feet, with possible blisters.
• Muscle weakness, tenderness, pain, or muscle rupture, or brownish discoloration of urine. If you also feel unwell or have a high fever, it may be due to abnormal breakdown of muscle cells (rhabdomyolysis) - a condition that can be life-threatening and lead to kidney problems. This condition can persist after stopping atorvastatin.

Very rare (may occur in less than 1 in 10,000 people):

• Lupus-like syndrome (including rash, joint disorders, and effects on blood cells).
• If you experience unexpected or unusual bleeding or bruising, it may indicate liver dysfunction. You should consult your doctor as soon as possible.

Other possible side effects of Torvacard neo:

Common (may occur in less than 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 cramps, pain in the hands and feet, 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 (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)
• hepatitis
• skin rash, skin rash and itching, hives
• neck pain, muscle fatigue
• fatigue, malaise, weakness, chest pain, swelling (especially in the ankles), elevated temperature
• presence of white blood cells in the urine

Rare (may occur in less than 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 occur in less than 1 in 10,000 people):

• allergic reactions - symptoms may include sudden wheezing and chest pain or tightness, swelling of the eyelids, face, lips, mouth, 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)

You should talk to your doctor if you experience weakness in your arms or legs, 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 you have high levels of sugars and fats in your blood, are overweight, or have high blood pressure. During treatment with this medicine, your doctor will monitor your condition.

Reporting side effects
If you experience any side effects, including those not listed in this leaflet, you should tell your 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
By reporting side effects, you can help gather more information on the safety of this medicine.

5. How to store Torvacard neo

The medicine should be stored out of 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. 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 Torvacard neo contains

The active substance is atorvastatin.
Torvacard neo, 10 mg: Each film-coated tablet contains 10 mg of atorvastatin (in the form of calcium trihydrate atorvastatin).
Torvacard neo, 20 mg: Each film-coated tablet contains 20 mg of atorvastatin (in the form of calcium trihydrate atorvastatin).
Torvacard neo, 40 mg: Each film-coated tablet contains 40 mg of atorvastatin (in the form of calcium trihydrate atorvastatin).
Torvacard neo, 80 mg: Each film-coated tablet contains 80 mg of atorvastatin (in the form of calcium trihydrate 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, you should contact the representative of the marketing authorization holder in Poland:

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