TORVACARD 20 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
   1. Read the package leaflet carefully before taking the medicine, as it contains
   2. Table of Contents of the Package Leaflet
2. What is Torvacard neo and what is it used for
3. Important information before taking Torvacard neo
   1. When not to take Torvacard neo
   2. Warnings and precautions
   3. Torvacard neo and other medicines
   4. Torvacard neo with food, drink, and alcohol
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and using machines
   7. Torvacard neo contains lactose monohydrate.
4. How to take Torvacard neo
   1. The duration of treatment with Torvacard neo is determined by your doctor.
   2. Taking too much Torvacard neo
   3. Missing a dose of Torvacard neo
   4. Stopping treatment with Torvacard neo
5. Possible side effects
   1. If you experience any of the following serious side effects or symptoms, stop taking Torvacard neo and contact your doctor immediately or go to the emergency department of your nearest hospital.
   2. Other possible side effects of Torvacard neo:
6. How to store Torvacard neo
7. Contents of the pack and other information
   1. What Torvacard neo contains
   2. What Torvacard neo looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
   5. For more information about this medicine, please contact the representative of the marketing authorization holder in Poland:

Package Leaflet: Information for the Patient

Torvacard neo,10 mg, coated tablets
Torvacard neo,20 mg, coated tablets
Torvacard neo,40 mg, coated tablets
Torvacard neo,80 mg, coated tablets
atorvastatin

Read the package 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 or pharmacist.
• 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 any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package 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 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 are not using 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, discuss 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 in 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 (underactive thyroid),
• if you have had repeated or unexplained muscle pain or muscle problems, or if similar problems have occurred in your relatives,
• if you have had muscle problems during treatment with other lipid-lowering medicines (e.g., other statins or fibrates),
• if you have had or have myasthenia (a disease that causes general muscle weakness, including in some cases muscles involved in breathing) or myasthenic syndrome (a condition 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 with any of the above conditions, the doctor will order a blood test before starting treatment with Torvacard neo 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 "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 blood sugar and fat levels, is overweight, or has high blood pressure, they may also be at risk of developing diabetes.

Torvacard neo and other medicines

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 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 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, colestyramine,
• 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 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. 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, 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 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 your doctor or pharmacist.

Driving and using machines

Normally, the medicine does not affect the ability to drive or use machines. However, do not drive if the medicine affects your ability to drive. Do 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, consult your doctor before taking the medicine.

3. How to take Torvacard neo

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Before starting treatment, your doctor will recommend a low-cholesterol diet. This diet should be continued during treatment with Torvacard neo.
The usual 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 Torvacard neo at intervals of at least 4 weeks. The maximum dose of Torvacard neo is 80 mg once a day.
Take the tablets with a glass of water, with or without food, at any time of day, but try to take your tablet at the same time each 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, consult your doctor.

Taking too much Torvacard neo

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

Missing a dose of Torvacard neo

If you forget to take a dose, take the next dose at the right time.
Do not take a double dose to make up for a forgotten dose.

Stopping treatment with Torvacard neo

If you have any further questions about taking this medicine or want to stop treatment, 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 following serious side effects or symptoms, stop taking Torvacard neo and contact your doctor immediately or go to the emergency department of your nearest hospital.

Rare (may affect up to 1 in 1,000 people):

• Severe allergic reaction causing swelling of the face, tongue, and throat, which can lead to severe breathing difficulties
• Severe skin 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 rupture, or brownish discoloration of urine. If you also feel unwell or have a high fever, this could be caused by abnormal muscle cell breakdown (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 you experience unexpected or unusual bleeding or bruising, this may indicate liver function disorders. Consult your doctor as soon as possible.

Other possible side effects of Torvacard neo:

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

• nose and throat infections, 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 arms and legs, 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 itching, hives, hair loss
• 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 affect up to 1 in 1,000 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)
• myasthenic syndrome (a condition that causes muscle weakness in the eyes)

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 blood sugar and fat levels, 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 any not listed in this leaflet, please inform 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.
Al. Jerozolimskie 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 provide more information on the safety of this medicine.

5. How to store Torvacard neo

Keep this 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.
No special precautions for storage are necessary.
Do not use this medicine if signs of deterioration are visible.
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 Torvacard neo contains

The active substance is atorvastatin.
Torvacard neo, 10 mg: Each coated tablet contains 10 mg of atorvastatin (as calcium trihydrate).
Torvacard neo, 20 mg: Each coated tablet contains 20 mg of atorvastatin (as calcium trihydrate).
Torvacard neo, 40 mg: Each coated tablet contains 40 mg of atorvastatin (as calcium trihydrate).
Torvacard neo, 80 mg: Each coated tablet contains 80 mg of atorvastatin (as calcium trihydrate).
Other ingredients are:
Core: calcium carbonate, microcrystalline cellulose (E 460), lactose monohydrate, hypromellose with low substitution degree, povidone K12, anhydrous colloidal 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, coated tablets, approximately 6 mm in diameter.
Torvacard neo, 20 mg: Yellowish, round, biconvex, coated tablets, approximately 8 mm in diameter.
Torvacard neo, 40 mg: Orange-yellow to yellow-orange, round, biconvex, coated tablets, approximately 10 mm in diameter.
Torvacard neo, 80 mg: Yellow-orange, round, biconvex, coated tablets, approximately 12 mm in diameter.
Pack sizes:
Torvacard neo 10 mg: 30, 60, or 90 coated tablets
Torvacard neo 20 mg: 30, 60, or 90 coated tablets
Torvacard neo 40 mg: 30, 60, or 90 coated tablets
Torvacard neo 80 mg: 30, 60, or 90 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:

For more information about this medicine, please contact the representative of the marketing authorization holder in Poland:

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