TORVACARD 40 mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
   1. Read the leaflet carefully before taking the medicine, as it contains
   2. Table of contents of the leaflet:
2. What is Torvacard and what is it used for
3. Important information before taking Torvacard
   1. When not to take Torvacard:
   2. Warnings and precautions
   3. Torvacard and other medicines
   4. Torvacard with food, drink, and alcohol
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and using machines
   7. Torvacard contains lactose monohydrate and sodium
4. How to take Torvacard
   1. The duration of treatment with Torvacard is determined by the doctor.
   2. Taking a higher dose of Torvacard than recommended
   3. Missing a dose of Torvacard
   4. Stopping treatment with Torvacard
5. Possible side effects
   1. If the patient experiences any of the serious side effects or symptoms, they should stop taking the medicine and contact their doctor or go to the emergency department of the nearest hospital immediately.
   2. Other possible side effects of Torvacard:
6. How to store Torvacard
7. Contents of the packaging and other information
   1. What Torvacard contains
   2. What Torvacard 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 under the following names:
   5. For further information on this medicine, the representative of the marketing authorization holder in Poland should be contacted:

Leaflet accompanying the packaging: patient information

TORVACARD 10,10 mg, film-coated tablets
TORVACARD 20,20 mg, film-coated tablets
TORVACARD 40,40 mg, film-coated tablets
Atorvastatin

Read the leaflet carefully before taking the medicine, as it contains

important information for the patient.

• This leaflet should be kept, so that it can be read again if necessary.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed specifically for this person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Torvacard and what is it used for

Torvacard belongs to a group of medicines called statins, which regulate lipid metabolism in the body.
Torvacard 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. Torvacard may also be used to reduce the risk of heart disease, even if cholesterol levels are normal. During treatment, a standard low-cholesterol diet should be continued.

2. Important information before taking Torvacard

When not to take Torvacard:

• if the patient is allergic to atorvastatin or any other ingredient 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
• in women of childbearing age who do not use effective methods of contraception
• in pregnant or breastfeeding women
• in women who are breastfeeding.

Warnings and precautions

Before starting treatment with Torvacard, the doctor or pharmacist should be consulted:

• in case of severe respiratory failure
• if the patient is taking or has taken within the last 7 days a medicine called fusidic acid (an antibiotic) orally or by injection. The combination of fusidic acid and Torvacard may lead to serious muscle problems (rhabdomyolysis)
• in case of a stroke with bleeding into the brain, 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 recurring or unexplained muscle pain or muscle problems in the past or similar problems in relatives
• in case of muscle problems during previous treatment with 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 may sometimes exacerbate the 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 liver disease
• in patients over 70 years of age.

In patients who are affected by any of the above situations, the doctor will order a blood test before starting treatment with Torvacard 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 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 and other medicines

The doctor or pharmacist should be informed about all medicines that the patient is currently taking or has recently taken, as well as any medicines that the patient plans to take.
Some medicines may change the effect of Torvacard, or the effect of these medicines on the body may be changed by Torvacard. This type of interaction may lead to reduced efficacy of one or both medicines. At the same time, it may increase the risk of serious side effects, including severe muscle damage known as rhabdomyolysis, described in section 4:

• medicines that affect 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 medicines that regulate lipid levels, such as gemfibrozil, other fibrates, cholestyramine.
• certain calcium channel blockers used in 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, and combination therapy with tipranavir/ritonavir, etc.
• certain medicines used to treat hepatitis C, such as telaprevir, boceprevir, and a combination product containing elbasvir with grazoprevir, ledipasvir with sofosbuvir.
• other medicines known to interact with Torvacard, 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 for 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 this medicine. The doctor will inform the patient when they can restart taking Torvacard. The simultaneous use of Torvacard 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 bacteremia).

Torvacard with food, drink, and alcohol

Information on the use of Torvacard 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 may change the effect of Torvacard.
Alcohol
During treatment with Torvacard, excessive alcohol consumption should be avoided.
Detailed information on this can be found in section 2 "Warnings and precautions”.

Pregnancy, breastfeeding, and fertility

Taking Torvacard during pregnancy or breastfeeding is contraindicated.
Taking Torvacard by women of childbearing age is contraindicated if they do not use effective methods of contraception.
Taking Torvacard during breastfeeding is contraindicated.
The safety of taking Torvacard during pregnancy and breastfeeding has not been established.
Before taking any medicine, the doctor or pharmacist should be consulted.

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. No tools or machines should be used if the medicine affects the ability to use them.

Torvacard contains lactose monohydrate and sodium

This medicine contains lactose monohydrate. If the doctor has determined that the patient has intolerance to some sugars, they should contact their doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet, which means that the medicine is considered "sodium-free”.

3. How to take Torvacard

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

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

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

Taking a higher dose of Torvacard than recommended

In case of accidental ingestion of too many Torvacard tablets (more than the usual daily dose), the patient should contact their doctor or the nearest hospital for advice.

Missing a dose of Torvacard

If a dose is missed, the patient should simply take the next dose at the scheduled time. A double dose should not be taken to make up for a missed dose.

Stopping treatment with Torvacard

In case of doubts about treatment or if the patient wants to stop treatment, they should consult their doctor or pharmacist.

4. Possible side effects

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

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

Rare (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 skin peeling and swelling, blisters, skin ulcers, and fever. Skin rash with pink or red spots, especially on the hands or feet, with possible blisters.
• Muscle weakness, tenderness, pain, or rupture, or brownish discoloration of the urine. If accompanied by a feeling of illness or high fever, it may be caused by muscle breakdown (rhabdomyolysis). Muscle breakdown may not always resolve, even if the patient stops taking atorvastatin, and can lead to kidney problems and be life-threatening.

Very rare (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, they should consult their doctor as soon as possible. This may indicate liver problems.

Other possible side effects of Torvacard:

Common (affect up to 1 in 10 people):

• nasal congestion, sore throat, nosebleeds
• allergic reactions
• increased blood glucose levels (in diabetic patients, blood glucose levels should continue to be closely monitored), increased creatine kinase levels in the blood
• headaches
• nausea, constipation, bloating, indigestion, diarrhea
• joint pain, joint swelling, muscle pain, muscle spasms, pain in the hands and feet, back pain
• blood test results indicating abnormal liver function

Uncommon (affect up to 1 in 100 people):

• loss of appetite, weight gain, decreased blood glucose levels (in diabetic patients, blood glucose levels should continue to be closely monitored)
• 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 or head
• vomiting, belching, abdominal pain, pancreatitis (causing abdominal pain)
• hepatitis
• skin rash, itching, hives, hair loss
• neck pain, muscle fatigue
• fatigue, malaise, weakness, chest pain, swelling, especially of the ankles, elevated temperature
• presence of white blood cells in the urine

Rare (affect up to 1 in 1000 people):

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

Very rare (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, mouth, tongue, or throat, difficulty breathing, collapse
• hearing loss
• gynecomastia (excessive growth of breast tissue in men)

Frequency not known (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)

The doctor should be consulted 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.

Reporting side effects
If side effects occur, including those not listed in this leaflet, the doctor, pharmacist, or nurse should be informed. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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
Side effects can also be reported to the marketing authorization holder or its representative in Poland.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Torvacard

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. The expiry date refers to the last day of the month.
There are no special storage precautions.
Do not use this medicine if signs of deterioration are visible.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked 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 contains

The active substance of Torvacard is atorvastatin.
Each film-coated tablet contains 10 mg, 20 mg, or 40 mg of atorvastatin in the form of atorvastatin calcium.
The other ingredients are: microcrystalline cellulose, heavy magnesium oxide, lactose monohydrate, sodium croscarmellose, low-substituted hydroxypropylcellulose, anhydrous colloidal silica, magnesium stearate
Coating: hypromellose, macrogol 6000, titanium dioxide (E171), talc.

What Torvacard looks like and contents of the pack

Torvacard 10, 10 mg, film-coated tablets: white or almost white, oval, biconvex film-coated tablets, approximately 9.0 x 4.5 mm in size;
Torvacard 20, 20 mg, film-coated tablets: white or almost white, oval, biconvex film-coated tablets, approximately 12.0 x 6.0 mm in size;
Torvacard 40, 40 mg, film-coated tablets: white or almost white, oval, biconvex film-coated tablets, approximately 13.9 x 6.9 mm in size.
Pack size: 30 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
Saneca Pharmaceuticals a.s., Nitrianska 100, 920 27 Hlohovec, Slovak Republic

This medicine is authorized in the Member States of the European Economic Area under the following names:

Czech Republic: Torvacard
Hungary: Torvacard 40 mg filmtabletta
Poland: Torvacard 10/20/40

For further information on this medicine, the representative of the marketing authorization holder in Poland should be contacted:

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:November 2024