TORVACARD 80 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. TORVACARD, 80 mg, film-coated tablets
   1. Read all of this leaflet carefully before taking this medicine because it contains important information for you.
   2. Contents of the pack and other information
3. What Torvacard is and what it is used for
4. What you need to know before you take 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, breast-feeding, and fertility
   6. Driving and using machines
   7. Torvacard contains lactose monohydrate and sodium
5. How to take Torvacard
   1. The duration of treatment with Torvacard is determined by your doctor.
   2. If you take more Torvacard than you should
   3. Forget to take Torvacard
   4. Stopping Torvacard treatment
6. Possible side effects
   1. If you experience any of the following serious side effects or symptoms, stop taking Torvacard and contact your doctor immediately or go to the emergency department at your nearest hospital.
   2. Other possible side effects of Torvacard:
   3. Reporting side effects
7. How to store Torvacard
8. Contents of the pack 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 more information about this medicine, please contact the representative of the marketing authorization holder in Poland:

Package Leaflet: Information for the Patient

TORVACARD, 80 mg, film-coated tablets

Atorvastatin

Read all of 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, 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

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

1. What Torvacard is and what it is used for

Torvacard belongs to a group of medicines known as statins, which regulate lipid metabolism in the body.
Torvacard is used to reduce the levels of lipids known as cholesterol and triglycerides in the blood when a low-fat diet and changes in lifestyle are not effective. Torvacard can also be used to reduce the risk of heart disease, even if the cholesterol level is normal. During treatment, a standard low-cholesterol diet should be continued.

2. What you need to know before you take Torvacard

When not to take Torvacard

• 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 had unexplained abnormal liver function tests,
• if you are taking glecaprevir/pibrentasvir for the treatment of hepatitis C virus infection,
• in women of childbearing age who are not using effective methods of contraception,
• in pregnant or breast-feeding women,
• in women who are breast-feeding.

Warnings and precautions

Before taking Torvacard, you should discuss this with your doctor or pharmacist:

• in case of severe respiratory failure,
• if you are taking or have taken in the last 7 days a medicine called fusidic acid (a medicine for bacterial infections) orally or by injection. The combination of fusidic acid and Torvacard can lead to serious muscle problems (rhabdomyolysis),
• in case of a stroke with bleeding in 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 disorders in the past or similar disorders in relatives,
• in case of muscle disorders during previous treatment with other lipid-lowering medicines (e.g. other statins or fibrates),
• if you have or 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 the development of myasthenia (see section 4),
• in case of regular consumption of large amounts of alcohol,
• in case of a history of liver disease,
• in patients over 70 years of age.

In patients who are affected by any of the above situations, the doctor will prescribe 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.
People with diabetes or those at risk of developing diabetes will be under close medical supervision while taking this medicine. People with high blood sugar and lipid levels, being overweight, and having high blood pressure may be at risk of developing diabetes.

Torvacard 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 may change the effect of Torvacard or the effect of these medicines on the body may be changed by Torvacard. 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:

• 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 pectoris or hypertension, 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 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 for 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 again.

Taking Torvacard 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 with food, drink, and alcohol

Information on the use of Torvacard can be found in section 3. However, please 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 may change the effect of Torvacard.
Alcohol
Avoid excessive alcohol consumption while taking this medicine.
Detailed information on this can be found in section 2 "Warnings and precautions".

Pregnancy, breast-feeding, and fertility

Taking Torvacard during pregnancy or breast-feeding is contraindicated.
Taking Torvacard in women of childbearing age is contraindicated if they do not use effective methods of contraception.
Taking Torvacard during breast-feeding is contraindicated.
The safety of Torvacard during pregnancy and breast-feeding 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 or use machines if the medicine affects your ability to do so.

Torvacard contains lactose monohydrate and sodium

This medicine contains lactose monohydrate. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, i.e. the medicine is essentially "sodium-free".

3. How to take Torvacard

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.
The usual dose of Torvacard for adults and children aged 10 years or older is 10 mg once daily. This dose may be increased if necessary by your doctor up to a dose suitable for you. Your doctor will adjust the dose of Torvacard at intervals of 4 weeks or more. The maximum dose of Torvacard is 80 mg once daily.
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 is determined by your doctor.

If you feel that the effect of Torvacard is too strong or too weak, talk to your doctor.

If you take more Torvacard than you should

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

Forget to take Torvacard

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

Stopping Torvacard treatment

If you have any doubts about taking this medicine or want to stop treatment, consult your doctor or pharmacist.

4. Possible side effects

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

If you experience any of the following serious side effects or symptoms, stop taking Torvacard and contact your doctor immediately or go to the emergency department at your nearest hospital.

Rare (affect up to 1 in 1,000 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 on the skin, mouth, eyes, genitals, and fever. Skin rash with pink-red spots, especially on the palms or soles, with possible blisters. Weakness, tenderness, pain, muscle rupture, or reddish-brown urine. If accompanied by malaise or high fever, it may be caused by muscle breakdown (rhabdomyolysis). Muscle breakdown does 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 you experience unexpected or unusual bleeding or bruising, this may indicate liver problems. You should consult your doctor as soon as possible.

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 cramps, 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, reduced 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)
• liver inflammation
• skin rash and 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 urine tests

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

• vision disorders
• unexpected bleeding or bruising (bruises)
• jaundice (yellowing of the skin and whites of the eyes)
• tendon rupture
• skin rash that may occur on the skin or mouth ulcers (drug-induced lichenoid reaction)
• purple skin discolorations (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 breast tissue growth 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)

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 risk of developing diabetes is higher in people with high blood sugar and lipid levels, being overweight, and having high blood pressure. Your doctor will monitor your condition while taking this medicine.

Reporting side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet.
Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych (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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Torvacard

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the outer packaging after "EXP". The expiry date refers to the last day of that month.
Store in the original package to protect the product from oxygen.
Do not use this medicine if you notice visible signs of deterioration.
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 contains

• The active substance is atorvastatin. Each film-coated tablet contains 80 mg of atorvastatin in the form of atorvastatin calcium.
• The other ingredients are: Core:meglumine, microcrystalline cellulose (E 460), lactose monohydrate, sodium croscarmellose, low-substituted hydroxypropylcellulose, anhydrous colloidal silica, magnesium stearate. Coating:hypromellose (E 464), macrogol 6000, titanium dioxide (E171), talc, yellow iron oxide (E172).

What Torvacard looks like and contents of the pack

Torvacard, 80 mg, are yellow-orange, oval, biconvex film-coated tablets.
Pack sizes: 14, 30, 90, or 100 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, Poland: Torvacard

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:November 2024