Torvacard

Patient Information Leaflet

TORVACARD, 80 mg, film-coated tablets
Atorvastatinum
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are similar.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents:

1. What Torvacard is and what it is 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 pack and other information

1. What Torvacard is and what it is used for

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

2. Important information before using Torvacard

When not to use Torvacard

• if the patient is allergic to atorvastatin or any of the other ingredients of this medicine (listed in section 6),
• if the patient currently has or has previously 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 are not using effective methods of contraception,
• in pregnant women or women planning to become pregnant,
• in breastfeeding women.

Warnings and precautions
Before starting treatment with Torvacard, discuss the following with your doctor or pharmacist:

• in case of severe respiratory insufficiency,
• if the patient is taking or has taken within the last 7 days the medicine fusidic acid (used to treat bacterial infections) orally or by injection. The combination of fusidic acid and Torvacard may lead to serious muscle problems (rhabdomyolysis),
• in case of haemorrhagic stroke or if there is a small amount of fluid in the brain from a previous stroke,
• in case of kidney disorders,
• in case of hypothyroidism (underactive thyroid),
• if the patient has a history of recurrent or unexplained muscle pain or muscle disorders, or if such disorders occurred in family members,
• if the patient has previously experienced muscle disorders while being treated with other lipid-lowering medicines (e.g. other statins or fibrates),
• if the patient currently has or has previously had myasthenia (a disease causing generalised muscle weakness, including in some cases muscles involved in breathing) or ocular myasthenia (a disease causing weakness of eye muscles), because statins may sometimes worsen symptoms of the disease or lead to the development of myasthenia (see section 4),
• if the patient regularly consumes large amounts of alcohol,
• if the patient has a history of liver disease,
• in patients over 70 years of age.

In patients with any of the above conditions, the doctor will order a blood test before starting treatment with Torvacard and, whenever possible, during treatment to monitor the risk of muscle-related adverse effects. It is known that the risk of muscle-related adverse effects, such as rhabdomyolysis, is greater when certain medicines are used concomitantly (see section 2 "Torvacard with other medicines").
Inform your doctor or pharmacist if muscle weakness persists. Additional tests and additional medicines may be necessary to diagnose and treat this condition.
Patients with diabetes or those at risk of developing diabetes will be under close medical supervision while taking this medicine. Patients with high levels of blood sugar and lipids, overweight, and high blood pressure may be at risk of developing diabetes.

Torvacard with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.

Some medicines may alter the effect of Torvacard, or the effect of these medicines may be altered by Torvacard. This type of interaction may reduce the effectiveness of one or both medicines. It may also increase the risk of serious adverse effects, including severe muscle damage known as rhabdomyolysis, described in section 4:

• medicines that affect the immune system, e.g. cyclosporine,

• certain antibiotics and antifungal medicines, e.g. erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid,

• other lipid-regulating medicines, e.g. gemfibrozil, other fibrates, cholestyramine,

• certain calcium channel blockers used for angina or high blood pressure, e.g. amlodipine, diltiazem; and medicines regulating heart rhythm, e.g. digoxin, verapamil, amiodarone,

• letermovir, a medicine used to prevent cytomegalovirus disease,

• medicines used to treat HIV infection, e.g.: ritonavir, lopinavir, atazanavir, indinavir, darunavir, and the combination therapy tipranavir/ritonavir, etc.,

• certain medicines used to treat hepatitis C, e.g. telaprevir, boceprevir, and combination products containing elbasvir with grazoprevir, ledipasvir with sofosbuvir,

• other medicines known to interact with Torvacard, including ezetimibe (which reduces cholesterol levels), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant used in epilepsy treatment), cimetidine (used to treat heartburn and stomach ulcers), phenazone (a painkiller), colchicine (used to treat gout), and antacids (medicines used for indigestion containing aluminium or magnesium),

• over-the-counter medicines: St John's wort (Hypericum perforatum),

• if the patient is taking fusidic acid orally to treat a bacterial infection, treatment with this medicine should be discontinued. The doctor will inform the patient when they can restart taking Torvacard. Concomitant use of Torvacard with fusidic acid may 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 skin structure infections and bloodstream infections caused by bacteria).

Torvacard with food, drink and alcohol
Information on how to take Torvacard is provided in section 3. However, please pay attention to the following:

Grapefruit juice
Do not consume more than one or two small glasses of grapefruit juice per day, as larger quantities may alter the effect of Torvacard.

Alcohol
Avoid consuming excessive amounts of alcohol while taking this medicine.
Further information on this topic is provided in section 2 "Warnings and precautions".

Pregnancy, breastfeeding and fertility
The use of Torvacard in women who are pregnant or planning to become pregnant is contraindicated.
The use of Torvacard in women of childbearing age is contraindicated if they are not using effective methods of contraception.
The use of Torvacard during breastfeeding is contraindicated.
The safety of using Torvacard during pregnancy and breastfeeding has not been established.
Before taking any medicine, consult your doctor or pharmacist.

Driving and using machines
Torvacard usually does not affect the ability to drive or operate machinery. However, patients should not drive or operate machinery if this medicine affects their ability to do so.

Torvacard contains lactose monohydrate and sodium
This medicine contains lactose monohydrate. If your doctor has diagnosed you with an intolerance to certain sugars, consult your doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per coated tablet, meaning the medicine is considered "sodium-free".

3. How to take Torvacard

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you are unsure,
you should consult 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 in adults and children aged 10 years or older is 10 mg once daily. If necessary,
your doctor may increase this dose gradually up to the dose appropriate for you. Your doctor will adjust
the dose at intervals of 4 weeks or longer. The maximum dose of Torvacard is 80 mg once daily.
Torvacard tablets should be swallowed whole with water; they may be taken at any time of day, with or
without food. However, you should try to take the 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, you should consult your doctor.
Taking more Torvacard than prescribed
If you accidentally take too many Torvacard tablets (more than the usual daily dose), you should contact
your doctor or the nearest hospital for advice.
Missing a dose of Torvacard
If you miss a dose, simply take the next dose at the scheduled time. Do not take a double dose to make up
for a missed dose.
Stopping Torvacard
If you have any concerns about taking this medicine, or if you wish to stop treatment, you should consult
your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If the patient experiences any of the serious adverse reactions or symptoms listed below, they should
stop taking the medicine immediately and contact their doctor or go to the emergency department of the
nearest hospital.
Rare (affects no more than 1 in 1,000 people):

• Severe allergic reaction causing swelling of the face, tongue, and throat, which may lead to severe breathing difficulties.
• Serious illness characterized by peeling and swelling of the skin, skin blisters, and sores in the mouth, eyes, and genital area, accompanied by fever. Skin rash with pink-red spots, particularly on the palms or soles, possibly with blisters. Weakness, tenderness, muscle pain, muscle rupture, or reddish-brown discoloration of urine. If accompanied by malaise or high fever, this may be due to rhabdomyolysis (breakdown of striated muscle). Rhabdomyolysis may not resolve even after discontinuation of atorvastatin and can lead to kidney problems and may be life-threatening.

Very rare (affects no more than 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, this may indicate liver abnormalities. Medical advice should be sought as soon as possible.

Other possible adverse reactions of Torvacard:
Common (affects no more than 1 in 10 people):

• Nasopharyngitis, sore throat, nosebleeds
• Allergic reactions
• Increased blood glucose levels (in patients with diabetes, blood glucose levels should continue to be monitored carefully), increased blood creatine kinase levels
• Headaches
• Nausea, constipation, bloating, indigestion, diarrhoea
• Joint pain, joint swelling, muscle pain, muscle cramps, pain in arms and legs, back pain
• Blood test results indicating abnormal liver function

Uncommon (affects no more than 1 in 100 people):

• Anorexia (loss of appetite), weight gain, decreased blood glucose levels (in patients with diabetes, blood glucose levels should continue to be monitored carefully)
• Nightmares, insomnia
• Dizziness, numbness or tingling in fingers, hands, and feet, reduced sensitivity to pain and touch, altered taste, memory loss
• Blurred vision
• Ringing in the ears or head
• Vomiting, belching, pain in the upper and lower abdomen, pancreatitis (causing abdominal pain)
• Hepatitis
• Rash, skin rash and itching, urticaria, hair loss
• Neck pain, muscle fatigue
• Fatigue, malaise, weakness, chest pain, swelling, especially of the ankles, elevated body temperature
• Presence of white blood cells in urine analysis

Rare (affects no more than 1 in 1,000 people):

• Visual disturbances
• Unexplained bleeding or bruising (bruises)
• Cholestasis (yellowing of the skin and whites of the eyes)
• Tendon rupture
• Rash which may appear on the skin or oral ulcers (lichenoid drug reaction)
• Purple skin lesions (symptoms of vasculitis)

Very rare (affects no more than 1 in 10,000 people):

• Allergic reactions – symptoms may include sudden shortness of breath and chest pain or tightness, swelling of the eyelids, face, lips, mouth, tongue or throat, breathing difficulties, collapse
• Hearing loss
• Gynaecomastia (excessive growth of glandular breast tissue in men)

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

• Persistent muscle weakness
• Myasthenia (a disease causing general muscle weakness, including in some cases muscles involved in breathing)
• Ocular myasthenia (a disease causing weakness of the eye muscles)

Patients should speak to their doctor if they experience weakness in arms or legs that worsens after periods of activity, double vision or drooping eyelids, difficulty swallowing, or shortness of breath.
Other possible adverse reactions reported during treatment with some statins (medicines of the same type):

• Sexual dysfunction
• Depression
• Breathing problems, including persistent cough and/or shortness of breath or fever
• Diabetes. The likelihood of developing diabetes is higher in people with high blood sugar and fat levels, overweight, and high blood pressure. The doctor will monitor the patient's condition during treatment with this medicine.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorization holder or its representative in Poland.
Reporting adverse reactions helps provide more information on the safety of the 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 stated on the outer packaging following
"Expiry date". The expiry date refers to the last day of the stated month.
Store in the original packaging to protect the product from exposure to oxygen.
Do not use this medicine if you notice any visible signs of deterioration.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This practice helps protect the environment.

6. Contents of the package and other information

What Torvacard contains

• The active substance is atorvastatin. Each 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, colloidal anhydrous 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 coated tablets.
Pack sizes: 14, 30, 90 or 100 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder:
Zentiva k.s., U kabelovny 130, Dolní Měcholupy, 102 37 Prague 10, Czech Republic

Manufacturers:
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 medicinal product is authorised in the Member States of the European Economic Area under the following names:
Czech Republic, Poland: Torvacard

For any further information about this medicine, please contact the local representative of the Marketing Authorisation Holder in Poland:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
tel.: +48 22 375 92 00