Torvacard 10

Package leaflet: Information for the patient

TORVACARD 10, 10 mg, coated tablets
TORVACARD 20, 20 mg, coated tablets
TORVACARD 40, 40 mg, coated tablets
Atorvastatin
Please 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, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet:

1. What Torvacard is and what it is used for
2. What you need to know 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. During treatment, you should continue to follow a standard low-cholesterol diet.

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 oral or injectable fusidic acid (a medicine used to treat bacterial infections). The combination of fusidic acid and Torvacard may lead to serious muscle problems (rhabdomyolysis)
• in case of hemorrhagic stroke, 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 recurrent or unexplained muscle pain or muscle problems in the past, or similar problems in family members
• in case of muscle problems during previous treatment with other lipid-lowering medicines (e.g. other statins or fibrates)
• if the patient currently has or has had myasthenia (a disease causing general 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)
• in case of regular consumption of large amounts of alcohol
• in case of liver disease
• in patients over 70 years of age.

In patients affected by any of the above conditions, the doctor will order a blood test before starting treatment with Torvacard and, whenever possible, during treatment, in order to monitor the risk of muscle-related adverse effects. It is known that the risk of muscle-related adverse effects, such as rhabdomyolysis, is higher when certain medicines are taken concomitantly (see section 2 "Torvacard with other medicines").
Inform your doctor or pharmacist if muscle weakness persists. Additional tests and medications may be necessary to diagnose and treat this condition.
Your doctor will closely monitor you during treatment with this medicine if you have diabetes or are at risk of developing diabetes. If you have high levels of blood sugar and fats, overweight, or high blood pressure, you may also 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 on the body 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:

• immunosuppressive medicines, 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, colestyramine
• certain calcium channel blockers used for angina or hypertension, e.g. amlodipine, diltiazem; and medicines regulating heart rhythm, e.g. digoxin, verapamil, amiodarone
• letermovir, a medicine used to prevent cytomegalovirus infection
• medicines used to treat HIV infection, e.g.: ritonavir, lopinavir, atazanavir, indinavir, darunavir, and the combination therapy of tipranavir/ritonavir, etc.
• certain medicines used to treat hepatitis C, e.g. telaprevir, boceprevir, and fixed-dose combinations containing elbasvir with grazoprevir, ledipasvir with sofosbuvir
• other medicines known to interact with Torvacard, including ezetimibe (which lowers 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 stopped. Your doctor will inform you when you can restart taking Torvacard. Concomitant use of Torvacard with fusidic acid may rarely lead to muscle weakness, tenderness or muscle pain (rhabdomyolysis). More information on rhabdomyolysis can be found in section 4.
• daptomycin (a medicine used to treat complicated skin and skin tissue infections and bloodstream infections caused by bacteria)

Torvacard, 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 drink more than one or two small glasses of grapefruit juice per day, as larger quantities may alter the effect of Torvacard.

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

Pregnancy, breastfeeding and fertility
Use of Torvacard in women who are pregnant or planning to become pregnant is contraindicated.
Use of Torvacard in women of childbearing potential is contraindicated if they are not using effective methods of contraception.
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 operating machinery
Normally, this medicine does not affect the ability to drive or operate machinery. However, patients should not drive if this medicine affects their ability to do so. Do not use any tools or machines if taking this medicine impairs your ability to operate them.

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 use Torvacard

This medicine should always be taken as directed by the physician or pharmacist. If in doubt,
consult the physician or pharmacist.
Before starting treatment, the physician will recommend adopting 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. If necessary,
the physician may increase the dose up to the dose appropriate for the individual patient.
The physician adjusts 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, it is advisable to take the tablet at the same time each day.
The duration of treatment with Torvacard is determined by the physician.
If you feel that the effect of Torvacard is too strong or too weak, consult your physician.
Taking more than the recommended dose of Torvacard
If an excessive number of Torvacard tablets is taken accidentally (more than the usual daily dose),
contact the physician or nearest hospital for advice.
Missing a dose of Torvacard
If a dose is missed, simply take the next dose at the scheduled time. Do not take a double dose to make up for a missed dose.
Stopping Torvacard treatment
If you have any doubts about using this medicine, or if you wish to discontinue treatment, consult your physician 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 a doctor or go to the emergency department of the
nearest hospital without delay.

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

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

Very rare (occurs in 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 problems. Medical advice should be sought as soon as possible.

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

• Nasal congestion, sore throat, nosebleeds
• Allergic reactions
• Increased blood glucose levels (in patients with diabetes, blood glucose levels should continue to be closely monitored), increased blood creatine kinase levels
• Headache
• 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 (occurs in 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 closely monitored)
• Nightmares, insomnia
• Dizziness, numbness or tingling in fingers and toes, 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 in the ankles, elevated temperature
• Presence of white blood cells in urine analysis

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

• Vision disorders
• Unexpected bleeding or bruising (bruises)
• Cholestasis (yellowing of the skin and whites of the eyes)
• Tendon rupture
• Rash which may appear on the skin or ulceration in the mouth (lichenoid drug reaction)
• Purple skin lesions (symptoms of vasculitis)

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

• Allergic reactions – symptoms may include sudden shortness of breath and chest pain or tightness, eyelid, facial, lip, oral, tongue or throat swelling, breathing difficulties, collapse
• Hearing loss
• Gynaecomastia (excessive development of glandular breast tissue in males)

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 eye muscles)

Talk to a doctor if the patient experiences weakness in arms or legs worsening with 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 occurrence of diabetes is more likely if the patient has high levels of blood sugar and fats, overweight or high blood pressure. The doctor will monitor the patient during treatment with this medicine.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a 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 the medicine out of the 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 stated month.
There are no special storage instructions.
Do not use this medicine if there are any 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 in this medicine is atorvastatin.
Each coated tablet contains 10 mg, 20 mg, or 40 mg of atorvastatin as atorvastatin calcium.
The other ingredients are: microcrystalline cellulose, heavy magnesium oxide, lactose monohydrate,
sodium croscarmellose, low-substituted hydroxypropylcellulose, colloidal anhydrous 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 sizes: 30 or 90 film-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
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 medicinal product is authorised in the European Economic Area countries under the following names:
Czech Republic: Torvacard
Hungary: Torvacard 40 mg filmtabletta
Poland: Torvacard 10/20/40

For more detailed information about this medicine, please contact the 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