Torvacard neo

Patient Information Leaflet

Torvacard neo, 10 mg, film-coated tablets
Torvacard neo, 20 mg, film-coated tablets
Torvacard neo, 40 mg, film-coated tablets
Torvacard neo, 80 mg, film-coated tablets
atorvastatinum
Please read 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 you personally. Do not give it 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

1. What Torvacard neo is and what it is 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 Torvacard neo is and what it is used for

Torvacard neo belongs to a group of medicines called statins, which regulate lipid (fat) metabolism in the body.
Torvacard neo is used to lower blood levels of lipids known as cholesterol and triglycerides, when diet alone and lifestyle changes are not effective. In people at increased risk of heart disease, Torvacard neo may be used to reduce this risk, even when cholesterol levels are within the normal range. During treatment, you should continue to follow a standard cholesterol-lowering diet.

2. Important information before using Torvacard neo

When not to use Torvacard neo

• if the patient is allergic to atorvastatin or any of the other components of this medicine (listed in section 6),
• if the patient currently has or has previously had liver disease,
• if the patient has unexplained abnormal results of liver function tests,
• if the patient is currently taking glecaprevir with pibrentasvir for the treatment of hepatitis C virus infection,
• if the patient is of childbearing age and is not using an effective method of contraception,
• if the patient is pregnant or planning to become pregnant,
• if the patient is breastfeeding.

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

• in case of severe respiratory failure,
• if the patient is taking or has taken within the last 7 days the medicine fusidic acid (used to treat bacterial infections) by mouth or by injection. The combination of fusidic acid and Torvacard neo may lead to serious muscle problems (rhabdomyolysis),
• if the patient has previously had a haemorrhagic stroke, or if there is a small amount of fluid in the brain from a previous stroke,
• if the patient has kidney problems,
• if the patient has hypothyroidism,
• if the patient has had recurrent or unexplained muscle pain or muscle problems, or if such problems have occurred in family members,
• if the patient has previously had muscle problems while taking other lipid-lowering medicines (e.g. other statins or fibrates),
• if the patient currently has or has previously 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 or lead to the development of myasthenia (see section 4),
• if the patient regularly consumes large amounts of alcohol,
• if the patient has previously had liver disease,
• if the patient is 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 neo and, where 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 neo and other medicines").
Inform your doctor or pharmacist if muscle weakness persists. Additional tests and treatment with other medicines may be necessary to diagnose and manage this condition.
While taking this medicine, your doctor will closely monitor you if you have diabetes or are at risk of developing diabetes. If the patient has high levels of sugar and fat in the blood, is overweight, or has high blood pressure, there may also be an increased risk of developing diabetes.

Torvacard neo and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

Some medicines may alter the effect of Torvacard neo, or the effect of these medicines may be altered by Torvacard neo. 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, cholestyramine,
• 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 in the treatment of HIV infection, e.g.: ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir in combination with ritonavir, etc.,
• certain medicines used to treat hepatitis C virus infection, e.g.: telaprevir, boceprevir, and fixed-dose combinations containing elbasvir with grazoprevir, ledipasvir with sofosbuvir,
• other medicines known to interact with Torvacard neo, 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 oral fusidic acid to treat a bacterial infection, treatment with this medicine must be stopped. The doctor will inform the patient when they can restart taking Torvacard neo. Concomitant use of Torvacard neo 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 soft tissue infections and bloodstream infections caused by bacteria).

Torvacard neo, food, drink and alcohol
Information on the use of Torvacard neo can be found 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 neo.

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

Pregnancy, breastfeeding and fertility
The use of Torvacard neo in women who are pregnant or planning to become pregnant is contraindicated.
The use of Torvacard neo in women of childbearing potential is contraindicated if they are not using effective contraception.
The use of Torvacard neo during breastfeeding is contraindicated.
The safety of atorvastatin use 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, the patient should not drive if this medicine affects their ability to do so. Do not use tools or machinery if taking this medicine affects your ability to operate them.

Torvacard neo contains lactose monohydrate.
If the patient has been previously diagnosed with an intolerance to certain sugars, the patient should consult their doctor before taking this medicine.

3. How to use Torvacard neo

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 a low-cholesterol diet. This diet should be
continued during treatment with Torvacard neo.
The usual dose of Torvacard neo in adults and children aged 10 years or older is 10 mg once daily. If necessary, the physician may increase this dose up to the dose appropriate for the patient. The physician adjusts the dose at intervals of 4 weeks or longer. The maximum dose of Torvacard neo is 80 mg once daily.
Torvacard neo tablets should be swallowed whole with water; they may be taken at any time of day, with or without food. However, it is recommended to take the tablet at the same time each day.
The duration of treatment with Torvacard neo is determined by the physician.
If the effect of Torvacard neo seems too strong or too weak, consult the physician.
Taking more than the recommended dose of Torvacard neo
If an excessive number of Torvacard neo tablets is accidentally taken (more than the normal daily dose), contact the physician or nearest hospital for advice.
Missed dose of Torvacard neo
If a dose of the medicine is missed, take the next dose at the usual time.
Do not take a double dose to make up for a missed dose.
Stopping Torvacard neo treatment
If there are any further doubts regarding the use of this medicine, or if the patient wishes to discontinue treatment, consult the 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 their doctor or go to the emergency department of the nearest hospital.
Rare (may occur 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 skin peeling and swelling, skin blisters, sores in the mouth, eyes, genitals, and fever. Skin rash with pink-red spots, especially on the palms or soles of the feet, possibly with blisters.
• Weakness, tenderness, pain, rupture of muscles, or red-brown discoloration of urine. If accompanied by malaise or high fever, this may be due to abnormal breakdown of muscle cells (rhabdomyolysis) – a condition that may be life-threatening and lead to kidney problems. This condition may persist after discontinuation of atorvastatin.

Very rare (may occur 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 impaired liver function. Medical advice should be sought as soon as possible.

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

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

Uncommon (may occur in no more than 1 in 100 people):

• Anorexia (loss of appetite), weight gain, decreased blood glucose levels (patients with diabetes should continue to monitor their blood glucose levels carefully)
• 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 and (or) in the 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 around the ankles), elevated temperature
• Presence of white blood cells in urine

Rare (may occur 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 injury
• Rash, which may appear on the skin, or oral ulcers (lichenoid drug reaction)
• Purple skin lesions (symptoms of vasculitis)

Very rare (may occur 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 cavity, tongue or throat swelling, breathing difficulties, collapse
• Hearing loss
• Gynaecomastia (enlargement of breasts in men)

Frequency not known (frequency 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)

Patients should speak to their doctor if they experience weakness in arms or legs worsening 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 occurrence of diabetes is more likely if the patient has high levels of sugars and fats in the blood, overweight or high blood pressure. During treatment with this medicine, the doctor will monitor the patient's condition.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, patients should inform their doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department for Monitoring Adverse Reactions of Medicinal Products 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, Faks: + 48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Torvacard neo

Keep this medicine out of 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 specified month.
No special storage instructions apply.
Do not use this medicine if signs of deterioration are visible.
Medicines must not be disposed of via the sewage system or household waste bins. Ask your
pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Torvacard neo contains
The active substance is atorvastatin.
Torvacard neo, 10 mg: Each film-coated tablet contains 10 mg of atorvastatin (as atorvastatin calcium trihydrate).
Torvacard neo, 20 mg: Each film-coated tablet contains 20 mg of atorvastatin (as atorvastatin calcium trihydrate).
Torvacard neo, 40 mg: Each film-coated tablet contains 40 mg of atorvastatin (as atorvastatin calcium trihydrate).
Torvacard neo, 80 mg: Each film-coated tablet contains 80 mg of atorvastatin (as atorvastatin calcium trihydrate).

The other ingredients are:
Core: calcium carbonate, microcrystalline cellulose (E 460), lactose monohydrate, low-substituted hydroxypropylcellulose, povidone K12, colloidal anhydrous silica, magnesium stearate (E 572).
Coating: hypromellose (E 464), macrogol 6000, titanium dioxide (E 171), talc, iron oxide yellow (E 172), lactose monohydrate.

What Torvacard neo looks like and contents of the pack
Torvacard neo, 10 mg: White or almost white, round, biconvex film-coated tablets, approximately 6 mm in diameter.
Torvacard neo, 20 mg: Yellowish, round, biconvex film-coated tablets, approximately 8 mm in diameter.
Torvacard neo, 40 mg: Orange-yellow to yellow-orange, round, biconvex film-coated tablets, approximately 10 mm in diameter.
Torvacard neo, 80 mg: Yellow-orange, round, biconvex film-coated tablets, approximately 12 mm in diameter.

Pack sizes:
Torvacard neo 10 mg: 30, 60 or 90 film-coated tablets
Torvacard neo 20 mg: 30, 60 or 90 film-coated tablets
Torvacard neo 40 mg: 30, 60 or 90 film-coated tablets
Torvacard neo 80 mg: 30, 60 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
Uždaroji Akcinė Bendrovė „Oriola Vilnius”, Laisvės pr. 75, LT-06144, Vilnius, Lithuania

This medicinal product is authorised in the European Economic Area and in Great Britain (Northern Ireland) under the following names:

For more detailed information about the medicinal product, please contact the representative of the responsible entity in Poland:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
Tel: +48 22 375 92 00