Torvalipin

Package leaflet: Information for the user

Torvalipin, 10 mg, film-coated tablets
Torvalipin, 20 mg, film-coated tablets
Torvalipin, 40 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 further questions, please consult 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 adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

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

1. What Torvalipin is and what it is used for

Torvalipin belongs to a group of medicines called statins, which regulate lipid (fat) metabolism in the body.
Torvalipin 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. Torvalipin may also be used to reduce the risk of heart disease, even when cholesterol levels are normal. Standard cholesterol-lowering diet should be continued during treatment.

2. Important information before using Torvalipin

When not to use Torvalipin

• 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
• 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
• if the patient is concurrently taking glecaprevir with pibrentasvir for the treatment of hepatitis C virus infection.

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

• if the patient has severe respiratory failure
• if the patient is taking or has taken oral or injectable fusidic acid (a medicine used to treat bacterial infections) within the last 7 days. Concomitant use of fusidic acid with Torvalipin may lead to serious muscle problems (rhabdomyolysis).
• if the patient has had a stroke with bleeding into the brain or has small fluid-filled pockets following previous strokes
• if the patient has kidney problems
• if the patient has hypothyroidism
• if the patient has recurrent or unexplained muscle pain, or has had muscle problems in the past, or if such problems occur in family members
• if the patient experienced 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 characterized by 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 the condition or trigger the onset of myasthenia (see section 4)
• if the patient regularly consumes large amounts of alcohol
• if the patient has had liver disease in the past
• 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 Torvalipin and, as appropriate, during treatment to monitor the risk of muscle-related adverse effects. The risk of muscle-related adverse effects, such as rhabdomyolysis, increases when other medicines are taken concomitantly (see section 2 “Torvalipin with other medicines”). You should also inform your doctor or pharmacist if the patient experiences persistent muscle weakness. Additional tests and treatments may be needed for diagnosis and management.
Patients who have diabetes or are at risk of developing diabetes will be closely monitored while taking this medicine. The risk of developing diabetes is higher if the patient has high blood glucose and lipid (fat) levels, overweight, and high blood pressure.

Torvalipin with 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 Torvalipin or their own effect may be altered by Torvalipin. Such interactions may cause one or both medicines to be less effective. Alternatively, the risk or severity of adverse effects may increase, including the risk of a serious, although rare, muscle disease 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
• if fusidic acid is required for the treatment of bacterial infection, treatment with this medicine should be temporarily discontinued. Your doctor will advise when to resume treatment with Torvalipin. Taking Torvalipin with fusidic acid may rarely lead to muscle weakness, pain, or tenderness (rhabdomyolysis). For information on rhabdomyolysis, see section 4.
• other lipid-regulating medicines, e.g. gemfibrozil, other fibrates, colestyramine
• certain calcium channel blockers used for angina or hypertension, e.g. amlodipine, diltiazem, and also medicines regulating heart rhythm, e.g. digoxin, verapamil, amiodarone
• letermovir, a medicine used to prevent cytomegalovirus disease
• protease inhibitors used in the treatment of HIV infection, i.e. efavirenz, ritonavir, lopinavir, atazanavir, indinavir, darunavir, co-administration of tipranavir with ritonavir, etc.
• certain medicines used in the treatment of hepatitis C, e.g. telaprevir, boceprevir, and combination medicines containing elbasvir with grazoprevir, ledipasvir with sofosbuvir
• other medicines known to interact with Torvalipin, including ezetimibe (a cholesterol-lowering agent), warfarin (a medicine that reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant used in epilepsy treatment), cimetidine (used to treat heartburn and gastric 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).

Torvalipin with food, drink and alcohol
Information on how to take Torvalipin can be found in section 3. 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 Torvalipin.

Alcohol
Avoid consuming large amounts of alcohol while taking this medicine. For detailed information, see section 2 “Warnings and precautions*”.

Pregnancy and breastfeeding
Do not use Torvalipin during pregnancy or if the patient plans to become pregnant.
Do not use Torvalipin in women of childbearing age unless the patient is using effective methods of contraception.
Do not use Torvalipin during breastfeeding.
The safety of using Torvalipin during pregnancy or breastfeeding has not been established. Before taking any medicine, consult your doctor or pharmacist.

Driving and using machines
Torvalipin usually does not affect the ability to drive or operate machinery.
However, do not drive if this medicine affects your ability to drive. Do not use any tools or machines if this medicine affects your ability to use them.

Torvalipin contains sodium
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 Torvalipin

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, which should be maintained
throughout treatment with Torvalipin.
The usual recommended starting dose of Torvalipin in adults and children aged 10 years or older is 10 mg once daily.
If necessary, your doctor may increase this dose gradually to the appropriate level for you. Your doctor will adjust the dose
at intervals of 4 weeks or longer. The maximum dose of Torvalipin is 80 mg once daily.
Torvalipin tablets should be swallowed whole with water and 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 Torvalipin is determined by your doctor.
If you feel that the effect of Torvalipin is too strong or too weak, you should consult your doctor.
Taking more Torvalipin than prescribed
If you accidentally take too many Torvalipin tablets (more than the usual daily dose), contact your doctor or the nearest hospital
for advice immediately.
Missed dose of Torvalipin
If you miss a dose, simply take the next dose at your usual scheduled time. Do not take a double dose to make up for the missed dose.
Stopping Torvalipin
If you have any doubts about taking this medicine, 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 any of the following adverse reactions or symptoms occur, stop taking the tablets and
seek immediate medical attention by contacting your doctor or going to the
nearest hospital or emergency department.
Rare: may affect no more than 1 in 1,000 people

• Severe allergic reactions causing swelling of the face, tongue, and throat, which may lead to difficulty breathing.
• Serious skin disorders with severe peeling and swelling of the skin, skin blisters, sores in the mouth, eyes, genital area, and fever. Skin rash with pink-red patches, which may be blistering, especially on the palms and soles.
• Muscle weakness, tenderness, muscle pain, muscle rupture, or red-brown discoloration of urine, particularly if associated with malaise or high fever—this may be due to abnormal breakdown of skeletal muscle (rhabdomyolysis). Abnormal breakdown of skeletal muscle may persist even after discontinuation of atorvastatin and can be life-threatening and lead to kidney problems.

Very rare: may affect no more than 1 in 10,000 people

• Lupus-like syndrome (including skin rash, joint disorders, and effects on blood cells)
• If unexpected or unusual bleeding or bruising occurs, consider the possibility of liver dysfunction. In such cases, contact your doctor as soon as possible.

Other possible adverse reactions of Torvalipin
Common: may affect up to 1 in 10 people:

• Nasal mucosal inflammation, sore throat, nosebleeds
• Allergic reactions
• Increased blood glucose levels (if the patient has diabetes, blood glucose levels should be closely monitored), increased creatine kinase levels
• Headache
• Nausea, constipation, flatulence with gas release, indigestion, diarrhea
• Joint pain, muscle pain, and back pain
• Blood test results indicating abnormalities in liver function.

Uncommon: may affect up to 1 in 100 people

• Loss of appetite, weight gain, decreased blood glucose levels (if the patient has diabetes, blood glucose levels should be closely monitored)
• Nightmares, insomnia
• Dizziness, numbness or tingling in fingers of hands and feet, reduced sensitivity to pain or touch, changes in taste perception, memory loss
• Blurred vision
• Ringing in the ears and/or head
• Vomiting, belching, pain in the upper and lower abdomen, pancreatitis (causing abdominal pain)
• Hepatitis
• Rash, skin rash and itching, urticaria, alopecia
• 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 affect up to 1 in 1,000 people

• Vision disorders
• Unexpected bleeding or bruising
• Cholestasis (yellowing of the skin and whites of the eyes)
• Tendon damage.

Very rare: may affect up to 1 in 10,000 people

• Allergic reactions—symptoms may include sudden wheezing and pain or pressure in the chest, eyelid, facial, lip, oral, tongue, or throat swelling, difficulty breathing, collapse
• Hearing loss
• Gynaecomastia (enlargement of breasts in males)

Frequency not known: frequency cannot be estimated from available data

• Persistent muscle weakness
• Myasthenia gravis (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 your doctor if you experience weakness in the arms or legs that worsens with activity, double vision or drooping eyelids, difficulty swallowing, or breathlessness.
Possible adverse reactions observed with some statins (medicines in the same class):

• Sexual dysfunction
• Depression
• Breathing problems including persistent cough and/or shortness of breath or fever
• Diabetes: more likely if the patient has high blood glucose and lipid (fat) levels, overweight, and high blood pressure. Your doctor will monitor you while you are taking this medicine.

Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 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.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Torvalipin

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after: EXP.
The expiry date refers to the last day of the stated month.
Do not store above 25°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Torvalipin contains

• The active substance is atorvastatin. Each coated tablet contains 10 mg, 20 mg, or 40 mg of atorvastatin in the form of calcium salt.
• The other ingredients are: mannitol, microcrystalline cellulose, calcium carbonate, povidone (K-30), sodium croscarmellose, sodium lauryl sulfate, colloidal anhydrous silica, magnesium stearate, hypromellose, titanium dioxide (E 171), macrogol 6000.

What Torvalipin looks like and contents of the pack
Torvalipin, coated tablets, 10 mg: white, round, biconvex, 7 mm.
Torvalipin, coated tablets, 20 mg: white, round, biconvex, 9 mm.
Torvalipin, coated tablets, 40 mg: white, oval, biconvex, 8.2 x 17 mm.
Pack contents: 30, 56, 98, or 100 coated tablets in blister packs contained in a cardboard box.

Marketing Authorisation Holder
Actavis Group PTC ehf.
Dalshraun 1
220 Hafnarfjörður
Iceland

Manufacturer
Balkanpharma – Dupnitsa AD
3 Samokovsko Shosse Str.
Dupnitsa 2600
Bulgaria

For further information about this medicinal product and its names in the countries of the European Economic Area, please contact the local representative of the Marketing Authorisation Holder:
Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, tel. (22) 345 93 00.