Torvalipin

Leaflet accompanying the packaging: information for the user

Torvalipin, 10 mg, coated tablets

Torvalipin, 20 mg, coated tablets

Torvalipin, 40 mg, coated tablets

Atorvastatin

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Torvalipin and what is it 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 packaging and other information

1. What is Torvalipin and what is it used for

Torvalipin belongs to a group of medicines called statins, which regulate lipid (fat) metabolism in the body.
Torvalipin is used to reduce the levels of lipids known as cholesterol and triglycerides in the blood, when a low-fat diet and lifestyle changes are not effective. Torvalipin may 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. Important information before taking Torvalipin

When not to take Torvalipin

• if the patient is allergic to atorvastatin or any of the other ingredients of this medicine (listed in section 6)
• if the patient has or has 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 or breastfeeding women
• if the patient is taking glecaprevir with pibrentasvir for the treatment of hepatitis C virus infection.

Warnings and precautions

Before starting treatment with Torvalipin, the patient should discuss the following with their doctor or pharmacist:

• if the patient has severe respiratory failure
• if the patient is taking or has taken fusidic acid (an antibiotic) orally or by injection in the last 7 days. Taking fusidic acid with Torvalipin can lead to serious muscle problems (rhabdomyolysis).
• if the patient has had a stroke with bleeding in the brain or has small fluid-filled pockets after previous strokes
• if the patient has kidney problems
• if the patient has hypothyroidism
• if the patient has recurring or unexplained muscle pain or has had muscle problems in the past, or if similar problems occur in relatives
• if the patient has had muscle problems while taking other lipid-lowering medicines (e.g., other statins or fibrates) in the past
• if the patient has or has had myasthenia (a disease characterized by general muscle weakness, including, in some cases, muscles involved in breathing) or myasthenia of the eye (a disease that causes eye muscle weakness), as statins can sometimes exacerbate the condition or lead to 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 who experience any of the above situations, the doctor will prescribe a blood test before starting treatment with Torvalipin and, if possible, during treatment to monitor the risk of muscle-related side effects. The risk of muscle-related side effects, such as rhabdomyolysis, increases when taking other medicines at the same time (see section 2 "Torvalipin and other medicines").
The patient should also inform their doctor or pharmacist if they experience persistent muscle weakness. Additional tests and medicines may be needed to diagnose and treat.
During treatment, patients with diabetes or at risk of developing diabetes will be closely monitored. The risk of developing diabetes is more likely if the patient has high blood glucose and lipid levels, is overweight, and has high blood pressure.

Torvalipin and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Some medicines may change the effect of Torvalipin or their effect may be changed by Torvalipin. Such interactions may make one or both of the medicines less effective. Another possibility is an increased risk or exacerbation of side effects, including the rare but serious muscle disease known as rhabdomyolysis (described in section 4):

• immunosuppressants, such as cyclosporine
• certain antibiotics and antifungals, such as erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin
• if it is necessary to take fusidic acid for the treatment of a bacterial infection, the patient should temporarily stop taking Torvalipin. The doctor will advise when to resume treatment with Torvalipin. Taking Torvalipin with fusidic acid can rarely lead to muscle weakness, pain, or tenderness (rhabdomyolysis). For information on rhabdomyolysis, see section 4.
• other lipid-lowering medicines, such as gemfibrozil, other fibrates, colestyramine
• certain calcium channel blockers used for angina or high blood pressure, 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
• protease inhibitors used to treat HIV infection, such as efavirenz, ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir with 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 Torvalipin, including ezetimibe (which lowers cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an antiepileptic medicine), cimetidine (used to treat heartburn and stomach ulcers), fenazon (a pain reliever), colchicine (used to treat gout), and antacids (medicines used to treat heartburn, containing aluminum or magnesium)
• over-the-counter medicines: St. John's wort.

Torvalipin with food, drink, and alcohol

Information on taking Torvalipin can be found in section 3. The patient should pay attention to the following:

Grapefruit juice
The patient should 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 Torvalipin.
Alcohol
The patient should avoid drinking large amounts of alcohol while taking this medicine. For more information, see section 2 "Warnings and precautions".

Pregnancy and breastfeeding

Torvalipin should not be taken during pregnancy or if the patient is planning to become pregnant.
Torvalipin should not be taken in women of childbearing age, unless the patient is using effective methods of contraception.
Torvalipin should not be taken during breastfeeding.
The safety of Torvalipin during pregnancy or breastfeeding has not been established. Before taking any medicine, the patient should consult their doctor or pharmacist.

Driving and using machines

Normally, Torvalipin does not affect the ability to drive or use machines.
However, the patient should not drive if the medicine affects their ability to drive. The patient should not use any tools or machines if the medicine affects their ability to use them.

Torvalipin contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per coated tablet, which means the medicine is considered "sodium-free".

3. How to take Torvalipin

This medicine should always be taken as directed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist.
Before starting treatment, the doctor will recommend a low-cholesterol diet, which should be continued during treatment with Torvalipin.
The recommended initial dose of Torvalipin for adults and children over 10 years of age is 10 mg once daily. This dose may be increased by the doctor if necessary, up to a dose suitable for the patient. The doctor will adjust the dose of Torvalipin at intervals of 4 weeks or more. The maximum dose of Torvalipin is 80 mg once daily.
Torvalipin tablets should be swallowed whole, with a glass of water, and can be taken at any time of day, with or without food. However, the patient should try to take the tablet at the same time every day.

The duration of treatment with Torvalipin is determined by the doctor.

If the patient feels that the effect of Torvalipin is too strong or too weak, they should consult their doctor.

Taking a higher dose of Torvalipin than recommended

If the patient has accidentally taken more Torvalipin tablets than the usual daily dose, they should contact their doctor or the nearest hospital for advice.

Missing a dose of Torvalipin

If the patient misses a dose, they should simply take the next dose at the scheduled time. The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Torvalipin

If the patient has any doubts about taking the medicine, they should consult their doctor or pharmacist.

4. Possible side effects

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

If any of the following side effects occur, the patient should stop taking the tablets and contact their doctor or go to the nearest hospital or emergency department immediately.

Rare:may affect up to 1 in 1000 people

• Severe allergic reactions, which can cause swelling of the face, tongue, and throat, and may lead to difficulty breathing.
• Severe skin and mucous membrane disorders, including severe skin peeling, blistering of the skin, mouth, eyes, genitals, and fever. Skin rash with reddish-purple spots, which can be blistering, especially on the palms and soles.
• Muscle weakness, tenderness, pain, or rupture, or brownish discoloration of the urine, especially if accompanied by malaise or high fever, may be caused by abnormal breakdown of striated muscle (rhabdomyolysis). Abnormal breakdown of striated muscle can persist even after stopping atorvastatin and can be life-threatening and cause kidney problems.

Very rare:may affect up to 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, they should consider the possibility of liver function disorders. In such cases, the patient should contact their doctor as soon as possible.

Other possible side effects of Torvalipin

Common:may affect up to 1 in 10 people:

• nasal congestion, sore throat, nosebleeds
• allergic reactions
• increased blood glucose levels (if the patient has diabetes, they should carefully monitor their blood glucose levels), increased creatine kinase levels
• headache
• nausea, constipation, bloating with gas, indigestion, diarrhea
• joint pain, muscle pain, and back pain
• blood test results indicating liver function disorders.

Uncommon:may affect up to 1 in 100 people

• loss of appetite (anorexia), weight gain, decreased blood glucose levels (if the patient has diabetes, they should carefully monitor their blood glucose levels)
• nightmares, insomnia
• dizziness, numbness or tingling in the fingers of the hands and feet, decreased sensitivity to pain or touch, changes in taste, memory loss
• blurred vision
• ringing in the ears and/or head
• vomiting, belching, upper and lower abdominal pain, pancreatitis (causing abdominal pain)
• hepatitis
• skin rash, skin rash and itching, hives, hair loss
• neck pain, muscle fatigue
• fatigue, malaise, weakness, chest pain, swelling, especially around the ankles, elevated temperature
• presence of white blood cells in the urine.

Rare:may affect up to 1 in 1000 people

• vision disorders
• unexpected bleeding or bruising
• jaundice (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, chest pain or tightness, swelling of the eyelids, face, lips, mouth, tongue, or throat, difficulty breathing, collapse
• hearing loss
• gynecomastia (breast enlargement in men).

Frequency not known:frequency cannot be estimated from the available data

• persistent muscle weakness
• myasthenia gravis (a disease that causes general muscle weakness, including, in some cases, muscles involved in breathing)
• myasthenia of the eye (a disease that causes eye muscle weakness)

The patient should talk to their doctor if they experience weakness in their arms or legs, which worsens after periods of activity, double vision, or drooping eyelids, difficulty swallowing, or shortness of breath.
Possible side effects observed after administration of some statins (medicines from the same group):

• sexual disorders
• depression
• breathing problems, including prolonged coughing and/or shortness of breath or fever
• diabetes: this is more likely if the patient has high blood glucose and lipid levels, is overweight, and has high blood pressure. The doctor will monitor the patient during treatment with this medicine.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor. Side effects can be reported directly to the Department of Drug Safety Monitoring of the 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Torvalipin

The medicine should be stored 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 month stated.
Do not store above 25°C.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Torvalipin contains

• The active substance of Torvalipin 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, silica colloidal anhydrous, magnesium stearate, hypromellose, titanium dioxide (E 171), macrogol 6000.

What Torvalipin looks like and contents of the pack

Torvalipin, 10 mg, coated tablets: white, round, biconvex, 7 mm.
Torvalipin, 20 mg, coated tablets: white, round, biconvex, 9 mm.
Torvalipin, 40 mg, coated tablets: white, oval, biconvex, 8.2 x 17 mm.
Packaging: 30, 56, 98, or 100 coated tablets in blisters in a cardboard box.

Marketing authorization holder

Actavis Group PTC ehf.
Dalshraun 1
220 Hafnarfjörður
Iceland

Manufacturer

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