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

Atorvastatin

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package 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 pack 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 metabolism in the body.
Torvalipin is used to reduce the levels of lipids, such 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 cholesterol levels are normal. During treatment, a standard low-cholesterol diet should be continued.

2. Important information before taking Torvalipin

When not to take Torvalipin

• in women of childbearing age who are not using effective methods of contraception
• in pregnant or breastfeeding women

Warnings and precautions

Before starting treatment with Torvalipin, discuss with your doctor or pharmacist:

• in patients over 70 years of age.

In patients who are affected by any of the above situations, the doctor will order 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").
You should also inform your doctor or pharmacist if you experience persistent muscle weakness. Additional tests and medications 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 you have high blood glucose and lipid levels, are overweight, and have high blood pressure.

Torvalipin and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Some medicines may change the effect of Torvalipin or their effect may change under the influence of Torvalipin. Such interactions can make one or both medicines less effective. Another possibility is an increased risk or exacerbation of side effects, including a serious, though rare, muscle disease known as rhabdomyolysis (described in section 4):

• medicines that modify the immune system, such as cyclosporine
• certain antibiotics and antifungal medicines, such as erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin
• other medicines that regulate lipid levels, such as gemfibrozil, other fibrates, cholestyramine
• 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 indigestion, 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. Pay attention to the following information:
Grapefruit juice
Do not drink more than one or two small glasses of grapefruit juice per day, as larger amounts of grapefruit juice can change the effect of Torvalipin.
Alcohol
Avoid consuming large amounts of alcohol while taking this medicine. For more information, see section 2 "Warnings and precautions".

Pregnancy and breastfeeding

Do not take Torvalipin during pregnancy or if you plan to become pregnant.
Do not take Torvalipin if you are of childbearing age, unless you are using effective methods of contraception.
Do not take Torvalipin while breastfeeding.
The safety of taking Torvalipin during pregnancy or breastfeeding has not been established. Before taking any medicine, consult your doctor or pharmacist.

Driving and using machines

Normally, Torvalipin does not affect the ability to drive or use machines.
However, do not drive if the 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 film-coated tablet, which means it is considered "sodium-free".

3. How to take Torvalipin

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Before starting treatment, your 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 your doctor if necessary, up to a dose suitable for you. Your doctor will adjust the dose at intervals of 4 weeks or more. The maximum dose of Torvalipin is 80 mg once daily.
Take the film-coated tablets whole with water and can be taken at any time of day, with or without food. However, try 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, consult your doctor.

If you take more Torvalipin than you should

If you accidentally take too many Torvalipin tablets (more than the usual daily dose), contact your doctor or the nearest hospital for advice.

Forget to take Torvalipin

If you miss a dose, simply take the next dose at the scheduled time. Do not take a double dose to make up for the missed dose.

Stopping Torvalipin treatment

If you have any doubts about taking the medicine, consult your doctor or pharmacist.

4. Possible side effects

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

If you experience any of the following side effects or symptoms, stop taking the tablets and contact your 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 disorders with severe peeling and swelling of the skin, blisters on the skin, in the mouth, on the eyes, genitals, and with fever. Skin rash with pink-red spots, which can be blistering, especially on the palms and soles.
• Muscle weakness, tenderness, muscle pain, muscle rupture, or brownish discoloration of 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 you experience unexpected or unusual bleeding or bruising, consider the possibility of liver function disorders. In this case, contact your 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 you have diabetes, monitor your blood glucose levels carefully), 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 (loss of appetite), weight gain, decreased blood glucose levels (if you have diabetes, monitor your blood glucose levels carefully)
• 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
• 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
• 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 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 muscles involved in breathing)
• myasthenia of the eye (a disease that causes eye muscle weakness)

Talk to your doctor if you experience weakness in your 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 difficulties, including prolonged coughing and/or shortness of breath or fever
• diabetes: this is more likely if you have high blood glucose and lipid levels, are overweight, and have high blood pressure. Your doctor will monitor you while taking this medicine.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Torvalipin

Keep this medicine out of the 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. 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 Torvalipin contains

• The active substance is atorvastatin. Each film-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, 10 mg film-coated tablets: white, round, biconvex, 7 mm.
Torvalipin, 20 mg film-coated tablets: white, round, biconvex, 9 mm.
Torvalipin, 40 mg film-coated tablets: white, oval, biconvex, 8.2 x 17 mm.
Pack contents: 30, 56, 98, or 100 film-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

For more information about the medicine and its names in the Member States of the European Economic Area, please contact the representative of the marketing authorization holder:

Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, tel. (22) 345 93 00.
Date of last revision of the package leaflet:April 2023.