Torvazin Plus

Package Leaflet: Information for the Patient

Torvazin Plus, 10 mg +10 mg, hard capsules
Torvazin Plus, 20 mg +10 mg, hard capsules
Torvazin Plus, 40 mg +10 mg, hard capsules
Atorvastatinum + Ezetimibum

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 any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the Package Leaflet:

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

1. What is Torvazin Plus and what is it used for

Torvazin Plus contains two different active substances in one capsule. One of the active substances is atorvastatin, which belongs to a group of medicines called statins, and the other active substance is ezetimibe.
Torvazin Plus is used in adults to lower the levels of total cholesterol, "bad" cholesterol (LDL), and fatty substances called triglycerides in the blood. Additionally, Torvazin Plus increases the levels of "good" cholesterol (HDL).
This medicine works by reducing the absorption of cholesterol in the gut and its production in the body.
In most people, high cholesterol does not affect how they feel, as it does not cause any symptoms. However, if left untreated, fatty deposits can build up in the walls of blood vessels, leading to narrowing of the vessels.
Sometimes, these narrowed vessels can become blocked, which can cut off the blood supply to the heart or brain, leading to a heart attack or stroke. By lowering cholesterol levels, the risk of having a heart attack, stroke, or other similar health problems can be reduced.
This medicine is used in patients who have not been able to control their cholesterol levels by diet alone. While taking this medicine, you should continue to follow a low-cholesterol diet.
Your doctor may prescribe Torvazin Plus if you are already taking atorvastatin and ezetimibe in the same doses.
This medicine does not help with weight loss.

2. Important information before taking Torvazin Plus

When not to take Torvazin Plus

• if you are allergic to atorvastatin, ezetimibe, or any of the other ingredients of this medicine (listed in section 6)
• if you have or have ever had liver disease
• if you have ever had unexplained liver test results
• if you are a woman of childbearing age and are not using reliable contraception
• if you are pregnant or breast-feeding
• if you are taking glecaprevir with pibrentasvir for the treatment of hepatitis C virus infection.

Warnings and precautions

Before taking Torvazin Plus, discuss this with your doctor or pharmacist.

• if you have severe respiratory failure
• if you are currently taking or have taken in the last 7 days a medicine called fusidic acid (an antibiotic) orally or by injection. The combination of fusidic acid and this medicine can cause serious muscle problems (rhabdomyolysis). (See "Torvazin Plus and other medicines").
• if you have had a stroke with bleeding into the brain or if you have small pockets of fluid in the brain after previous strokes
• if you have kidney problems
• if you have reduced thyroid function (hypothyroidism)
• if you have had repeated muscle pain or muscle disease in yourself or your family
• if you have had muscle problems while taking other cholesterol-lowering medicines (such as other statins or fibrates)
• if you have or have had muscle weakness (myasthenia), as statins can sometimes worsen the symptoms of this disease or trigger myasthenia (see section 4).
• if you regularly drink large amounts of alcohol
• if you have a history of liver disease
• if you are over 70 years old.

You should contact your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness while taking Torvazin Plus.

Because in rare cases, muscle problems can be serious, including muscle breakdown, which can cause kidney damage. It is known that atorvastatin causes muscle problems. Cases of muscle problems have also been reported with ezetimibe.
Your doctor or pharmacist should also be informed if muscle weakness persists. To diagnose and treat this condition, additional tests and medications may be necessary.
During treatment with this medicine, your doctor will carefully monitor you for signs of diabetes or an increased risk of developing diabetes. You are at risk of developing diabetes if you have high levels of sugar and fat in your blood, are overweight, and have high blood pressure.
Tell your doctor about all your medical conditions, including allergies.
Do not take Torvazin Plus with fibrates (cholesterol-lowering medicines), as this combination has not been tested.

Children and adolescents

Torvazin Plus should not be used in children and adolescents under 18 years of age.

Torvazin Plus and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.
Some medicines may affect the way Torvazin Plus works, or Torvazin Plus may affect the way they work. This type of interaction can reduce the effectiveness of one or both medicines. Alternatively, it can increase the risk of side effects, including rhabdomyolysis (breakdown of skeletal muscle), described in section 4.

• Medicines that affect the immune system, such as cyclosporine
• Certain antibiotics, such as erythromycin, clarithromycin, telithromycin, rifampicin (used to treat bacterial infections)
• Certain antifungal medicines, such as ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole
• Other medicines that regulate lipid levels, such as gemfibrozil, other fibrates, nicotinic acid, derivatives, colestyramine, colestipol
• Certain calcium channel blockers used to treat angina and high blood pressure, such as amlodipine, diltiazem
• Medicines that regulate heart rhythm, such as digoxin, verapamil, amiodarone
• Letermovir, a medicine used to prevent cytomegalovirus disease
• Medicines used to treat HIV infection, such as ritonavir, lopinavir, atazanavir, indinavir, darunavir, efavirenz, fosamprenavir, delavirdine, tipranavir/ritonavir, etc.
• Certain medicines used to treat hepatitis C virus infection, such as telaprevir, boceprevir, and a combination product containing elbasvir and grazoprevir, ledipasvir and sofosbuvir
• Fusidic acid. If you need to take fusidic acid by mouth for a bacterial infection, you will need to stop taking Torvazin Plus for a while. Your doctor will tell you when it is safe to start taking Torvazin Plus again. Taking this medicine with fusidic acid can rarely cause muscle weakness, tenderness, and 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 bacteremia)
• Other medicines with known interactions with this medicine:
• warfarin, phenprocoumon, acenocoumarol, and fluindione (medicines that prevent blood clots)
• oral contraceptives (birth control pills)
• styrene (an antiepileptic medicine used in epilepsy)
• cimetidine (used to treat heartburn and stomach ulcers)
• phenazone (a pain reliever)
• colchicine (used to treat gout)
• antacids (medicines that neutralize stomach acid, containing aluminum or magnesium)
• St. John's Wort (a herbal medicine used to treat depression)

Torvazin Plus with food and drink

Instructions on how to take this medicine can be found in section 3. Note the following:
Grapefruit juice
Do not drink more than one or two small glasses of grapefruit juice per day, as large amounts of grapefruit juice can affect the way this medicine works.
Alcohol
Avoid excessive alcohol consumption while taking this medicine. For more information, see section 2 "Warnings and precautions".

Pregnancy and breast-feeding

Do not take Torvazin Plus if you are pregnant, trying to become pregnant, or think you may be pregnant. Women of childbearing age must use reliable contraception during treatment with this medicine. If you become pregnant while taking this medicine, stop taking it and consult your doctor.
Do not take Torvazin Plus if you are breast-feeding.
The safety of this medicine during pregnancy and breast-feeding has not been established.
If you are pregnant, breast-feeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Torvazin Plus is unlikely to affect your ability to drive or use machines.
However, be aware that some people may experience dizziness after taking this medicine. If you experience dizziness, consult your doctor before driving or using machines.

Torvazin Plus contains sodium and sucrose

Torvazin Plus contains sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means it is essentially "sodium-free".

3. How to take Torvazin Plus

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 to take this medicine, you should be on a diet to lower your cholesterol level.
The recommended dose is one capsule of the prescribed strength once a day.

Torvazin Plus should be taken once a day.

The capsules can be taken at any time of day, with or without food, but it is recommended to take the medicine at the same time every day.
Swallow the capsule whole with water.
This medicine is not suitable for initial treatment.
Initiation of treatment or dose adjustments should only be done under the guidance of a specialist using the individual components and after establishing the appropriate doses, the patient can be switched to Torvazin Plus.
If your doctor has prescribed Torvazin Plus with colestyramine or another bile acid sequestrant (to lower cholesterol), take Torvazin Plus at least 2 hours before or 4 hours after taking the bile acid sequestrant.

What to do if you take more Torvazin Plus than you should

If you accidentally take more Torvazin Plus capsules than you should (more than the prescribed dose), contact your doctor or go to the nearest hospital for advice.

What to do if you forget to take Torvazin Plus

If you forget to take a dose, take the next dose at the right time. Do not take a double dose to make up for a forgotten dose.

What to do if you want to stop taking Torvazin Plus

Tell your doctor if you want to stop taking Torvazin Plus. Your cholesterol levels may rise again if you stop taking this medicine.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

If you experience any of the following serious side effects, stop taking Torvazin Plus and contact your doctor immediately or go to the nearest hospital.

Rare (may affect up to 1 in 1,000 people):

• Severe allergic reaction causing swelling of the face, tongue, and throat, which can lead to severe breathing difficulties.
• Severe skin disease characterized by blistering, peeling, and bleeding of the skin, mouth, eyes, genitals, and fever. Skin rash with reddish-purple spots, especially on the hands or soles of the feet, with possible blistering.
• Muscle weakness, tenderness, pain, or rupture, or brownish discoloration of the urine, especially if accompanied by feeling unwell or having a high fever, can be caused by abnormal muscle breakdown (rhabdomyolysis). Abnormal muscle breakdown does not always go away, even after stopping this medicine, and can be life-threatening and lead to kidney problems.

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

• If you experience unexpected or unusual bleeding or bruising, this may indicate liver problems. You should consult your doctor as soon as possible.
• A disease similar to lupus (including rash, joint pain, and effects on blood cells).

Other possible side effects

Common (may affect up to 1 in 10 people):

• Common cold (inflammation of the nasal passages and throat)
• Allergic reactions
• Increased blood sugar levels, headache
• sore throat
• nosebleeds
• constipation
• bloating (excessive gas in the intestines)
• indigestion
• nausea
• diarrhea
• abdominal pain
• muscle pain
• joint pain
• arm and leg pain
• muscle spasms
• joint swelling
• back pain
• fatigue
• increased results of some blood tests that check liver function or muscle damage (CK)
• increased results of some liver function blood tests (transaminases)

Uncommon (may affect up to 1 in 100 people):

• Low blood sugar levels
• Weight gain
• Decreased or lost appetite
• nightmares
• insomnia
• dizziness
• numbness or tingling in the fingers and toes
• reduced sensation of pain or touch
• taste disturbances
• memory loss
• blurred vision
• ringing in the ears
• hot flashes
• high blood pressure
• cough
• vomiting
• belching
• pancreatitis (leading to severe abdominal pain that can radiate to the back)
• heartburn
• dry mouth
• gastritis
• liver inflammation
• hives
• itching
• skin rash
• hair loss
• neck pain
• muscle fatigue
• general feeling of being unwell (malaise)
• weakness (lack of energy and strength)
• chest pain
• pain
• swelling (especially of the hands and feet)
• fever
• positive test results for white blood cells in the urine.
• increased liver enzyme levels in the blood

Rare (may affect up to 1 in 1,000 people):

• Decreased platelet count, which can increase the risk of bruising/bleeding (thrombocytopenia)
• Nerve damage in the arms and legs (such as numbness)
• Vision problems
• Bile duct obstruction (yellowing of the skin and whites of the eyes)
• A raised, red rash, sometimes with target-shaped lesions (erythema multiforme)
• A rash that can occur on the skin or mouth ulcers (lichenoid drug reaction)
• Purple skin lesions (signs of vasculitis)
• Muscle disease with muscle weakness (myopathy)
• Muscle inflammation
• Tendon damage

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

• Hearing loss
• Liver failure
• Gynecomastia (breast enlargement in men)

Not known (cannot be estimated from the available data):

• Depression
• Shortness of breath
• Gallstones or cholecystitis (which can cause abdominal pain, nausea, vomiting)
• Persistent muscle weakness (immune-mediated necrotizing myopathy)
• Myasthenia (a disease that causes general muscle weakness, including muscles involved in breathing)
• Myasthenic syndrome (a disease that causes muscle weakness in the eyes)

Tell your doctor if you experience weakness in your arms or legs, worsening after periods of activity, double vision, or drooping eyelids, difficulty swallowing, or shortness of breath.

Side effects that have been reported with some statins

• Sexual problems
• Breathing problems, including persistent cough and (or) shortness of breath or fever.
• Diabetes. The risk of developing diabetes is higher in people with high levels of sugar and fat in the blood, who are overweight, and have high blood pressure. Your doctor will monitor your condition while taking this medicine.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +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 Torvazin Plus

Keep this medicine out of the sight and reach of children.
Store in a temperature below 30 °C.
Store in the original package to protect from moisture.
Do not use this medicine after the expiry date stated on the package after EXP.
The expiry date refers to the last day of the month stated.
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 Torvazin Plus contains

• The active substances are atorvastatin (as atorvastatin calcium trihydrate) and ezetimibe. Each capsule contains 10 mg, 20 mg, or 40 mg of atorvastatin and 10 mg of ezetimibe.
• The other ingredients are: Core: calcium carbonate, hydroxypropylcellulose, polysorbate 80, croscarmellose sodium, sucrose, maize starch, talc, mannitol, microcrystalline cellulose, hypromellose, povidone (K-25), sodium lauryl sulfate, magnesium stearate

Capsule shell:
Torvazin Plus, 10 mg +10 mg, hard capsules:
Cap: titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), black iron oxide (E 172), gelatin
Torvazin Plus, 20 mg +10 mg, hard capsules:
Cap: titanium dioxide (E 171), red iron oxide (E 172), gelatin
Torvazin Plus, 40 mg +10 mg, hard capsules:
Cap: titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), black iron oxide (E 172), gelatin
Capsule body: titanium dioxide (E 171), yellow iron oxide (E 172), gelatin

What Torvazin Plus looks like and contents of the pack

Torvazin Plus, 10 mg +10 mg, hard capsules:
Hard gelatin capsule, size 0, with a caramel-colored cap and a yellow body, filled with pellets and a tablet.
Torvazin Plus, 20 mg +10 mg, hard capsules:
Hard gelatin capsule, size 0, with a reddish-brown cap and a yellow body, filled with pellets and a tablet.
Torvazin Plus, 40 mg +10 mg, hard capsules:
Hard gelatin capsule, size 0, with a dark brown cap and a yellow body, filled with pellets and a tablet.
Capsule filling
Atorvastatin IR pellets:
Spheroidal pellets
Ezetimibe 10 mg tablet:
One round, flat tablet with beveled edges, engraved with a stylized letter E on one side and the number 612 on the other side.
30, 60, 70, 80, 90, 100, and 120 hard capsules in blisters of OPA/Aluminum/PVC/Aluminum in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Egis Pharmaceuticals PLC
Keresztúri út 30-38
1106 Budapest
Hungary

Manufacturer

Egis Pharmaceuticals PLC
Bökényföldi út 118-120
1165 Budapest
Hungary
Egis Pharmaceuticals PLC
Mátyás király u. 65
9900 Körmend
Hungary

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Hungary
Torvazin Duo 10 mg/10 mg, 20 mg/10 mg, 40 mg/10 mg hard capsules
Poland
Torvazin Plus
Romania
Torvazin Plus 10 mg/10 mg, 20 mg/10 mg, 40 mg/10 mg capsules
Slovakia
Torvazin Plus 10 mg/10 mg, 20 mg/10 mg, 40 mg/10 mg
Bulgaria
Торвазин Плюс (аторвастатин/езетимиб) 10 mg/10 mg, 20 mg/10 mg, 40 mg/10 mg hard capsules
Lithuania
EXTROTAN 10 mg/10 mg, 20 mg/10 mg, 40 mg/10 mg hard capsules (atorvastatin/ezetimibe)
Latvia
EXTROTAN 10 mg/10 mg, 20 mg/10 mg, 40 mg/10 mg hard capsules
Spain
Atorduo 10mg/10mg, 20mg/10mg, 40mg/10mg hard capsules
Cyprus Cholzet 10mg/10mg, 20mg/10mg, 40mg/10mg hard capsules
Estonia Atorduo 10mg/10mg, 20mg/10mg, 40mg/10mg hard capsules
France Junaliza 10mg/10mg, 20mg/10mg, 40mg/10mg hard capsules
Portugal Atorduo 10mg/10mg, 20mg/10mg, 40mg/10mg hard capsules
To obtain more detailed information, contact the representative of the marketing authorization holder.
EGIS Polska sp. z o.o.:
ul. Komitetu Obrony Robotników 45D
02-146 Warsaw
Phone: +48 22 417 92 00

Date of last revision of the package leaflet:

• 11.09.2024