Torvazin Plus

Leaflet attached to the packaging: patient information

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

You should carefully read the contents of the leaflet before taking 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.
• 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 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 so-called statins, and the other active substance is ezetimibe.
Torvazin Plus is used in adult patients to reduce the level of total cholesterol, "bad" cholesterol (LDL) and fatty substances called triglycerides in the blood. Additionally, Torvazin Plus increases the level of "good" cholesterol (HDL).
This medicine reduces cholesterol levels in two ways. It reduces the absorption of cholesterol in the digestive tract and its production in the body.
In most people, high cholesterol levels do not affect how they feel, because they do 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 block the flow of blood to the heart or brain, causing a heart attack or stroke. By reducing cholesterol levels, the risk of heart attack, stroke, or other similar health problems can be reduced.
This medicine is used in patients who have not achieved adequate cholesterol control using a cholesterol-lowering diet alone. During treatment with this medicine, a low-cholesterol diet should still be followed.
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 the patient is allergic to atorvastatin, ezetimibe or any of the other ingredients of this medicine (listed in section 6)
• if the patient has liver disease
• if the patient has ever had unexplained abnormal blood test results indicating liver function
• if the patient is of childbearing age and is not using adequate contraception
• if the patient is pregnant or trying to become pregnant
• if the patient is breastfeeding
• if the patient is taking glecaprevir with pibrentasvir for the treatment of hepatitis C virus infection.

Warnings and precautions

Before starting treatment with Torvazin Plus, you should discuss it with your doctor or pharmacist.

• if the patient has severe respiratory failure
• if the patient is currently taking or has taken within the last 7 days a medicine called fusidic acid (an antibiotic used to treat bacterial infections) orally or by injection. The combination of fusidic acid and this medicine can lead to serious muscle problems (rhabdomyolysis). (See "Torvazin Plus and other medicines").
• if the patient has had a stroke with bleeding into the brain or if the patient has small fluid-filled pockets in the brain after strokes
• if the patient has kidney problems
• if the patient has reduced thyroid function (hypothyroidism)
• if the patient has had recurring muscle pain of unknown cause or muscle disease in the patient or family history
• if the patient has had muscle disorders in the past related to the use of other lipid-lowering medicines (e.g. other statins or fibrates)
• if the patient has or has had myasthenia (a disease causing general muscle weakness, including in some cases muscles involved in breathing) or myasthenia gravis (a disease causing muscle weakness in the eyes), as statins can sometimes exacerbate symptoms of the disease or lead to myasthenia (see section 4).
• if the patient regularly consumes large amounts of alcohol
• if the patient has a history of liver disease
• if the patient is 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 disorders can be severe, including muscle breakdown, which can cause kidney damage. It is known that atorvastatin causes muscle disorders. Cases of muscle disorders have also been reported during treatment 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 closely monitor you for diabetes or the risk of developing it. You are at risk of developing diabetes if you have high blood sugar and fat levels, are overweight, and have high blood pressure.
You should inform your doctor about all your illnesses, including allergies.
You should avoid taking Torvazin Plus and fibrates (cholesterol-lowering medicines) at the same time, as this treatment has not been tested.

Children and adolescents

Torvazin Plus is not recommended for use in children and adolescents under 18 years of age.

Torvazin Plus and other medicines

You should 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 Torvazin Plus, or Torvazin Plus may change their effect. 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 lipid-regulating medicines, such as gemfibrozil, other fibrates, nicotinic acid, derivatives, cholestyramine, colestipol
• Certain calcium channel blockers used in angina pectoris and hypertension, such as amlodipine, diltiazem
• Medicines that regulate heart function, 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 combination, etc.
• Certain medicines used to treat hepatitis C virus infection, such as telaprevir, boceprevir, and a combination product containing elbasvir with grazoprevir, ledipasvir with sofosbuvir
• Fusidic acid. If the patient must take fusidic acid orally for a bacterial infection, they must stop taking this medicine for a while. The doctor will say when it is safe to start taking Torvazin Plus again. Taking this medicine with fusidic acid can rarely lead to muscle weakness, tenderness, and pain (rhabdomyolysis). More information on rhabdomyolysis - see section 4.
• daptomycin (a medicine used to treat complicated skin and soft tissue infections and bloodstream infections caused by bacteria)
• Other medicines with known interactions with this medicine:
• warfarin, phenprocoumon, acenocoumarol, and flindione (medicines that prevent blood clots)
• oral contraceptives (medicines that prevent pregnancy)
• stiripentol (an antiepileptic medicine used in epilepsy)
• cimetidine (used in 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 medicine used to treat depression)

Torvazin Plus with food and drink

Instructions on how to take this medicine, see section 3. You should pay attention to the following:
Grapefruit juice
You should not drink more than one or two small glasses of grapefruit juice per day, as large amounts of grapefruit juice can affect the action of this medicine.
Alcohol
You should avoid excessive alcohol consumption while taking this medicine. For more information, see section 2 "Warnings and precautions".

Pregnancy and breastfeeding

Torvazin Plus should not be taken if the patient is pregnant, trying to become pregnant, or suspects that she may be pregnant. During treatment with this medicine, women should use adequate contraception. If a woman becomes pregnant while taking this medicine, she should stop taking it immediately and consult her doctor.
Torvazin Plus should not be taken during breastfeeding.
The safety of using this medicine during pregnancy and breastfeeding has not been confirmed yet.
If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before taking this medicine.

Driving and using machines

It is not expected that Torvazin Plus will affect the ability to drive or use machines.
However, you should keep in mind that some people may experience dizziness after taking this medicine. If the patient experiences dizziness, they should consult their doctor before driving or operating machinery.

Torvazin Plus contains sucrose and sodium

Torvazin Plus contains sucrose. If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means that the medicine is considered "sodium-free".

3. How to take Torvazin Plus

This medicine should always be taken as directed by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.
Before starting to take this medicine, you should follow a cholesterol-lowering diet.
The recommended daily dose for adults is one capsule of the given strength once a day.

Torvazin Plus should be taken once a day.

The capsules can be taken at any time, regardless of meals, but it is recommended to take the medicine at the same time every day.
The capsule should be swallowed whole and washed down with water.
This medicine is not suitable for starting treatment.
Initiation of treatment or changes in dosage, if necessary, should only be done using the active substances in the form of separate medicines, and only after determining the appropriate doses can you switch to Torvazin Plus.
If the doctor has prescribed Torvazin Plus with cholestyramine or another bile acid sequestrant (used to lower cholesterol), this medicine should be taken at least 2 hours before or 4 hours after taking the bile acid sequestrant.

Taking a higher dose of Torvazin Plus than recommended

If you have accidentally taken more capsules of Torvazin Plus than the usual dose, you should contact your doctor or go to the nearest hospital for advice.

Missing a dose of Torvazin Plus

If you miss a dose, you should take the next dose at the right time, according to the schedule. You should not take a double dose to make up for the missed dose.

Stopping treatment with Torvazin Plus

You should tell your doctor if you want to stop taking Torvazin Plus. Cholesterol levels may rise again if you stop taking this medicine.
If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

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

If you experience any of the following serious side effects, you should stop taking this medicine and contact your doctor or go to the emergency department of your nearest hospital immediately.

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 disease characterized by widespread skin peeling, blistering, and rash, with fever.
• Muscle weakness, tenderness, pain, or muscle rupture, especially if accompanied by feeling unwell or 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 the patient experiences unexpected or unusual bleeding or bruising, it may indicate liver function disorders. The patient should consult their doctor as soon as possible.
• A disease syndrome similar to lupus (including rash, joint disorders, and effects on blood cells).

Other possible side effects

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

• common cold (inflammation of the nasal and throat mucosa)
• 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
• feeling tired
• increased results of some blood tests that check liver or muscle function (CK)
• increased results of some liver function blood tests (aminotransferases)

Uncommon side effects (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 of the hands and feet
• reduced sensation of pain or touch
• taste disorders
• 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 malaise (feeling of general weakness)
• 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 side effects (may affect up to 1 in 1,000 people):

• reduced platelet count, which can increase the risk of bruising/bleeding (thrombocytopenia)
• nerve damage in the legs and arms (such as numbness)
• vision disorders
• bile duct obstruction (jaundice of the skin and whites of the eyes)
• a bulging red rash, sometimes with target-shaped lesions (erythema multiforme)
• a rash that can occur on the skin or ulcers in the mouth (lichenoid drug reaction)
• purple skin lesions (signs of vasculitis)
• muscle disease with muscle weakness (myopathy)
• muscle inflammation
• tendon damage

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

• hearing loss
• liver failure
• gynecomastia (breast enlargement in men)

Unknown frequency (cannot be estimated from the available data):

• depression
• shortness of breath
• gallstones or cholecystitis (which can cause abdominal pain, nausea, vomiting)
• persisting muscle weakness (immunomediated necrotizing myopathy)
• myasthenia (a disease causing general muscle weakness, including in some cases muscles involved in breathing)
• myasthenia gravis (a disease causing muscle weakness in the eyes)

You should talk to 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 disorders
• breathing problems, including persistent cough and (or) shortness of breath or fever.
• diabetes. The risk of developing diabetes is higher in people with high blood sugar and fat levels, overweight, and high blood pressure. Your doctor will monitor your condition while taking this medicine.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should tell your doctor or pharmacist, or nurse. 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
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 gather more information on the safety of this medicine.

5. How to store Torvazin Plus

The medicine should be stored out of sight and reach of children.
Store in a temperature below 30 °C.
Store in the original packaging to protect from moisture.
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 specified month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Torvazin Plus contains

• The active substance of the medicine is atorvastatin (in the form of atorvastatin calcium trihydrate) and ezetimibe. Each capsule contains 10 mg, 20 mg, or 40 mg of atorvastatin and 10 mg of ezetimibe.
• Other ingredients are: Core: calcium carbonate, hydroxypropyl cellulose, polysorbate 80, croscarmellose sodium, sucrose, pellets (sucrose and cornstarch), talc, mannitol, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, 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 of each strength: 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:
a 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:
a 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:
a 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:
spherical pellets
Ezetimibe 10 mg tablet:
a single, flat, beveled-edge tablet with a stylized letter E engraved on one side and the number 612 engraved 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 твърди капсули
Lithuania
EXTROTAN 10 mg/10 mg, 20 mg/10 mg, 40 mg/10 mg kietosios kapsulės (atorvastatinas/ezetimibas)
Latvia
EXTROTAN 10 mg/10 mg, 20 mg/10 mg, 40 mg/10 mg cietās kapsulas
Spain
Atorduo 10mg/10mg, 20mg/10mg, 40mg/10mg cápsulas duras
Cyprus Cholzet 10mg/10mg, 20mg/10mg, 40mg/10mg σκληρά καψάκια
Estonia Atorduo 10mg/10mg, 20mg/10mg, 40mg/10mg kõvakapslid
France Junaliza 10mg/10mg, 20mg/10mg, 40mg/10mg gélule
Portugal Atorduo 10mg/10mg, 20mg/10mg, 40mg/10mg cápsulas
To obtain more detailed information, you should contact the representative of the marketing authorization holder.
EGIS Polska sp. z o.o.:
ul. Komitetu Obrony Robotników 45D
02-146 Warsaw
Phone number: +48 22 417 92 00

Date of last revision of the leaflet:

• 11.09.2024