Zentasta

Leaflet accompanying the packaging: patient information

Zentasta, 10 mg + 10 mg, tablets

Zentasta, 10 mg + 20 mg, tablets

Zentasta, 10 mg + 40 mg, tablets

Zentasta, 10 mg + 80 mg, tablets

Ezetimibe + Atorvastatin

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 you can read it again if you need to.
• If you have any doubts, you should consult your 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 Zentasta and what is it used for
• 2. Important information before taking Zentasta
• 3. How to take Zentasta
• 4. Possible side effects
• 5. How to store Zentasta
• 6. Contents of the packaging and other information

1. What is Zentasta and what is it used for

Zentasta is a medicine that lowers high cholesterol levels. Zentasta contains ezetimibe and atorvastatin.
Zentasta is used in adults to lower the level of total cholesterol, including "bad" cholesterol (LDL cholesterol) and fatty substances called triglycerides in the blood. Additionally, Zentasta increases the level of "good" cholesterol (HDL cholesterol).
Zentasta works through two mechanisms that lower cholesterol levels. It reduces the absorption of cholesterol in the digestive tract and inhibits the production of cholesterol in the body.
Cholesterol is one of several fatty substances present in the circulatory system. Total cholesterol consists mainly of LDL cholesterol and HDL cholesterol fractions.
LDL cholesterol is often called "bad" cholesterol because it can accumulate on the walls of arteries, forming atherosclerotic plaques. Eventually, these plaques can cause narrowing of the arteries, resulting in restricted or blocked blood flow to vital organs such as the heart and brain. Restricted blood flow can lead to heart attack or stroke.
HDL cholesterol is often called "good" cholesterol because it helps prevent the accumulation of bad cholesterol in the arteries and prevents heart disease.
Triglycerides are another type of fat present in the blood that can contribute to the increased risk of developing heart disease.
Zentasta is used in patients for whom diet alone is not enough to control cholesterol levels. While taking this medicine, you should follow a cholesterol-lowering diet.
Your doctor may prescribe Zentasta if you are already taking both substances - atorvastatin and ezetimibe - in the doses contained in this medicine.
Zentasta is used if the patient has:

• high blood cholesterol levels (primary hypercholesterolemia) [heterozygous and homozygous familial and non-familial]) or high blood fat levels (mixed hyperlipidemia).
• heart disease, Zentasta reduces the risk of heart attack, stroke, surgery to increase blood flow to the heart, or hospitalization due to chest pain.

Zentasta does not affect weight loss.

2. Important information before taking Zentasta

When not to take Zentasta

• if the patient is allergic to ezetimibe, 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
• if the patient is of childbearing age and does not use effective contraception
• if the patient is pregnant, plans to become pregnant, or is breastfeeding
• if the patient is taking glecaprevir/pibrentasvir for the treatment of hepatitis C
• if the patient needs to take fusidic acid orally to treat a bacterial infection, they should stop taking this medicine immediately. The doctor will inform the patient when it is safe to restart taking Zentasta. Taking Zentasta with fusidic acid can rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

Warnings and precautions

Before starting to take Zentasta, you should discuss with your doctor or pharmacist:

• if the patient has had a hemorrhagic stroke or has small fluid-filled sacs in the brain after previous strokes
• if the patient has kidney disease
• if the patient has hypothyroidism (underactive thyroid)
• if the patient experiences recurring or unexplained muscle pain or has had muscle disease or a family history of muscle disease
• if the patient is currently taking or has taken fusidic acid (an antibiotic) orally or by injection in the last 7 days. The combination of fusidic acid and a medicine containing ezetimibe and atorvastatin may lead to serious muscle problems (rhabdomyolysis)
• if the patient has experienced muscle problems while taking other cholesterol-lowering medicines (e.g., other "statins" or "fibrates")
• if the patient regularly consumes large amounts of alcohol
• if the patient has had liver disease in the past
• if the patient is over 70 years old
• if the patient has severe respiratory failure
• if the patient has or has had myasthenia (a disease that causes general muscle weakness, including muscles involved in breathing) or ocular myasthenia (a disease that causes muscle weakness in the eyes), as statins can sometimes exacerbate symptoms of the disease or lead to myasthenia (see section 4)

You should contact your doctor immediately if you experience unexplained

muscle pain, tenderness, or weakness while taking this medicine.In rare cases, muscle problems can be serious, including muscle breakdown leading to kidney damage.
If any of these situations apply to you (or you are unsure), you should consult your doctor or pharmacist before taking Zentasta, as your doctor will need to perform a blood test before starting this medicine and, if possible, during treatment to assess the risk of muscle-related side effects. The risk of muscle-related side effects, such as rhabdomyolysis (muscle breakdown), increases when taking certain medicines at the same time (see section 2, "Zentasta and other medicines").
During therapy, your doctor will closely monitor your health if you have diabetes or are at risk of developing diabetes. The likelihood of developing diabetes is higher in people with high blood sugar and fat levels, overweight, or high blood pressure.
In a small number of people, statins can affect the liver. This is identified by a simple blood test that checks for elevated liver enzyme levels. For this reason, your doctor will regularly perform this blood test (liver function test) while you are taking Zentasta. It is essential to go to your doctor for laboratory tests.
You should inform your doctor about all your medical conditions, including allergies.

Children and adolescents

Zentasta should not be used in children and adolescents.

Zentasta and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
You should avoid taking Zentasta and fibrates (cholesterol-lowering medicines) at the same time.
There are several medicines that can change the effect of Zentasta or whose effect can be changed by Zentasta (see section 3). This type of interaction can reduce the effectiveness of one or both medicines. It can also increase the risk or severity of side effects, including serious muscle problems, such as rhabdomyolysis, described in section 4:

• cyclosporine (often used in patients who have had an organ transplant).
• erythromycin, clarithromycin, telithromycin, fusidic acid, rifampicin (used to treat bacterial infections).
• ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole (used to treat fungal infections).
• gemfibrozil, other fibrates, nicotinic acid, and derivatives, colestyramine, colestipol (medicines used to regulate fat levels).
• certain calcium channel blockers used to treat angina and high blood pressure, such as amlodipine, diltiazem.
• digoxin, verapamil, amiodarone (medicines that regulate heart rhythm).
• letermovir (a medicine used to prevent cytomegalovirus disease).
• medicines used to treat HIV, such as ritonavir, lopinavir, atazanavir, indinavir, darunavir, the combination of tipranavir with ritonavir (used to treat AIDS).
• antiviral medicines used to treat hepatitis C, such as telaprevir, boceprevir, and the combination of elbasvir, grazoprevir, ledipasvir/sofosbuvir.
• if oral fusidic acid is necessary to treat a bacterial infection, you should temporarily stop taking this medicine. Your doctor will tell you when it is safe to restart taking Zentasta. Taking Zentasta with fusidic acid can rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.
• daptomycin (a medicine used to treat complicated skin and skin structure infections and bacteremia).
• Other medicines that interact with Zentasta
• oral contraceptives (birth control pills).
• styrene (an antiepileptic medicine used to treat epilepsy).
• cimetidine (a medicine used to treat heartburn and stomach ulcers).
• phenazone (a pain reliever).
• antacids (medicines that contain aluminum or magnesium).
• warfarin, phenprocoumon, acenocoumarol, or fluindione (medicines used to prevent blood clots).
• colchicine (used to treat gout).
• St. John's Wort (Hypericum perforatum) (a medicine used to treat depression).

Zentasta with food and drink

See section 3 for information on how to take Zentasta. You should pay attention to the following:

Grapefruit juice
You should not drink more than one or two small glasses of grapefruit juice, as larger amounts may change the effect of Zentasta.
Alcohol
You should avoid drinking too much alcohol while taking this medicine. See section 2, "Warnings and precautions".

Pregnancy, breastfeeding, and fertility

Zentasta should not be taken if you are pregnant, plan to become pregnant, or think you may be pregnant.
Zentasta should not be taken by women of childbearing age unless they use effective contraception. If you become pregnant while taking Zentasta, you should stop taking it immediately and inform your doctor as soon as possible.
Zentasta should not be taken during breastfeeding.
If you are pregnant, breastfeeding, or think you may be pregnant, or are planning to become pregnant, you should consult your doctor or pharmacist before taking this medicine.

Driving and using machines

You should not expect Zentasta to affect your ability to drive or use machines. However, you should consider that some people may experience dizziness after taking Zentasta. If you experience dizziness after taking this medicine, you should not drive or use machines.

Zentasta contains lactose and sodium

If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means it is essentially "sodium-free".

3. How to take Zentasta

This medicine should always be taken as directed by your doctor. Your doctor will determine the dose of Zentasta suitable for you, depending on your current treatment and individual risk.
If you have any doubts, you should consult your doctor or pharmacist.

• Before starting to take Zentasta, you should follow a cholesterol-lowering diet
• While taking Zentasta, you should follow a cholesterol-lowering diet

How to take Zentasta
The recommended dose of Zentasta is one tablet, taken orally, once a day, preferably at the same time every day. The tablet should be swallowed with a sufficient amount of liquid (e.g., one glass of water).
When to take Zentasta
Zentasta can be taken at any time of day. It can be taken with or without food.
If your doctor has prescribed Zentasta and another cholesterol-lowering medicine containing the active substance cholestyramine or another bile acid sequestrant, you should take Zentasta at least 2 hours before or 4 hours after taking the bile acid sequestrant.

Taking a higher dose of Zentasta than recommended

You should contact your doctor or pharmacist.

Missing a dose of Zentasta

You should not take a double dose to make up for a missed dose. You should take your usual dose of Zentasta the next day at the usual time.
If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

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

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

• A severe allergic reaction causing swelling of the face, tongue, and throat, which can cause severe breathing difficulties.
• A severe skin reaction with blistering and peeling of the skin, blisters on the skin, mouth, and eyes, genital areas, and fever, rash with reddish-purple spots, especially on the palms or soles of the feet, with possible blisters.
• Muscle weakness, tenderness, pain, or muscle breakdown, or brownish discoloration of the urine, and especially if you also feel unwell or have a high fever, this may be caused by muscle breakdown. This condition can be life-threatening and lead to kidney disease.

You should consult your doctor as soon as possible if you experience unexpected or unusual bleeding or bruising, as this may indicate liver problems.

Other possible side effects of Zentasta:

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

• Nasal congestion, sore throat, nosebleeds.
• Allergic reactions.
• Increased blood sugar levels; if you have diabetes, you should carefully monitor your blood sugar levels.
• Headaches.
• Nausea, constipation, gas, diarrhea, indigestion, abdominal pain.
• Sore throat and (or) larynx.
• Joint pain and (or) pain in the hands or feet, back pain, muscle pain, muscle spasms, joint swelling.
• Increased creatine kinase activity in the blood.
• Increased liver enzyme activity (ALT and (or) AST).
• Feeling tired.
• Blood test results indicating abnormal liver function.

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

• Decreased blood sugar levels (patients with diabetes should carefully monitor their blood sugar levels).
• Loss of appetite, weight gain.
• Cough.
• Muscle weakness, neck pain, chest pain, swelling, especially of the ankles, elevated temperature.
• Hot flashes, high blood pressure.
• Vomiting, belching, pancreatitis, and liver inflammation, heartburn, stomach inflammation, dry mouth.
• Redness of the skin, rash, and itching, hives, hair loss.
• Nightmares, difficulty sleeping.
• Dizziness, numbness, memory loss (amnesia), taste disturbances, memory loss, sensory disturbances.
• Blurred vision.
• Ringing in the ears.
• Feeling of general discomfort, anxiety, or pain.
• Weakness.
• Increased activity of the liver enzyme gamma-glutamyltransferase.
• Presence of white blood cells in the urine test.

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

• Decreased platelet count.
• Numbness, tingling, or burning sensation in the hands or feet (peripheral neuropathy).
• Muscle inflammation, tendon inflammation, sometimes with tendon rupture, muscle weakness as a symptom of muscle fiber loss.
• Vision disturbances.
• Yellowing of the skin and whites of the eyes.
• Rash that can occur on the skin or ulcers in the mouth (lichenoid drug reaction).
• Purple skin discoloration (symptoms of vasculitis).

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

• Anaphylactic shock caused by an allergic reaction.
• Hearing loss.
• Liver failure.
• Breast enlargement in men.

Frequency not known: (cannot be estimated from the available data)

• Allergic reactions, including rash and swelling of the deeper layers of the skin.
• Shortness of breath, gallbladder inflammation, gallstones.
• Persistent muscle weakness.
• Myasthenia (a disease that causes general muscle weakness, including muscles involved in breathing).
• Ocular myasthenia (a disease that causes 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.
Additionally, after the medicine was placed on the market, the following side effects were reported during the use of some statins (cholesterol-lowering medicines):

• Breathing difficulties, including chronic cough and (or) shortness of breath or fever.
• Diabetes. The development of diabetes is more likely if you have high blood sugar and fat levels, are overweight, or have high blood pressure. During treatment with this medicine, your doctor will monitor your condition.
• Depression.
• Sexual function disorders.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. 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 181 C, 02-222 Warsaw
tel.: +48 22 49 21 301, fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Side effects can be reported to the marketing authorization holder or its representative in Poland.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Zentasta

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiration date stated on the carton and packaging after "EXP". The expiration date refers to the last day of the month.
Store in the original packaging to protect from light.
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 packaging and other information

What Zentasta contains

• The active substances of Zentasta are ezetimibe and atorvastatin. Each tablet contains 10 mg of ezetimibe and 10 mg, 20 mg, 40 mg, or 80 mg of atorvastatin (in the form of atorvastatin calcium trihydrate).
• The other ingredients are: lactose monohydrate, calcium carbonate, microcrystalline cellulose, sodium lauryl sulfate, croscarmellose sodium, povidone K30, hydroxypropylcellulose, magnesium stearate, polysorbate 80.

What Zentasta looks like and contents of the pack

Zentasta, 10 mg + 10 mg, are white or almost white, capsule-shaped tablets (12.7 mm x 5.1 mm) with "1" embossed on one side.
Zentasta, 10 mg + 20 mg, are white or almost white, capsule-shaped tablets (14.5 mm x 5.8 mm) with "2" embossed on one side.
Zentasta, 10 mg + 40 mg, are white or almost white, capsule-shaped tablets (16.4 mm x 6.3 mm) with "3" embossed on one side.
Zentasta, 10 mg + 80 mg, are white or almost white, capsule-shaped tablets (17.0 mm x 8.0 mm) with "4" embossed on one side.
The tablets are packaged in blisters of OPA/Aluminum/PVC film, covered with aluminum foil, containing 10, 30, 90, or 100 tablets, in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder

Zentiva, k.s.,
U kabelovny 130
Dolní Měcholupy
102 37 Prague 10
Czech Republic

Manufacturer

Hennig Arzneimittel GmbH & Co. KG
Liebigstr. 1-2
65439 Flörsheim am Main
Germany
Bluepharma - Indústria Farmacêutica, S.A.
Sao Martinho do Bispo
3045-016 Coimbra
Portugal

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

Czech Republic, Slovakia, Romania, Portugal: ZETOVAR
Estonia, Latvia, Lithuania: TORZELIP
Poland: ZENTASTA

For more information about this medicine, you should contact the representative of the marketing authorization holder in Poland:

Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
Tel. +48 (22) 375 92 00
Date of last revision of the leaflet:April 2025