Mizetam

Leaflet attached to the packaging: patient information

Mizetam, 10 mg + 10 mg, tablets

Mizetam, 10 mg + 20 mg, tablets

Mizetam, 10 mg + 40 mg, tablets

Mizetam, 10 mg + 80 mg, tablets

Ezetimibe + Atorvastatin

It is essential to carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept in case it needs to be read again.
• In case of any doubts, the patient should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Mizetam and what is it used for

Mizetam is a medicine that lowers high cholesterol levels. Mizetam contains ezetimibe and atorvastatin.
Mizetam 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, Mizetam increases the level of "good" cholesterol (HDL cholesterol).
Mizetam works through two mechanisms that lower cholesterol levels. It reduces the absorption of cholesterol in the gastrointestinal 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.
LDL cholesterol is often referred to as "bad" cholesterol because it can accumulate on the walls of arteries, forming 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 a heart attack or stroke.
HDL cholesterol is often referred to as "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, which can contribute to an increased risk of developing heart disease.
Mizetam is used in patients for whom diet alone is not sufficient to control cholesterol levels. During treatment with this medicine, a cholesterol-lowering diet should be followed.
If the patient has heart disease, Mizetam reduces the risk of heart attack, stroke, surgery to increase blood flow to the heart, or hospitalization due to chest pain.
The doctor may prescribe Mizetam if the patient is already taking both substances - atorvastatin and ezetimibe - in the doses contained in this medicine.
Mizetam does not affect weight loss.

2. Important information before taking Mizetam

When not to take Mizetam:

• 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 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 medicines containing glecaprevir and pibrentasvir for the treatment of hepatitis C virus infection.
• if it is necessary to take fusidic acid orally to treat a bacterial infection, the patient should stop taking this medicine. The doctor will inform the patient when it is safe to restart taking Mizetam. Taking Mizetam 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 treatment with Mizetam, the patient should discuss it with their doctor or pharmacist if:

• the patient has or has had muscular dystrophy (a disease that causes general muscle weakness, including in some cases 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 the development of myasthenia (see section 4).
• the patient has a history of hemorrhagic stroke or has small fluid-filled cavities in the brain after previous strokes.
• the patient has kidney disease.
• the patient has hypothyroidism (underactive thyroid).
• the patient experiences recurring or unexplained muscle pain or has had muscle disease or a family history of muscle disease.
• the patient has experienced muscle-related side effects while taking other lipid-lowering medicines (e.g., other "statins" or "fibrates").
• the patient is currently taking or has taken within the last 7 days a medicine called fusidic acid (an antibiotic) orally or by injection. The combination of fusidic acid and a medicine containing ezetimibe and atorvastatin may lead to serious consequences, including muscle problems (rhabdomyolysis).
• the patient regularly consumes large amounts of alcohol.
• the patient has a history of liver disease.
• the patient is over 70 years old.

The patient should immediately contact their doctor in case of unexplained

muscle pain, tenderness, or weakness while taking Mizetam.In rare cases, muscle-related side effects can be serious, including muscle breakdown leading to kidney damage.
Before taking Mizetam, the patient should consult their doctor or pharmacist if:

• the patient has severe respiratory failure.

If any of the above situations apply to the patient (or the patient is unsure), they should consult their doctor or pharmacist before taking Mizetam, as the doctor will need to perform a blood test before starting treatment with 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 (breakdown of skeletal muscle), increases when taking certain medicines concurrently (see section 2 "Mizetam and other medicines").
During treatment, the doctor will closely monitor the patient's health if they 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, and high blood pressure.
The patient should inform their doctor about all their illnesses, including allergies.

Children and adolescents

Mizetam is not recommended for use in children and adolescents.

Mizetam 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.
The patient should avoid taking Mizetam and fibrates (cholesterol-lowering medicines) at the same time.
There are several medicines that can affect the action of Mizetam or whose action may be affected by Mizetam (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 a serious muscle condition called "rhabdomyolysis," described in section 4:

• cyclosporine (a medicine often used in patients who have had an organ transplant).
• erythromycin, clarithromycin, telithromycin, fusidic acid, rifampicin (antibiotics).
• ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole (antifungal medicines).
• gemfibrozil, other fibrates, and fenofibrate derivatives, nicotinic acid, 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).
• medicines used to treat HIV, such as ritonavir, lopinavir, atazanavir, indinavir, darunavir, the combination of tipranavir and ritonavir (used to treat AIDS).
• antiviral medicines used to treat hepatitis C virus infection, such as telaprevir, boceprevir, the combination of elbasvir and grazoprevir, letermovir given with cyclosporine.
• if it is necessary to take fusidic acid orally to treat a bacterial infection, the patient should stop taking this medicine. The doctor will indicate when it is safe to restart taking Mizetam. Taking Mizetam with fusidic acid can rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.
• Other medicines that interact with the combination product:
• oral contraceptives (medicines that prevent pregnancy).
• 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).

Mizetam with food and alcohol

See section 3 for information on how to take Mizetam. The patient should note the following:

Grapefruit juice
The patient should not exceed the consumption of one or two small glasses of grapefruit juice per day, as larger amounts may affect the action of Mizetam.
Alcohol
The patient should avoid consuming excessive amounts of alcohol during treatment with this medicine. See section 2 "Warnings and precautions."

Pregnancy, breastfeeding, and fertility

Mizetam should not be taken if the patient is pregnant, plans to become pregnant, or suspects they may be pregnant.
Mizetam should not be used by women of childbearing age unless they use effective contraception. If the patient becomes pregnant while taking Mizetam, they should stop taking this medicine immediately and inform their doctor as soon as possible.
Mizetam should not be taken during breastfeeding.
If the patient is pregnant, breastfeeding, suspects they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.

Driving and using machines

The patient should not expect Mizetam to affect their ability to drive or operate machinery. However, the patient should consider that some people may experience dizziness after taking Mizetam. If the patient experiences dizziness after taking this medicine, they should not drive or operate machinery.

Mizetam contains lactose

If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking this medicine.

Mizetam contains sodium

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

3. How to take Mizetam

This medicine should always be taken as directed by the doctor. The doctor will determine the dose of Mizetam suitable for the patient based on their current treatment and individual risk.
In case of doubts, the patient should consult their doctor or pharmacist.

• Before starting treatment with Mizetam, the patient should follow a cholesterol-lowering diet.
• During treatment with Mizetam, the patient should follow a cholesterol-lowering diet.

How to dose Mizetam
The recommended dose of Mizetam 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 Mizetam
Mizetam can be taken at any time, with or without food.
If the doctor has prescribed Mizetam and another cholesterol-lowering medicine containing cholestyramine or another bile acid sequestrant, the patient should take Mizetam at least 2 hours before or 4 hours after taking the bile acid sequestrant.

Taking a higher dose of Mizetam than recommended

The patient should contact their doctor or pharmacist.

Missing a dose of Mizetam

The patient should not take a double dose to make up for a missed dose. They should take their usual dose of Mizetam the next day at the usual time.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

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

If the patient experiences any of the following serious side effects, they should stop taking Mizetam and immediately contact their doctor or go to the emergency department of the nearest hospital and bring the packaging of the medicine.

and

• Severe allergic reaction causing swelling of the face, tongue, and throat, which can cause severe breathing difficulties.
• Severe skin condition characterized by peeling and swelling of the skin, blisters on the skin, mouth, eyes, genitals, and fever, skin rash with pink-red spots, especially on the palms or soles, with possible blisters.
• Muscle weakness, tenderness, pain, or rupture, or brownish-red urine, and in particular, if the patient also experiences malaise or high fever, it may be due to muscle breakdown. This condition can be life-threatening and lead to kidney disease.
• Lupus-like syndrome (including rash, joint disorders, and effects on blood cells).

The patient should consult their doctor as soon as possible if they experience unexpected or unusual bleeding or bruising, which may indicate liver problems.
Common (may affect up to 1 in 10 people):

• nasal congestion, sore throat, nosebleeds,
• allergic reactions,
• increased blood glucose levels, in diabetic patients, blood glucose levels should be carefully monitored,
• headache,
• nausea, constipation, bloating, diarrhea, indigestion, abdominal pain,
• sore throat and (or) larynx,
• joint pain and (or) pain in 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):

• edema due to allergic reactions,
• decreased blood glucose levels (diabetic patients should carefully monitor their blood glucose levels),
• loss of appetite, weight gain,
• cough,
• muscle weakness, neck pain, chest pain,
• hot flashes, high blood pressure,
• vomiting, belching, pancreatitis, and liver inflammation, heartburn, stomach inflammation, dry mouth,
• skin redness, hives, skin rash, and itching, hair loss,
• nightmares, difficulty sleeping,
• dizziness, numbness, taste disorders, memory loss (amnesia), sensory disturbances,
• blurred vision,
• ringing in the ears,
• feeling unwell, restlessness, 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,
• swelling of the deeper layers of the skin of the face, tongue, throat, abdomen, hands, or feet (angioedema),
• widespread rash forming sharply defined red spots or rash with blisters and peeling skin, especially around the mouth, nose, eyes, and genitals due to an allergic reaction,
• muscle inflammation, tendon inflammation, sometimes with tendon rupture, muscle weakness as a symptom of muscle fiber loss,
• vision disorders,
• yellowing of the skin and whites of the eyes.

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

• anaphylactic shock due to 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,
• physical weakness, loss of strength, loss of muscle tissue due to the action of antibodies,
• depression,
• myasthenia (a disease that causes general muscle weakness, including in some cases muscles involved in breathing),
• ocular myasthenia (a disease that causes muscle weakness in the eyes). The patient should talk to their doctor if they experience muscle weakness in their arms or legs, worsening after periods of activity, double vision, or drooping eyelids, difficulty swallowing, or shortness of breath.
  In addition, 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 likelihood of its occurrence depends on the presence or absence of risk factors (fasting glucose ≥5.6 mmol/l, BMI >20 kg/m, elevated triglycerides, history of hypertension),
  • depression,
  • sexual function disorders.

  Reporting side effects

  If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their 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 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, more information can be collected on the safety of the medicine.

  5. How to store Mizetam

  The medicine should be stored out of sight and reach of children.
  The medicine should not be used after the expiration date stated on the carton and blister pack after "EXP". The expiration date refers to the last day of the specified month.
  The inscription on the packaging after the abbreviation "EXP" indicates the expiration date, and after the abbreviation "Lot" indicates the batch number.
  Store in the original packaging to protect from light.
  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 Mizetam contains

  • The active substances of Mizetam 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).
  • Other ingredients are: lactose monohydrate, calcium carbonate, microcrystalline cellulose, sodium lauryl sulfate, croscarmellose sodium, povidone K30, hydroxypropylcellulose, magnesium stearate, polysorbate 80.

  What Mizetam looks like and what the packaging contains

  Mizetam, 10 mg + 10 mg: white or almost white capsule-shaped tablet (12.7 mm x 5.1 mm),
  with the inscription "1" on one side.
  Mizetam, 10 mg + 20 mg: white or almost white capsule-shaped tablet (14.5 mm x 6.8 mm),
  with the inscription "2" on one side.
  Mizetam, 10 mg + 40 mg: white or almost white capsule-shaped tablet (16.4 mm x 6.3 mm),
  with the inscription "3" on one side.
  Mizetam, 10 mg + 80 mg: white or almost white capsule-shaped tablet (17.0 mm x 8.0 mm),
  with the inscription "4" on one side.
  Mizetam is available in packs of 10, 30, 90, and 100 tablets in OPA/Aluminum/PVC blisters in a cardboard box.
  Not all pack sizes may be marketed.

  Marketing authorization holder and manufacturer

  Marketing authorization holder

  Polpharma S.A.
  Pelplińska 19, 83-200 Starogard Gdański
  phone: +48 22 364 61 01

  Manufacturer

  Hennig Arzneimittel GmbH & Co. KG
  Liebigstr. 1-2
  65439 Flörsheim Am Main, Hessen
  Germany
  
  Polpharma S.A.
  Pelplińska 19, 83-200 Starogard Gdański
  Date of last revision of the leaflet:March 2025