Ezetimibe Mylan
Italy
Table of Contents
Package leaflet: Information for the patient
Ezetimibe Mylan 10 mg tablets
ezetimibe
Generic medicine
Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
- If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What Ezetimibe Mylan is and what it is used for
- What you need to know before taking Ezetimibe Mylan
- How to take Ezetimibe Mylan
- Possible side effects
- How to store Ezetimibe Mylan
- Contents of the pack and other information
1. What is Ezetimibe Mylan and what is it used for?
Ezetimibe Mylan contains the active substance ezetimibe. Ezetimibe Mylan is a medicine used to lower elevated cholesterol levels. Ezetimibe Mylan reduces levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and fats in the blood called triglycerides. Ezetimibe Mylan also increases levels of "good" cholesterol (HDL cholesterol).
LDL cholesterol is often called "bad" cholesterol because it can accumulate in the walls of arteries, forming plaques. Over time, this plaque buildup can lead to narrowing of the arteries. This narrowing can slow down or block blood flow to vital organs such as the heart and brain. This blockage of blood flow may cause a heart attack or stroke.
HDL cholesterol is often called "good" cholesterol because it helps prevent "bad" cholesterol from building up in the arteries and protects against heart disease.
Triglycerides are another form of fat in the blood that may increase the risk of heart disease.
Ezetimibe Mylan works by reducing the absorption of cholesterol from the digestive tract. Ezetimibe Mylan does not help with weight loss.
The cholesterol-lowering effect of Ezetimibe Mylan adds to that provided by statins, a group of medicines that work by reducing the body's own production of cholesterol.
Ezetimibe Mylan is used for patients who cannot control their cholesterol levels with a cholesterol-lowering diet alone. You must follow a cholesterol-lowering diet while taking this medicine.
Ezetimibe Mylan is used in addition to diet if you have:
-
elevated cholesterol levels in the blood (primary hypercholesterolemia [heterozygous familial and non-familial])
together with a statin, when your cholesterol is not adequately controlled with a statin alone
alone, when treatment with statins is not appropriate or not tolerated -
an inherited disease (homozygous familial hypercholesterolemia) that increases cholesterol levels in the blood. You will also be prescribed a statin, and you may be prescribed other medicines
-
an inherited disease (homozygous sitosterolemia, also known as phytosterolemia) – which increases levels of plant sterols in the blood.
If you have heart disease, Ezetimibe Mylan in combination with cholesterol-lowering medicines called statins reduces the risk of heart attack, stroke, surgical intervention to improve blood flow to the heart, or hospitalization due to chest pain.
Ezetimibe Mylan does not help you to lose weight.
2. What you need to know before taking Ezetimibe Mylan
If Ezetimibe Mylan is prescribed together with a statin, please read the patient information leaflet for that specific medicine.
Do not take Ezetimibe Mylan if:
- you are allergic to ezetimibe or to any of the other ingredients of this medicine (listed in section 6).
Do not take Ezetimibe Mylan together with a statin if:
- you currently have liver problems
- you are pregnant or breastfeeding.
Warnings and precautions
Talk to your doctor or pharmacist before taking Ezetimibe Mylan.
Inform your doctor about all medical conditions you have, including allergies.
Your doctor should order a blood test before starting treatment with Ezetimibe Mylan in combination with a statin, to check how well your liver is functioning.
Your doctor may also ask you to have periodic blood tests to monitor liver function after you start taking Ezetimibe Mylan with a statin.
If you have moderate or severe liver problems, the use of Ezetimibe Mylan is not recommended.
The safety and efficacy of Ezetimibe Mylan administered in combination with fibrates (medicines used to lower cholesterol) have not been established.
If you experience muscle pain, tenderness, or weakness while taking these tablets—especially if accompanied by fever—inform your doctor immediately.
Children and adolescents
Do not give this medicine to children and adolescents aged 6 to 17 years unless prescribed by a specialist, as there is limited data on safety and efficacy in this age group.
Do not give this medicine to children under 6 years of age, as there is no available information on its use in this age group.
Other medicines and Ezetimibe Mylan
Inform your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including those obtained without a prescription. In particular, inform your doctor or pharmacist if you are taking any of the following medicines:
- cyclosporine (a medicine often used in organ transplant patients)
- medicines that prevent blood clotting, such as warfarin, phenprocoumon, acenocoumarol, or fluindione (anticoagulants)
- cholestyramine (a medicine used to lower cholesterol), as it may alter the effectiveness of Ezetimibe Mylan
- fibrates (medicines used to lower cholesterol).
Pregnancy and breastfeeding
Do not take Ezetimibe Mylan together with a statin if you are pregnant, trying to become pregnant, or think you may be pregnant. If you become pregnant while taking Ezetimibe Mylan with a statin, stop both treatments immediately and contact your doctor.
There is no experience with the use of Ezetimibe Mylan without a statin during pregnancy.
Do not take Ezetimibe Mylan together with a statin while breastfeeding, as it is not known whether both medicines are excreted in human milk. Ezetimibe Mylan—even when taken alone without a statin—should not be used during breastfeeding.
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
Ezetimibe Mylan is not expected to affect your ability to drive or operate machinery. However, you should be aware that some people may experience dizziness after taking Ezetimibe Mylan.
Ezetimibe Mylan contains lactose monohydrate and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially "sodium-free".
3. How to take Ezetimibe Mylan
Take Ezetimibe Mylan exactly as prescribed by your doctor. Continue taking your other cholesterol-lowering medicines unless your doctor tells you otherwise. If in doubt, consult your doctor or pharmacist.
Before starting Ezetimibe Mylan, you must follow a cholesterol-lowering diet.
You must continue this diet while taking Ezetimibe Mylan.
Adults and adolescents (aged 10 to 17 years)
The recommended dose is one 10 mg Ezetimibe Mylan tablet once daily, taken by mouth.
You may take the tablets at any time of day, with or without food.
Instructions for opening the peel-off foil blister pack
- Do not push the tablet out through the blister.
- For perforated blisters: remove either side of the perforated area as shown in the figure.
- Hold the blister strip at the edges and separate one blister from the rest of the strip by gently tearing along the perforation around it.
- Carefully peel back the paper covering from the unsealed area.
- Remove the tablet from the opened blister.
If your doctor has prescribed Ezetimibe Mylan together with a statin, both medicines may be taken at the same time. In this case, also refer to the specific dosing instructions provided in the patient information leaflet of the other medicine.
If your doctor has prescribed Ezetimibe Mylan together with colestyramine or any other bile acid sequestrant (cholesterol-lowering medicines), you must take Ezetimibe Mylan at least 2 hours before or 4 hours after taking the bile acid sequestrant.
If you take more Ezetimibe Mylan than you should
If you take more Ezetimibe Mylan than prescribed, contact your doctor or pharmacist.
If you forget to take Ezetimibe Mylan
Do not take a double dose to make up for the missed dose. Simply take your next dose at the usual time the following day.
If you stop taking Ezetimibe Mylan
Talk to your doctor or pharmacist before stopping treatment with this medicine, as your cholesterol levels may rise again.
If you have any questions about how to use this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.
Tell your doctor or go to the nearest hospital emergency department immediately if you experience any of the
following serious side effects. These side effects are not known (frequency cannot be estimated from the available
data), but may require urgent medical attention:
- muscle pain, tenderness, or weakness of unknown cause. This is because, in rare cases, muscle problems, including injury to muscle tissue leading to kidney damage, can be serious and potentially life-threatening
- allergic reactions, including swelling of the face, lips, tongue, and/or throat, which may cause difficulty breathing or swallowing (requiring immediate treatment)
- inflammation of the pancreas, often with severe abdominal pain
- gallstones or inflammation of the gallbladder (which may cause abdominal pain, feeling unwell)
- red, raised rash, sometimes with target-shaped lesions
- inflammation of the liver (which may cause fatigue, fever, feeling unwell, general malaise, yellowing of the skin and eyes, pale stools, and dark urine).
When used alone, the following side effects have been reported:
Common (may affect up to 1 in 10 people):
- abdominal pain
- diarrhoea
- flatulence
- feeling of fatigue.
Uncommon (may affect up to 1 in 100 people):
- increases in blood test values related to liver function and muscle function
- cough
- indigestion
- heartburn
- feeling unwell
- joint pain
- muscle spasms
- neck pain
- decreased appetite
- pain
- chest pain
- hot flushes
- high blood pressure.
Additionally, when the medicine was used together with a statin, the following side effects have been reported:
Common (may affect up to 1 in 10 people):
- increases in blood test values related to liver function
- headache
- muscle pain
Uncommon (may affect up to 1 in 100 people):
- tingling sensation
- dry mouth
- stomach discomfort, feeling unwell, vomiting with blood, blood in stools
- rash
- urticaria
- back pain
- muscle weakness
- pain in arms and legs
- unusual tiredness or weakness
- swelling, especially of the hands and feet.
Additionally, when used with or without a statin, the following side effects have been reported:
Not known (frequency cannot be estimated from the available data):
- dizziness
- allergic reactions including rash and urticaria
- constipation
- reduction in blood cell count, which may cause bruising/bleeding (thrombocytopenia)
- tingling sensation
- depression
- unusual tiredness or weakness
- shortness of breath.
When used together with fenofibrate, the following side effect has been reported:
Common (may affect up to 1 in 10 people):
- abdominal pain.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Ezetimibe Mylan
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister, packaging, or bottle after "EXP". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Bottles: use within 100 days of opening.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
6. Package contents and other information
What Ezetimibe Mylan contains
The active substance is ezetimibe. Each tablet contains 10 mg of ezetimibe.
The other components are: monohydrate lactose (see section 2 "Ezetimibe Mylan contains monohydrate lactose"), sodium lauryl sulfate (E487), sodium croscarmellose, hypromellose (E464), crospovidone (type B), microcrystalline cellulose, magnesium stearate.
Description of the appearance of Ezetimibe Mylan and package contents
Ezetimibe Mylan 10 mg tablets are white to off-white, capsule-shaped tablets with bevelled edges, marked with "M" on one side and "EE1" on the other.
Ezetimibe Mylan 10 mg tablets are available in blisters or peelable foil blisters containing 14, 28, 30, 56, 84, 90, 98 and 100 tablets; unit-dose perforated divisible blisters containing 14 x 1, 28 x 1, 30 x 1, 50 x 1, 90 x 1 and 98 x 1 tablets; calendar blister packs containing 28 and 30 tablets; and plastic bottles containing 14, 28, 50, 56, 84, 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Mylan S.p.A.
Via Vittor Pisani 20
20124 Milan, Italy
Manufacturer
Mylan Hungary Kft, H-2900 Komárom, Mylan utca 1, Hungary
Mylan Germany GmbH Zweigniederlassung Bad Homburg v. d. Hoehe, Benzstrasse 1, Bad Homburg v. d. Hoehe, Hessen, 61352, Germany
This medicinal product is authorized in other EEA member states and in the United Kingdom (Northern Ireland)
under the following names:
Belgium Ezetimibe Viatris 10 mg tabletten
Cyprus Ezetimibe/Mylan 10 mg Tablets
Czech Republic Ezetimib Viatris 10 mg, tablety
Denmark Ezetimibe Viatris
France EZETIMIBE VIATRIS 10 mg, comprimé
Germany Ezetimib Mylan 10 mg Tabletten
Greece Ezetimibe Mylan 10 mg Tablets
Ireland Ezetimibe 10 mg Tablets
Italy Ezetimibe Mylan
Luxembourg Ezetimibe Viatris 10 mg comprimés
Portugal Ezetimiba Mylan
Spain Ezetimiba Viatris 10 mg comprimidos EFG
Sweden Ezetimibe Viatris
Netherlands Ezetimibe Viatris 10 mg, tabletten
United Kingdom (Northern Ireland) Ezetimibe 10 mg Tablets