ETIBAX 10 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Etibax, 10 mg, Tablets
   1. Read All of This Leaflet Carefully Before Taking This Medicine.
   2. Table of Contents of the Leaflet
3. What Etibax Is and What It Is Used For
4. Important Information Before Taking Etibax
   1. When Not to Take Etibax:
   2. When Not to Take Etibax in Combination with a Statin:
   3. Warnings and Precautions
   4. Children and Adolescents
   5. Etibax and Other Medications
   6. Pregnancy, Breastfeeding, and Fertility
   7. Driving and Using Machines
   8. Etibax Contains Lactose and Sodium
5. How to Take Etibax
   1. Taking Etibax and a Statin
   2. Taking Etibax and Another Medication Containing a Bile Acid Sequestrant (e.g., Cholestyramine)
   3. Taking More Than the Recommended Dose of Etibax
   4. Missing a Dose of Etibax
   5. Stopping Etibax
6. Possible Side Effects
   1. Seek Medical Attention Immediately If You Experience:
   2. Additional Side Effects Observed in Patients Taking Ezetimibe with Simvastatin or Medications Containing Ezetimibe or Simvastatin:
   3. Reporting Side Effects
7. How to Store Etibax
8. Contents of the Pack and Other Information
   1. What Etibax Contains
   2. What Etibax Looks Like and Contents of the Pack
   3. Marketing Authorization Holder
   4. Manufacturer/Importer

Package Leaflet: Information for the User

Etibax, 10 mg, Tablets

Ezetimibe

Read All of This Leaflet Carefully Before Taking This Medicine.

• Keep This 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. Do Not Pass It on to Others. It May Harm Them, Even if Their Symptoms Are the Same as Yours.
• If You Experience Any of the Following Symptoms, Tell Your Doctor or Pharmacist. See Section 4.

Table of Contents of the Leaflet

• 1. What Etibax Is and What It Is Used For
• 2. Important Information Before Taking Etibax
• 3. How to Take Etibax
• 4. Possible Side Effects
• 5. How to Store Etibax
• 6. Contents of the Pack and Other Information

1. What Etibax Is and What It Is Used For

Etibax Is Used to Lower High Cholesterol Levels.
This Medication Lowers the Level of Total Cholesterol, "Bad" Cholesterol (LDL Cholesterol), and Fatty Substances Called Triglycerides in the Blood. Additionally, Etibax Increases the Level of "Good" Cholesterol (HDL Cholesterol).
Ezetimibe, the Active Substance in Etibax, Reduces the Absorption of Cholesterol in the Gastrointestinal Tract.
Etibax Enhances the Effect of Statins, a Group of Medications That Lower Cholesterol Produced by the Body.
Cholesterol Is One of Several Fatty Substances Found in the Blood. Total Cholesterol Consists Mainly of LDL and HDL Cholesterol Fractions.
LDL Cholesterol Is Often Referred to as "Bad" Cholesterol Because It Can Build Up in the Walls of Arteries in the Form of Plaque. The Accumulation of This Plaque Can Eventually Lead to Narrowing of the Arterial Lumen, Which Can Cause a Reduction in Blood Flow or Blockage of Blood Flow to Vital Organs Such as the Heart and Brain. Blockage of Blood Flow Can Cause a Heart Attack or Stroke.
HDL Cholesterol Is Often Referred to as "Good" Cholesterol Because It Helps Prevent the Build-Up of "Bad" Cholesterol in the Arteries and Protects Against the Development of Heart Disease.
Triglycerides Are Another Type of Fat Found in the Blood, Which Can Contribute to an Increased Risk of Developing Heart Disease.
The Medication Is Used in Patients for Whom Diet Alone Is Not Enough to Control Blood Cholesterol Levels. While Taking This Medication, You Should Continue to Follow a Cholesterol-Lowering Diet.
Etibax Is Used as a Supplement to a Cholesterol-Lowering Diet in the Following Cases:

• High Blood Cholesterol Levels (Primary Hypercholesterolemia [Heterozygous Familial or Non-Familial])
• In Combination with a Statin, If Cholesterol Levels Are Not Adequately Controlled with Statin Therapy Alone
• As a Single Medication (Monotherapy), If Statin Therapy Is Not Suitable or Is Poorly Tolerated
• Genetic Disorders (Homozygous Familial Hypercholesterolemia), Which Cause High Blood Cholesterol Levels. The Patient Will Also Be Treated with a Statin and May Receive Other Treatments.
• Genetic Disorders (Homozygous Sitosterolemia, Also Known as Phytosterolemia), Which Cause High Levels of Plant Sterols in the Blood.
• Heart Disease. Etibax, When Taken with Cholesterol-Lowering Medications Called Statins, Reduces the Risk of Heart Attack, Stroke, Surgery to Increase Blood Flow to the Heart, or Hospitalization for Chest Pain.

Etibax Has No Effect on Weight Loss.

2. Important Information Before Taking Etibax

If You Are Taking Etibax in Combination with a Statin, Read the Package Leaflet for That Medication.

When Not to Take Etibax:

• If You Are Allergic (Hypersensitive) to Ezetimibe or Any of the Other Ingredients of This Medication (See Section 6: Contents of the Pack and Other Information).

When Not to Take Etibax in Combination with a Statin:

• If You Currently Have Liver Problems.
• If You Are Pregnant or Breastfeeding.

Warnings and Precautions

Before Starting Etibax, Discuss It with Your Doctor or Pharmacist.

• Tell Your Doctor About Any Medical Conditions, Including Allergies.
• Before Starting Etibax in Combination with a Statin, Your Doctor Should Perform Blood Tests to Evaluate Liver Function.
• Your Doctor May Also Perform Blood Tests to Evaluate Liver Function After Starting Etibax in Combination with a Statin.

Etibax Is Not Recommended for Patients with Moderate or Severe Liver Impairment.
If You Experience Muscle Pain or Weakness, Seek Medical Attention Immediately.
This Could Be a Sign of a Muscle Condition Called Rhabdomyolysis.
The Safety and Efficacy of Etibax in Combination with Certain Cholesterol-Lowering Medications, Fibrates, Have Not Been Established.

Children and Adolescents

Do Not Use This Medication in Children and Adolescents (Aged 6 to 17 Years) Unless Prescribed by a Specialist Due to a Lack of Data on Safety and Efficacy.
Do Not Use This Medication in Children Under 6 Years of Age Due to a Lack of Data in This Age Group.

Etibax and Other Medications

Tell Your Doctor or Pharmacist About All Medications You Are Currently Taking or Plan to Take.
In Particular, Tell Your Doctor If You Are Taking Medications Containing Any of the Following Active Substances:

• Cyclosporine (Often Used in Patients Who Have Received an Organ Transplant)
• Medications Containing Substances That Prevent Blood Clots, Such as Warfarin, Phenprocoumon, Acenocoumarol, or Flindione (Anticoagulant Medications)
• Cholestyramine (Also Used to Lower Cholesterol Levels), as It Affects the Action of Etibax
• Fibrates (Also Used to Lower Cholesterol Levels)

Pregnancy, Breastfeeding, and Fertility

Do Not Take Etibax in Combination with a Statin If You Are Pregnant, Plan to Become Pregnant, or Suspect You May Be Pregnant. If You Become Pregnant While Taking Etibax in Combination with a Statin, Stop Taking Both Medications and Consult Your Doctor.
There Is No Clinical Data on the Use of Etibax Alone During Pregnancy.
If You Are Pregnant, Ask Your Doctor for Advice Before Taking This Medication.
Do Not Take Etibax in Combination with a Statin During Breastfeeding, as It Is Not Known Whether the Medication Passes into Breast Milk.
Etibax Should Not Be Used in Breastfeeding Women, Even Without a Statin.
Ask Your Doctor or Pharmacist for Advice Before Taking Any Medication.

Driving and Using Machines

Etibax Is Not Expected to Affect Your Ability to Drive or Use Machines.
However, Consider That Some People May Experience Dizziness After Taking This Medication.

Etibax Contains Lactose and Sodium

Etibax Tablets Contain a Sugar Called Lactose. If You Have Been Diagnosed with an Intolerance to Some Sugars, Consult Your Doctor Before Taking This Medication.
This Medication Contains Less Than 1 mmol of Sodium (23 mg) per Tablet, Which Means It Is Essentially "Sodium-Free".

3. How to Take Etibax

Always Take This Medication Exactly as Your Doctor Has Told You. Unless Your Doctor Has Told You Otherwise, Continue to Take Any Other Cholesterol-Lowering Medications You Are Already Taking. If You Are in Doubt, Consult Your Doctor or Pharmacist.

• Before Starting Etibax, Follow a Cholesterol-Lowering Diet.
• While Taking This Medication, Continue to Follow a Cholesterol-Lowering Diet.

The Recommended Dose Is One Tablet Taken Orally Once a Day.
Etibax Can Be Taken at Any Time of Day, with or Without Food.

Taking Etibax and a Statin

If Your Doctor Has Prescribed Etibax and a Statin, You Can Take Both Medications at the Same Time. In This Case, Read the Dosing Information in the Package Leaflet for the Other Medication.

Taking Etibax and Another Medication Containing a Bile Acid Sequestrant (e.g., Cholestyramine)

If Your Doctor Has Prescribed Etibax and Another Cholesterol-Lowering Medication Containing Cholestyramine or Another Bile Acid Sequestrant, Take Etibax at Least 2 Hours Before or 4 Hours After Taking the Bile Acid Sequestrant.

Taking More Than the Recommended Dose of Etibax

Consult Your Doctor or Pharmacist.

Missing a Dose of Etibax

Do Not Take a Double Dose to Make Up for a Forgotten Tablet. Take Your Usual Dose the Next Day at the Same Time.

Stopping Etibax

Discuss This with Your Doctor or Pharmacist, as Your Cholesterol Levels May Rise Again.
If You Have Any Further Questions on the Use of This Medication, Ask Your Doctor or Pharmacist.

4. Possible Side Effects

Like All Medications, Etibax Can Cause Side Effects, Although Not Everybody Gets Them.

Seek Medical Attention Immediately If You Experience:

• Unexplained Muscle Pain, Tenderness, or Weakness. In Rare Cases, Muscle Symptoms, Including Muscle Breakdown, Can Be Severe and Life-Threatening.
• Allergic Reactions, Including Swelling of the Face, Lips, Tongue, and/or Throat, Which May Cause Difficulty in Breathing or Swallowing (Which Require Immediate Treatment). These Include Hypersensitivity Reactions, Anaphylaxis, and Angioedema.
• A Raised, Red Rash, Sometimes with Target-Shaped Lesions (Erythema Multiforme)

Other Side Effects
When Ezetimibe Is Taken Alone, the Following Side Effects Have Been Reported:
Common(May Affect Up to 1 in 10 People)

• Abdominal Pain;
• Diarrhea;
• Bloating;
• Feeling Tired.

Uncommon(May Affect Up to 1 in 100 People)

• Increased Levels of Certain Liver or Muscle Enzymes in the Blood;
• Cough;
• Indigestion;
• Heartburn, Nausea;
• Joint Pain;
• Muscle Cramps;
• Neck Pain;
• Decreased Appetite;
• Pain;
• Chest Pain;
• Flushing;
• High Blood Pressure.

In Addition, When Taken in Combination with a Statin, the Following Side Effects Have Been Reported:
Common(May Affect Up to 1 in 10 People)

• Increased Levels of Certain Liver Enzymes in the Blood;
• Headache, Muscle Pain.

Uncommon(May Affect Up to 1 in 100 People)

• Numbness;
• Dry Mouth;
• Itching, Rash, Hives;
• Back Pain;
• Muscle Weakness, Pain in Arms and Legs;
• Unexplained Tiredness or Weakness; Swelling, Especially of the Hands and Feet;
• Pain, Nausea, Vomiting, Vomiting Blood, Blood in Stool (Gastritis).

When Taken in Combination with Fenofibrate, the Following Side Effect Has Been Reported:
Common(May Affect Up to 1 in 10 People)

• Abdominal Pain.

In Addition, the Following Side Effects Have Been Reported:
Rare(May Affect Up to 1 in 10,000 People)

• Dizziness;
• Muscle Pain;
• Liver Problems;
• Allergic Reactions, Including Rash and Hives;
• Muscle Pain, Tenderness, or Weakness, Muscle Breakdown;
• Gallstones or Inflammation of the Gallbladder (Which May Cause Abdominal Pain, Nausea, Vomiting);
• Pancreatitis, Often with Severe Abdominal Pain;
• Constipation;
• Decreased Blood Cell Count, Which May Cause Bruising/Bleeding (Thrombocytopenia);
• Numbness;
• Depression;
• Unexplained Tiredness or Weakness;
• Shortness of Breath.

Additional Side Effects Observed in Patients Taking Ezetimibe with Simvastatin or Medications Containing Ezetimibe or Simvastatin:

• Hair Loss; Red, Raised Rash, Sometimes with Target-Shaped Lesions (Erythema Multiforme);
• Blurred Vision and Vision Disturbances (Each May Affect Up to 1 in 1,000 People);
• Rash That May Occur on the Skin or Mouth Ulcers (Drug-Induced Pemphigus) (Each May Affect Up to 1 in 10,000 People);
• Muscle Pain, Tenderness, or Weakness, Muscle Breakdown; Muscle Damage (Which May Affect Up to 1 in 10,000 People); Tendon Disorders, Sometimes Complicated by Tendon Rupture;
• Gynecomastia (Breast Enlargement in Men) (Which May Affect Up to 1 in 10,000 People).

Reporting Side Effects

If You Experience Any Side Effects, Including Those Not Listed in This Leaflet, Tell Your Doctor or Pharmacist, or Nurse. You Can Also Report Side Effects Directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49-21-301, Fax: +48 22 49-21-309,
Website: https://smz.ezdrowie.gov.pl
You Can Also Report Side Effects to the Marketing Authorization Holder.
By Reporting Side Effects, You Can Help Provide More Information on the Safety of This Medication.

5. How to Store Etibax

Keep This Medication Out of the Sight and Reach of Children.
Do Not Use This Medication After the Expiration Date Stated on the Carton or Blister Pack.
The Expiration Date Refers to the Last Day of the Month.
Store Below 25°C.
Do Not Throw Away Medications via Wastewater or Household Waste. Ask Your Pharmacist How to Dispose of Medications No Longer Needed. This Will Help Protect the Environment.

6. Contents of the Pack and Other Information

What Etibax Contains

• The Active Substance Is Ezetimibe. Each Tablet Contains 10 mg of Ezetimibe.
• The Other Ingredients Are: Lactose Monohydrate, Croscarmellose Sodium, Povidone K30, Sodium Lauryl Sulfate, Cornstarch, Magnesium Stearate.

What Etibax Looks Like and Contents of the Pack

Uncoated Capsule-Shaped Tablets, 7.9-8.5 mm in Length, White or Off-White in Color, with "E 10" Engraved on One Side and a Smooth Surface on the Other.
The Following Pack Sizes Are Available:

• Aclar-Coated Blister Packs Containing 28 or 90 Tablets in a Cardboard Box,
• Cold-Formed Blister Packs Containing 28 or 90 Tablets in a Cardboard Box,
• HDPE Bottles Containing 100 Tablets.

Not All Pack Sizes May Be Marketed.

Marketing Authorization Holder

Ranbaxy (Poland) Sp. z o.o.
Ul. Idzikowskiego 16
00-710 Warsaw

Manufacturer/Importer

Terapia S.A., Str. Fabricii nr.124, 400632 Cluj Napoca, Romania
Sun Pharmaceutical Industries Europe B.V., Polarisavenue 87, 2132 JH Hoofddorp, Noord-Holland,
Netherlands
To Find Out More About the Names of This Medication in Other EU Countries, Contact the Marketing Authorization Holder.
Date of Last Revision of the Leaflet:29.06.2023