Bevim

Package Leaflet: Information for the User

Bewim, 10 mg, Film-Coated Tablets

Prasugrel

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this Package Leaflet, You May Need to Read it Again.
• If You Have Any Further Questions, Ask Your Doctor or Pharmacist.
• This Medication has been Prescribed for You Only. Do Not Pass it on to Others. It may Harm them, even if their Symptoms are the Same as Yours.
• If You Experience any Side Effects, including those not Listed in this Package Leaflet, Tell Your Doctor or Pharmacist. See Section 4.

Package Leaflet Contents

• 1. What is Bewim and What is it Used for
• 2. Important Information Before Taking Bewim
• 3. How to Take Bewim
• 4. Possible Side Effects
• 5. How to Store Bewim
• 6. Package Contents and Other Information

1. What is Bewim and What is it Used for

Bewim, which Contains the Active Substance Prasugrel, Belongs to a Group of Medications Called Antiplatelet Medications. Platelets are Very Small Blood Cells that Circulate in the Blood. When a Blood Vessel is Damaged, for Example, by a Cut, Platelets Clump Together to Help Form a Blood Clot. Platelets Play a Crucial Role in Stopping Bleeding. The Formation of a Blood Clot in a Hardened Artery, such as a Coronary Artery, is Very Dangerous, as it can Block the Flow of Blood, Causing a Heart Attack (Myocardial Infarction), Stroke, or Death. The Presence of a Blood Clot in the Arteries that Supply Blood to the Heart can Reduce Blood Flow and Cause Unstable Angina (Severe Chest Pain). Bewim Inhibits Platelet Clumping and Thus Reduces the Risk of Blood Clot Formation. Bewim has been Prescribed by Your Doctor because You have had a Heart Attack or Unstable Angina, and You have Undergone a Procedure to Open Up Blocked Arteries in Your Heart. You may have had a Procedure where one or more Stents were Placed to Keep the Blocked or Narrowed Artery that Supplies Blood to the Heart Open. Bewim Reduces the Risk of Having Another Heart Attack, Stroke, or Death from these Events. Your Doctor will also Recommend Taking Aspirin (Acetylsalicylic Acid), which is also an Antiplatelet Medication.

2. Important Information Before Taking Bewim

When Not to Take Bewim

• If You are Allergic (Hypersensitive) to Prasugrel or any of the Other Ingredients of this Medication (Listed in Section 6). An Allergic Reaction may Cause a Rash, Itching, Swelling of the Face, Swelling of the Lips or Tongue, or Shortness of Breath. If You Experience these Symptoms, Tell Your Doctor Immediately.
• If You Have a Medical Condition that is Currently Causing Bleeding, such as Stomach or Intestinal Bleeding.
• If You Have Ever had a Stroke or a Transient Ischemic Attack (TIA).
• If You Have Severe Liver Disease.

Warnings and Precautions

Before Starting Bewim:
Starting Bewim should be Discussed with Your Doctor.
If any of the Following Situations Apply to You, You should Inform Your Doctor Before Taking Bewim:

• If You Have an Increased Risk of Bleeding, such as:
• Age 75 or Older. Your Doctor will Recommend a Daily Dose of 5 mg (Half a Tablet), as the Risk of Bleeding is Higher in Patients Over 75 Years Old;
• Recent Severe Injury;
• Recent Surgery (Including Dental Surgery);
• Recent or Recurring Stomach or Intestinal Bleeding (e.g., Stomach Ulcer or Colon Polyps);
• Body Weight Less than 60 kg. If You Weigh Less than 60 kg, Your Doctor will Recommend a Daily Dose of 5 mg (Half a Tablet);
• Moderate Kidney or Liver Disease;
• Taking Certain Medications (See "Bewim and Other Medications");
• Planned Surgery (Including Dental Surgery) in the Next Seven Days. Due to the Increased Risk of Bleeding, Your Doctor may Recommend Temporarily Stopping Bewim.
• If You Have Had an Allergic Reaction (Hypersensitivity) to Clopidogrel or Other Antiplatelet Medications, Inform Your Doctor Before Starting Bewim. If You Experience an Allergic Reaction After Taking Bewim, such as a Rash, Itching, Swelling of the Face, Swelling of the Lips or Tongue, or Shortness of Breath, Tell Your Doctor Immediately.

While Taking Bewim:
Tell Your Doctor Immediately if You Experience a Medical Condition Called Thrombotic Thrombocytopenic Purpura (TTP), which can Cause Symptoms such as Fever, Purple Spots on the Skin that can Look like Red Pinpoint Spots, with or without Symptoms of Extreme Fatigue, Confusion, Yellowing of the Skin or Eyes (Jaundice) (See Section 4 "Possible Side Effects").

Children and Adolescents

Bewim should not be Used in Children and Adolescents Under 18 Years of Age.

Bewim and Other Medications

Tell Your Doctor About all Medications You are Currently Taking, or have Recently Taken, and any Medications You Plan to Take, Including those Available Without a Prescription, Dietary Supplements, or Herbal Medications. In Particular, Inform Your Doctor if You are Taking Clopidogrel (an Antiplatelet Medication), Warfarin (an Anticoagulant), or "Non-Steroidal Anti-Inflammatory Medications" Used to Treat Pain and Fever (such as Ibuprofen, Naproxen, Etoricoxib). Taking these Medications with Bewim may Increase the Risk of Bleeding.
Tell Your Doctor if You are Taking Morphine or Other Opioids (Used to Treat Severe Pain).
While Taking Bewim, only Take other Medications if Your Doctor has Approved them.

Pregnancy, Breast-Feeding

If You are Pregnant or Breast-Feeding, Think You may be Pregnant or are Planning to have a Baby, Ask Your Doctor or Pharmacist for Advice Before Taking this Medication.
If You are Pregnant or Think You may be Pregnant, Inform Your Doctor Before Taking Bewim.
Bewim should only be Used After Discussing the Potential Benefits and Risks with Your Doctor.
If You are Breast-Feeding, Ask Your Doctor or Pharmacist for Advice Before Taking any Medication.

Driving and Using Machines

It is Unlikely that Bewim will Affect Your Ability to Drive or Use Machines.

Bewim Contains Lactose

If You have been Told by Your Doctor that You have an Intolerance to some Sugars, Contact Your Doctor Before Taking this Medication.

3. How to Take Bewim

Always Take this Medication Exactly as Your Doctor has Told You. If You are Not Sure, Check with Your Doctor or Pharmacist.
The Usual Dose of Bewim is 10 mg Once a Day. Treatment should be Initiated with a Single 60 mg Dose.
If You Weigh Less than 60 kg or are Over 75 Years Old, the Daily Dose of Bewim is 5 mg (Half a Tablet). Your Doctor will Recommend the Appropriate Dose of Aspirin (Usually Between 75 mg and 325 mg Once a Day).
Bewim can be Taken with or Without Food. Take Your Dose at About the Same Time Each Day. The Tablet can be Divided into Equal Doses.
It is Very Important to Inform Your Doctor, Dentist, and Pharmacist that You are Taking Bewim.

Taking More than the Recommended Dose of Bewim

Immediately Contact Your Doctor or Hospital, as there is an Increased Risk of Bleeding. Show the Package Leaflet to Your Doctor.

Missing a Dose of Bewim

If You Miss a Dose, Take it as Soon as Possible. If You Forget to Take a Dose for the Whole Day, Take the Next Dose at the Usual Time the Next Day. Do Not Take a Double Dose to Make Up for a Forgotten Dose.
When Using Packages of 28 Tablets, You can Check the Day You Last Took a Tablet on the Calendar Printed on the Blister Pack.

Stopping Bewim

Do Not Stop Taking Bewim Without Consulting Your Doctor. Stopping Bewim Too Soon may Increase the Risk of a Heart Attack.
If You have any Questions About this Medication, Ask Your Doctor or Pharmacist.

4. Possible Side Effects

Like all Medications, this Medication can Cause Side Effects, although not Everybody gets them.
You should Immediately Contact Your Doctor if You Experience:

• Sudden Numbness or Weakness of the Arm, Leg, or Face, Especially if it Affects one Side of the Body,
• Sudden Confusion, Difficulty Speaking or Understanding Others,
• Sudden Difficulty Moving, Loss of Balance or Coordination,
• Sudden Dizziness or Severe Headache of Unknown Cause. All these Events can be Symptoms of a Stroke. A Stroke is an Uncommon Side Effect in Patients Taking Bewim who have Never had a Stroke or TIA Before.

You should also Immediately Contact Your Doctor if You Experience:

• Fever and Purple Spots on the Skin that can Look like Red Pinpoint Spots, with or without Symptoms of Extreme Fatigue, Confusion, Yellowing of the Skin or Eyes (Jaundice) (See Section 2 "Important Information Before Taking Bewim"),
• Rash, Itching, Swelling of the Face, Swelling of the Lips or Tongue, or Shortness of Breath. These can be Symptoms of a Severe Allergic Reaction (See Section 2 "Important Information Before Taking Bewim").

You should Contact Your Doctor as Soon as Possible if You Experience:

• Blood in the Urine,
• Bleeding from the Back Passage, Blood in the Stool, or Black Stool,
• Uncontrolled Bleeding, e.g., from a Cut. All these Symptoms can Indicate Bleeding, the Most Common Side Effect of Bewim. Severe Bleeding, although Uncommon, can be Life-Threatening.

Common Side Effects (May Affect up to 1 in 10 People)

• Bleeding from the Stomach or Intestine,
• Bleeding from the Injection Site,
• Nosebleeds,
• Rash,
• Small Red Spots on the Skin (Purpura),
• Blood in the Urine,
• Bleeding Under the Skin (Hematoma) or into a Muscle, Causing Swelling,
• Low Hemoglobin or Red Blood Cell Count (Anemia)
• Bruising.

Uncommon Side Effects (May Affect up to 1 in 100 People)

• Allergic Reaction (Rash, Itching, Swelling of the Lips or Tongue, or Shortness of Breath),
• Spontaneous Bleeding into the Eye, Back Passage, Gums, or into the Abdomen Around Internal Organs,
• Bleeding After Surgery,
• Coughing Up Blood-Stained Sputum,
• Blood in the Stool.

Rare Side Effects (May Affect up to 1 in 1000 People)

• Low Platelet Count,
• Bleeding Under the Skin (Hematoma) Causing Swelling.

Reporting Side Effects

If You Experience any Side Effects, including those not Listed in this Package Leaflet, Tell Your Doctor, Pharmacist, or Nurse. You can Report Side Effects Directly to the Department for Monitoring of Adverse Reactions to Medicinal Products, the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: 22 49 21 301, Fax: 22 49 21 309
Email: [email protected]
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 Bewim

Keep this Medication out of the Sight and Reach of Children.
Do Not Use this Medication After the Expiry Date Stated on the Blister Pack and the Carton (EXP). The Expiry Date Refers to the Last Day of the Month.
There are no Special Storage Conditions for this Medication.
Medications should not be Disposed of via Wastewater or Household Waste. Ask Your Pharmacist how to Dispose of Medications that are no Longer Needed. This will Help Protect the Environment.

6. Package Contents and Other Information

What Bewim Contains

• The Active Substance is Prasugrel.

Each Film-Coated Tablet Contains 10 mg of Prasugrel (as a Base).

• The Other Ingredients are: Lactose, Hydroxypropylcellulose, Croscarmellose Sodium, Glyceryl Dibehenate, Sodium Lauryl Sulfate; Tablet Coating -Opadry AMB II 88A220016 Yellow:Polyvinyl Alcohol, Talc, Titanium Dioxide (E 171), Glycerol Monocaprylate (Type 1), Sodium Lauryl Sulfate, Yellow Iron Oxide (E 172)

What Bewim Looks Like and Contents of the Package

Yellow, Round, Biconvex Film-Coated Tablets, with "B23" Engraved on one Side and a Score Line on the Other Side. The Diameter of the Tablet is Approximately 10 mm.
The Tablet can be Divided into Equal Doses.
28, 30, 56, 60, and 90 Film-Coated Tablets are Packaged in Blisters.
Blister Pack: OPA/Aluminum/PVC/Aluminum, in a Cardboard Box.
Not all Pack Sizes may be Marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

GEDEON RICHTER POLSKA Sp. z o.o.
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki

Manufacturer

Gedeon Richter România S.A.
99-105 Cuza Vodă Street 99-105
540306 Târgu-Mureş
Romania

Date of Last Revision of the Package Leaflet: