Pluscard

Package Leaflet: Information for the Patient

Pluscard, 100 mg + 40 mg, Tablets

(Acetylsalicylic Acid + Glycine)

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

This Medication Should Always be Taken Exactly as Described in the Patient Leaflet or as Advised by a Doctor or Pharmacist.

• Keep this Leaflet, so you can Read it Again if you Need to.
• If you Need Advice or Additional Information, Consult a Pharmacist.
• If you Experience any Side Effects, including any Possible Side Effects not Listed in the Leaflet, Inform your Doctor or Pharmacist. See Section 4.
• If there is no Improvement or you Feel Worse, Contact your Doctor.

Table of Contents of the Leaflet

• 1. What is Pluscard and what is it used for
• 2. Important Information before Taking Pluscard
• 3. How to Take Pluscard
• 4. Possible Side Effects
• 5. How to Store Pluscard
• 6. Package Contents and other Information

1. What is Pluscard and what is it used for

Pluscard Contains two Active Substances: Acetylsalicylic Acid and Glycine.
Acetylsalicylic Acid Inhibits the "Clumping" (Aggregation) of Blood Platelets, and Glycine Protects the Gastrointestinal Tract from the Irritating Effects of Acetylsalicylic Acid.
In Clinical Trials, it has been Shown that Small Doses of Acetylsalicylic Acid (50 to 325 mg)
Effectively Inhibit Platelet Aggregation, Playing a Significant Role in Preventing the Formation of Blood Clots in Blood Vessels.
The Second Active Substance of the Medication, Glycine, Increases the Solubility of Acetylsalicylic Acid and
Facilitates its Absorption.
Pluscard is Used:

• to Prevent Myocardial Infarction in Patients with Cardiovascular Disease;
• to Prevent Thromboembolic Complications after Myocardial Infarction, Stroke, Coronary Artery Procedures, and Angina Pectoris;
• in Acute Myocardial Infarction or Suspected Acute Myocardial Infarction.

2. Important Information before Taking Pluscard

When not to Take Pluscard:

150 mg per Day in the Third Trimester of Pregnancy (the Last Three Months of Pregnancy). Due to the Risk of Reye's Syndrome, Acetylsalicylic Acid should not be Used in Children under 16 Years of Age.

Warnings and Precautions

Before Starting to Take Pluscard, Discuss it with your Doctor or Pharmacist:

You should Consult your Doctor even if the Above Warnings Refer to Situations that Occurred in the Past.

Special Precautions in Certain Patient Groups Taking this Medication:

Children and Adolescents
Due to the Possible Role in the Development of Reye's Syndrome (a Disease Characterized by Damage to Multiple Organs, Mainly the Brain and Liver), Acetylsalicylic Acid should not be Used in Children under 16 Years of Age.
Patients with Renal and/or Hepatic Impairment
Caution should be Exercised when Administering the Medication to Patients with Renal and/or Hepatic Impairment.
Elderly Patients
Elderly Patients (over 65 Years of Age) should be Especially Careful when Following the Doctor's Instructions. The Medication should be Used in Smaller Doses and at Longer Intervals, due to the Increased Risk of Adverse Effects.

Pluscard and other Medications

Tell your Doctor or Pharmacist about all Medications you are Currently Taking, have Recently Taken, or Plan to Take.
Contact your Doctor if you are Taking any of the Following Medications.

• Angiotensin-Converting Enzyme (ACE) Inhibitors(used to Treat High Blood Pressure): Acetylsalicylic Acid Reduces their Antihypertensive Effect.
• Acetazolamide(used to Treat Glaucoma): Acetylsalicylic Acid may Significantly Increase the Concentration and Toxicity of Acetazolamide .
• Anticoagulant Medications(e.g., Heparin, Warfarin): Concurrent Use of Acetylsalicylic Acid and Anticoagulant Medications may Enhance the Anticoagulant Effect, Increasing the Risk of Bleeding.
• Valproic Acid(used to Treat Epilepsy, among other Conditions): Acetylsalicylic Acid Enhances the Toxic Effect of Valproic Acid, while Valproic Acid Enhances the Anti-Aggregatory Effect of Acetylsalicylic Acid, Increasing the Risk of Bleeding.
• Diuretics(medications that Increase Urine Production): Acetylsalicylic Acid may Reduce their Efficacy and Enhance the Toxic Effect of Furosemide on the Ear.
• Methotrexate(used to Treat Certain Cancers and Rheumatoid Arthritis): Acetylsalicylic Acid Enhances the Toxic Effect of Methotrexate on the Bone Marrow. Pluscard should not be Used Concurrently with Methotrexate in Doses of 15 mg per Week or Higher.
• Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)(e.g., Ibuprofen) or Pain Relievers(e.g., Paracetamol): Concurrent Use of Acetylsalicylic Acid with these Medications is not Recommended, due to the Increased Risk of Peptic Ulcer Disease and Gastrointestinal Bleeding.
• CorticosteroidsUsed Systemically (so-called Steroids, used to Treat Rheumatic Disease, among other Conditions): with the Exception of Hydrocortisone (used as Replacement Therapy in Addison's Disease), when Administered Concurrently with Acetylsalicylic Acid, they Increase the Risk of Peptic Ulcer Disease and Gastrointestinal Bleeding, and Reduce the Concentration of Salicylates in the Blood during Treatment, while Increasing the Risk of Salicylate Overdose after Treatment.
• Antidiabetic Medications:Acetylsalicylic Acid Enhances the Blood Sugar-Lowering Effect of these Medications. Pluscard should not be Used Concurrently with Sulfonylurea Derivatives.
• Medications that Increase Uric Acid Excretion(e.g., Probenecid, Sulfinpyrazone): Salicylates Weaken the Effect of Medications that Increase Uric Acid Excretion. Pluscard should not be Taken Concurrently with Medications Used to Treat Gout.
• Digoxin(used to Treat Heart Failure and Heart Rhythm Disorders): Acetylsalicylic Acid may Enhance its Effect.
• Thrombolytic Medications(used to Prevent Blood Clot Formation): Acetylsalicylic Acid may Enhance the Effect of Thrombolytic Medications, such as Streptokinase and Alteplase.
• Muscle Relaxants(e.g., Baclofen): Glycine Enhances the Effect of Muscle Relaxants.
• Metal Compounds:Glycine may Form Complexes with Metal Compounds, so they should not be Used Concurrently with Pluscard.
• Metamizole:Concurrent Use of Metamizole with Acetylsalicylic Acid may Reduce the Inhibition of Blood Coagulation by Acetylsalicylic Acid, and the Blood-Thinning Effect may be Weaker. Therefore, Metamizole should be Used with Caution in Patients Taking Acetylsalicylic Acid in Small Doses to Prevent Myocardial Infarction and Stroke.

Pluscard with Food, Drink, and Alcohol

Pluscard should be Taken with or after a Meal and Washed Down with 1 Glass of Liquid.
Alcohol Often Increases the Frequency and Severity of Gastrointestinal Bleeding Caused by Acetylsalicylic Acid. You should not Drink Alcohol during Treatment.

Pregnancy and Breastfeeding

If you are Pregnant or Breastfeeding, Think you may be Pregnant, or are Planning to have a Child, Consult your Doctor or Pharmacist before Taking this Medication.
Pregnancy
The Medication should not be Used during Pregnancy, before Taking the Medication, Consult your Doctor.
Acetylsalicylic Acid in a Dose > 150 mg per Day is Contraindicated during the Last Trimester of Pregnancy without Special Medical Advice, as Acetylsalicylic Acid may Cause Fetal Developmental Abnormalities and Complications during Delivery.
Breastfeeding
Consult your Doctor before Taking the Medication. Salicylates Pass into Breast Milk in Small Amounts, so you should Avoid Taking the Medication during Breastfeeding.

Driving and Operating Machines

Pluscard does not Affect the Ability to Drive Vehicles or Operate Machines.

3. How to Take Pluscard

This Medication should Always be Taken Exactly as Described in the Patient Leaflet or as Advised by a Doctor or Pharmacist.
In Case of Doubt, Consult your Doctor or Pharmacist.
The Decision to Start Treatment and the Dose of Pluscard should be Made by a Doctor.

Recommended Dose:

• Adults and Adolescents over 16 Years of Age:
• Prevention of Myocardial Infarction: usually 1 Tablet per Day.
• Prevention of Thromboembolic Complications after:
• Myocardial Infarction: usually 1 Tablet per Day;
• Stroke: usually 2 Tablets per Day.
• Prevention of Thromboembolic Complications after Coronary Artery Procedures: usually 1 Tablet per Day.
• In Angina Pectoris: usually 1 Tablet per Day.
• In Acute Myocardial Infarction or Suspected Acute Myocardial Infarction: 3 Tablets as a Single Dose - they should be Chewed Thoroughly to Accelerate Absorption.

Tablets should be Taken with or after a Meal, Washed Down with Water.
Tablets should be Swallowed Whole (except for the Indication: Acute Myocardial Infarction or Suspected Acute Myocardial Infarction).
Elderly Patients:
There is no Precise Data on the Benefit-Risk Ratio of Acetylsalicylic Acid in this Patient Group. It is Recommended that the Doctor Choose the Dose of the Medication Based on the Renal Function of Elderly Patients.
Patients with Renal and/or Hepatic Impairment:
Caution should be Exercised when Administering the Medication to Patients with Severe Renal and/or Hepatic Impairment.

Taking a Higher than Recommended Dose of Pluscard

Symptoms of Overdose Include: Ringing or Buzzing in the Ears, Headache, Diarrhea, Abdominal Pain, Disorientation, Dizziness, Drowsiness, Rapid Breathing, Nausea, Vomiting, Ketoacidosis, Respiratory Alkalosis, and Metabolic Acidosis. Additionally, Decreased Central Nervous System Function may Lead to Coma. Cardiac Arrest and Respiratory Failure may also Occur.
In Case of Overdose, Contact your Doctor Immediately, who, if Necessary, will Provide Appropriate Treatment (Administration of Activated Charcoal, Symptomatic Treatment).

Missing a Dose of Pluscard

In Case of a Missed Dose, Take it as Soon as Possible.
However, if it is Almost Time for the Next Dose, Skip the Missed Dose.
Do not Take a Double Dose to Make up for the Missed Dose.
If you have any Further Doubts about the Use of this Medication, Consult 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 Inform your Doctor or Go to the Nearest Hospital if:

• you Experience Angioedema (Rapidly Progressing Swelling of the Skin, Subcutaneous Tissue, Mucous Membranes, or Submucosal Tissue). Swelling in the Head and Neck Area may Cause Difficulty Swallowing and Breathing;
• you Experience Bleeding, such as Gastrointestinal Bleeding (symptoms: Black Stool) or Hemorrhage.

The Following Side Effects may Occur:

• Abdominal Pain, Heartburn, or Indigestion, Feeling of Fullness in the Upper Abdomen, Nausea with or without Vomiting;
• Damage to the Gastric Mucosa;
• Relapse of Peptic Ulcer Disease;
• Gastrointestinal Bleeding (black, tarry Stool), Perforation (perforation of the Stomach or Intestine). Gastric Ulcer Occurs in 15% of Patients who have been Taking Acetylsalicylic Acid for a Long Time;
• Focal Necrosis of Hepatocytes, Liver Tenderness, and Enlargement (especially in Patients with Juvenile Rheumatoid Arthritis, Systemic Lupus Erythematosus, Rheumatic Fever, or a History of Liver Disease);
• Transient Increase in Serum Aminotransferase Activity, Alkaline Phosphatase, and Bilirubin Concentration;
• Proteinuria, Presence of Leukocytes and Erythrocytes in Urine, Renal Papillary Necrosis, Interstitial Nephritis;
• Heart Failure;
• Hypertension;
• Tinnitus (usually as a Sign of Overdose), Hearing Disorders, Dizziness;
• Thrombocytopenia (decreased Platelet Count), Anemia due to Microbleeding from the Gastrointestinal Tract, Hemolytic Anemia in Patients with Glucose-6-Phosphate Dehydrogenase Deficiency, Decreased White Blood Cell Count (leukopenia, agranulocytosis, eosinopenia), Increased Risk of Bleeding, Prolonged Bleeding Time, Prolonged Coagulation Time;
• especially in Patients with Asthma, Allergic Reactions may Occur (difficulty Breathing, Coughing, Chest Tightness, Dizziness, Skin Rash, Angioedema, Bronchospasm, Anaphylactic Shock).

Reporting Side Effects

If you Experience any Side Effects, including any Side Effects not Listed in the Leaflet, Inform your Doctor or Pharmacist, or Nurse.
Side Effects can be Reported Directly to the Department for Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Aleje 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, you can Help Gather more Information on the Safety of the Medication.

5. How to Store Pluscard

The Medication should be Stored in a Place that is not Visible and not Accessible to Children.
Store in a Temperature below 25°C.
Do not Use this Medication after the Expiration Date Stated on the Box: EXP.
The Expiration Date Refers to the Last Day of the Specified Month.
Medications should not be Disposed of in Sewers or Household Waste Containers. Ask your Pharmacist what to do with Medications that are no Longer Needed. This will Help Protect the Environment.

6. Package Contents and other Information

What Pluscard Contains

• The Active Substances of the Medication are Acetylsalicylic Acid and Glycine. One Tablet Contains 100 mg of Acetylsalicylic Acid and 40 mg of Glycine.
• The Other Excipients are: Potato Starch, Talc.

What Pluscard Looks Like and what the Package Contains

The Medication has the Form of Triangular Tablets, Convex on both Sides, White in Color, with a Cross Engraved on one Side and a Break Line on the other Side.
The Break Line on the Tablet is only to Facilitate Breaking, not to Divide the Tablet into Equal Doses.
The Package Contains: 15, 20, 30, 40, or 60 Tablets in Blisters in a Cardboard Box.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
phone: (42) 22-53-100

Manufacturer

Medicofarma S.A.
ul. Tarnobrzeska 13
26-613 Radom

Date of the Last Update of the Leaflet: