Polopirina C Plus

Package Leaflet: Information for the Patient

Polopiryna C Plus, 500 mg + 300 mg + 200 mg, Effervescent Powder

Acetylsalicylic Acid + Ascorbic Acid + Calcium

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

This Medication Should Always be Taken Exactly as Described in this Package Leaflet or as Directed by a Doctor or Pharmacist.

• Keep this Package Leaflet to be Able to Read it Again if Necessary.
• If Advice or Additional Information is Needed, Consult a Pharmacist.
• If the Patient Experiences any Adverse Reactions, Including any Possible Adverse Reactions not Listed in this Package Leaflet, Inform a Doctor or Pharmacist. See Section 4.
• -If there is no Improvement or the Patient Feels Worse after 3-5 Days, Consult a Doctor.

Table of Contents of the Package Leaflet

• 1. What is Polopiryna C Plus and What is it Used for
• 2. Important Information Before Taking Polopiryna C Plus
• 3. How to Take Polopiryna C Plus
• 4. Possible Adverse Reactions
• 5. How to Store Polopiryna C Plus
• 6. Package Contents and Other Information

1. What is Polopiryna C Plus and What is it Used for

Polopiryna C Plus is a Combination Medication Containing Acetylsalicylic Acid, Ascorbic Acid (Vitamin C), and Calcium. Acetylsalicylic Acid Belongs to the Group of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). It has Anti-Pyretic, Analgesic, and Anti-Inflammatory Effects. Ascorbic Acid (Vitamin C) and Calcium Affect the Normal Functioning of Blood Vessel Walls, Reducing their Permeability and Exerting Anti-Edematous Effects. The Buffering Substances in the Medication Enable Rapid and Complete Dissolution of Polopiryna C Plus in Water, Making it Easily Absorbable and Well-Tolerated. The Medication is Recommended for Use in the Following Indications: Fever and Pain Associated with the Common Cold and Flu; Mild to Moderate Pain (Toothache, Neuralgia, Joint and Muscle Pain, Headache, Migraine).

2. Important Information Before Taking Polopiryna C Plus

When Not to Take Polopiryna C Plus

If the Patient is Hypersensitive to Acetylsalicylic Acid or Other Salicylates, Ascorbic Acid, Calcium, or any of the Other Components of the Medication (Listed in Section 6); In the Case of Active Peptic Ulcer Disease of the Stomach or Duodenum; Inflammatory Conditions of the Gastrointestinal Tract; In the Case of Hemorrhagic Diathesis, Coagulation Disorders, or the Use of Anticoagulant Medications; In the Case of Acid-Base Balance Disorders (in Diabetes, Uremia, Tetany); If the Patient has Significantly Elevated Calcium Levels in the Blood; If the Patient has Asthma Associated with Nasal Polyps (Induced or Exacerbated by Acetylsalicylic Acid); In Severe Renal, Hepatic, or Cardiac Failure; During Pregnancy and Breastfeeding; In Patients with Phenylketonuria (a Genetic Disorder Characterized by a Deficiency of Phenylalanine Hydroxylase); In Children Under 12 Years of Age with Chickenpox or Flu.

Warnings and Precautions

Particular Caution Should be Exercised when Taking Polopiryna C Plus if the Patient has a History of Hypersensitivity (Allergy) to Other NSAIDs; In the Case of Allergic Diseases (Asthma, Hay Fever); In the Case of Menstrual Bleeding or Excessive Uterine Bleeding; Before Surgical Procedures (Do not Take the Medication for at Least 5 Days); In the Case of Gout (Chronic Disease Associated with Purine Metabolism Disorders); After a History of Peptic Ulcer Disease or Gastrointestinal Bleeding; During Concomitant Treatment with Anticoagulant Medications (e.g., Oral Antivitamins K, Heparin, Low Molecular Weight Heparins, Antiplatelet Agents - Ticlopidine, Indobufen); In Patients with Renal or Hepatic Impairment; In the Case of Intrauterine Contraceptive Devices; In Patients with Hypertension; In Patients with Heart Failure; If the Patient has a Deficiency of Glucose-6-Phosphate Dehydrogenase (Due to the Risk of Hemolytic Anemia); In Patients Over 65 Years of Age - a Lower Dose Should be Administered - See Section 3. Consuming Alcohol During Treatment with the Medication may Enhance the Irritant Effect of Acetylsalicylic Acid on the Gastrointestinal Tract. The Use of Acetylsalicylic Acid in Children Under 12 Years of Age with Viral Infections (Chickenpox or Flu) may Cause the Onset of a Rare Disease Leading to Liver and Brain Damage, Known as Reye's Syndrome. Polopiryna C Plus Belongs to a Group of Medications that may Adversely Affect Fertility in Women. This Effect is Transient and Reverses After the End of Therapy. The Administration of Medications Containing Acetylsalicylic Acid may be Associated with a Slight Increase in the Risk of Heart Attack (Myocardial Infarction) or Stroke. This Risk Increases with Long-Term Administration of High Doses of the Medication. Do not Exceed the Recommended Dose and Duration of Treatment (3-5 Days). In the Case of Heart Problems, a History of Stroke, or Suspected Risk of these Disorders (e.g., Elevated Blood Pressure, Diabetes, Elevated Cholesterol Levels, Smoking), Consult a Doctor or Pharmacist.

Polopiryna C Plus and Other Medications

Inform the Doctor about all Medications Currently Being Taken or Recently Taken, as well as any Medications Planned to be Taken. Acetylsalicylic Acid (Like Other NSAIDs) Should not be Taken Concomitantly with the Following Medications, as it may Enhance their Effects: Hypoglycemic Agents (e.g., Insulin, Sulfonylurea Derivatives), Due to the Displacement of these Medications from Protein Binding; Anticoagulant Medications (e.g., Coumarin Derivatives, Heparin), Antiplatelet Agents (e.g., Ticlopidine), which may Increase the Risk of Bleeding and Prolong Bleeding Time; Sulfonamides Used in Bacterial Infections and Phenytoin, an Antiepileptic Medication. Acetylsalicylic Acid Administered Concomitantly with Sulfonamides not only Enhances their Effects but also Shortens their Duration of Action; Digoxin Used in the Treatment of Heart Failure, as it Increases its Blood Concentration; The Toxic Effect of Methotrexate on the Bone Marrow, Used in the Treatment of Cancer and Rheumatoid Arthritis, Due to the Displacement of Methotrexate from Protein Binding by Salicylates; The Toxic Effect of Valproic Acid, an Antiepileptic Medication. Due to the Synergistic Effect of Acetylsalicylic Acid and Valproic Acid, the Anti-Aggregatory Effect of the Medication and the Tendency to Bleeding may be Enhanced. Concomitant Administration of Acetylsalicylic Acid with Corticosteroids and Other NSAIDs or Alcohol Consumption During Treatment with Acetylsalicylic Acid Increases the Risk of Adverse Reactions from the Gastrointestinal Tract (Peptic Ulcer Disease, Bleeding) and Kidney Damage. Acetylsalicylic Acid Weakens: The Effect of Medications Used in the Treatment of Gout (e.g., Probenecid), which may Exacerbate the Symptoms of the Disease when Administered Concomitantly with Acetylsalicylic Acid; The Effect of Diuretic Medications (e.g., Furosemide), by Retaining Sodium and Water in the Body; The Effect of Certain Antihypertensive Medications (from the Group of Angiotensin-Converting Enzyme Inhibitors, e.g., Captopril, Enalapril), Due to Decreased Glomerular Filtration in the Kidneys. Ascorbic Acid (Vitamin C) in the Medication Increases the Elimination Rate of Amphetamine Derivatives and Tricyclic Antidepressants. It may Interfere with the Results of Certain Tests Performed by Oxidoreduction Methods (e.g., Glucose or Creatinine Determination in Blood and Urine, Stool Examination for Occult Blood). Calcium Reduces the Absorption of Fluoride Compounds and Antibiotics from the Fluoroquinolone and Tetracycline Groups; to Avoid this Interaction, a Three-Hour Interval is Required Between the Administration of these Medications and Calcium Compounds. Concomitant Administration of Digitalis Glycosides (e.g., Digoxin Derivatives) and Calcium Compounds Increases the Risk of Cardiac Arrhythmias. Thiazide Diuretics (e.g., Hydrochlorothiazide) Increase the Renal Reabsorption of Calcium and Pose a Risk of Hypercalcemia (Elevated Calcium Levels in the Blood). Calcium in Combination with Vitamin D may Weaken the Effect of Verapamil and Other Calcium Channel Blockers.

Polopiryna C Plus with Food and Drink

The Medication is Recommended to be Taken After a Meal.

Pregnancy and Breastfeeding

If the Patient is Pregnant or Breastfeeding, or Thinks she may be Pregnant or is Planning to have a Child, she Should Consult a Doctor or Pharmacist Before Taking this Medication. The Components of the Medication Pass Through the Placental Barrier to the Fetal Tissues. During Pregnancy, Polopiryna C Plus Should be Taken only on the Explicit Recommendation of a Doctor, After a Careful Assessment of the Risk-Benefit Ratio. Do not Take the Medication in the Last Trimester of Pregnancy, as it may Cause Fetal Developmental Abnormalities and Complications During Delivery. Polopiryna C Plus Passes into Breast Milk in Small Amounts. In the Case of Occasional Use, there is no Need to Interrupt Breastfeeding.

Driving and Operating Machinery

Polopiryna C Plus Taken in the Recommended Doses Does not Impair Psychophysical Abilities, Does not Affect the Ability to Drive Vehicles or Operate Machinery.

Polopiryna C Plus Contains Aspartame and Sodium

The Medication Contains 20 mg of Aspartame in each Sachet. Aspartame is a Source of Phenylalanine. It may be Harmful to Patients with Phenylketonuria. This is a Rare Genetic Disorder in which Phenylalanine Accumulates in the Body Due to its Impaired Elimination. The Medication Contains 178 mg of Sodium (the Main Component of Table Salt) in each Sachet. This Corresponds to 8.9% of the Maximum Recommended Daily Intake of Sodium in the Diet for Adults. This Should be Taken into Account in Patients with Reduced Renal Function and in Patients Controlling their Sodium Intake.

3. How to Take Polopiryna C Plus

This Medication Should Always be Taken Exactly as Described in the Package Leaflet or as Directed by a Doctor or Pharmacist. In Case of Doubt, Consult a Doctor or Pharmacist. The Recommended Dose is: Adults: 1-2 Sachets 3 Times a Day. Maximum Daily Dose - 6 Sachets. Elderly Patients (Over 65 Years of Age): 1 Sachet 3 Times a Day. Maximum Daily Dose - 3 Sachets. Adolescents Over 12 Years of Age: 1 Sachet 3 Times a Day. Maximum Daily Dose - 3 Sachets. The Contents of one Sachet Should be Dissolved in 1/2 Glass of Boiled, Cooled Water, Mixed, and Drunk. If the Patient Feels that the Medication is too Strong or too Weak, they Should Consult a Doctor. Do not Take the Medication for More than 3-5 Days Without Medical Consultation.

Overdose of Polopiryna C Plus

In the Event of Accidental Ingestion of a Dose Significantly Exceeding the Recommended Daily Dose, the Following Overdose Symptoms may Occur (Related to the Presence of Acetylsalicylic Acid): Rapid Breathing, Nausea, Vomiting, Vision and Hearing Disorders (Tinnitus), Headaches and Dizziness, Acid-Base and Electrolyte Imbalance (e.g., Potassium Deficiency), Decreased Blood Glucose Levels, Skin Changes. In the Event of an Overdose, Immediately Consult a Doctor or Pharmacist. The Doctor will Perform Gastric Lavage and, if Necessary, Administer Medications to Correct Electrolyte Imbalance and other Symptoms of Overdose.

Missed Dose of Polopiryna C Plus

Polopiryna C Plus is Taken as Needed. If a Dose is Missed and Symptoms Persist, Take the Next Dose. Do not Take a Double Dose to Make up for a Missed Dose.

4. Possible Adverse Reactions

Like all Medications, Polopiryna C Plus can Cause Adverse Reactions, although not Everybody will Experience them. During Treatment with the Medication, the Following Adverse Reactions may Occur: Blood and Lymphatic System Disorders

• Blood Coagulation Disorders, Increased Menstrual Bleeding.

Immune System Disorders

• In Hypersensitive Individuals, Skin Changes may Occur: Rash, Urticaria,
• Acetylsalicylic Acid is Thought to be Able to Induce an Asthma Attack in Adults or Shortness of Breath.

Nervous System Disorders

• Dizziness, Sweating, Tinnitus.

Gastrointestinal Disorders

• -Nausea, Vomiting, Abdominal Pain,
• Exacerbation or Recurrence of Peptic Ulcer Disease,
• Mucosal Erosion and Gastrointestinal Bleeding in the Form of Coffee Ground Vomiting and Melena.

In Connection with the Treatment with NSAIDs, Edema, Hypertension, and Heart Failure have been Reported. The Administration of Medications Containing Acetylsalicylic Acid may be Associated with a Slight Increase in the Risk of Heart Attack (Myocardial Infarction) or Stroke. The Medication is Generally Well-Tolerated when Taken in the Recommended Doses.

Reporting Adverse Reactions

If any Adverse Reactions Occur, Including any Possible Adverse Reactions not Listed in this Package Leaflet, Inform a Doctor or Pharmacist. Adverse Reactions can be Reported Directly to the Department of Pharmacovigilance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products Al. Jerozolimskie 181C 02-222 Warsaw Tel.: +48 22 49 21 301 Fax: +48 22 49 21 309 Website: https://smz.ezdrowie.gov.pl Adverse Reactions can also be Reported to the Marketing Authorization Holder. By Reporting Adverse Reactions, more Information can be Collected on the Safety of the Medication.

5. How to Store Polopiryna C Plus

Do not Store Above 25°C. Protect from Moisture. The Medication Should be Stored in a Place Inaccessible to Children. Do not Use the Medication After the Expiry Date Stated on the Packaging. The Expiry Date Refers to the Last Day of the Specified Month. Do not Use the Medication if the Appearance of the Powder in the Sachets has Changed. Medications Should not be Disposed of in the Drain or Household Waste Containers. Ask a Pharmacist how to Dispose of Unused Medications. This will Help Protect the Environment.

6. Package Contents and Other Information

What Polopiryna C Plus Contains

• The Active Substances of the Medication are: Acetylsalicylic Acid, Ascorbic Acid (Vitamin C), and Calcium (in the Form of Calcium Lactogluconate). Each Sachet Contains 500 mg of Acetylsalicylic Acid, 300 mg of Ascorbic Acid (Vitamin C), and 200 mg of Calcium (in the Form of Calcium Lactogluconate).
• Other Ingredients: Sodium Hydrogen Carbonate (178 mg of Sodium Ions); Citric Acid, Anhydrous; Aspartame; Lemon Flavor; Sodium Lauryl Sulfate; β-Carotene; Povidone K-25.

What Polopiryna C Plus Looks Like and What the Package Contains

The Medication is in the Form of an Effervescent Powder Packaged in Sachets. Sachets Made of Heat-Sealable, Laminated Aluminum Foil (Paper/Aluminum/PE) in a Cardboard Box. The Package Contains 6, 10, 14, 20, or 28 Sachets. Not all Package Sizes may be Marketed.

Marketing Authorization Holder

Zakłady Farmaceutyczne POLPHARMA SA ul. Pelplińska 19, 83-200 Starogard Gdański

Manufacturer

SENSILAB Polska Spółka z ograniczoną odpowiedzialnością - S.K.A. ul. Gen. Mariana Langiewicza 58 95-050 Konstantynów Łódzki To Obtain more Detailed Information about this Medication, Contact the Local Representative of the Marketing Authorization Holder. POLPHARMA Biuro Handlowe Sp. z o.o. ul. Bobrowiecka 6, 00-728 Warszawa tel. 22 364 61 01

Date of the Last Update of the Package Leaflet: