Adproctin

Package Leaflet: Information for the Patient

ADPROCTIN

500 mg, Hard Capsules

Calcii dobesilas monohydricus

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, You May Need to Read it Again.
• If You Need Advice or Further Information, Consult a Pharmacist.
• If You Experience any Side Effects, Including those not Listed in this Package Leaflet, Tell Your Doctor or Pharmacist. See Section 4.
• If There is no Improvement or You Feel Worse After 7 Days, Consult a Doctor.

Package Leaflet Contents

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

1. What is Adproctin and What is it Used for

Adproctin is a Medication in the Form of Hard Capsules. It Contains the Active Substance Calcium Dobesilate Monohydrate, which Acts on the Walls of Blood Vessels. It Reduces their Excessive Permeability and Fragility, and Increases their Resistance, Thus Preventing Fluid Penetration through the Vessel Walls. Additionally, it Accelerates Collagen Synthesis, which is an Important Component of Arterial Walls. Adproctin Reduces Blood Viscosity, Increases Erythrocyte Elasticity, and has Anti-Aggregatory Effects. This Results in Improved Peripheral Venous Circulation, Reduced Venous Stasis, and Inhibition of Thrombotic Changes Associated with Varicose Vein Formation. Adproctin also Reduces the Permeability and Fragility of Lymphatic Vessels and Improves Lymphatic Drainage, Resulting in Reduced Swelling.

Indications for Use

Symptomatic Treatment of Anal Varices (Hemorrhoids). Adproctin is Indicated for Use in Adults.

2. Important Information Before Taking Adproctin

Contraindications

• If the Patient is Allergic to the Active Substance or any of the Other Ingredients of this Medication (Listed in Section 6),
• In Children and Adolescents.

Warnings and Precautions

Do not Use for More than 4 Weeks Without Consulting a Doctor. If There is no Improvement or the Patient Feels Worse After 7 Days, Consult a Doctor. The Medication Should be Used with Caution in Patients with Liver Function Disorders or if there is Active Gastric or Duodenal Ulcer, or Chronic Gastritis. Periodic Monitoring of Gastric and Duodenal Function is Recommended. In Case of Exacerbation of Symptoms, the Medication Should be Discontinued and a Doctor Consulted. If Symptoms such as Fever, Sore Throat or Pharynx, Pain when Swallowing, Nasal Mucositis, Oral Mucositis, Genital or Anal Area Inflammation Occur, Stop Taking the Medication and Consult a Doctor, as these may be Symptoms of a Serious Disease - Agranulocytosis. Consult a Doctor, even if the Above Warnings Refer to Past Situations.

Use in Patients with Renal Impairment

Use with Caution in Patients with Renal Impairment. In Patients with Severe Renal Impairment, Especially those Undergoing Dialysis, a Reduced Dose of the Medication Should be Used.

Children and Adolescents

The Effect of the Medication has not been Studied in Children and Adolescents. The Medication Should not be Used in Children and Adolescents.

Adproctin and Other Medications

Tell Your Doctor or Pharmacist About all Medications You are Currently Taking or Have Recently Taken, as well as any Medications You Plan to Take. There is no Data on the Interaction of Adproctin with Other Medications. Adproctin may Affect the Results of Laboratory Tests for Serum Creatinine Levels. Therefore, Inform Your Doctor About all Laboratory Tests Performed on You, Especially those that Assess Renal Function. If it is Necessary to Collect Samples for Tests (e.g., Blood Samples) While Taking Adproctin, Collect the Samples Before the First Daily Dose of the Medication to Minimize the Potential Impact of the Medication on Test Results.

Adproctin with Food and Drink

The Medication is Taken Orally, During Main Meals.

Pregnancy and Breastfeeding

If You are Pregnant or Breastfeeding, Think You may be Pregnant or are Planning to Have a Child, Consult a Doctor or Pharmacist Before Taking this Medication. Pregnancy Adproctin may be Used in Pregnant Women Only if the Potential Benefit of the Medication Outweighs the Possible Risk to the Fetus. Adproctin is Contraindicated in the First Trimester of Pregnancy. Breastfeeding The Medication Passes into Breast Milk in Very Small Amounts. There is no Data on the Effect on the Breastfed Infant, so Before Taking Adproctin, Breastfeeding Should be Stopped.

Driving and Operating Machines

Adproctin Does not Affect the Ability to Drive and Operate Machines.

3. How to Take Adproctin

This Medication Should Always be Taken Exactly as Described in this Package Leaflet or as Directed by a Doctor or Pharmacist. If You have any Doubts, Consult a Doctor or Pharmacist.

Recommended Dose

Unless Otherwise Directed by a Doctor, the Usual Dose for Adults is 1 to 2 Capsules per Day (Equivalent to a Daily Dose of 500 mg to 1000 mg). The Duration of Treatment Depends on the Severity of Symptoms and the Progression of the Disease. Do not Take for More than 4 Weeks Without Consulting a Doctor. If There is no Improvement or You Feel Worse After 7 Days, Consult a Doctor.

Patients with Renal Impairment

The Efficacy and Safety of Calcium Dobesilate have not been Assessed in Patients with Renal Impairment. Use Adproctin with Caution in Patients with Renal Impairment. In Case of Severe Renal Impairment Requiring Dialysis, Reduce the Dose of the Medication.

Patients with Liver Impairment

The Efficacy and Safety of Calcium Dobesilate have not been Assessed in Patients with Liver Impairment. Use Adproctin with Caution in Patients with Liver Impairment.

Method of Administration

The Medication is Taken Orally, During Main Meals.

Overdose

If You Take More than the Recommended Dose, Consult a Doctor or Pharmacist.

Missed Dose

Do not Take a Double Dose to Make up for a Missed Dose. If You have any Further Doubts About Taking this Medication, Consult a Doctor or Pharmacist.

4. Possible Side Effects

Like all Medications, Adproctin can Cause Side Effects, although not Everybody gets them. Rare (in Less than 1 in 1000 People, but More than 1 in 10,000 People):

• Abdominal Pain,
• Nausea,
• Diarrhea,
• Vomiting,
• Skin Reactions,
• Joint Pain,
• Headache and Dizziness,
• Fever.

Very Rare (in Less than 1 in 10,000 People):

• Suppression of Bone Marrow Function with Agranulocytosis (an Acute Condition that may be Characterized by High Fever, Infections in the Mouth or Inflammatory Conditions in the Anal and Genital Areas). In such Cases, Stop Taking the Medication and Consult a Doctor.

Local and Generalized Allergic Reactions (Rash, Urticaria) have been Reported. Most Side Effects Disappear After Discontinuation of Adproctin or Dose Reduction.

Reporting Side Effects

If You Experience any Side Effects, Including those not Listed in this Package Leaflet, Tell Your Doctor or Pharmacist. Side Effects can be Reported Directly to the Department of Medicinal Product Monitoring, 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. Side Effects can also be Reported 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 Adproctin

Store Below 30°C. Store in the Original Packaging to Protect from Moisture. Keep the Medication out of Sight and Reach of Children. Do not Use this Medication After the Expiration Date Stated on the Packaging. The Expiration Date Refers to the Last Day of the Specified Month. 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 Adproctin Contains

• The Active Substance of the Medication is Calcium Dobesilate Monohydrate. One Hard Capsule Contains 500 mg of Calcium Dobesilate Monohydrate.
• Other Ingredients are: Microcrystalline Cellulose, Magnesium Stearate, Titanium Dioxide (E 171), Indigotine (E 132), Gelatin.

What Adproctin Looks Like and Package Contents

Adproctin is Available in the Form of Hard Capsules. The Capsule is Oval, Two-Part. The Inner Part (Body) is White, the Outer Part (Cap) is Blue. The Capsule Contents are White or Almost White Powder. Available Packages: 30 Hard Capsules, 60 Hard Capsules. PVC/PVDC/Aluminum Blisters in a Cardboard Box. Not all Package Sizes may be Marketed.

Marketing Authorization Holder and Manufacturer

Pharmaceutical Cooperative "GALENA", ul. Krucza 62, 53-411 Wrocław, Poland. Date of Last Update of the Package Leaflet:17.02.2021