Pegorion Iunior

Package Leaflet: Information for the User

Pegorion Junior, 6 g, Powder for Oral Solution

Macrogol

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 the Package Leaflet or as Advised 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 the Package Leaflet, Tell Your Doctor or Pharmacist. See Section 4.
• If After 14 Days there is no Improvement or You Feel Worse, Consult a Doctor.

Package Leaflet Contents:

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

1. What is Pegorion Junior and What is it Used for

Pegorion Junior is Used to Treat Constipation. The Active Substance, Macrogol, Absorbs Water, Increasing the Amount of Water in the Intestinal Contents, Making the Stool Softer and Restoring Normal Intestinal Motility.
If After 14 Days there is no Improvement or You Feel Worse, Consult a Doctor.

2. Important Information Before Taking Pegorion Junior

When Not to Take Pegorion Junior

• If You are Allergic to Macrogol;
• If You Have a Bowel Obstruction (Intestinal Blockage) Due to Physiological or Functional Disorders of the Intestinal Wall;
• If You Have a Perforation of the Intestinal Wall;
• If You Have Severe Inflammatory Bowel Disease (e.g., Crohn's Disease, Ulcerative Colitis, Toxic Megacolon);\li>If You Have Abdominal Pain of Unknown Cause.

Warnings and Precautions

Before Taking Pegorion Junior, Discuss it with Your Doctor or Pharmacist.

• If Constipation Occurs Suddenly or Worsens. This May be Due to Intestinal Obstruction;
• If You Experience Sudden Abdominal Pain or Rectal Bleeding While Taking Pegorion Junior for Bowel Cleansing, Seek Medical Attention Immediately.
• If You Have Liver or Kidney Dysfunction or are Taking Diuretics and Experience Diarrhea;

moczopędne and Diarrhea Occurs;

• If Constipation is Accompanied by Pain, Fever, or Upset Stomach.

Remember that Treating Constipation with any Medication is Only a Supplement to a Healthy Lifestyle and Diet, for Example:

• Taking Increased Amounts of Fluids and Dietary Fiber,
• Adequate Physical Activity and Rehabilitation of Intestinal Rhythm.

Children and Adolescents

The Medication is Not Recommended for Children Under 2 Years of Age.
Treatment of Constipation in Children Should Not Last Longer than 3 Months, Due to the Lack of Appropriate Clinical Data Beyond this Period. Therefore, After 3 Months of Treatment, a Full Clinical Examination Should be Performed to Determine the Cause of Constipation in the Patient.
In Case of Diarrhea, Caution Should be Exercised in Patients with a Tendency to Develop Water-Electrolyte Imbalance.

Pegorion Junior 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. Pegorion Junior May Reduce the Absorption of Other Medications.
If You Need to Thicken Liquids to Swallow them Safely, Pegorion Junior May Counteract the Thickening Effect.

Pregnancy and Breastfeeding

Pegorion Junior Can be Used During Pregnancy and Breastfeeding.

Driving and Operating Machinery

Pegorion Junior Does Not Affect the Ability to Drive or Operate Machinery.

3. How to Take Pegorion Junior

Always Take this Medication Exactly as Described in this Package Leaflet or as Advised by Your Doctor or Pharmacist. If You are Uncertain, Consult Your Doctor or Pharmacist.
Dissolve One Sachet of Powder (6 g) in 200 ml (a Glass) of Liquid: Water, Juice, Tea, or Coffee. For Children Under 8 Years of Age, the Contents of a 6 g Sachet Can be Dissolved in 100 ml (Half a Glass) of Water or Juice if Necessary. The Solution Should be Prepared Just Before Drinking.
Treatment of Chronic Constipation
Adults and Children Over 8 Years:
The Recommended Dose is 2 Sachets (2 x 6 g) Once or Twice a Day.
Children 4-7 Years:
The Recommended Dose is 1 Sachet (6 g) Once or Twice a Day.
Children 2-3 Years:
The Recommended Dose is 1 Sachet (6 g) Once a Day.
Children Under 2 Years:
The Medication is Not Recommended for Children Under 2 Years of Age.
The Dose Can be Increased or Decreased Depending on the Response to Treatment, to Achieve Regular Bowel Movements and Soft Stool.
Treatment with Pegorion Junior Usually Lasts for a Maximum of 2 Weeks. If Symptoms Do not Improve After 2 Weeks of Treatment, Consult a Doctor. The Doctor May Also Recommend Longer Treatment. Long-Term Treatment May be Necessary if You are Taking Medications that Cause Constipation or Have a Disease that Causes Constipation.

Overdose of Pegorion Junior

Large Doses May Cause Abdominal Pain, Diarrhea, and Vomiting. In Case of Overdose, Discontinue the Medication.

4. Possible Side Effects

Like all Medications, Pegorion Junior Can Cause Side Effects, Although not Everybody Gets them.
Some of the Possible Side Effects May be Serious. These Include, for Example:
Very Rare Side Effects (May Occur in Less than 1 in 10,000 People):

• Anaphylactic Reactions, Such as Anaphylactic Shock (Sudden Drop in Blood Pressure and Other Possible Symptoms, Such as Fever, Rash, and Swelling of the Face, Mouth, or Throat), Angioedema (Sudden, Recurring Swelling of the Skin, Mucous Membranes, or Internal Organs).

If You Experience any of these Symptoms or Other Serious Symptoms, Seek Medical Attention Immediately.
If You Experience an Allergic Reaction, Do not Take Another Dose of this Medication and Consult a Doctor.

Other Side Effects

Common Side Effects (May Occur in Less than 1 in 10 People):

• Abdominal Pain, Abdominal Distension, Nausea, Flatulence with Gas Passage or Diarrhea

Uncommon Side Effects (May Occur in Less than 1 in 100 People):

• Vomiting, Urgent Need to Defecate, Incontinence

Very Rare Side Effects (May Occur in Less than 1 in 10,000 People):

• Allergic Reactions, Such as Rash, Itching, Urticaria

Frequency Not Known (Frequency Cannot be Estimated from the Available Data):

• Electrolyte Disturbances and Dehydration, Especially in Elderly Patients

Additional Side Effects in Children and Adolescents

Common Side Effects (May Occur in Less than 1 in 10 People):

• Abdominal Pain, Diarrhea (Which May Cause Anal Pain)

Uncommon Side Effects (May Occur in Less than 1 in 100 People):

• Vomiting, Flatulence, Nausea

Frequency Not Known (Frequency Cannot be Estimated from the Available Data):

• Allergic Reactions, Such as Urticaria, Rash, Itching

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 Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 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.
Reporting Side Effects will Help to Gather More Information on the Safety of this Medication.

5. How to Store Pegorion Junior

Store the Medication in a Place Out of Sight and Reach of Children.
The Medication Does not Require any Special Storage Conditions.
Do not Use this Medication After the Expiry Date Stated on the Carton and Sachet After the Term "Expiry Date (EXP)". The Expiry 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 Pegorion Junior Contains

• The Active Substance is Macrogol 4000. One Sachet Contains 6 Grams of Macrogol 4000.
• The Medication Does not Contain any Other Ingredients.

What Pegorion Junior Looks Like and What the Package Contains

White or Almost White Powder.
Package Contents: 10, 20, or 50 Sachets in a Package.
Not all Package Sizes May be Marketed.

Marketing Authorization Holder

Orion Corporation
Orionintie 1
02200 Espoo
Finland

Manufacturer

Orion Corporation, Orion Pharma
Orionintie 1
02200 Espoo
Finland
To Obtain More Detailed Information on this Medication, Contact the Local Representative of the Marketing Authorization Holder:
Orion Pharma Poland Sp. z o. o.
[email protected]
Date of Last Update of the Package Leaflet:29.10.2021