Pegorion junior

Patient Information Leaflet

Pegorion Junior, 6 g, powder for oral solution
Macrogolum
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
the doctor or pharmacist.

• Keep this leaflet for future reference.
• If advice or further information is needed, please consult your pharmacist.
• If the patient experiences any adverse reactions, including any possible side effects not listed in this leaflet, inform the doctor or pharmacist. See section 4.
• If there is no improvement after 14 days, or if the patient feels worse, consult a doctor.

Table of contents:

1. What Pegorion Junior is and what it is used for
2. What you need to know before taking Pegorion Junior
3. How to take Pegorion Junior
4. Possible side effects
5. How to store Pegorion Junior
6. Contents of the pack and other information

1. What Pegorion Junior is and what it is used for

Pegorion Junior is used for the treatment of constipation. Macrogol – the active substance in this medicine –
binds water. As a result, the amount of water in the intestinal contents increases, the stool becomes softer,
and normal intestinal motility is restored.
If there is no improvement after 14 days, or if the patient feels worse, medical advice should be sought.

2. Important information before taking Pegorion Junior

When not to use Pegorion Junior

• if the patient is allergic to macrogol;
• if the patient has intestinal obstruction (intestinal blockage) due to physiological or functional disorders of the intestinal wall;
• if the patient has intestinal wall perforation;
• if the patient has severe inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis, toxic megacolon);
• if the patient has abdominal pain of unknown cause.

Warnings and precautions
Before starting treatment with Pegorion Junior, discuss this with your doctor or pharmacist.

• if constipation has occurred suddenly or worsened. This may be caused by intestinal obstruction;
• if during treatment with Pegorion Junior for bowel cleansing, the patient experiences sudden abdominal pain or rectal bleeding, medical advice should be sought immediately;
• if the patient has impaired liver or kidney function, or if the patient is taking diuretic medicines and develops diarrhoea;
• if constipation is accompanied by pain, fever or gastrointestinal upset.

It should be remembered that treatment of constipation with any medicinal product is only an adjunct to a healthy lifestyle and diet, for example:

• increased fluid and dietary fibre intake,
• appropriate physical activity and rehabilitation of intestinal rhythm.

Children and adolescents
The medicine is not recommended for use in children under 2 years of age.
In children, treatment of constipation should not last longer than 3 months, due to lack of adequate clinical data beyond this 3-month period. Therefore, after 3 months of treatment, a full clinical evaluation should be performed to determine the cause of constipation in the patient.
In case of diarrhoea, caution is advised in patients prone to developing water-electrolyte imbalances.

Pegorion Junior and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. Pegorion Junior may reduce the absorption of other medicinal products.
If the patient requires thickened fluids to enable safe swallowing, Pegorion Junior may counteract the thickening effect.

Pregnancy and breastfeeding
Pegorion Junior may be used during pregnancy and breastfeeding.

Driving and operating machinery
Pegorion Junior has no influence on the ability to drive or operate machinery.

3. How to take Pegorion Junior

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
One sachet of powder (6 g) should be dissolved in 200 ml (one glass) of liquid: water, juice, tea, or coffee. In children under 8 years of age, the contents of one 6 g sachet may, if necessary, be dissolved in 100 ml (half a glass) of water or juice. The solution should be prepared immediately before drinking.

Treatment of chronic constipation
Adults and children over 8 years of age:
The recommended dose is 2 sachets (2 x 6 g) once or twice daily.
Children aged 4–7 years:
The recommended dose is 1 sachet (6 g) once or twice daily.
Children aged 2–3 years:
The recommended dose is 1 sachet (6 g) once daily.
Children under 2 years of age:
Pegorion Junior is not recommended for use in children under 2 years of age.

The dose may be increased or decreased depending on the response to treatment, so as to achieve regular bowel movements and soft stools.

Treatment with Pegorion Junior usually lasts up to 2 weeks. If symptoms do not improve after 2 weeks of treatment, consult your doctor. Your doctor may recommend longer treatment. Long-term treatment may be necessary if the patient is taking medicines causing constipation or has a disease causing constipation.

Taking more Pegorion Junior than recommended
Large doses may cause abdominal pain, diarrhoea, and vomiting. In case of overdose, stop taking the medicine.

4. Possible adverse reactions

Like any medicinal product, this medicine can cause adverse reactions, although not everyone will experience them.
Some of the possible adverse reactions may be serious. These include, for example:
Very rare adverse reactions (may occur in less than 1 in 10,000 people):

• Hypersensitivity reactions such as anaphylactic shock (sudden drop in blood pressure and other possible symptoms such as fever, rash, and swelling of the face, oral cavity, or throat), angioedema (sudden, episodic swelling of the skin, mucous membranes, or internal organs).

If any of these symptoms or other serious symptoms occur, contact a doctor or the emergency department of the nearest hospital immediately to receive appropriate treatment.
If any allergic reaction occurs, do not take the next dose of this medicine and contact your doctor.
Other adverse reactions
Common adverse reactions (may occur in less than 1 in 10 people):

• abdominal pain, bloating, nausea, flatulence with gas release, or diarrhoea

Uncommon adverse reactions (may occur in less than 1 in 100 people):

• vomiting, urgent need to defecate, faecal incontinence

Very rare adverse reactions (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 available data):

• electrolyte disturbances and dehydration, particularly in elderly patients

Additional adverse reactions in children and adolescents
Common adverse reactions (may occur in less than 1 in 10 people):

• abdominal pain, diarrhoea (which may cause anal pain)

Uncommon adverse reactions (may occur in less than 1 in 100 people):

• vomiting, bloating, nausea

Frequency not known (frequency cannot be estimated from available data):

• hypersensitivity reactions such as urticaria, rash, itching

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Pegorion Junior

Keep this medicine out of sight and reach of children.
No special storage conditions are required for this medicine.
Do not use this medicine after the expiry date stated on the carton and sachet following
the wording "Expiry date (EXP)". The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. Doing so will help protect the environment.

6. Contents of the pack and other information

What Pegorion Junior contains

• The active substance is macrogol 4000. One sachet contains 6 grams of macrogol 4000.
• The medicine contains no other ingredients.

What Pegorion Junior looks like and contents of the pack
White or almost white powder.
Pack contents: 10, 20 or 50 sachets per pack.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Orion Corporation
Orionintie 1
02200 Espoo
Finland

Manufacturer
Orion Corporation, Orion Pharma
Orionintie 1
02200 Espoo
Finland

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Orion Pharma Poland Sp. z o.o.
[email protected]