Pegorion

Package Leaflet: Information for the User

Pegorion, 12 g, Powder for Oral Solution

Macrogol

Read the Package Leaflet Carefully Before Taking the Medicinal Product

This medicinal product should always be taken exactly as described in this package leaflet or as directed by your doctor or pharmacist.

• Keep this package leaflet. You may need to read it again.
• If you have any further questions, ask your pharmacist.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.
• If after 14 days there is no improvement or you feel worse, you should contact your doctor.

Table of Contents of the Package Leaflet:

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

1. What is Pegorion and What is it Used For

Pegorion is used to treat constipation and to soften and ease the passage of hard or dry stools (faecal impaction/obstruction). The active substance, macrogol, works by absorbing water, thereby increasing the amount of water in the stools, making them softer and easier to pass. If after 14 days there is no improvement or you feel worse, you should contact your doctor.

2. Important Information Before Taking Pegorion

When Not to Take Pegorion

• if you are allergic to macrogol;
• if you have a bowel obstruction due to a physical or functional disorder of the bowel wall;
• if you have a perforation of the bowel wall;
• if you have severe inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis, toxic megacolon);
• if you have abdominal pain of unknown origin.

Warnings and Precautions

Before taking Pegorion, talk to your doctor or pharmacist.

• if constipation occurs suddenly or gets worse. This could be a sign of bowel obstruction;
• if you experience sudden abdominal pain or rectal bleeding while taking Pegorion for bowel clearance, you should contact your doctor or seek medical attention immediately.
• if you have liver or kidney problems or if you are taking diuretics and experience diarrhoea;
• if constipation is accompanied by pain, fever, or abdominal discomfort.

Remember that treatment of constipation with any medicinal product is only a supplement to a healthy lifestyle and diet, for example:

• increased fluid and fibre intake,
• regular physical activity and bowel habit rehabilitation.

Children and Adolescents

Pegorion powder for oral solution in a 12 g sachet is not intended for use in children under 8 years of age. For children aged 2 to 7 years, 6 g sachets (Pegorion Junior powder for oral solution 6 g) are available. In children, treatment of constipation should not last more than 3 months due to the lack of adequate clinical data beyond 3 months. 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 should be exercised in patients with a tendency to develop water and electrolyte imbalance.

Pegorion and Other Medicinal Products

Tell your doctor or pharmacist about all medicinal products you are taking or have recently taken, as well as any you plan to take. Pegorion may reduce the absorption of other medicinal products. If you need to thicken fluids to be able to swallow them safely, Pegorion may counteract the thickening effect.

Pregnancy and Breastfeeding

Pegorion can be used during pregnancy and breastfeeding.

Driving and Using Machines

Pegorion has no influence on the ability to drive and use machines.

3. How to Take Pegorion

Take this medicinal product exactly as described in this package leaflet or as directed by your doctor or pharmacist. If you are not sure, talk to your doctor or pharmacist. One sachet of powder (12 g) should be dissolved in 200 ml (a glass) of liquid: water, juice, tea, or coffee. The solution should be prepared just before taking. Treatment of chronic constipation: Adults and children over 8 years: The recommended dose is 1 sachet (12 g) once or twice daily. The dose can be adjusted to produce a comfortable and consistent bowel movement. Pegorion powder for oral solution in a 12 g sachet is not intended for use in children under 8 years of age. For children aged 2 to 7 years, 6 g sachets (Pegorion Junior powder for oral solution 6 g) are available. Treatment with Pegorion usually lasts for up to 2 weeks. If symptoms do not improve after 2 weeks of treatment, you should contact your doctor. Your doctor may also recommend longer treatment. Long-term treatment may be necessary if you are taking medicinal products that cause constipation or have a disease that causes constipation. Softening of dry stools (treatment of faecal impaction/obstruction): Adults and children over 12 years: 5-10 sachets (5-10 x 12 g) per day for 1-3 days. Patients with cardiovascular disorders: The dose should be divided so that no more than two sachets are taken in one hour.

Overdose of Pegorion

Large doses may cause abdominal pain, diarrhoea, and vomiting. In case of overdose, stop taking the medicinal product.

4. Possible Side Effects

Like all medicinal products, Pegorion can cause side effects, although not everybody gets them. Some side effects can be serious. These include:

• Very rare side effects (may affect up to 1 in 10,000 people): Anaphylactic reactions (e.g., anaphylactic shock), angioedema (e.g., sudden swelling of the skin, mucous membranes, or internal organs).

If you experience any of these symptoms or other serious symptoms, you should contact your doctor or the emergency department of your nearest hospital immediately. If you experience an allergic reaction, do not take another dose of this medicinal product and talk to your doctor.

Other Side Effects

Common side effects (may affect up to 1 in 10 people):

• abdominal pain, abdominal distension, nausea, flatulence, or diarrhoea

Uncommon side effects (may affect up to 1 in 100 people):

• vomiting, urgent need to have a bowel movement, faecal incontinence

Very rare side effects (may affect up to 1 in 10,000 people):

• allergic reactions, such as rash, itching

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

• electrolyte and water balance disorders and dehydration, especially in elderly patients

Additional Side Effects in Children and Adolescents

Common side effects (may affect up to 1 in 10 people):

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

Uncommon side effects (may affect up to 1 in 100 people):

• vomiting, flatulence, nausea

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

• allergic reactions, such as urticaria, rash, itching

Reporting of Side Effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181 C, 02-222 Warszawa, 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 authorisation holder. By reporting side effects, you can help provide more information on the safety of this medicinal product.

5. How to Store Pegorion

Keep this medicinal product out of the sight and reach of children. This medicinal product does not require any special storage conditions. Do not use this medicinal product after the expiry date which is stated on the carton and sachet after EXP. The expiry date refers to the last day of that month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the Package and Other Information

What Pegorion Contains

• The active substance is macrogol 4000. One sachet contains 12 grams of macrogol 4000.
• The medicinal product does not contain any other ingredients.

What Pegorion Looks Like and Contents of the Package

White or almost white powder. The package contains 10, 20, or 50 sachets. 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 on this medicinal product, please contact the local representative of the marketing authorisation holder: Orion Pharma Poland Sp. z o.o., [email protected]. Date of Last Revision of the Package Leaflet:29.10.2021