Macrogol Aurovitas

Package Leaflet: Information for the User

Macrogol Aurovitas, 10 g, Powder for Oral Solution in Sachet

Macrogol 4000

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed to you by a doctor and is intended for your use only. Do not give it to others. The medicine may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Macrogol Aurovitas and what is it used for
• 2. Important information before taking Macrogol Aurovitas
• 3. How to take Macrogol Aurovitas
• 4. Possible side effects
• 5. How to store Macrogol Aurovitas
• 6. Contents of the package and other information

1. What is Macrogol Aurovitas and what is it used for

The active substance of Macrogol Aurovitas is macrogol 4000, which belongs to a group of laxative medicines with an osmotic effect. It works by increasing the amount of water in the stool, helping to overcome problems associated with slow bowel movements. Macrogol Aurovitas is not absorbed into the bloodstream and is not broken down in the body.
Macrogol Aurovitas is used for the symptomatic treatment of constipation in adults and children over 8 years old.
The medicine comes in the form of a powder, which should be dissolved in a glass of water (at least 50 ml) and taken. The medicine usually takes effect within 24 to 48 hours.
Treatment of constipation with laxatives should only supplement a healthy lifestyle and diet.

2. Important information before taking Macrogol Aurovitas

When not to take Macrogol Aurovitas

• If the patient is allergic to macrogol (polyethylene glycol) or any other ingredient of this medicine (listed in section 6).
• If the patient has a severe intestinal disease:
• inflammatory bowel disease (such as ulcerative colitis, Crohn's disease) or abnormal narrowing of the intestine;
• intestinal perforation or risk of intestinal perforation;
• intestinal obstruction or suspected intestinal obstruction;
• abdominal pain of unknown cause.

Do not take this medicineif any of the above symptoms occur. In case of doubts, consult a doctor or pharmacist before taking the medicine.

Warnings and precautions

Before taking Macrogol Aurovitas, discuss it with a doctor or pharmacist.
There have been reports of allergic reactions, including rash and swelling of the face or throat (anaphylaxis) after taking products containing macrogol (polyethylene glycol) in adults. There have been single reports of allergic reactions that led to fainting or collapse and caused general malaise. If such symptoms occur, stop taking Macrogol Aurovitas and seek medical attention immediately.
If, during the use of Macrogol Aurovitas for bowel cleansing, the patient experiences sudden abdominal pain or rectal bleeding, they should consult a doctor or seek medical attention immediately.
Since this medicine may sometimes cause diarrhea, consult a doctor or pharmacist before taking it, especially in cases of:

• impaired liver or kidney function;
• use of diuretics (water pills) or in elderly patients, as they may be at increased risk of low sodium (salt) or potassium levels in the blood.

Before taking Macrogol Aurovitas, consult a doctor or pharmacist if the patient has swallowing difficulties. In patients with swallowing difficulties, avoid mixing Macrogol Aurovitas - a laxative containing macrogol (polyethylene glycol) - with food thickeners based on starch. This may cause the formation of a watery liquid that can enter the lungs and cause pneumonia.

Macrogol Aurovitas and other medicines

Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines they plan to take.
During the use of Macrogol Aurovitas, there may be a temporary decrease in the absorption of other medicines, leading to a decrease in their effectiveness, particularly for medicines with a narrow therapeutic index or a short half-life, such as digoxin, antiepileptic drugs, coumarins, and immunosuppressants, leading to a decrease in their effectiveness.
Macrogol Aurovitas may reduce the effectiveness of thickeners used to thicken liquids for safe swallowing.

Pregnancy and breastfeeding

Macrogol Aurovitas can be used during pregnancy and breastfeeding.
If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medicine.

Driving and using machines

No studies have been conducted on the effects of Macrogol Aurovitas on the ability to drive and use machines.

Macrogol Aurovitas contains sorbitol

In case of intolerance to some sugars before taking this medicine, consult a doctor. This medicine contains small amounts of a sugar called sorbitol, which can be used in diabetes or a galactose-free diet.
Macrogol Aurovitas contains 3.1-4.6 mg of sorbitol per sachet.
This medicine contains less than 1 mmol (23 mg) of sodium per sachet, which means it is essentially "sodium-free".
However, Macrogol Aurovitas can be used in patients with diabetes or those on a galactose-free diet.

3. How to take Macrogol Aurovitas

Always take this medicine exactly as prescribed by a doctor or pharmacist. In case of doubts, consult a doctor or pharmacist.

Adults and children over 8 years old

The recommended dose is one to two sachets per day, taken preferably in the morning as a single dose.
The daily dose depends on the effect achieved and ranges from one sachet every other day (especially in children) to a maximum of two sachets per day.
The contents of the sachet should be dissolved in a glass of water (at least 50 ml) immediately before consumption, then drink the prepared solution.

Note:

• The effect of Macrogol Aurovitas usually starts within 24-48 hours after administration.
• In children, the duration of use of Macrogol Aurovitas should not exceed 3 months.
• Improved bowel movements achieved with Macrogol Aurovitas can be maintained provided a healthy lifestyle and dietary recommendations are followed.
• Inform the doctor or pharmacist if symptoms worsen or if there is no improvement.

Taking more than the recommended dose of Macrogol Aurovitas

Taking too much macrogol may cause diarrhea, abdominal pain, or vomiting.
Diarrhea usually resolves after stopping the medicine or reducing the dose.
In case of severe diarrhea or vomiting, seek medical attention immediately, as treatment to prevent loss of electrolytes (salts) accompanying fluid loss may be necessary.

Missing a dose of Macrogol Aurovitas

Take the next dose as soon as possible, but do not take a double dose to make up for the missed dose.

4. Possible side effects

Like all medicines, Macrogol Aurovitas can cause side effects, although not everybody gets them.
Side effects that are usually mild and do not last long include:

In children:

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

• abdominal pain;
• diarrhea, which can also cause anal discomfort.

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

• nausea (vomiting) or vomiting;
• abdominal bloating.

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

• allergic reactions (hypersensitivity) (rash, hives, swelling of the face or throat, difficulty breathing, fainting or collapse).

In adults:

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

• abdominal pain;
• bloating;
• nausea;
• diarrhea.

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

• vomiting;
• sudden need to have a bowel movement;
• fecal incontinence.

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

• low potassium levels in the blood, which can cause muscle weakness, tremors, or irregular heartbeat;
• low sodium levels in the blood, which can cause fatigue and disorientation, muscle tremors, seizures, and coma;
• dehydration caused by severe diarrhea, especially in elderly patients;
• symptoms of an allergic reaction, such as skin redness, rash, hives, swelling of the face or throat, difficulty breathing, fainting or collapse.

Reporting side effects

If side effects occur, including those not listed in this leaflet, inform a doctor or pharmacist. Side effects can be reported directly to the Department of Medicines Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +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 gather more information on the safety of this medicine.

5. How to store Macrogol Aurovitas

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and sachet after EXP or "Expiry Date". The expiry date refers to the last day of the month.
There are no special storage instructions for this medicine.
Do not use the medicine if visible signs of deterioration are observed.
Medicines should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the package and other information

What Macrogol Aurovitas contains

• The active substance is macrogol 4000. Each sachet contains 10 g of macrogol 4000.
• The other ingredients are: sodium saccharin (E 954), orange-grapefruit flavor [contains orange oil, grapefruit oil, orange juice, citral, acetaldehyde, linalool, ethyl butyrate, alpha-terpineol, octanal, beta & gamma hexenol, maltodextrin, gum arabic, sorbitol (E 420), butylhydroxyanisole (E 320)].

What Macrogol Aurovitas looks like and contents of the package

Macrogol Aurovitas is a white or almost white powdery powder with a waxy or paraffin-like appearance and an orange odor.
The carton contains 10, 20, 30, 50, 60, or 100 sachets.
Not all pack sizes may be marketed.

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warsaw
e-mail: [email protected]

Manufacturer/Importer:

APL Swift Services (Malta) Ltd
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua João de Deus, n.º 19, Venda Nova
2700-487 Amadora
Portugal

This medicine is authorized in the Member States of the European Economic Area under the following names:

Belgium:
Macrogol AB 10 g powder for oral solution in sachet
Italy:
Macrogol Aurobindo
Netherlands:
Macrogol Sanias 10 g, powder for oral solution in sachet
Portugal:
Macrogol Generis
Poland
Macrogol Aurovitas
Spain:
Macrogol Aurovitas 10 g powder for oral solution in sachet

Date of last revision of the package leaflet: 03/2023