Macrogol aurovitas

Package leaflet: Information for the user

Macrogol Aurovitas, 10 g, oral solution powder in sachet
Macrogolum 4000
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Leaflet contents

1. What Macrogol Aurovitas is and what it is 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 pack and other information

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

The active substance in Macrogol Aurovitas is macrogol 4000, which belongs to a group of medicines
called osmotic laxatives. It works by increasing the amount of
water in the stool, which helps overcome problems associated with slow intestinal transit. Macrogol
Aurovitas is not absorbed into the bloodstream and is not metabolized in the body.
Macrogol Aurovitas is used for the symptomatic treatment of constipation in adults and children aged 8 years and older.
The medicine is in the form of a powder which should be dissolved in a glass of water (at least 50 ml) and taken orally.
The effect usually occurs within 24 to 48 hours.
Constipation treatment with medicines should only be a supplement to a healthy lifestyle and diet.

2. Important information before using Macrogol Aurovitas

When not to use Macrogol Aurovitas

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

Do not take this medicine if any of the above symptoms occur. In case of doubt, consult a doctor or pharmacist before taking the medicine.
Warnings and precautions
Before starting to take Macrogol Aurovitas, discuss this with your doctor or pharmacist.
Allergic reactions, including rash and swelling of the face or throat (angioedema), have been reported after administration of products containing macrogol (polyethylene glycol) in adults. Isolated allergic reactions leading to fainting or collapse and causing general malaise have been reported. If such symptoms occur, discontinue use of Macrogol Aurovitas and seek immediate medical advice.
If, during treatment with Macrogol Aurovitas for bowel cleansing, the patient experiences sudden abdominal pain or rectal bleeding, contact a doctor or seek immediate medical assistance.
Since this medicine may occasionally cause diarrhoea, consult a doctor or pharmacist before taking it if:

• liver or kidney function is impaired;
• the patient is taking diuretics (water tablets) or is elderly, as these patients may be at increased risk of low blood sodium or potassium levels.

Before using Macrogol Aurovitas, consult a doctor or pharmacist if the patient has known swallowing difficulties. In patients with swallowing difficulties, avoid mixing Macrogol Aurovitas – a bowel cleansing agent containing macrogol (polyethylene glycol) – with food thickeners based on starch. This may result in the formation of a watery fluid, which could enter the lungs and cause pneumonia.
Macrogol Aurovitas and other medicines
Tell 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.
During treatment with Macrogol Aurovitas, there may be a transient reduction in the absorption of other medicinal products, leading to decreased efficacy, particularly affecting medicinal products with a narrow therapeutic index or short half-life, such as digoxin, antiepileptic drugs, coumarins, and immunosuppressive drugs, resulting in reduced effectiveness.
Macrogol Aurovitas may reduce the effectiveness of thickening agents used to thicken liquids for safe swallowing.
Pregnancy and breastfeeding
Macrogol Aurovitas may be used during pregnancy and breastfeeding.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
Driving and operating machinery
No studies on the effects on the ability to drive and (or) operate machinery have been conducted.
Macrogol Aurovitas contains sorbitol
If intolerance to certain sugars has been diagnosed, consult a doctor before taking this medicine. This medicine contains small amounts of a sugar called sorbitol, which may be used in diabetes or galactose-free diets.
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, i.e. it is essentially "sodium-free".
Macrogol Aurovitas may be used in patients with diabetes or on a galactose-free diet.

3. How to use Macrogol Aurovitas

This medicine should always be used as directed by a physician or pharmacist. If in doubt,
consult a physician or pharmacist.
Adults and children over 8 years of age
The recommended dose is one to two sachets per day, preferably taken as a single dose in the morning.
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 a sachet should be dissolved in a glass of water (at least 50 ml) immediately before
administration, then the prepared solution should be consumed.
Note:

• The effect of Macrogol Aurovitas begins within 24–48 hours after administration.
• In children, the duration of treatment with Macrogol Aurovitas should not exceed 3 months.
• The improvement in peristalsis achieved with Macrogol Aurovitas may be maintained provided a healthy lifestyle and dietary recommendations are followed.
• Inform your physician or pharmacist if symptoms worsen or if there is no improvement.

Use of a higher than recommended dose of Macrogol Aurovitas
Taking too high a dose of macrogol may cause diarrhea, abdominal pain, or vomiting.
Diarrhea usually resolves after discontinuation of the medicine or after reducing the dose.
In case of severe diarrhea or vomiting, contact a physician as soon as possible, as treatment to prevent loss of salts (electrolytes) accompanying fluid loss may be necessary.
Missed dose of Macrogol Aurovitas
Take the next dose as soon as possible, but do not use a double dose to make up for the missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Adverse reactions, which are usually mild and do not last long, include:
In children:
Common (may affect 1 in 10 people):

• abdominal pain;
• diarrhoea, which may also cause pain around the anus.

Uncommon (may affect 1 in 100 people):

• nausea or vomiting;
• abdominal distension.

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

• allergic reactions (hypersensitivity) (rash, urticaria, facial or throat swelling, breathing difficulties, fainting or collapse).

In adults:
Common (may affect 1 in 10 people):

• abdominal pain;
• bloating;
• nausea;
• diarrhoea.

Uncommon (may affect 1 in 100 people):

• vomiting;
• sudden urge to defecate;
• faecal incontinence.

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

• hypokalaemia (low blood potassium levels), which may cause muscle weakness, tremor, or irregular heartbeat;
• hyponatraemia (low blood sodium levels), which may cause fatigue and confusion, muscle twitching, seizures, and coma;
• dehydration due to severe diarrhoea, particularly in elderly people;
• symptoms of allergic reaction, such as skin redness, rash, urticaria, facial or throat swelling, breathing difficulties, fainting or collapse.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions enables better assessment of the medicine's safety and helps provide more information on its safe use.

5. How to store Macrogol Aurovitas

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton and
on the sachet after: EXP or "Expiry date". The expiry date refers to the last day of the stated month.
There are no special storage instructions for this medicine.
Do not use the medicine if you notice any visible signs of deterioration.
Medicines must 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 pack and other information

What Macrogol Aurovitas contains

• The active substance is macrogol 4000. Each sachet contains 10 g of macrogol 4000.
• Other ingredients are: Sodium saccharin (E 954), orange-grapefruit flavour [containing 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 pack
Macrogol Aurovitas is a white or almost white, free-flowing powder with a waxy or paraffin-like appearance and an orange odour.
The cardboard package contains 10, 20, 30, 50, 60 or 100 sachets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warszawa
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 medicinal product is authorised 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