Aurogo

Leaflet attached to the packaging: patient information

AuroGo, 13.7 g, powder for oral solution

Macrogol 3350 + sodium chloride + sodium bicarbonate + potassium chloride

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

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor, pharmacist, or nurse.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is AuroGo and what is it used for
• 2. Important information before taking AuroGo
• 3. How to take AuroGo
• 4. Possible side effects
• 5. How to store AuroGo
• 6. Package contents and other information

1. What is AuroGo and what is it used for

The name of this medicine is AuroGo, 13.7 g, powder for oral solution. It has a laxative effect and is used to treat constipation in adults, adolescents, and the elderly. The medicine should not be given to children under 12 years of age. AuroGo helps maintain normal bowel peristalsis, even when constipation lasts a long time. AuroGo can also be used for severe constipation called fecal impaction.

2. Important information before taking AuroGo

Do not take AuroGo

• if the patient is allergic to the active substances or any of the other ingredients of this medicine (listed in section 6). Or if the patient has:
• intestinal obstruction,
• perforation of the intestinal wall,
• severe inflammatory bowel disease, such as ulcerative colitis, Crohn's disease, or toxic megacolon.

Warnings and precautions

Before starting AuroGo, the patient should discuss it with their doctor, pharmacist, or nurse. During AuroGo treatment, the patient should continue to drink plenty of fluids. The fluid taken with AuroGo should not replace regular fluid intake. If side effects occur, such as swelling, shortness of breath, fatigue, dehydration (symptoms are increased thirst, dry mouth, and weakness), or heart problems, the patient should stop taking AuroGo and contact their doctor immediately. If the patient experiences sudden abdominal pain or rectal bleeding while taking AuroGo for bowel cleansing, they should contact their doctor or seek medical help immediately.

Heart disease

If the patient is taking AuroGo for fecal impaction, they should follow the special instructions given in section 3.

AuroGo and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. During AuroGo treatment, some medicines (e.g., antiepileptics) may not work properly. The patient should not take any other oral medicines with AuroGo or within 1 hour before and 1 hour after taking AuroGo. If fluid thickening is necessary for safe swallowing, AuroGo may counteract the effect of the thickener.

Pregnancy and breastfeeding

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

Driving and using machines

AuroGo does not affect the ability to drive or use machines.

AuroGo contains sodium

The maximum recommended daily dose of AuroGo for constipation contains 558 mg of sodium (found in salt). This corresponds to 27.9% of the recommended maximum daily sodium intake in adults. The patient should consult their doctor or pharmacist if they need to take 3 or more sachets per day for an extended period, especially if they have been advised to follow a low-sodium diet.

Only for fecal impaction

The maximum recommended daily dose of AuroGo for fecal impaction contains 1494 mg of sodium (found in salt). This corresponds to 74.7% of the recommended maximum daily sodium intake in adults. The patient should consult their doctor or pharmacist if they need to take 3 or more sachets per day for an extended period, especially if they have been advised to follow a low-sodium diet.

3. How to take AuroGo

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor, pharmacist, or nurse. If in doubt, the patient should consult their doctor, pharmacist, or nurse. The medicine can be taken at any time with or without food. The patient should dissolve the contents of one sachet in 125 ml (half a glass) of water and drink it.

Constipation

The dose of AuroGo is the contents of one sachet dissolved in 125 ml (half a glass) of water. The medicine should be taken 1 to 3 times a day, depending on the severity of constipation.

Fecal impaction

Before taking AuroGo, the patient should consult their doctor about the occurrence of fecal impaction. For fecal impaction, the patient should take 8 sachets of AuroGo per day. The contents of each sachet should be dissolved in 125 ml (half a glass) of water. The patient should take 8 sachets within 6 hours and, if necessary, continue treatment for up to 3 days. Patients with heart disease should not take more than 2 sachets within 1 hour.

How to prepare the solution

The patient should open the sachet and pour its contents into a glass. Add about 125 ml (half a glass) of water to the glass. Stir well until the powder dissolves, and the AuroGo solution is clear or slightly opalescent, then drink it. If the patient is taking AuroGo for fecal impaction, it is easier to dissolve 8 sachets in 1 liter of water.

Duration of treatment

Constipation

Treatment usually lasts 2 weeks. The patient should contact their doctor if it is necessary to take this medicine for a longer period. If constipation is caused by diseases such as Parkinson's disease, multiple sclerosis, or by taking other medicines that cause constipation, the doctor may recommend taking AuroGo for longer than 2 weeks. If it is necessary to take AuroGo for a longer period, the patient should contact their doctor. Usually, during long-term treatment, the dose can be reduced to 1 or 2 sachets per day.

Fecal impaction

Treatment should not last longer than 3 days.

Taking more than the recommended dose of AuroGo

The patient may experience severe diarrhea, which can lead to dehydration. In this case, the patient should stop taking AuroGo and drink plenty of fluids. If in doubt, the patient should contact their doctor or pharmacist.

Missing a dose of AuroGo

The patient should not take a double dose to make up for a missed dose. The patient should take the missed dose as soon as possible.

4. Possible side effects

Like all medicines, AuroGo can cause side effects, although not everybody gets them.

The patient should stop taking AuroGo and immediately tell their doctor if:

• a severe allergic reaction occurs, which causes difficulty breathing or swelling of the face, lips, tongue, or throat.

Other side effects include:

• allergic reactions, which can cause skin rash, itching, redness, or hives, swelling of hands, feet, or ankles, headache, and high or low potassium levels in the blood.

Sometimes, the patient may experience indigestion, abdominal pain, or rumbling in the abdomen. In the initial period of AuroGo treatment, the patient may also experience abdominal bloating, gas-related disorders, nausea, or vomiting, and may feel anal pain or experience mild diarrhea. These side effects usually disappear if the dose of AuroGo is reduced. Frequency not known (frequency cannot be estimated from the available data):

• changes in fluid or electrolyte levels in the body (low potassium levels, low sodium levels).

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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. Side effects can also be reported to the marketing authorization holder or its representative in Poland. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store AuroGo

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the sachet or carton after: EXP. The expiry date "EXP" means the last day of the specified month. Do not store above 25°C. The prepared solution should be stored in the refrigerator at a temperature of 5 ± 3°C and used within 24 hours. Do not use this medicine if the patient notices damage to the sachet. Medicines should not be disposed of via wastewater or household waste containers. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What AuroGo contains

The active substances of AuroGo are: macrogol 3350, sodium chloride, sodium bicarbonate, and potassium chloride. The other ingredients are: orange flavor Silarom, lemon-lime flavor "ME", colloidal silica anhydrous, and sodium saccharin. Each sachet of AuroGo contains 13.1250 g of macrogol 3350, 0.1785 g of sodium bicarbonate, 0.3507 g of sodium chloride, and 0.0466 g of potassium chloride.

What AuroGo looks like and what the pack contains

Powder for oral solution. AuroGo is a white, crystalline powder. AuroGo is available in a carton containing 10, 20, 30, or 50 sachets of powder. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Aurovitas Pharma Polska Sp. z o.o.

ul. Sokratesa 13D lok. 27
01-909 Warsaw
Poland

Manufacturer

Klocke Pharma-Service GmbH

Strassburger Strasse 77
77767 Appenweier
Germany
Hermes Pharma Ges.m.b.H.
Schwimmschulweg 1a
9400 Wolfsberg
Austria

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

Poland:
AuroGo
Belgium:
Macrogol+electrolytes Apotex 13.7 g powder for oral solution

If the patient has any further questions or concerns, they should ask their doctor or pharmacist or the representative of the marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o.

tel.: 22 311 20 00

Date of last revision of the leaflet: 06.2025