Aurogo
Poland
Table of Contents
Package leaflet: Information for the user
AuroGo, 13.7 g, powder for oral solution
Macrogol 3350 + sodium chloride + sodium bicarbonate + potassium chloride
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
You should always take this medicine exactly as described in this patient leaflet, or as your
doctor, pharmacist, or nurse has advised.
- Keep this leaflet. You may need to read it again.
- If you need advice or additional information, please contact your pharmacist.
- If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.
- If you do not get better or if you feel worse, you should contact your doctor.
Contents of the leaflet
- What AuroGo is and what it is used for
- Important information before taking AuroGo
- How to take AuroGo
- Possible side effects
- How to store AuroGo
- Contents of the pack and other information
1. What AuroGo is and what it is used for
The name of this medicine is AuroGo, 13.7 g, powder for oral solution. It has a laxative effect and is used in the treatment of constipation in adults, adolescents, and elderly people.
This medicine should not be given to children under 12 years of age.
AuroGo helps maintain normal intestinal peristalsis (bowel function), even in cases of long-standing constipation. AuroGo can also be used in severe constipation known as faecal impaction.
2. Important information before taking AuroGo
Do not take AuroGo
- if the patient is allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6). Or if the patient has:
- intestinal obstruction,
- intestinal wall perforation,
- severe intestinal inflammatory disease, such as ulcerative colitis, Crohn's disease, or toxic megacolon (pseudomegacolon).
Warnings and precautions
Before starting to take AuroGo, the patient should discuss this with a doctor, pharmacist, or nurse.
While taking AuroGo, it is important to continue drinking large amounts of fluid. The fluid taken with AuroGo must not replace regular fluid intake.
If adverse effects such as swelling, shortness of breath, fatigue, dehydration (symptoms include increased thirst, dry mouth, and weakness), or heart problems occur, stop taking AuroGo and contact a doctor immediately.
If, during treatment with AuroGo for bowel cleansing, the patient experiences sudden abdominal pain or rectal bleeding, contact a doctor or seek immediate medical attention.
Heart conditions
If the patient is taking AuroGo due to faecal impaction, follow the special instructions provided in section 3.
AuroGo and other medicines
Inform the doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.
While taking AuroGo, certain medicines, such as antiepileptic drugs, may not work as effectively.
Do not take any other oral medicines at the same time as AuroGo, or within one hour before or one hour after taking AuroGo.
If thickening of fluids is required to facilitate swallowing, AuroGo may interfere with the action of the thickener.
Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
AuroGo may be used during pregnancy and breastfeeding.
Driving and operating machinery
AuroGo has no effect on the ability to drive or operate machinery.
AuroGo contains sodium
The maximum recommended daily dose of the medicine used for constipation contains 558 mg of sodium (present in table salt). This corresponds to 27.9% of the recommended maximum daily sodium intake in the diet of adults.
Consult a doctor or pharmacist if taking 3 or more sachets per day for an extended period, especially if the patient has been advised to follow a low-sodium diet.
Applies only to the indication faecal impaction
The maximum recommended daily dose of the medicine used for faecal impaction contains 1494 mg of sodium (present in table salt). This corresponds to 74.7% of the recommended maximum daily sodium intake in the diet of adults.
Consult a doctor or pharmacist if taking 3 or more sachets per day for an extended period, especially if the patient has been advised to follow a low-sodium diet.
3. How to take AuroGo
This medicine should always be taken exactly as described in this patient information leaflet or as directed by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse.
AuroGo can be taken at any time, with or without food. The contents of each sachet should be dissolved in 125 ml (half a glass) of water and then drunk.
Constipation
The dose of AuroGo is the contents of 1 sachet dissolved in 125 ml (half a glass) of water. The medicine should be taken 1 to 3 times daily, depending on the severity of constipation.
Faecal impaction
Before using AuroGo, consult your doctor to confirm the presence of faecal impaction.
In case of faecal impaction, take 8 sachets of AuroGo per day.
Dissolve the contents of each sachet in 125 ml (half a glass) of water. Take the 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 medicinal solution
Open the sachet and pour its contents into a glass. Add approximately 125 ml (half a glass) of water. Stir well until the powder dissolves and the AuroGo solution becomes clear or slightly opalescent, then drink it. If the patient is using AuroGo due to faecal impaction, it may be easier to dissolve 8 sachets in 1 litre of water.
Duration of treatment
Constipation
Treatment usually lasts 2 weeks. Contact your doctor if longer use of this medicine is needed. If constipation is caused by conditions such as Parkinson's disease, multiple sclerosis (MS), or by taking other medicines that cause constipation, your doctor may recommend using AuroGo for longer than 2 weeks. If prolonged treatment with AuroGo is required, consult your doctor.
During long-term treatment, the dose is usually reduced to 1 or 2 sachets per day.
Faecal impaction
Treatment should not last longer than 3 days.
If you take more AuroGo than you should
Severe diarrhoea may occur, which could lead to dehydration. In such a case, stop taking AuroGo and drink plenty of fluids. If in doubt, contact your doctor or pharmacist.
If you forget to take AuroGo
Do not take a double dose to make up for a missed dose. Take the missed dose as soon as possible.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
You must stop taking AuroGo and immediately inform your doctor if:
- a severe allergic reaction occurs causing difficulty in breathing or swelling of the face, lips, tongue or throat.
Other adverse effects include:
- allergic reactions which may cause skin rash, itching, redness of the skin or hives, swelling of the hands, feet or ankles, headache, and high or low blood potassium levels.
Indigestion, abdominal pain or gurgling in the stomach may sometimes occur. During the initial period of treatment with AuroGo, abdominal bloating, intestinal gas-related discomfort, nausea or vomiting may also occur; the patient may experience anal pain and mild diarrhoea may develop. These adverse effects usually resolve if the dose of AuroGo is reduced.
Frequency unknown (frequency cannot be estimated from the available data):
- changes in body fluid or electrolyte levels (low potassium levels, low sodium levels).
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects 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 181C, 02-222 Warsaw, phone: +48 22 49-21-301, fax: +48 22 49-21-309, website: https://smz.ezdrowie.gov.pl . Adverse effects can also be reported to the marketing authorisation holder or to the representative of the marketing authorisation holder in Poland. By reporting adverse effects, additional information on the safety of this medicine can be collected.
5. How to store AuroGo
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the sachet or cardboard
pack after: EXP. The expiry date "EXP" refers to the last day of the stated month.
Do not store above 25°C.
The prepared solution should be stored in a refrigerator at 5 ± 3°C and used within 24
hours.
Do not use this medicine if the sachet is damaged.
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 AuroGo contains
The active substances in this medicine are: macrogol 3350, sodium chloride, sodium bicarbonate, and potassium chloride.
Other ingredients are: orange flavour Silarom, lemon-lime flavour "ME",
colloidal anhydrous silica, and sodium saccharin.
Each AuroGo sachet 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 contents of the pack
Oral rehydration powder.
AuroGo is a white, crystalline powder. AuroGo is available in cardboard packaging containing 10, 20, 30, or 50 sachets of powder.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lok. 27
01-909 Warsaw
Poland
Manufacturers
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 authorised for marketing in the European Economic Area countries under the following names:
Poland: AuroGo
Belgium: Macrogol+electrolytes Apotex 13.7 g powder for oral solution
For any further questions or doubts, please contact your doctor, pharmacist, or representative of the Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
Tel.: 22 311 20 00