Package leaflet: Information for the patient

GoGanza 13.8 g powder for oral solution

macrogol 3350, sodium chloride, sodium hydrogen carbonate, potassium chloride
Generic Medicine
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.
Keep this leaflet. You may need to read it again.

If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4. Contents of this leaflet:
1. What GoGanza is and what it is used for
2. What you need to know before taking GoGanza
3. How to take GoGanza
4. Possible side effects
5. How to store GoGanza
6. Contents of the pack and other information

1. What GoGanza is and what it is used for

GoGanza is a laxative (a medicine used to help bowel evacuation) for the long-term treatment of (chronic) constipation in adults, adolescents, and the elderly. It is not recommended for children under 12 years of age.
GoGanza helps achieve adequate bowel evacuation even if constipation has been present for a long time.
GoGanza is also effective in the treatment of fecal impaction (a condition in which a large amount of stool accumulates in the rectum and/or colon, causing difficulty in evacuation).

2. What you need to know before taking GoGanza

Do not take GoGanza:

if you are allergic to macrogol 3350, sodium chloride, sodium bicarbonate, potassium chloride, or any of the other ingredients of this medicine (listed in section 6)
if you have intestinal obstruction (bowel blockage, ileus)
if you have a perforation of the intestinal wall
if you have a severe inflammatory bowel disease such as ulcerative colitis, Crohn’s disease, or toxic megacolon. If any of these conditions apply to you, consult your doctor or pharmacist. Warnings and precautions Talk to your doctor or pharmacist before taking GoGanza. If you have heart disease and are taking this medicine for faecal impaction, follow the specific instructions on how to take the medicine as described in section 3 of this leaflet.

During treatment
While taking GoGanza, you must continue to drink plenty of fluids. The water used to prepare the GoGanza mixture must not replace your regular fluid intake.
If you develop symptoms indicating changes in blood electrolyte levels such as swelling of the body, shortness of breath, fatigue, dehydration (symptoms include increased thirst, dry mouth, and weakness), or heart problems, stop taking GoGanza and contact your doctor immediately (see section 4 “Possible side effects”).
Children
Do not give this medicine to children under 12 years of age.
Other medicines and GoGanza
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.
Some medicines, for example antiepileptic drugs, may not work as effectively if taken at the same time as GoGanza.
Do not take other oral medicines at the same time as GoGanza, or within one hour before or one hour after taking GoGanza.
If you need to thicken liquids to swallow them safely, GoGanza may interfere with the thickening agent’s effect.
Pregnancy and breastfeeding
GoGanza may be taken during pregnancy and while breastfeeding.
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
GoGanza contains sodium, sorbitol, and potassium
This medicine contains 8.1 mmol (187.7 mg) of sodium (a key component of table salt) per sachet. This corresponds to 9.4% of the maximum daily recommended dietary intake for an adult.
The maximum recommended dose of this medicine (8 sachets) contains 1501.6 mg of sodium (a component of table salt). This corresponds to 75% of the maximum daily recommended dietary intake for an adult.
Talk to your doctor or pharmacist if you need to take 3 or more sachets per day for a prolonged period, especially if you have been advised to follow a low-sodium diet.
The lime-lemon flavour in GoGanza contains 0.76 mg of sorbitol per sachet. The cumulative effect of sorbitol (or fructose) intake from other products and dietary sources should be considered during treatment with this medicine. The sorbitol content in oral medicines may affect the effectiveness of other oral medicines you are taking.
This medicine contains 0.63 mmol of potassium per 125 ml. This should be taken into account in patients with reduced kidney function or in patients following a low-potassium diet.

3. How to take GoGanza

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Adults, children (aged 12 years and older), and elderly:
The recommended dose for constipation is one sachet one to three times daily.
This medicine can be taken at any time, with or without food or drink.
Constipation:
One dose of GoGanza is one sachet.
Take one sachet 1–3 times a day, depending on the severity of your constipation.
Fecal impaction:
For the treatment of fecal impaction, a dose of 8 sachets per day of GoGanza is required.
The 8 sachets should be taken within 24 hours, if necessary for up to 3 days.
If you have a heart condition, do not take more than 2 sachets per hour.
How to mix:
Open the sachet and pour the contents into a glass. Add approximately 125 ml of water to the glass (half a glass). Stir well until all the powder has dissolved and the GoGanza solution is clear or slightly cloudy, then drink the solution.
If you are taking GoGanza for fecal impaction, it may be easier to dissolve 8 sachets in 1 litre of water. The solution must be covered and stored in the refrigerator for no longer than 24 hours; any unused solution must be discarded after this time.
Duration of treatment
Constipation:
Treatment with GoGanza usually lasts about 2 weeks.
If you need to take GoGanza for a longer period, consult your doctor.
If your constipation is caused by a medical condition such as Parkinson's disease or multiple sclerosis, or if you are taking medicines that cause constipation, your doctor may advise you to take GoGanza for longer than 2 weeks.
Generally, during long-term treatment, the dose may be reduced to 1 or 2 sachets per day.
Fecal impaction:
Treatment with GoGanza may last up to 3 days.
If you take more GoGanza than you should
This may cause abdominal pain and bloating, nausea (vomiting), or diarrhoea. If this occurs, contact your doctor or pharmacist.
You may experience excessive diarrhoea, which could lead to dehydration. In this case, stop treatment with GoGanza and drink plenty of fluids. If you are concerned, consult your doctor or pharmacist.
If you forget to take GoGanza
If you forget to take a dose, take it as soon as you remember, then continue as before.
Do not take a double dose to make up for the missed dose.
If you stop taking GoGanza
To get the maximum benefit from GoGanza, always complete the treatment as instructed in this patient information leaflet. This will ensure that your constipation resolves; otherwise, it may persist.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If you experience any of the following side effects, stop taking this medicine and go immediately to your doctor or the nearest hospital emergency department:
Not known (frequency cannot be estimated from the available data)

severe allergic reaction causing sudden signs of allergy such as shortness of breath, breathing difficulties, or swelling of the face, lips, tongue, throat, or other body parts (anaphylaxis, angioedema)
disturbances in body fluids or blood electrolyte levels (low potassium levels, low sodium levels). You may experience fatigue, dehydration, shortness of breath, swelling of feet and legs due to fluid retention, or heart problems.

Other possible side effects
Not known (frequency cannot be estimated from the available data)

skin rash, itching, redness of the skin, or hives
swelling of hands, feet, or ankles
shortness of breath
headache
high or low blood potassium levels
digestive disturbances, stomach ache or rumbling, feeling of fullness (bloating), flatulence
feeling unwell (nausea) or being unwell (vomiting)
discomfort of rectum and anus (lower abdomen)
diarrhoea. You may have mild diarrhoea while taking GoGanza. This side effect usually improves if you reduce the dose of GoGanza taken.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store GoGanza

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and sachet. The expiry date refers to the last day of that month.
Do not store above 25°C.
Do not use this medicine if you notice that any of the sachets are damaged.
Store the reconstituted solution covered and in the refrigerator (from 2°C to 8°C), and use it within 24 hours. After 24 hours, any unused solution must be discarded.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What GoGanza contains
The active substances contained in each 13.8 g sachet are:
Macrogol 3350 13.125 g
Sodium chloride 350.7 mg
Sodium hydrogen carbonate 178.5 mg
Potassium chloride 46.6 mg
When dissolved in 125 ml of water, each sachet provides:
Sodium 65 mmol/l
Chloride 53 mmol/l
Hydrogen carbonate 17 mmol/l
Potassium 5 mmol/l
The other excipients are anhydrous colloidal silica, sodium saccharin, orange flavour (the orange flavour contains: flavouring substances and preparations, maltodextrin, acacia gum, alpha-tocopherol) and lime lemon flavour (the lime lemon flavour contains: flavouring preparations, maltodextrin, mannitol, gluconolactone, sorbitol (see section 2 “GoGanza contains sodium, sorbitol and potassium”), acacia gum, anhydrous colloidal silica).

Description of the appearance of GoGanza and contents of the pack
GoGanza is a white powder.
Each sachet contains 13.8 g of powder and is available in packs of 20, 30, 50 and 100 sachets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milano, Italy

Manufacturer
Klocke Pharma-Service GmbH, Strassburger Strasse 77, 77767 Appenweier, Germany
Hermes Pharma GmbH., Schwimmschulweg 1a, 9400 Wolfsberg, Austria

This medicinal product is authorised in the European Economic Area and the United Kingdom under the following names:
Finland: Duphagol
Italy: GoGanza
Portugal: Magolac
Sweden: Laximyl powder for oral solution
United Kingdom: Molative 13.8 g powder for oral solution