PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Macrogol Sandoz 13.125 g + 351 mg + 179 mg + 47 mg powder for oral solution

Macrogol 3350/sodium chloride/sodium hydrogen carbonate/potassium chloride
Generic medicine
Please read this leaflet carefully before using this medicine as 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 others, even if they have the same symptoms as you, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Macrogol Sandoz is and what it is used for
What you need to know before taking Macrogol Sandoz
How to take Macrogol Sandoz
Possible side effects
How to store Macrogol Sandoz
Contents of the pack and other information

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

Macrogol Sandoz is a laxative used for the treatment of constipation (especially in cases of persistent constipation) in adults, adolescents and elderly patients. It is not recommended for children under 12 years of age.
Macrogol Sandoz is also used for the treatment of accumulation of hard stools in the intestine (known as fecal impaction), which may be caused by persistent constipation.
Macrogol 3350 softens the stools, facilitating their passage and providing relief from constipation. The electrolytes (salts) help maintain normal levels of sodium, potassium and water in the body during treatment of constipation.

2. What you need to know before taking Macrogol Sandoz

Do not take Macrogol Sandoz

if you are allergic to macrogol 3350, sodium chloride, sodium hydrogen carbonate, potassium chloride, or any of the other ingredients of this medicine (listed in section 6)
if you have intestinal wall perforation
if you have intestinal blockage (intestinal obstruction, ileus)
if you have a severe inflammatory bowel disease, such as ulcerative colitis, Crohn's disease, or toxic megacolon.

Consult your doctor or pharmacist before taking this medicine.
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Warnings and precautions
Before taking Macrogol Sandoz for the treatment of faecal impaction, this condition must be confirmed by a doctor.
If you have heart problems and are taking Macrogol Sandoz for faecal impaction, follow the specific instructions in section 3.
If you feel weak, short of breath, very thirsty with headache, have difficulty breathing when lying down, or have swollen ankles, stop taking this medicine and contact your doctor immediately.
Children
Do not give this medicine to children under 12 years of age.
Other medicines and Macrogol Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines, such as antiepileptic drugs, may not work as effectively when taken together with Macrogol Sandoz. Therefore, do not take any other oral medicines one hour before or one hour after taking this medicine.
Pregnancy and breastfeeding
Macrogol Sandoz can be taken during pregnancy and while breastfeeding. If you are pregnant or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
This medicine has no effect on the ability to drive or operate machinery.
Macrogol Sandoz contains sodium and sorbitol
The maximum recommended daily dose of this medicine when used for constipation contains 564 mg of sodium (found in table salt). This is equivalent to 28.2% of the maximum recommended daily sodium intake for adults.
Talk to your doctor or pharmacist if you need three or more sachets per day for a prolonged period, especially if you have been advised to follow a low-sodium diet.
The maximum recommended daily dose of this medicine when used for faecal impaction contains 1504 mg of sodium (present in cooking salt). This corresponds to 75.2% of the maximum recommended daily sodium intake for adults.
Talk to your doctor or pharmacist if you require three or more sachets per day for a prolonged period, especially if you have been advised to follow a low-salt (low-sodium) diet.
The lime and lemon flavour of this medicine contains 0.8 mg of sorbitol (E420) in each sachet.
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3. How to take Macrogol Sandoz

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Constipation
One dose of Macrogol Sandoz is one sachet dissolved in 125 ml (1/8 of a litre) of water. Take it 1–3 times a day, depending on the severity of your constipation.
Treatment with this medicine usually lasts about 2 weeks. If you need to take the medicine for longer, please consult your doctor. If your constipation is caused by a disease such as Parkinson's disease or multiple sclerosis (MS), or if you are taking medicines that cause constipation, your doctor may advise you to take this medicine for more than 2 weeks. If you need to take this medicine for a longer period, please consult your doctor. For long-term treatment, the dose can usually be reduced to 1 or 2 sachets per day.
Accumulation of hard stools in the bowel (faecal impaction)
Before taking the medicine for faecal impaction, it must be confirmed that you have this condition. A dose of 8 sachets per day of Macrogol Sandoz is required for the treatment of faecal impaction. Each sachet should be dissolved in 125 ml (1/8 of a litre) of water. The 8 sachets should be taken within 6 hours, for up to 3 days if necessary.
If you have a heart condition, do not take more than 2 sachets in one hour.
How to mix
Open the sachet and pour the contents into a glass. Add approximately 125 ml or one-eighth of a litre of water. Stir well until the powder has dissolved and the solution is clear or slightly cloudy, then drink it.
If you are being treated for faecal impaction, you may dissolve the contents of all eight sachets together in a large container (in one litre of water).
This medicine should be taken by mouth.
Children
Do not give this medicine to children under 12 years of age.
If you take more Macrogol Sandoz than you should
This may cause severe abdominal pain, bloating, vomiting (nausea), or diarrhoea.
Excessive diarrhoea may lead to dehydration. In this case, stop treatment and drink plenty of fluids. If you are concerned, contact your doctor or pharmacist.
If you forget to take Macrogol Sandoz
Take the dose as soon as you remember.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not
everyone gets them.
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If you experience any of the following side effects, stop taking
Macrogol Sandoz and contact your doctor immediately:

If you have signs of an allergic reaction, such as rash, itching, redness of the skin, shortness of breath or difficulty breathing, or swelling of the face, lips, tongue, or throat.
If you have signs of an electrolyte imbalance (salts), such as swelling (especially in the ankles), feeling weak, dehydration, increasing tiredness, or increased thirst with headache. These symptoms may indicate that the level of potassium in your blood is either higher or lower than normal.

Other side effects include:

Swelling of the hands, feet, and ankles
Headache
Indigestion, stomach discomfort, or stomach rumbling
Feeling bloated, flatulence, nausea, or vomiting
Pain in the anus (rectal)
Diarrhoea (when starting this medicine)

These side effects usually improve if you reduce the amount of Macrogol
Sandoz you are taking.
The frequency of these side effects is not known (cannot be estimated from the
available data).
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 .
By reporting side effects, you can help provide more information
on the safety of this medicine.

5. How to store Macrogol Sandoz

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 on the sachet.
The expiry date refers to the last day of that month.
Do not store above 25°C.
The reconstituted Macrogol Sandoz solution may be covered and stored in the refrigerator (2–8°C) and must be used within 24 hours. Discard any unused solution after 24 hours.
Do not use this medicine if you notice that any of the sachets are damaged.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
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6. Package contents and other information

What Macrogol Sandoz contains
The active substances are:
Each sachet contains:
Macrogol 3350 13.125 g
Sodium chloride 0.3507 g
Sodium hydrogen carbonate 0.1785 g
Potassium chloride 0.0466 g
The other components are anhydrous colloidal silica, sodium saccharin, orange flavour
(the orange flavour contains: flavouring substances and flavouring preparations,
maltodextrin, gum arabic (E414), alpha-tocopherol (E307)) and lime and lemon flavour
(the lime and lemon flavour contains: natural lemon oil, natural lemon flavour powder,
lime flavour powder, maltodextrin, mannitol (E421), gluconolactone (E575), sorbitol (E420),
gum arabic (E414), anhydrous colloidal silica (E551)).

Description of the appearance of Macrogol Sandoz and contents of the pack
Macrogol Sandoz is a white, freely flowing powder.
Each sachet contains 13.8 g of powder and is packed in cartons containing 2, 6, 8, 10, 20, 30, 50, 60 (2x30) and 100 (2x50) sachets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Sandoz SPA, L.go Umberto Boccioni 1, 21040 Origgio (VA)

Responsible pharmaceutical companies for batch release
Klocke Pharma-Service GmbH, Strassburger Strasse 77, 77767 Appenweier, Germany
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany
Hermes Pharma GmbH, Allgäu 36, 9400 Wolfsberg, Austria

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
United Kingdom Compound Macrogol 13.8g Powder for Oral Solution
Austria Laxoglam - Pulver zur Herstellung einer Lösung zum Einnehmen
Belgium Macrogol + elektrolytes Sandoz poeder voor drank
Denmark Gangiden
Finland Laxiriva jauhe oraaliliuosta varten
Germany Macrogol HEXAL plus Elektrolyte Pulver zur Herstellung einer Lösung zum Einnehmen
Ireland Macrolief 13.8g sachet, powder for oral solution
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Italy Macrogol Sandoz
Luxembourg Macrogol + elektrolytes Sandoz poudre pour solution buvable
Netherlands Macrogol en elektrolyten Sandoz 13,8 g, poeder voor drank
Portugal Actolaxan
Spain Atolaxant 13.7 g polvo para solución oral
Sweden Laxiriva pulver till oral lösning, i dospåse
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