Laxogol powder for the preparation of a solution for oral use

Laxogol is a laxative used to treat chronic constipation.

Application

1. What is Laxogol and what is it used for?

Laxogol is a laxative used to treat chronic constipation. Use in children under 12 years of age is not recommended.
Macrogol 3350 softens your stool and allows for easier passage, relieving you of constipation. The electroytes (salts) help maintain normal levels of the body's sodium, potassium and water while treating your constipation.

How is it applied?

What is Laxogol and what is it used for?

Laxogol is a laxative used to treat chronic constipation. Use in children under 12 years of age is not recommended.
Macrogol 3350 softens your stool and allows for easier passage, relieving you of constipation. The electroytes (salts) help maintain normal levels of the body's sodium, potassium and water while treating your constipation.

What should you pay attention to before taking it?

What should you know before taking Laxogol?

Laxogol must not be taken
- if you are allergic to macrogol 3350, sodium chloride, sodium hydrogen carbonate, potassium chloride or any of the other ingredients listed in section 6. Other ingredients of this medicine
- if you have intestinal perforation
- if you have intestinal obstruction
- if you have severe inflammatory bowel disease such as. ulcerative colitis, Crohn's disease or toxic megacolon

Please tell your doctor or pharmacist if this applies to you.

Warnings and precautions
Please talk to your doctor or pharmacist before taking Laxogol.
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Taking Laxogol with other medicines
The effect of some medicines such as antiepileptic drugs may be reduced if taken at the same time as Laxogol.
Inform your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines.

Taking Laxogol with food and drink
Laxogol can be taken at any time, regardless of the intake of food and drink.

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Driving and ability to operate machinery
Laxogol has no or negligible effect on driving and ability to operate machinery.

Laxogol contains potassium, sodium and sorbitol (lemon-lime flavour)
Laxogol contains 0.63 mmol (25 mg) of potassium per sachet. This should be taken into account if you take more than one sachet a day and have impaired kidney function, or you are on a controlled potassium diet.

Laxogol contains 8.1 mmol (187 mg) of sodium per sachet. If you have to follow a low-salt diet, you should take this into account.

The lemon-lime flavouring in Laxogol contains sorbitol (E420). Please only take this medicine after consulting your doctor if you are known to suffer from a sugar intolerance.

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How should the medicine be taken?

How to take Laxogol?

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Adults, children (12 years and over) and elderly patients:
The usual dose for constipation is 1 sachet 1 to 3 times a day.

Making the solution
Open the sachet and pour the contents into a glass. Add approx. 125 ml water. Stir until the powder has dissolved and then drink the solution.

Duration of use
The duration of use for constipation should not normally exceed 2 weeks.

If you have taken a larger amount of Laxogol than you should
This could cause severe pain and bloating in the abdomen (stomach), vomiting (nausea) or diarrhoea. In this case, contact your doctor or pharmacist.
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If you forget to take Laxogol
If you forget to take it, take the dose as soon as you remember. Continue the application with the intended dosage. Do not take twice the amount if you have forgotten to take it before.

If you stop taking Laxogol
To get the most benefit from Laxogol, always take the medicine according to the package leaflet. This will ensure that your constipation is relieved, otherwise the symptoms you are suffering from may persist.

If your symptoms get worse or do not improve after 14 days, you must see a doctor.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

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What are the possible side effects?

How to store Laxogol?

Keep this medicine out of the reach of children.

You must not use this medicine after the expiry date which is stated on the carton and sachets after "EXP". The expiry date refers to the last day of the month indicated.

Do not store above 25 °C.

You must not use this medicine if you notice that a sachet is damaged.

The prepared ready-to-use solution can be stored covered and in the refrigerator (2 °C to 8 °C) and must be used within 24 hours. After 24
hours, any unused solution must be discarded.

Do not dispose of medicines in sewage or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. In doing so, they contribute to the protection of the environment.

Special instructions for storage

5. How to store Laxogol?

Keep this medicine out of the reach of children.

Do not use this medicine after the expiry date which is stated on the carton and pouches after ,,EXP". The expiry date refers to the last day of the month indicated.

Do not store above 25 °C.

Do not use this medicine if you notice that a sachet is damaged.

The prepared ready-to-use solution can be stored covered and in the refrigerator (2 °C to 8 °C)and must be used within 24 hours. After 24
hours, any unused solution must be discarded.

Do not dispose of medicines in sewage or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. In doing so, they contribute to the protection of the environment.

Special notes on the content

Contents of the pack and other information

What Laxogol contains

The active ingredients per sachet are:

Macrogol 3350 (polyethylene glycol 3350) 13.125 g

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Sodium chloride	0.3507 g
Sodium hydrogen carbonate	0.1785 g
potassium chloride	0.0466 g

The other ingredients are:
Highly dispersed silicon dioxide, saccharin sodium, orange flavour (orange flavour contains: Flavouring substances and flavouring extracts, maltodextrin, gum arabic, alpha-tocopherol) and Lemon-Lime Flavour (Lemon-Lime Flavour contains: Flavouring extracts, maltodextrin, mannitol (E421), D-glucono-1,5-lactone, sorbitol (E420), gum arabic, highly dispersed silicon dioxide).

Like Laxogol Looks like and contents of the pack.
Laxogol is a white powder.

Each sachet contains 13.8 g of powder and comes in packs of 2, 6, 8, 10, 20, 30, 50, 60 (2 x 30) and 100 (2 x 50) sachets.

Not all pack sizes may be marketed.