DULCOSOFT

DULCOSOFT solution

Product properties

DulcoSoft solution
Oral solution
5 g Macrogol 4000 in 10 ml water

Dear patient, please read the following instructions for use carefully, as they contain important information on what you should consider when using DulcoSoft solution. If you have any questions, please contact your doctor or pharmacist.

DulcoSoft solution is a medical device for softening hard stools and for the symptomatic treatment of irregular, hard bowel movements. Keep these instructions for use. You may want to read them again later.

In these instructions for use

1. WHAT IS DULCOSOFT SOLUTION AND WHAT IS IT USED FOR?
2. WHAT IS DULCOSOFT SOLUTION AND WHAT IS IT USED FOR?
3. HOW TO TAKE DULCOSOFT SOLUTION?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE DULCOSOFT SOLUTION?
6. FURTHER INFORMATION

1. WHAT IS DULCOSOFT SOLUTION AND WHAT IS IT USED FOR?

If normal bowel activity is slowed down, this can lead to hard, compact stools with difficult and painful bowel movements. DulcoSoft solution contains the osmotically active ingredient Macrogol 4000, which binds water and thus increases the fluid content in the colon. In this way, hard stools are softened and their further transport through the intestine is facilitated - for regular, easier bowel movements. Macrogol 4000 acts purely physically. Absorption into the bloodstream is negligible; it remains in the intestine, from where it is excreted unchanged. The effectiveness of the product remains unchanged even with prolonged use.

DulcoSoft solution is used for:

• Softening hard stools.
• Relief from irregular, hard bowel movements.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING DULCOSOFT SOLUTION?

DulcoSoft solution must not be taken:

• if you are hypersensitive (allergic) to Macrogol (polyethylene glycol) or any of the other ingredients of DulcoSoft solution (see 6. Further information).
• in severe inflammatory bowel disease (such as ulcerative colitis, Crohn's disease) or abnormal bowel dilation (toxic megacolon).
• in the case of a bowel perforation or risk of bowel perforation.
• in the case of intestinal obstruction or suspected intestinal obstruction or intestinal narrowing.
• in the case of abdominal pain of unknown cause.

Do not take this product if you have any of the above conditions. If you are not quite sure, ask your doctor or pharmacist first before taking DulcoSoft solution.

Special care should be taken when taking DulcoSoft solution

As with any laxative, an organic cause should be ruled out before starting treatment. DulcoSoft solution should not be taken regularly daily for a long period of time without clarifying the cause of the intestinal problems. In the case of persistent abdominal pain, you should consult a doctor. In the case of diarrhoea, caution is advised in patients who are prone to disturbances in the water or salt (electrolyte) balance (e.g. in elderly patients, in patients with impaired liver or kidney function or in patients taking diuretics (water tablets)), and monitoring of electrolyte levels should be considered. Allergic reactions (such as anaphylactic shock, anaphylactic reaction, angioedema (e.g. facial swelling), hives, rash and hypersensitivity) have been observed in patients taking Macrogol-containing preparations. If you notice any of the above signs or symptoms, you should stop taking DulcoSoft solution and seek medical attention immediately.

Pregnancy and breastfeeding

DulcoSoft solution can be taken during pregnancy and breastfeeding, as the absorption of Macrogol 4000 is negligible and therefore no effects are to be expected. However, it is advisable to ask your doctor before taking DulcoSoft solution if you are pregnant or breastfeeding.

Use in children

This medical device must not be used in children under 2 years of age.

Use in diabetics

DulcoSoft solution is suitable for diabetics. The solution contains no sugar.

Taking DulcoSoft solution together with medicines

Macrogol 4000 increases the osmotic pressure in the intestine and can therefore alter the absorption of other preparations taken at the same time. Please inform your doctor or pharmacist if you are taking/using or have recently taken/used any other medicines, or if other medicines have been used in your child, even if they are non-prescription medicines.

3. HOW TO TAKE DULCOSOFT SOLUTION?

Always take DulcoSoft solution exactly as described in these instructions for use. If you are not quite sure, ask your doctor or pharmacist. Use in children up to 8 years of age should only be on medical advice.

Adults and children aged 8 years and over

Unless otherwise prescribed by your doctor, the usual dose is: 20 to 40 ml solution (equivalent to 10 to 20 g Macrogol 4000) per day, preferably as a single dose in the morning.

Children aged 4 to 7 years

Unless otherwise prescribed by your doctor, the usual dose is: 16 to 32 ml solution (equivalent to 8 to 16 g Macrogol 4000) per day, preferably as a single dose in the morning.

Children aged 2 to 3 years

Unless otherwise prescribed by your doctor, the usual dose is: 8 to 16 ml solution (equivalent to 4 to 8 g Macrogol 4000) per day, preferably as a single dose in the morning.

The dose of DulcoSoft solution is measured with the enclosed dosing cup and can be adjusted according to the effect achieved. The correct dose is the lowest dose that results in regular, soft stools. DulcoSoft solution is suitable for daily use. Depending on individual needs, the recommended dosage can be taken daily or every other day. DulcoSoft solution should only be taken diluted. DulcoSoft solution is flavourless and can be mixed with a drink of your choice, e.g. with a glass (approx. 150 ml) of water, fruit juice or tea, to suit your personal taste.

Please note

The effect of DulcoSoft solution usually occurs 24 to 72 hours after ingestion. Clinical studies show that regular use usually results in a bowel movement once a day. If constipation persists, its cause should be investigated. Children should not take DulcoSoft solution for more than 3 months.

If you have taken more DulcoSoft solution than you should

You may experience diarrhoea, abdominal pain, bloating and vomiting, which will stop after discontinuing treatment or reducing the dose. High fluid loss due to diarrhoea or vomiting may require correction of the salt (electrolyte) balance, so you should contact a doctor.

If you forget to take DulcoSoft solution

Do not take a double dose to make up for a forgotten dose.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

DulcoSoft solution can have side effects, but not everyone gets them. The side effects were generally mild and transient

Adults and children

Diarrhoea, abdominal pain, bloating, nausea, vomiting, faecal incontinence and flatulence. Allergic reactions (such as anaphylactic shock, anaphylactic reaction, angioedema (e.g. facial swelling), hives, rash and hypersensitivity) can occur rarely.
In the case of diarrhoea, it may be considered to initiate therapeutic measures against a salt (electrolyte)/fluid loss, if necessary. Diarrhoea usually disappears when the dose is discontinued or reduced. In children, diarrhoea can cause soreness around the anus.

Please inform your doctor or pharmacist if any of the listed side effects affect you significantly or if you notice any side effects not listed in these instructions for use.

5. HOW TO STORE DULCOSOFT SOLUTION?

Keep out of reach of children. Please do not use DulcoSoft solution after the expiry date stated on the folding box and bottle label. The expiry date refers to the last day of the month. Please do not store DulcoSoft solution above 25°C and do not refrigerate. DulcoSoft solution has a shelf life of 6 weeks after opening the bottle.

6. FURTHER INFORMATION

10 ml oral solution contains: 5 g Macrogol 4000 in dissolved form. The oral solution is available in a 250 ml pack. Other ingredients: Macrogol 400, citric acid, potassium sorbate (preservative) and purified water.

• Salt-free.
• Suitable for patients on a low-salt diet. Also free of potassium chloride and sodium hydrogen carbonate.
• Sugar-free: Suitable for diabetics.
• Gluten-free.

Manufacturer

Hälsa Pharma GmbH
Maria-Goeppert-Straße 5
23562 Lübeck

Distributor

Sanofi-Aventis Deutschland GmbH 65926 Frankfurt am Main

Postal address

Postfach 80 08 60
65908 Frankfurt am Main
Telephone: 0800 56 56 010
Telefax: 0800 56 56 011
www.dulcolax.de

This information for use was last revised in March 2018.

Source: Information from the package leaflet
Status: 12/2019