Consumer medicine information

Dulcosoft Powder

Macrogol 4000

BRAND INFORMATION

Brand name

Dulcosoft

Active ingredient

Macrogol 4000

Schedule

Unscheduled

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Dulcosoft Powder.

What is in this leaflet

This leaflet answers some common questions about Dulcosoft Powder.

It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor or pharmacist has weighed the risks of you taking Dulcosoft Powder against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What Dulcosoft Powder is used for

Dulcosoft Powder belongs to a group of medicines called osmotic laxatives. It works by drawing water to your stool, which loosens the stool and increases stool volume, helping to overcome sluggish bowels gradually within 24 to 48 hours.

It is used for the treatment of constipation in adults and children aged 8 years and above.

Dulcosoft Powder is not absorbed into the bloodstream or broken down in the body.

Before you take it

When you must not take it

Do not take Dulcosoft Powder if you:

  • Are allergic to it or any of the ingredients listed at the end of this leaflet.
    Some symptoms of an allergic reaction include skin rash, itching, shortness of breath or swelling of the face, lips or tongue, which may cause difficulty in swallowing or breathing.

Do not take Dulcosoft Powder if you have an existing severe intestinal disease such as:

  • inflammatory bowel disease (such as ulcerative colitis, Crohn's disease) or abnormal dilation of the bowel
  • perforation of the bowel or risk of perforation of the bowel
  • a blockage in the intestine
  • painful belly of unknown cause

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Dulcosoft Powder is not recommended for children below the age of 8 years.

Do not take it after the expiry date (exp) printed on the pack.

Do not take it if the packaging is torn or shows signs of tampering. If it has expired or is damaged return it to your pharmacist for disposal

Before you start to take it

Tell your doctor or pharmacist if you have allergies to any other substances, such as foods, preservatives or dyes or any of the ingredients listed at the end of this leaflet.

Tell your doctor or pharmacist if you:

  • think you could be pregnant or you plan to become pregnant while taking Dulcosoft Powder
  • are breastfeeding or planning to breastfeed
  • have liver problems
  • are taking diuretics (water tablets)
  • are using starch-based food thickeners
  • are elderly as you may be at risk of low sodium (salt) or potassium levels in the blood.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop as these may interfere with Dulcosoft Powder.

Dulcosoft Powder may lessen the effect of starch-based food thickeners.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking Dulcosoft Powder.

How to take it

Follow all directions for use written on the medicine's label.

Do not take more than the recommended dose on the label or for a longer period of time.

Check with your doctor or pharmacist if you are not sure.

How much to take

Adult
The recommended adult dose is 1 to 2 sachets daily, preferably taken as a single dose in the morning.

Children and adolescents
In children 8 years and above, the recommended dose is 1-2 sachets daily, preferably taken as a single dose in the morning.

The daily dose should be adapted as required to produce regular soft stools and may range from one sachet every other day (especially in children) up to 2 sachets a day. If administered regularly, the frequency of bowel movements tends to be one movement per day.

How to take it

Dulcosoft Powder is a powder that you dissolve in a glass of water (125mL) and drink immediately.

When to take it

It does not matter if you take Dulcosoft Powder before or after food and it is recommended to be taken in the morning.

How long to take it

Dulcosoft Powder usually takes 24 to 48 hours to work.

Improvement in the frequency of your bowel movements after taking Dulcosoft Powder can be maintained by keeping to a healthy lifestyle and diet.

If you forget to take it

Take the next dose as soon as you remember.

Do not take a double dose to make up for the dose that you missed.

If you are not sure what to do, ask your doctor or pharmacist.

If you take too much (overdose)

Taking too much Dulcosoft Powder may cause diarrhoea, which usually disappears when treatment is stopped or the dose reduced. If you have lost a large amount of fluids by diarrhoea or vomiting, contact your doctor as you may require treatment to prevent loss of salts (electrolytes due to fluid loss).

Contact your doctor or the poisons information centre (telephone Australia 13 11 26 or New Zealand 0800 poison or 0800 764766), or go to accident and emergency at your nearest hospital, if you think you or anyone else may have taken too much Dulcosoft Powder.

While you are taking it

Things you must do

Talk to your pharmacist or doctor if the symptoms worsen or not improve.

Dulcosoft Powder can be taken during pregnancy and whilst breast feeding. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Things you must not do

Do not take more than the recommended dose unless your doctor or pharmacist tells you to.

Do not give this medicine to anyone else, even if they have the same condition as you.

Do not use this medicine to treat any other complaints unless your doctor or pharmacist tells you to.

Things that would be helpful for constipation

It is generally recommended to consider healthy lifestyle measures such as adequate hydration, physical activity, and increased natural fibre intake.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Dulcosoft Powder.

This medicine helps most people with constipation, but it may have unwanted side effects in a few people.

You should go straight to hospital if you have difficulty in breathing, start to look flushed, or have any other symptom that you think might mean you are having a serious allergic reaction.

Tell your doctor as soon as possible if you notice any of the following:

  • Allergic reactions (rash, hives, swelling of the face or throat, breathing difficulties, faintness or collapse).

Tell your doctor or pharmacist if you notice any of the following and they worry you:

  • Stomach pain or discomfort
  • Inability to retain stools in the rectum
  • Bloating
  • Nausea
  • Diarrhoea
  • Vomiting
  • Gas
  • Urgent need to go to the toilet

Other side effects not listed above may occur in some consumers.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

Tell your doctor or pharmacist if you notice any other side effects.

Ask your doctor or pharmacist to answer any questions you may have.

After using it

Storage

Keep the medicine in a cool dry place where the temperature stays below 25°C. Store in its original container to protect from light.

Do not store it or any other medicine in the bathroom or near a sink. Do not leave it in the car on hot days or on window sills. Heat and dampness can destroy some medicines.

Keep it where children cannot reach it.

Disposal

Ask your pharmacist what to do with any medicine that is left over after the expiry date has passed.

Product description

What it looks like

Dulcosoft Powder is a white powder and the reconstituted solution is colourless and clear.

Pack sizes of 10 or 20 sachets are available. Not all pack sizes may be marketed.

Ingredients

Active ingredient:
The active ingredient, macrogol 4000. Each sachet contains 10g.

Sponsor

Sanofi Consumer Healthcare
87 Yarraman Place, Virginia
Qld 4014, Australia
Toll-free: 1800 818 806

AUST R 336393

This leaflet was prepared in June 2022

dulcopow-ccds2-cmiv2-10jun22

Published by MIMS April 2024

BRAND INFORMATION

Brand name

Dulcosoft

Active ingredient

Macrogol 4000

Schedule

Unscheduled

 

1 Name of Medicine

Macrogol 4000.

2 Qualitative and Quantitative Composition

Dulcosoft sachet contains 10 g of macrogol 4000 per sachet.

3 Pharmaceutical Form

Powder for oral solution in sachet.
White powder, free of large agglomerates, packed in a sachet for the preparation of an oral solution.

4 Clinical Particulars

4.1 Therapeutic Indications

For the relief from constipation. Treatment of chronic constipation.

4.2 Dose and Method of Administration

Dose.

Adults. 1 to 2 sachets (10 to 20 g macrogol 4000) per day, preferably taken as a single dose in the morning.
Paediatric population.

Children ≥ 8 years and adolescents.

1 to 2 sachets (10 to 20 g macrogol 4000) per day, preferably taken as a single dose in the morning.

Children (< 8 years).

Dulcosoft is not recommended for use in children below the age of 8 years.

Method of administration.

Oral use. Each sachet should be dissolved in 125 mL of water just before use.
It is recommended to start with the lowest dose. The dose should be adjusted up or down as required to produce regular soft stools.

Adults and children 8 years and over.

Start by taking 1 sachet a day, dissolved in a glass of water or fruit juice.
If needed, increase to 2 sachets a day, taken as a single dose preferably in the morning.
Continue to take it until your bowel movements return to normal.
Dulcosoft works within 24 to 48 hours.
Adjustment dose may be required to produce regular soft stools:

Children 8 to 12 years.

1 sachet on alternate days to a maximum of 3 sachets each day.
Should be limited to 3 months except under medical supervision.

Adults and children over 12 years.

1 sachet on alternate days to a maximum of 4 sachets each day.
To be taken at least 2 hours before or 2 hours after other medication to avoid possibility of reducing the absorption of other medicines.
The maximum recommended daily dose can also be divided equally into singular doses to be taken in the morning and evening.
The effect of Dulcosoft becomes usually apparent within 24 to 48 hours after its initial administration. If administered regularly, the frequency of bowel movements tends to be one movement per day.

Duration of treatment.

In children ≥ 8 years and adolescents, treatment should not exceed 3 months unless supervised by a physician due to a limitation of clinical data for treatment lasting longer than 3 months.

4.3 Contraindications

Hypersensitivity to the active substance.
Severe inflammatory bowel disease (such as ulcerative colitis, Crohn's disease) or toxic megacolon.
Digestive perforation or risk of digestive perforation.
Ileus or suspicion of intestinal obstruction or symptomatic stenosis.
Painful abdominal syndromes of indeterminate cause.

4.4 Special Warnings and Precautions for Use

Precaution before and during treatment.

As with all laxatives, an organic disorder should have been ruled out before initiation of treatment.
Without investigating the cause of constipation, Dulcosoft should not be taken on a continuous daily basis for an extended period of time. The patient is instructed to seek medical advice in case of persistent abdominal pain.
In patients with swallowing problems, who need the addition of a thickener to solutions to enhance an appropriate intake, interactions should be considered. (See Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).

Risks in specific populations.

In case of diarrhoea and/or vomiting, caution should be exercised in patients who are prone to a disturbance of water or electrolyte balance (e.g. elderly, patients with impaired hepatic or renal function or patients taking diuretics) and electrolyte control should be considered.

Allergic reactions.

Allergic conditions (such as anaphylactic shock, anaphylactic reaction, angioedema, urticaria, rash and hypersensitivity) have been reported with drugs containing macrogol (polyethylene glycol).

Use in the elderly.

In case of diarrhoea and/or vomiting, caution should be exercised in elderly patients.

Paediatric use.

Dulcosoft is not recommended for use in children below the age of 8 years.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Macrogol 4000 increases the osmotic pressure in the gut, and thus might modify the intestinal absorption of drugs concomitantly administered.
Macrogol 4000 may result in a potential interactive effect if used with starch-based food thickeners. The macrogol ingredient counteracts the thickening effect of starch, effectively liquefying preparations that need to remain thick for people with swallowing problems.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No studies on the effect on human fertility have been conducted. No effects on fertility are anticipated, since systemic exposure to macrogol 4000 is negligible (see Section 5.2 Pharmacokinetic Properties).
(Category B1)
Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human foetus having been observed.
A healthcare professional should be consulted before using Dulcosoft in pregnancy.
 A healthcare professional should be consulted before using Dulcosoft during lactation.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

Undesirable effects are listed under headings of frequency using the following conventions:
Very common: ≥ 1/10, Common: ≥ 1/100 to < 1/10, Uncommon: ≥ 1/1,000 to < 1/100, Rare: ≥ 1/10,000 to < 1/1,000, Very rare: < 1/10,000, Not known: cannot be estimated from the available data.

Tabulated list of adverse reactions.

Adult.

In clinical trials, side effects have been minor and transitory and have mainly concerned the gastrointestinal system. See Table 1.

Paediatric population.

As in adult population, adverse reactions have generally been minor and transitory and have mainly concerned the gastrointestinal system.
Frequency type and severity of adverse reactions in children have been observed to be comparable to adults. See Table 2.
Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at http://www.tga.gov.au/reporting-problems.

4.9 Overdose

Symptoms.

Overdose and/or abuse may lead to diarrhoea, abdominal pain, abdominal distention and vomiting which disappears when treatment is temporarily interrupted or the dose reduced.

Therapy.

Excessive fluid loss by diarrhoea or vomiting may require correction of electrolyte disturbances.
For information on the management of overdose, contact the Poison Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Laxatives, osmotically acting laxatives, ATC code: A06AD15.

Mechanism of action.

Macrogol 4000 softens the stool by retaining water molecules. Thereby it increases the stool volume, which triggers colon motility via neuromuscular pathways. The physiological consequence is an improved propulsive colonic transportation of the softened stools which facilitates defaecation.
Different doses of macrogol are shown to have different effects on intestinal function. In healthy volunteers, low doses increase stool weight without modifying oro-anal transit time. In constipated patients, low doses decrease stool consistency, increase stool frequency, and facilitate stool evacuation without modifying stool weight and colonic transit time. Bloating produced by the administration of macrogol is usually due to intestinal distention by water binding.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

Macrogol 4000 is only minimally absorbed, i.e. 0.05%, from the intestine of healthy subjects following an oral administration of 2 g.

Metabolism.

Like other polyethylene glycols with molecular masses exceeding 3000 Da, macrogol 4000 does not undergo any intestinal enzymatic degradation or bacterial metabolism.

Excretion.

Urinary excretion of macrogols occurs through passive glomerular filtration. Macrogol 4000 is excreted unchanged in urine with mean urinary recovery ranging from 0.05% to 0.46%. Macrogol 4000 is eliminated in the faeces with very high recovery rates ranging between 93% and 100%.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

Toxicological studies in different species of animals did not reveal any signs of systemic or local gastrointestinal toxicity of macrogol 4000. Macrogol 4000 had no teratogenic, mutagenic, nor carcinogenic effect. No studies on fertility are available.

6 Pharmaceutical Particulars

6.1 List of Excipients

None.

6.2 Incompatibilities

Macrogol 4000 increases the osmotic pressure in the gut, and thus might modify the intestinal absorption of drugs concomitantly administered.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Do not store above 25°C.
Store in its original container to protect from light.

6.5 Nature and Contents of Container

Sachet (aluminium / paper).
Unidose sachets in packs of 10 or 20 sachets.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Chemical structure.


CAS number.

25322-68-3.

7 Medicine Schedule (Poisons Standard)

Not scheduled.

Summary Table of Changes