Dulcobalance 10 g, powder for oral solution in sachet

Each sachet contains 10 g of macrogol 4000.

Macrogol 4000…………………………………….. 10.00 g

Flavour (orange-grapefruit)*……………………….. 0.15 g

Saccharin sodium…………………………………... 0.017 g

Per sachet of 10.17 g

*Sorbitol and sulphur dioxide are constituents of orange-grapefruit flavour:

Sorbitol (E420)…………………………………….. 1.8 mg per sachet

Sulphur dioxide (E220)……………………………. 0.24*10^-2 mg per sachet

For a full list of excipients: see section 6.1.

Powder for an oral solution in a sachet.

Almost white powder with an odour and taste of orange-grapefruit.

Symptomatic treatment of constipation in adults and children aged 8 years and above.

An organic disorder should have been ruled out before initiation of treatment.

Dulcobalance should remain a temporary adjuvant treatment to appropriate lifestyle and dietary management of constipation, and with a maximum 3-month treatment course in children. If symptoms persist despite associated dietary measures, an underlying cause should be suspected and treated.

Oral use

1 to 2 sachets per day, preferably taken as a single dose in the morning. Each sachet should be dissolved in a glass of water just before use.

The effect of Dulcobalance becomes apparent within 24 to 48 hours after its administration.

In children, treatment should not exceed 3 months due to a lack of clinical data for treatment lasting longer than 3 months. Treatment-induced restoration of bowel movements will be maintained by lifestyle and dietary measures.

The daily dose should be adapted according to the clinical effects and may range from one sachet every other day (especially in children) up to 2 sachets a day.

- severe inflammatory bowel disease (such as ulcerative colitis, Crohn's disease) or toxic megacolon, associated with symptomatic stenosis,

- digestive perforation or risk of digestive perforation

- ileus or suspicion of intestinal obstruction,

- painful abdominal syndromes of indeterminate cause,

- hypersensitivity to macrogol (polyethylene glycol) or to any of the excipients.

Warnings

The treatment of constipation with any medicinal product is only an adjuvant to a healthy lifestyle and diet, for example:

- increased intake of liquids and dietary fibre,

- appropriate physical activity and rehabilitation of the bowel reflex.

Patients with hereditary problems of fructose intolerance should not take this medicinal product.

Due to the presence of sulphur dioxide, it may rarely cause severe hypersensitivity reactions and bronchospasm.

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

Precautions for use

Very rare cases of hypersensitivity reactions (rash, urticaria, oedema) have been reported with drugs containing macrogol (polyethylene glycol). Exceptional cases of anaphylactic shock have been reported.

Dulcobalance does not contain a significant quantity of sugar or polyol and can be prescribed to diabetic patients or patients on a galactose-free diet.

Not applicable.

Pregnancy

Macrogol 4000 was not teratogenic in rats or rabbits

No effects during pregnancy are anticipated, since systemic exposure to Dulcobalance is negligible. Dulcobalance can be used during pregnancy.

Lactation

No effects on the breast-feeding newborn/infant are anticipated since the systemic exposure of the breast-feeding woman to macrogol 4000 is negligible. Dulcobalance can be used during breast-feeding.

Not applicable

Adverse Drug Reactions are listed under headings of frequency using the following categories:

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).

Adult population:

The undesirable effects listed in the table below have been reported during clinical trials (including 600 adult patients) and post-marketing use. Generally, adverse reactions have been minor and transitory and have mainly concerned the gastrointestinal system:

Paediatric population:

The undesirable effects listed in the table below have been reported during clinical trials including 147 children aged from 6 months to 15 years and post-marketing use. As in adult population, adverse reactions have generally been minor and transitory and have mainly concerned the gastrointestinal system:

* Diarrhoea may cause perianal soreness

Overdose leads to diarrhoea which disappears when treatment is temporarily interrupted or the dosage is reduced.

Excessive fluid loss by diarrhoea or vomiting may require correction of electrolyte disturbances.

Cases of aspiration have been reported when extensive volumes of polyethylene glycol and electrolytes were administered with nasogastric tube. Neurologically impaired children who have oromotor dysfunction are particularly at risk of aspiration.

Osmotically acting laxatives

ATC code: A06AD15

High molecular weight (4000) macrogols are long linear polymers which retain water molecules by means of hydrogen bonds. When administered by the oral route, they lead to an increase in volume of intestinal fluids.

The volume of unabsorbed intestinal fluid accounts for the laxative properties of the solution.

The pharmacokinetic data confirm that macrogol 4000 undergoes neither gastrointestinal resorption nor biotransformation following oral ingestion.

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. Potential drug interaction studies performed in rats on some NSAIDs, anticoagulants, gastric antisecretory agents, or on a hypoglycaemic sulfamide showed that Dulcobalance did not interfere with gastrointestinal absorption of these compounds.

Saccharin sodium (E954), orange-grapefruit flavour**

** Composition of the orange-grapefruit flavour:

Orange and grapefruit oils, concentrated orange juice, citral, acetaldehyde, linalol, ethyl butyrate, alpha terpineol, octanal, beta gamma hexenol, maltodextrine, gum arabic, sorbitol, BHA (E320) and sulphur dioxide (E220).

Not applicable

3 years

This medicinal product does not require any special storage conditions

(Paper / Aluminium / PE) sachet.

Single dose sachets presented in pack sizes of 10, 20, 50 and 100 sachets

Not all pack sizes may be marketed

No special requirements

Boehringer Ingelheim Limited

Consumer Healthcare

Ellesfield Avenue

Bracknell

Berkshire

RG12 8YS

United Kingdom

PL 00015/0318

Date of first authorisation: 11 July 2008

Date of last renewal: 5 May 2010

November 2010