Molaxole powder for oral solution

Each sachet contains following active substances

The content of electrolyte ions per sachet when made up to 125 ml of solution.

For a full list of excipients, see section 6.1.

Powder for oral solution

A white crystalline powder.

For the treatment of chronic constipation. Resolving faecal impaction, defined as refractory constipation with faecal loading of the rectum and/or colon confirmed by physical examination of the abdomen and rectum.

Chronic constipation :

Adults: 1-3 sachets daily in divided doses. Normal dose for most patients is 1-2 sachets per day. Depending on the individual response 3 sachets per day might be needed. .

A course of treatment for constipation does not normally exceed two weeks, although this can be repeated if required.

For extended use, the lowest effective dose should be used.

Children:

Not recommended for children below 12 years old.

Faecal impaction:

Adults: 8 sachets daily, all of which should be consumed within a 6 hour period.

A course of treatment for faecal impaction does not normally exceed 3 days.

Children:

Not recommended for children below 12 years old.

Administration:

Each sachet should be dissolved in 125 ml water. For use in faecal impaction 8 sachets may be dissolved in 1 litre of water.

Patients with impaired cardiovascular function:

For the treatment of faecal impaction the dose should be divided so that no more than two sachets are taken in any one hour.

Patients with renal insufficiency:

No dosage change is necessary for treatment of either constipation or faecal impaction.

Intestinal perforation or obstruction due to structural or functional disorder of the gut wall, ileus, severe inflammatory conditions of the intestinal tracts, such as Crohn´s disease and ulcerative colitis and toxic megacolon.

Hypersensitivity to the active substances or to any of the excipients.

The cause of constipation should be investigated if daily use of laxatives is necessary.

Patients using this preparation should seek medical advice if there is no improvement after two weeks.

Long term use can be necessary in serious chronical or refractory constipation due to i.e multiple sclerosis (MS) or Parkinsons disease, or constipation induced by drugs, especially opioides or antimuscarine products.

If patients develop any symptoms indicating shifts of fluid/electrolytes (e.g. oedema, shortness of breath, increasing fatigue, dehydration, cardiac failure) Molaxole should be stopped immediately and electrolytes measured, and any abnormality should be treated appropriately.

There is no clinical data on the use of Molaxole in children, therefore it is not recommended.

No clinical interactions with other medicinal products have been reported.

Pregnancy

There is no experience of the use of Molaxole during pregnancy and lactation and it should only be used if considered essential by the physician.

There is no effect on the ability to drive and use machines.

Adverse events are listed below by system organ class and frequency. Frequencies are defined as: 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).

The most common undesirable effects is gastrointestinal effects.

Severe pain or distension can be treated by nasogastric aspiration. Extensive fluid loss by diarrhoea or vomiting may require correction of electrolyte disturbances.

Pharmacotherapeutic group: Osmotically acting laxatives.

ATC-code: A06A D65

Macrogol 3350 acts by virtue of its osmotic action in the gut, which induces a laxative effect. Macrogol 3350 increases the stool volume which triggers colon motility via neuromuscular pathways. The physiological consequences are an improved propulsive colonic transportation of the softened stools and a facilitation of the defecation. Electrolytes combined with macrogol 3350 are exchanged across the intestinal barrier (mucosa) with serum electrolytes and excreted in faecal water without net gain or loss of sodium, potassium or water.

For the indication of faecal impaction controlled comparative studies have not been performed with other treatments (e.g. enemas). In a non-comparative study in 27 adult patients, macrogol, sodium chloride, potassium chloride and sodium hydrogen carbonate cleared the faecal impaction in 12/27 (44%) after 1 days´ treatment; 23/27 (85%) after 2 days´ treatment and 24/27 (89%) at the end of 3 days.

Clinical studies in the use of macrogol, sodium chloride, potassium chloride and sodium hydrogen carbonate in chronic constipation have shown that the dose needed to produce normal formed stools tends to reduce over time. Many patients respond to between 1 and 2 sachets a day, but this dose should be adjusted depending on individual response.

Macrogol is unchanged along the gut. It is virtually unabsorbed from the gastro-intestinal tract and has no known pharmacological activity. Any macrogol 3350 that is absorbed is excreted via the urine.

Preclinical studies provide evidence that macrogol 3350 has no significant systemic toxicity potential, although no tests of its effects on reproduction or genotoxicity have been conducted.

There are no long term animal toxicity or carcinogenicity studies involving macrogol 3350, although there are toxicity studies using high levels of orally administered high molecular weight macrogols that provide evidence of safety at the recommended therapeutic dose.

Acesulfam potassium (E950), lemon flavour.

Not applicable.

3 years.

Store the reconstituted solution in refrigerator (2°C-8°C) and discard any solution not used within 6 hours.

This medicinal product does not require any special temperature storage conditions.

Store in the original package in order to protect from moisture.

For storage conditions of the reconstituted medicinal product, see section 6.3.

Sachets of Paper/LDPE/Aluminium/LDPE alternatively

Sachets of Paper/PE/Aluminium/ Ethylene Methacrylic Acid Copolymer e.g. Surlyn

Package of: 2, 6, 8, 10, 20, 30, 40, 50, 60 and 100 sachets.

Not all pack sizes may be marketed.

No special requirements.

Meda Pharmaceuticals Ltd

249 West George Street

Glasgow

G2 4RB

Trading as:

Meda Pharmaceuticals Ltd

Skyway House

Parsonage Road

Takeley

Bishop's Stortford

CM22 6PU

PL 15142/0108

27/01/2009

27 September 2010