Consumer medicine information

MOVICOL Flavour Free

Macrogol 3350; Potassium chloride; Sodium bicarbonate; Sodium chloride

BRAND INFORMATION

Brand name

Movicol Flavour Free

Active ingredient

Macrogol 3350; Potassium chloride; Sodium bicarbonate; Sodium chloride

Schedule

Unscheduled

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using MOVICOL Flavour Free.

What is this medicine?

This medicine is Movicol Flavour Free. Each sachet contains:

  • Macrogol 3350 - 13.125 g
  • Sodium chloride - 350.8 mg
  • Sodium bicarbonate - 178.6 mg
  • Potassium chloride - 50.2 mg

When it is made into a drink with 125 mL of water, each sachet gives the equivalent of:

  • Sodium - 65 mmol/L
  • Chloride - 53 mmol/L
  • Bicarbonate - 17 mmol/L
  • Potassium - 5.4 mmol/L

Each sachet contains 13.7 grams of powder. You add water to the powder to make a drink.

What is Movicol Flavour Free used for?

This medicine helps you to have a comfortable bowel movement even if you have been constipated for a long time. It also works in faecal impaction (as determined by your doctor).

Before you take Movicol Flavour Free

Do not take this medicine if your doctor has told you that you have:

  • an obstruction in your intestine (gut)
  • a perforated gut wall
  • severe inflammatory bowel disease, like ulcerative colitis, Crohn’s disease, or toxic megacolon
  • paralysis of the bowel
  • an allergy to macrogol.

Pregnancy and breast feeding
If you are pregnant, talk to your doctor before you take MOVICOL Flavour Free.

Movicol Flavour Free can be taken whilst breast feeding.

Other Medications
Laxative products such as Movicol Flavour Free have the potential to interact with other medications, by altering their absorption. Close monitoring of the effects of your medications may be necessary when you commence or cease to take Movicol Flavour Free regularly. It is important that you should discuss this with your doctor.

How to take Movicol Flavour Free

Constipation: The recommended dose is 1 sachet a day.

This can be increased to 2 or 3 sachets daily if necessary.

Faecal impaction: The dose is 8 sachets a day taken within 6 hours. You may need to take this dose for up to 3 days. If you have a heart condition do not take more than two sachets in any one hour.

Open the sachet and pour contents into a glass. Add about 125 mL of water into the glass. Stir well until all the powder has dissolved and the Movicol Flavour Free solution is clear, or slightly hazy, then drink it. If you like, you can add a flavour such as orange squash to the drink.

If you are taking Movicol Flavour Free for faecal impaction, it may be easier to dissolve 8 sachets in 1 litre of water.

Drink plenty of water. Increase fibre in diet, except in cases of medication-induced constipation. Prolonged use of laxatives is undesirable and may lead to dependence. If symptoms persist seek medical advice. In some circumstances, prolonged use may be necessary but should only be under medical supervision.

If you take too much Movicol Flavour Free and get bad diarrhoea, stop taking it until it clears. If constipation recurs, you should check with your doctor or pharmacist before taking a new course of Movicol Flavour Free. If you are worried, contact your doctor or pharmacist.

What about side effects?

Sometimes people have stomach ache or rumbles, or an allergic reaction, or feel bloated or sick. You may have diarrhoea especially when starting to take Movicol Flavour Free. If you feel weak, breathless, very thirsty with a headache, or get puffy ankles stop taking MOVICOL Flavour Free and tell your doctor. Tell your doctor or pharmacist if you think MOVICOL Flavour Free is causing you any problem.

How to store MOVICOL Flavour Free

Store your medicine at room temperature (below 30ºC). Do not use it after the expiry date on the label. Once you have made up Movicol Flavour Free in water put it in the fridge (2-8ºC) and keep it covered. Throw away any solution not used within a 24 hour period.

Keep all medicines away from children.

AUST R 181834

Date: 1 April 2015

Norgine Pty Limited,
3/14 Rodborough Road,
Frenchs Forest NSW 2086

1800 766 936

MOVICOL is a registered trademarks of the Norgine group of companies.

Published by MIMS March 2016

BRAND INFORMATION

Brand name

Movicol Flavour Free

Active ingredient

Macrogol 3350; Potassium chloride; Sodium bicarbonate; Sodium chloride

Schedule

Unscheduled

 

1 Name of Medicine

Macrogol 3350 and electrolytes (sodium chloride, sodium bicarbonate, potassium chloride).

2 Qualitative and Quantitative Composition

Each sachet of Movicol Flavour Free powder contains macrogol 3350 13.125 g, sodium chloride 350.8 mg, sodium bicarbonate 178.6 mg, potassium chloride 50.2 mg.
The content of electrolyte ions per sachet when made up to 125 mL is: sodium 65 mmol/L, potassium 5.4 mmol/L, chloride 53 mmol/L, bicarbonate 17 mmol/L.

3 Pharmaceutical Form

Powder for oral solution.
Free flowing white powder.

4 Clinical Particulars

4.1 Therapeutic Indications

For effective relief from constipation, treatment of chronic constipation. Movicol Flavour Free is also effective in resolving faecal impaction, defined as refractory constipation with faecal loading of the rectum and/or colon confirmed by physical examination of abdomen and rectum.

4.2 Dose and Method of Administration

Constipation.

The dose is 1 sachet daily. This may be increased to 2-3 sachets daily, if required.

Faecal impaction.

8 sachets daily, consumed within 6 hours. A course of treatment for faecal impaction does not normally exceed 3 days.

Administration.

For oral administration. Each sachet should be dissolved in 125 mL water. For faecal impaction 8 sachets may be dissolved in 1 litre of water. Store reconstituted solution in a refrigerator and discard any solution not used within 24 hours.

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.

4.3 Contraindications

Intestinal perforation or obstruction due to structural or functional disorder of the gut wall, ileus and severe inflammatory conditions of the intestinal tract, such as Crohn's disease, ulcerative colitis and toxic megacolon.
Known hypersensitivity to macrogol or any of the ingredients.

4.4 Special Warnings and Precautions for Use

The fluid content of Movicol Flavour Free when re-constituted with water does not replace regular fluid intake and adequate fluid intake must be maintained.
Adverse reactions are possible as described, see Section 4.8 Adverse Effects (Undesirable Effects). If patients develop any symptoms indicating shifts of fluid/ electrolytes (e.g. oedema, shortness of breath, increasing fatigue, dehydration, cardiac failure) Movicol Flavour Free should be stopped immediately and electrolytes measured, and any abnormality should be treated appropriately.
The absorption of other medicines could transiently be reduced due to a decrease in gastro-intestinal transit time induced by Movicol Flavour Free (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).
This medicinal product contains 187 mg of sodium per sachet, equivalent to 9.3% of the WHO recommended maximum daily intake of 2 g sodium for an adult. The maximum daily dose of this product for constipation (i.e. 3 sachets) is equivalent to 28% of the WHO recommended maximum daily intake for sodium. Movicol is considered high in sodium. This should be particularly taken into account for those on a low salt diet.
As with all laxatives, prolonged use is not usually recommended and may lead to dependence. If prolonged use is necessary, it should only be under medical supervision. Extended use may be necessary in the care of patients with severe chronic or resistant constipation, secondary to multiple sclerosis or Parkinson's disease, or induced by regular constipating medication, in particular opioids and antimuscarinics. Patients should be advised to drink plenty of water. They should also increase fibre in the diet, except in the case of medication-induced constipation.

Use in the elderly.

No data available.

Paediatric use.

Movicol paediatric dosages (the Movicol Junior range) are approved for use in children aged 2 years and above, for chronic constipation and faecal impaction only.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

There is a possibility that the absorption of other medicines could be transiently reduced during use with Movicol Flavour Free (see Section 4.4 Special Warnings and Precautions for Use). There have been isolated reports of decreased efficacy with some concomitantly administered medicinal products, e.g. anti-epileptics.
A theoretical potential also exists for decreased absorption (rate and extent) of drugs which are generally poorly absorbed or are contained in sustained or modified release dosage forms. This is more likely to occur if Movicol Flavour Free is overdosed to induce watery diarrhoea.
Movicol Flavour Free may have a potential interactive effect when 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 data available.
(Category B1)
Pregnancy 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 fetus having been observed. Studies in animals have not shown evidence of an increased occurrence of fetal damage.
There were no direct embryotoxic or teratogenic effects in rats at maternally toxic doses up to 40 g/kg/day, 51x the maximum recommended dose in humans for chronic constipation and 19x for faecal impaction.
Indirect effects, including reduction in fetal and placental weights, reduced fetal viability and abortions, were noted in the rabbit at doses below the maximum recommended human dose. Rabbits are particularly sensitive to the effects of GI acting substances, and the findings are considered most likely a reflection of poor maternal condition as a result of an exaggerated pharmacodynamic response rather than direct embryofetal toxicity. There was no indication of a teratogenic effect.
No effects on the breastfed newborn/ infant are anticipated since the systemic exposure of the breast-feeding woman to macrogol 3350 is negligible.
Movicol Flavour Free can be used during breast-feeding.

4.7 Effects on Ability to Drive and Use Machines

Movicol Flavour Free has no influence on the ability to drive or use machines.

4.8 Adverse Effects (Undesirable Effects)

Reactions related to the gastrointestinal tract occur most commonly. These reactions may occur as a consequence of expansion of the contents of the gastrointestinal tract, and an increase in motility due to the pharmacologic effects of Movicol Flavour Free. Diarrhoea usually responds to dose reduction. See Table 1.

Reporting suspected adverse effects.

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 www.tga.gov.au/reporting-problems in Australia.

4.9 Overdose

Severe pain or distension can be treated by nasogastric aspiration. Extensive fluid loss by diarrhoea or vomiting may require correction of electrolyte disturbances. For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Macrogol 3350 exerts an 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 consequence is an improved propulsive colonic transportation of the softened stools and a facilitation of defaecation. 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 and water.
The laxative action of macrogol has a time course which will vary according to the severity of the constipation being treated.

Clinical trials.

Faecal impaction.

In a non-comparative study in 27 adult patients, Movicol cleared the faecal impaction in 12/27 (44%) after 1 day's treatment, 23/27 (85%) after 2 day's treatment and 24/27 (89%) at the end of 3 days. Controlled comparative studies have not been performed with other treatments (e.g. enemas).

5.2 Pharmacokinetic Properties

Macrogol 3350 is unchanged along the gut. It is virtually unabsorbed from the gastrointestinal tract. Any macrogol 3350 that is absorbed is excreted via the urine.

5.3 Preclinical Safety Data

Genotoxicity.

Preclinical studies provide evidence that macrogol 3350 has no significant systemic toxicity potential, based on conventional studies of pharmacology, repeated dose toxicity, genotoxicity and toxicity to reproduction.

Carcinogenicity.

There are long-term animal toxicity and carcinogenicity studies involving macrogol 3350. Results from these and other toxicity studies using high levels of orally administered high molecular weight macrogols provide evidence of safety at the recommended therapeutic dose.

6 Pharmaceutical Particulars

6.1 List of Excipients

None.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

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

Store below 30°C.

6.5 Nature and Contents of Container

Boxes of 8 sachets and 30 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.

Macrogol 3350.


Sodium chloride.

NaCl.

Sodium bicarbonate.

NaHCO3.

Potassium chloride.

KCl.

CAS number.

Macrogol 3350.

25322-68-3.

Sodium chloride.

7647-14-5.

Sodium bicarbonate.

144-55-8.

Potassium chloride.

7447-40-7.

7 Medicine Schedule (Poisons Standard)

Unscheduled.

Summary Table of Changes