Consumer medicine information

MOVICOL Junior Chocolate Flavour

Macrogol 3350; Sodium chloride; Sodium bicarbonate; Potassium chloride

BRAND INFORMATION

Brand name

Movicol Junior Chocolate Powder for oral solution

Active ingredient

Macrogol 3350; Sodium chloride; Sodium bicarbonate; Potassium chloride

Schedule

Unscheduled

 

Consumer medicine information (CMI) leaflet

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

What is this medicine?

The name of this medicine is Movicol Junior Chocolate Flavour. Each sachet contains:

  • Macrogol 3350 - 6.563 g
  • Sodium chloride - 175.4 mg
  • Sodium bicarbonate - 89.3 mg
  • Potassium chloride - 15.9 mg

When it is made into a drink with 62.5 mL of water, each sachet gives the equivalent of:

  • Sodium - 65 mmol/L
  • Chloride - 51 mmol/L
  • Bicarbonate - 17 mmol/L
  • Potassium - 5.4 mmol/L

Movicol Junior Chocolate also contains chocolate flavour and acesulfame potassium as a sweetener The chocolate flavour includes maltodextrin, acacia gum, vegetable oils and fats, propylene glycol, benzyl alcohol, and sulfites.

Each sachet contains 6.9 grams of Movicol Junior Chocolate powder. You add the water to the powder to make a drink.

What is Movicol Junior Chocolate used for?

MOVICOL Junior Chocolate is used in children aged 2 years and older and adults for the treatment of chronic constipation. Constipation is the “less frequent than normal” passing of firm or hard stools. MOVICOL Junior Chocolate helps you to have a comfortable bowel movement even if you have been constipated for a long time.

Chronic Constipation in Children:

Most normal children will occasionally experience constipation, which will normally require no more than a healthy diet, plenty of exercise, regular toilet use and, sometimes, occasional use of laxatives.

However, a small proportion of children will pass stools less frequently than 3 times per week, with excessive straining and discomfort or pain at these times. If your child has this more severe type of constipation your doctor needs to be involved in making a supervised plan of treatment for your child over the next 6 –12 months. Treatments may require daily use of a product such as Movicol Junior Chocolate which can keep stools of normal consistency and restore a normal pattern of passing stools.

Movicol Junior Chocolate is also used in children aged 2 years and older for the treatment of faecal impaction (as determined by your doctor), and for the prevention of recurrence of faecal impaction.

Before you take Movicol Junior Chocolate

Do not take Movicol Junior Chocolate 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 or any of the ingredients

Pregnancy and breast feeding
If you are pregnant, talk to your doctor before you take MOVICOL Junior Chocolate. Movicol Junior Chocolate can be taken whilst breast feeding.

Other Medicines
Laxative products such as Movicol Junior Chocolate 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 start or stop taking MOVICOL Junior Chocolate regularly. It is important that you should discuss this with your doctor.

How to take Movicol Junior Chocolate

Chronic Constipation/Prevention of recurrence of faecal impaction:

Children aged 2-5 years: The usual starting dose is 1 sachet daily.

Children aged 6-11 years: The usual starting dose is 2 sachets daily. The dose should be adjusted up or down as required to produce regular soft stools. The maximum dose needed does not normally exceed 4 sachets daily.

Use in children aged 2 years and older should be limited to 12 weeks except under medical supervision. Movicol Junior Chocolate is not recommended for children below 2 years of age.

Adults and children 12 years and older: The recommended dose of MOVICOL Junior Chocolate is 2 sachets a day. This can be increased up to 6 sachets daily if necessary, depending on the severity of your constipation. For chronic constipation the dose may be reduced to 1 sachet daily, according to individual response.

For patients 12 years and older using 2 sachets daily or more, it is recommended to use Movicol Chocolate.

FAECAL IMPACTION:

Children (2 – 11 years):

A course of treatment with Movicol Junior Chocolate is for up to 7 days as follows:

Treatment can be stopped when the medicine has worked. This is shown by the patient passing large volumes of stool or watery diarrhoea. Movicol Junior Chocolate is not recommended for the treatment of faecal impaction in children with a heart or kidney condition.

Do not use Movicol Junior Chocolate to treat faecal impaction in children for longer than 7 days. If symptoms persist, see your doctor.

If you take too much Movicol Junior Chocolate and get bad diarrhoea, stop taking Movicol Junior Chocolate until the diarrhoea stops. If constipation returns, you should check with your doctor or pharmacist. If you are worried, contact your doctor or pharmacist.

General Recommendations when taking Laxatives

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. In some circumstances, prolonged use may be necessary but should only be under medical supervision.

How to Prepare Movicol Junior Chocolate

Open the sachet and pour contents into a glass. Add 62.5 mL (about ¼ cup) of water into the glass. Stir well until all the powder has dissolved and the Movicol Junior Chocolate solution is clear or slightly hazy, then drink it.

For use in faecal impaction, the correct number of sachets can be made up in advance and kept covered and refrigerated for 24 hours. For example 12 sachets can be made up into 750 mL of water and 16 sachets into one litre of water.

What about side effects?

Like all medicines, Movicol Junior Chocolate can have side effects. Sometimes people have indigestion, stomach ache or rumbles. You may also feel bloated, suffer from wind, feel sick or vomit, may also experience soreness of the anus (bottom) and may have mild diarrhoea when starting to take Movicol Junior Chocolate. Diarrhoea generally gets better if you reduce the amount of Movicol Junior Chocolate you take. If necessary, discuss reducing the dose with your doctor or pharmacist. Other side effects include allergic reactions which may cause a skin rash, itching, reddening of the skin or a nettle rash. Tell your doctor or pharmacist if you think Movicol Junior Chocolate is causing you any problem.

Tell your doctor immediately and stop taking Movicol Junior Chocolate if you:

  • Get a serious allergic reaction which causes difficulty in breathing, or swelling of the face, lips, tongue or throat.
  • If you feel weak, breathless, very thirsty with a headache, or get puffy ankles.

How to store Movicol Junior Chocolate

Storing Movicol Junior Chocolate sachets

Store the sachets below 30ºC. Do not use Movicol Junior Chocolate after the expiry date on the pack.

Storing prepared solution of Movicol Junior Chocolate

If you do not drink it straightaway, the prepared Movicol Chocolate solution can be kept covered in the fridge (2-8ºC) for up to 24 hours. After that time, any remaining solution should be thrown away.

Keep out of reach of children.

AUST R 207698

Date: 25 January 2017

Norgine Pty Limited,
3/14 Rodborough Road,
Frenchs Forest NSW 2086
1800 766 936

MOVICOL, NORGINE and the sail logo are registered trademarks of the Norgine group of companies.

BRAND INFORMATION

Brand name

Movicol Junior Chocolate Powder for oral solution

Active ingredient

Macrogol 3350; Sodium chloride; Sodium bicarbonate; Potassium 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 Junior Chocolate Flavour powder contains: macrogol 3350 6.563 g, sodium chloride 175.4 mg, sodium bicarbonate 89.3 mg, potassium chloride 15.9 mg.
The content of electrolyte ions per sachet when made up to 62.5 mL is: sodium 65 mmol/L, potassium 5.4 mmol/L, chloride 51 mmol/L, bicarbonate 17 mmol/L.

Excipients with known effect.

Benzyl alcohol and sulfites.
For full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Powder for oral solution.
Free-flowing white powder.

4 Clinical Particulars

4.1 Therapeutic Indications

For effective relief of constipation in adults. For treatment of chronic constipation in adults and children aged 2 years and older. For resolving faecal impaction, defined as refractory constipation with faecal loading of the rectum, or the rectum and colon, confirmed by physical examination of abdomen and rectum, in adults and children aged 2 years and older. For prevention of recurrence of faecal impaction in children aged 2 years and older. Use in children aged 2 years and older should be limited to 12 weeks except under medical supervision.

4.2 Dose and Method of Administration

Adults and children over 12 years.

Constipation.

The dose is 2 sachets daily and may be increased up to 6 sachets daily if required. For chronic constipation the dose may be reduced to 1 sachet daily according to individual response.
For patients of 12 years and older using 2 sachets daily or more, it is recommended to use Movicol Chocolate Flavour.

Faecal impaction.

16 sachets daily, all of which should be consumed within 6 hours. A course of treatment for faecal impaction does not normally exceed 3 days.
For patients of 12 years and older it is recommended to use Movicol Chocolate Flavour.

Children 2 years and older.

Chronic constipation and prevention of recurrence of faecal impaction.

Children aged 2-5 years.

The usual starting dose is 1 sachet daily.

Children 6-11 years.

The usual starting dose is 2 sachets daily.
The dose should be adjusted up or down as required to produce regular soft stools. The maximum dose does not normally exceed 4 sachets a day.
Use in children aged 2 years and older should be limited to 12 weeks except under medical supervision.
Movicol Junior Chocolate Flavour is not recommended for children below 2 years of age.

Faecal impaction.

Children 2-11 years.

A course of treatment for faecal impaction with Movicol Junior Chocolate Flavour is for up to 7 days as follows:
The dosage regimen in Table 1 should be stopped once disimpaction has occurred. An indicator of disimpaction is the passage of a large volume of stools. After disimpaction, it is recommended that the child follows an appropriate bowel management programme to prevent reimpaction.
Movicol Junior Chocolate Flavour is not recommended for children under 2 years of age.

Patients with impaired cardiovascular function.

Adults and children over 12 years.

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

Children (2-11 years).

There are no clinical data for this group of patients, therefore Movicol Junior Chocolate Flavour is not recommended for use in this patient group.

Patients with renal insufficiency.

Adults and children over 12 years.

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

Children (2-11 years).

There are no clinical data for this group of patients, therefore Movicol Junior Chocolate Flavour is not recommended for use in this patient group.
Also see Section 4.4 Special Warnings and Precautions for Use.

Administration.

For oral administration. Each sachet should be dissolved in 62.5 mL (about ¼ cup) of water.
For use in faecal impaction, the correct number of sachets can be reconstituted in advance and kept covered and refrigerated for 24 hours. For example 12 sachets can be made up into 750 mL of water and 16 sachets into one litre of water.

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 Junior Chocolate Flavour 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 Junior Chocolate Flavour 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 Junior Chocolate Flavour (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).
Movicol Junior Chocolate Flavour contains 93.4 mg of sodium per sachet, equivalent to 4.6% 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. 6 sachets in adults and children over 12 years) is equivalent to 28% of the WHO recommended maximum daily intake for sodium. Movicol Junior Chocolate Flavour is considered high in sodium. This should be particularly taken into account for those on a low salt diet.
Benzyl alcohol may cause anaphylactoid reactions. The acceptable daily intake of benzyl alcohol is 5 mg/kg. Movicol Junior Chocolate Flavour contains 7.0 mg benzyl alcohol per sachet. Due to the amount of benzyl alcohol in the product, Movicol Junior Chocolate Flavour should be used with caution and only if necessary, in pregnancy, lactation, liver or kidney impairment because of the risk of benzoic acid accumulation and toxicity (metabolic acidosis).
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. 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.

The safety and efficacy of Movicol Junior Chocolate Flavour in the treatment of chronic constipation in children under two years of age has not been established.

Chronic constipation in children.

Constipation is the less-frequent-than-usual passage of firm or hard stools. Most normal children will occasionally experience constipation, which will normally require no more than a healthy diet, plenty of exercise, regular toilet use and, sometimes, occasional use of laxatives. However, a small proportion of children will pass stools less frequently than 3 times per week, with excessive straining and discomfort or pain at these times.
For these children a supervised plan of treatment over a period of at least 6-12 months, utilising a product such as Movicol Junior Chocolate Flavour, to restore normal patterns of toilet use and stool formation may be considered appropriate. However, safety and efficacy of Movicol Junior Chocolate Flavour has only been proved for a period of up to three months. Treatment should be stopped gradually and resumed if constipation recurs.

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 Junior Chocolate Flavour (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 Junior Chocolate Flavour is overdosed to induce watery diarrhoea.
Movicol Junior Chocolate Flavour 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

See Section 4.4 Special Warnings and Precautions for Use.

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 Junior Chocolate Flavour can be used during breast-feeding.

4.7 Effects on Ability to Drive and Use Machines

Movicol Junior Chocolate Flavour 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 Junior Chocolate Flavour. Diarrhoea usually responds to dose reduction. See Table 2.

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.
In a non-comparative study in 63 children, Movicol cleared the faecal impaction in 92% of patients within 3-7 days of treatment (median 6 days). For the 2-4 years age group, the average total number of sachets required was equivalent to 28.6 Movicol Junior Chocolate Flavour sachets, and for the 5-11 age group, the average total number of sachets required was equivalent to 47.2 Movicol Junior Chocolate Flavour sachets.

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

Also contains chocolate flavour (includes maltodextrin, acacia gum, vegetable oils and fats, propylene glycol, benzyl alcohol, and sulfites) and potassium acesulfame as a sweetener.

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 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