Consumer medicine information

What is this medicine?

This medicine is called MOVICOL Liquid. Each 25 mL dose contains:

• Macrogol 3350 - 13.125 g
• Sodium chloride - 350.7 mg
• Sodium bicarbonate - 178.5 mg
• Potassium chloride - 46.6 mg

When 25 mL is made into a drink by adding 100 mL of water, it contains:

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

It also contains orange flavour, the preservatives benzyl alcohol, methyl hydroxybenzoate (E218), ethyl hydroxybenzoate (E214) and the sweeteners sucralose (E955) and potassium acesulfame (E950).

A 500 mL bottle contains 20 doses of MOVICOL Liquid. It comes with a 25 mL measuring cup.

What is MOVICOL Liquid 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 diagnosed by your doctor). MOVICOL Liquid is for use in adults and children 12 years of age or over.

Before you take MOVICOL Liquid

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 or any of the ingredients.

If you have a heart condition you should not take more than two doses of MOVICOL Liquid in any one hour.

MOVICOL Liquid is for use in adults and children 12 years of age or over. Safety in children 12 years of age and under has not been established. Other MOVICOL products are available for use in children under 12 years.

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

MOVICOL Liquid can be taken whilst breast feeding.

Other Medicines
Laxative products such as MOVICOL Liquid have the potential to interact with other medications, by altering their absorption. There have been isolated reports of medicines for epilepsy being less effective. Close monitoring of the effects of your medications may be necessary when you commence or cease to take MOVICOL Liquid regularly. It is important that you should discuss this with your doctor.

How to take MOVICOL Liquid

Adults and Children over 12 years of age.

This product must be diluted before use.

One dose is 25 mL of MOVICOL Liquid diluted with 100 mL of water, to make a total volume of 125 mL.

Constipation:
The recommended dose is one dose daily.

This can be increased to 2 or 3 doses daily if necessary. If extended treatment is required for constipation, do not exceed the maximum recommended dose of 3 doses daily.

Faecal impaction:
The dose is 8 doses 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 2 doses in any one hour.

How to mix:
Open the bottle and measure 25 mL using the measuring cup. Pour the Liquid into a glass and then add 100 mL of water (see diagram below).

When the MOVICOL Liquid Orange flavour solution is clear, drink it.

If you are taking MOVICOL Liquid for faecal impaction, it may be more convenient to add eight 25 mL measures to 800 mL of water. It is essential to dilute MOVICOL Liquid as directed. This will help to reduce any potential risk of dehydration.

Please rinse the measuring cup after use and replace it on the bottle. Any diluted MOVICOL solution not used within 24 hours should be disposed of.

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 Liquid and get bad diarrhoea, stop taking it until it stops. If constipation recurs, you should check with your doctor or pharmacist before taking a new course of MOVICOL Liquid. 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 Liquid. If you feel weak, breathless, very thirsty with a headache, or get puffy ankles stop taking MOVICOL Liquid and tell your doctor. Tell your doctor or pharmacist if you think MOVICOL Liquid is causing you any problem.

How to store MOVICOL Liquid

Store your medicine at room temperature (below 30ºC). Do not use it after the expiry date on the label. Discard any remaining MOVICOL Liquid 30 days after first opening the bottle. You can mark the discard date on the bottle label.

After you have diluted MOVICOL Liquid Orange flavour in water, if you cannot drink it straight away, keep it covered. Throw away any diluted solution not used within a 24 hour period.

Keep all medicines out of the reach of children.

MOVICOL Liquid is a Pharmacy Medicine.

AUST R 212114

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

1 Name of Medicine

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

2 Qualitative and Quantitative Composition

Each 25 mL of Movicol Liquid Orange Concentrate contains: macrogol 3350 13.125 g, sodium chloride 350.7 mg, sodium bicarbonate 178.5 mg, potassium chloride 46.6 mg.
The concentration of electrolyte ions when 25 mL is made up with water to 125 mL is: sodium 65 mmol/L, potassium 5.4 mmol/L, chloride 53 mmol/L, bicarbonate 17 mmol/L.

Excipients with known effect.

3 Pharmaceutical Form

Liquid concentrate for oral solution.
Clear colourless liquid.

4 Clinical Particulars

4.1 Therapeutic Indications

For use in adults and children over 12 years of age for effective relief from constipation and treatment of chronic constipation. Movicol Liquid Orange Concentrate 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, in adults and children over 12 years of age.

4.2 Dose and Method of Administration

The product must not be taken undiluted and may only be diluted in water. Measure 25 mL of Movicol Liquid Orange Concentrate with the 25 mL measuring cup provided, then add this to 100 mL of water. Any unused diluted solution should be discarded within 24 hours.

Adults.

Constipation.

Faecal impaction.

Children.

Patients with impaired cardiovascular function.

Patients with renal insufficiency.

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 Liquid Orange Concentrate 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 Liquid Orange Concentrate 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 gastrointestinal transit time induced by Movicol Liquid Orange Concentrate (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).
Movicol Liquid Orange Concentrate contains 187 mg of sodium in each diluted dose of 125 mL, 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 doses) is equivalent to 28% of the WHO recommended maximum daily intake for sodium. Movicol Liquid Orange Concentrate 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. Movicol Liquid Orange Concentrate contains benzyl alcohol (45.6 mg/25 mL); if extended treatment is required for the management of constipation the maximum recommended dose of 3 times 25 mL dose per day should not be exceeded. The Acceptable Daily Intake of benzyl alcohol is 5 mg/kg. Movicol Liquid Orange Concentrate 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. 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.

Paediatric use.

Effects on laboratory tests.

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 Liquid Orange Concentrate (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. antiepileptics.
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 Liquid Orange Concentrate is overdosed to induce watery diarrhoea.
Movicol Liquid Orange Concentrate 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.

4.7 Effects on Ability to Drive and Use Machines

Movicol 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 Liquid Orange Concentrate. Diarrhoea usually responds to dose reduction. See Table 1.

Reporting suspected adverse effects.

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.

Clinical trials.

Faecal impaction.

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.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Movicol Liquid Orange Concentrate for oral solution also contains sucralose (E955), orange flavour (contains ethanol), acesulfame potassium (E950), water, and the following preservatives; benzyl alcohol 45.6 mg per 25 mL, methyl hydroxybenzoate (E218) 11.3 mg per 25 mL, ethyl hydroxybenzoate (E214) 5.6 mg per 25 mL.

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. Any diluted solution should be discarded after 24 hours.

6.5 Nature and Contents of Container

Movicol Liquid Orange Concentrate for oral solution requires dilution before use. Each 25 mL contains 13.125 g of macrogol 3350 and electrolytes.
It is supplied in a 500 mL plastic bottle, with a clear plastic 25 mL measuring cup.

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.

Sodium bicarbonate.

Potassium chloride.

CAS number.

Macrogol 3350.

Sodium chloride.

Sodium bicarbonate.

Potassium chloride.

7 Medicine Schedule (Poisons Standard)

S2 Pharmacy Medicine.

Summary Table of Changes