Consumer medicine information

What is this medicine?

The name of this medicine is Movicol Lemon-Lime Flavour. Each sachet contains:

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

Movicol Lemon-Lime also contains lemon and lime flavour, and acesulfame potassium as a sweetener. The lemon and lime flavour includes the following ingredients; acacia solids, maltodextrin, lime oil, lemon oil, citral, and citric acid.

MOVICOL Lemon-Lime is lactose-free, gluten-free and sucrose-free. Each sachet contains 13.8 grams of Movicol powder. You add water to the powder to make a drink.

What is Movicol Lemon-Lime used for?

Movicol Lemon-Lime helps you to have a comfortable bowel movement even if you have been constipated for a long time.

Movicol Lemon-Lime also works in faecal impaction (as determined by your doctor).

Before you take Movicol Lemon-Lime

Do not take Movicol Lemon-Lime 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 other ingredients.

Use in Children
Movicol Lemon-Lime is for use in adults and children 12 years of age or over. The MOVICOL Junior range is available for use in children aged 2 to 11 years of age.

Pregnancy and breast feeding
If you are pregnant talk to your doctor before you take Movicol Lemon-Lime.

Movicol Lemon-Lime can be taken while breast feeding.

Other Medications
Laxative products such as Movicol Lemon-Lime 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 Lemon-Lime regularly. It is important that you should discuss this with your doctor.

How to take Movicol Lemon-Lime

Constipation: The recommended dose of Movicol Lemon-Lime 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 Lemon-Lime solution is clear or slightly hazy, then drink it. If you like, you can add a flavour such as orange cordial to the drink.

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

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. 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 Lemon-Lime and get bad diarrhoea, stop taking Movicol Lemon-Lime until it clears. If constipation returns, you should check with your doctor or pharmacist. If you are worried, contact your doctor or pharmacist.

What about side effects?

Like all medicines, Movicol Lemon-Lime 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 Lemon-Lime. Diarrhoea generally gets better if you reduce the amount of Movicol Lemon-Lime 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 Lemon-Lime is causing you any problem.

Tell your doctor immediately and stop taking Movicol Lemon-Lime 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 Lemon-Lime

Storing Movicol Lemon-Lime sachets
Store the sachets below 25°C. Do not use Movicol Lemon-Lime after the expiry date on the pack.

Storing prepared solution of Movicol-Lemon-Lime
If you do not drink it straightaway, the prepared Movicol Lemon-Lime solution can be kept covered in the fridge (2 - 8°C) for up to 6 hours. After that time, throw away any remaining solution.

Keep out of reach of children.

AUST R 60786

Date: 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.

Published by MIMS February 2018

1 Name of Medicine

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

2 Qualitative and Quantitative Composition

Each sachet of Movicol Lemon-Lime Flavour powder contains macrogol 3350 13.125 g, sodium chloride 350.7 mg, sodium bicarbonate 178.5 mg, potassium chloride 46.6 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 with an odour of lemon-lime.

4 Clinical Particulars

4.1 Therapeutic Indications

For effective relief from constipation, treatment of chronic constipation. Movicol Lemon-Lime Flavour 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.

Faecal impaction.

Administration.

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 Lemon-Lime 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 Lemon-Lime 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 gastrointestinal transit time induced by Movicol Lemon-Lime Flavour (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.

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 Lemon-Lime 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 Lemon-Lime Flavour is overdosed to induce watery diarrhoea.
Movicol Lemon-Lime 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

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

Movicol Lemon-Lime 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 Lemon-Lime Flavour. 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) or the National Poisons Centre on 0800 POISON/0800 764766 (New Zealand).

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 Lemon-Lime Flavour also contains acesulfame potassium (E950) and lemon and lime flavour (the flavour contains acacia solids, maltodextrin, lime oil, lemon oil, citral, and citric acid).

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 25°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.

Sodium bicarbonate.

Potassium chloride.

CAS number.

Macrogol 3350.

Sodium chloride.

Sodium bicarbonate.

Potassium chloride.

7 Medicine Schedule (Poisons Standard)

Unscheduled.

Summary Table of Changes