Patient Information Leaflet LAXAGOL ORANGE FLAVOUR Powder for oral solution

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

This medicine is available without prescription. However you still need to take LAXAGOL ORANGE FLAVOUR carefully to get the best results from it.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor or pharmacist.

•    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

•    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

In this leaflet:

1.    What is LAXAGOL ORANGE FLAVOUR and what it is used for

2.    What you need to know before you take LAXAGOL ORANGE FLAVOUR

3.    How to take LAXAGOL ORANGE FLAVOUR

4.    Possible side effects

5.    How to store LAXAGOL ORANGE FLAVOUR

6.    Contents of the pack and other information

1.    What is LAXAGOL ORANGE FLAVOUR and what it is used for

The name of this medicine is LAXAGOL ORANGE FLAVOUR powder for oral solution. It is a laxative for the treatment of constipation in adults, adolescents and elderly. It is not recommended for children below 12 years of age.

LAXAGOL ORANGE FLAVOUR helps you to have a normal bowel movement even if you have been constipated for a long time. LAXAGOL ORANGE FLAVOUR also works when there is a build up of hard faeces in your bowel which may be a result of long-term constipation (called faecal impaction).

LAXAGOL ORANGE FLAVOUR contains macrogol 3350 which makes your faeces softer and easier to pass, giving you relief from constipation. The electrolytes help to maintain your body’s normal levels of sodium, potassium and water while you are being treated for constipation.

2.    What you need to know before you take LAXAGOL ORANGE FLAVOUR

Do not take LAXAGOL ORANGE FLAVOUR if your doctor has told you that you have:

•    a blockage in your intestine (gut obstruction, ileus)

•    a perforated gut wall

•    severe inflammatory bowel disease like ulcerative colitis, Crohn’s disease or toxic megacolon

• an allergy (hypersensitivity) to macrogol 3350, sodium chloride, sodium hydrogen carbonate, potassium chloride or any of the other ingredients of LAXAGOL ORANGE FLAVOUR

Warnings and precautions

Take special care with LAXAGOL ORANGE FLAVOUR

Before taking LAXAGOL ORANGE FLAVOUR to treat faecal impaction, you should have this condition confirmed by your doctor.

Heart conditions

Follow the special instructions in section 3 if you are taking LAXAGOL ORANGE FLAVOUR for faecal impaction.

LAXAGOL ORANGE FLAVOUR contains 0.68mmol (26mg) of potassium per sachet. This should be taken into consideration if you take more than one sachet daily and you have reduced kidney function, or if you are on a controlled potassium diet. If this is the case please contact your doctor or pharmacist.

LAXAGOL ORANGE FLAVOUR contains 8.13mmol (187mg) of sodium per sachet. This should be taken into consideration if you are on a controlled sodium diet. If this is the case please contact your doctor or pharmacist.

Other medicines and LAXAGOL ORANGE FLAVOUR

Please inform your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including medicines obtained without a prescription. You should not take any other medicines by mouth for one hour before and for one hour after taking LAXAGOL ORANGE FLAVOUR.

Pregnancy, breast feeding and fertility

If you are pregnant or breast feeding talk to your doctor before taking LAXAGOL ORANGE FLAVOUR

Driving and using machines

LAXAGOL ORANGE FLAVOUR does not affect your ability to drive or use machines.

LAXAGOL ORANGE FLAVOUR contains orange flavouring

The flavouring used in LAXAGOL ORANGE FLAVOUR may rarely cause allergic reactions (itch or rash) and difficulty in breathing. If this happens to you then stop taking LAXAGOL ORANGE FLAVOUR and immediately see your doctor.

3. How to take LAXAGOL ORANGE FLAVOUR

Always take LAXAGOL ORANGE FLAVOUR exactly as your doctor or pharmacist has told you. You should check with your doctor or pharmacist if you are not sure. LAXAGOL ORANGE FLAVOUR should be taken orally. This medicine can be taken at any time with or without food or drink

Constipation:

A dose of LAXAGOL ORANGE FLAVOUR is 1 sachet.

Take this 1 -3 times a day according to the severity of your constipation.

Faecal impaction:

A dose is 8 sachets a day of LAXAGOL ORANGE FLAVOUR for the treatment of faecal impaction. The 8 sachets should be taken within 6 hours for up to 3 days if required. If you have a heart condition do not take more than 2 sachets (in 250ml of water) in any one hour.

How to mix:

Open the sachet and pour the contents into a glass. Add about 125ml or a quarter pint of water to the glass. Stir well until all the powder has dissolved and the LAXAGOL ORANGE FLAVOUR solution is clear or slightly hazy, then drink it. If you are taking LAXAGOL ORANGE FLAVOUR for faecal impaction it may be easier to dissolve 8 sachets in 1 litre of water.

Duration of treatment:

Constipation:

Treatment with LAXAGOL ORANGE FLAVOUR usually lasts for about 2 weeks. If you need to take LAXAGOL ORANGE FLAVOUR for longer, please see your doctor. If your constipation is caused by an illness such as Parkinson’s disease or multiple sclerosis (MS), or if you take medicines that cause constipation your doctor may recommend that you take LAXAGOL ORANGE FLAVOUR for longer than 2 weeks.

Usually for long term treatment that dose can be lowered to either 1 or 2 sachets a day.

Faecal impaction:

Treatment with LAXAGOL ORANGE FLAVOUR can be for up to 3 days.

If you take more LAXAGOL ORANGE FLAVOUR than you should:

You may develop diarrhoea, experience severe pains in the abdomen and or vomiting.

If this happens, contact your doctor or pharmacist. Stop taking LAXAGOL ORANGE FLAVOUR until it clears.

If you forget to take LAXAGOL ORANGE FLAVOUR:

Take the dose as soon as you remember to take it and then continue on as before. Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, LAXAGOL ORANGE FLAVOUR can have side effects, although not everybody gets them.

If you experience any of the following side effects, stop taking LAXAGOL ORANGE FLAVOUR and see your doctor immediately:

•    Get a serious allergic reaction which causes difficulty in breathing, or swelling of the face, lips, tongue or throat.

The following side effects are also possible:

•    Allergic reactions which may cause a skin rash, itching, reddening of the skin or a nettle rash, swollen hands, feet or ankles, headaches and high and low levels of potassium in the blood.

•    Sometimes you may 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 LAXAGOL

ORANGE FLAVOUR. These side effects generally get better if you reduce the amount LAXAGOL ORANGE FLAVOUR you take.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5.    How to store LAXAGOL ORANGE FLAVOUR

Keep all medicines out of the sight and reach of children.

Do not use LAXAGOL ORANGE FLAVOUR after the expiry date which is stated on the carton and sachet after EXP. The expiry date refers to the last day of that month.

Do not store above 25°C.

Once you have made up LAXAGOL ORANGE FLAVOUR in water, if you cannot drink it straight away keep it covered and in the fridge (2 - 8°C). Throw away any solution not used within a 6 hour period.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6.    Content of the pack and other information What LAXAGOL ORANGE FLAVOUR contains:

Each 13.8g sachet of LAXAGOL ORANGE FLAVOUR contains the following:

•    Macrogol 3350: 13.125 g

•    Sodium Chloride: 0.3507 g

•    Sodium Bicarbonate (sodium hydrogen carbonate): 0.1785 g

•    Potassium Chloride: 0.0466 g

LAXAGOL ORANGE FLAVOUR also contains orange flavour and acesulfame potassium as a sweetener. Orange flavour contains the following ingredients: nature-identical flavouring substances, flavouring preparations, natural flavouring substances, maltodextrin, acacia gum and ascorbic acid.

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

•    Sodium: 65 millimoles/litre

•    Chloride: 53 millimoles/litre

•    Potassium: 5.4 millimoles/litre

•    Bicarbonate (hydrogen carbonate): 17 millimoles/litre

What LAXAGOL ORANGE FLAVOUR looks like and contents of the pack

LAXAGOL ORANGE FLAVOUR is a white powder that is packed in sachets. It has a lemon and lime taste and smell.

LAXAGOL ORANGE FLAVOUR is available in boxes of 2, 8, 20, 30, 50 or 100 sachets. Not all pack sizes may be marketed.

Marketing authorisation holder

Auden Mckenzie (Pharma Division) Ltd.

Mckenzie House,

Bury Street, Ruislip,

Middlesex,

HA4 7TL UK

Manufacturer

M&A Pharmachem Ltd.

Bolton,

England,

BL5 2AL UK

This leaflet was last approved in revised in April 2016.

For information in large print, on tape, on CD or in Braille, phone 01895 627 420.