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LAXIDO ORANGE POWDER FOR ORAL SOLUTION

Active substance(s): MACROGOL 3350 / POTASSIUM CHLORIDE / SODIUM CHLORIDE / SODIUM HYDROGEN CARBONATE

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Package leaflet: Information for the patient

Laxido Orange
Powder for oral solution
Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor,
pharmacist or nurse have told you.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. See section 4.
- You must talk to a doctor if you do not feel better or if you feel worse after
14 days for chronic constipation, or after 3 days for faecal impaction.

Laxido Orange with food and drink
Food and drink have no influence on the effect of Laxido Orange.
Pregnancy and breast-feeding
Laxido Orange can be taken during pregnancy and whilst breast-feeding. If you
are pregnant or breast-feeding, think you may be pregnant or are planning to
have a baby, ask your doctor or pharmacist for advice before taking this
medicine.
Driving and using machines
Laxido Orange has no effect on the ability to drive or use machines.
Laxido Orange contains potassium and sodium
Laxido Orange 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.
Laxido Orange contains 8.13mmol (187mg) of sodium per sachet. This should
be taken into consideration if you are on a controlled sodium diet.

What is in this leaflet:
1. What Laxido Orange is and what it is used for
2. What you need to know before you take Laxido Orange
3. How to take Laxido Orange
4. Possible side effects
5. How to store Laxido Orange
6. Contents of the pack and other information

3. How to take Laxido Orange

1. What Laxido Orange is and what it is used for

Constipation
The usual dose for constipation is one sachet taken one to three times daily.

Macrogol 3350 is a laxative used for the treatment of constipation, especially if
you have been constipated for a long time. It is also used to treat a build up of
hard faeces in your bowel which may be a result of long-term constipation (this
is known as faecal impaction). Macrogol 3350 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 Laxido Orange

Always take this medicine exactly as described in this leaflet or as your doctor,
pharmacist or nurse have told you. Check with your doctor, pharmacist or nurse
if you are not sure. Laxido Orange should be taken orally.
Laxido Orange is a laxative for the treatment of constipation and faecal
impaction in adults, children (aged 12 years and above) and the elderly.

Faecal impaction
The usual dose for faecal impaction is eight sachets daily. All eight sachets
must be taken within a six hour period. If you have a heart condition, do not
take more than two sachets (in 250ml of water) in any one hour.
How to mix
Laxido Orange should be made up by dissolving the contents of one sachet in a
glass of water (125ml or a quarter pint). Stir well until all the powder has
dissolved. If you are being treated for faecal impaction, you can dissolve the
contents of all eight sachets together in a large container (in one litre of water).

Do not take Laxido Orange:
- if you are allergic (hypersensitive) to macrogol 3350, sodium chloride,
sodium hydrogen carbonate, potassium chloride, or any of the other
ingredients of this medicine (listed in section 6)
- if you have a perforation in the wall of your intestine
- if you have a blockage in your intestine
- if you have paralysis of the intestine (for example, your intestines may stop
working due to intestinal surgery or severe infection)
- if you have ulcerative colitis, Crohn’s disease or toxic megacolon

Duration of treatment
Constipation
The course of treatment for constipation does not normally last longer than 2
weeks. Your treatment may last for longer than two weeks if you have ongoing
constipation, or a disease that causes constipation (such as Parkinson’s disease
or multiple sclerosis), or if you are taking other regular medicines that can
cause constipation. In these cases, your doctor may reduce your dose to one
sachet taken one or two times daily.

If any of these applies to you, please talk to your doctor, pharmacist or nurse for
further advice.

Faecal impaction
The course of treatment for faecal impaction does not normally last longer than
3 days.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Laxido Orange to treat
faecal impaction, as prior to taking this medicine it should be confirmed that
you have this condition.
Other medicines and Laxido Orange
Some medicines, e.g. anti-epileptics, may not work as effectively if they are
taken at the same time as Laxido Orange. Please tell your doctor or pharmacist
if you are taking, have recently taken or might take any other medicines. You
should not take any other medicines by mouth for one hour before and for one
hour after taking Laxido Orange.

If you take more Laxido Orange than you should
You may experience severe pains and swelling in your abdomen, or vomiting
or diarrhoea, which can lead to dehydration. If this occurs, stop taking Laxido
Orange and drink plenty of fluids. If you are worried contact your doctor or
pharmacist.
If you forget to take Laxido Orange
If you forget to take a dose, take it as soon as you remember and then continue
on as before. Do not take a double dose to make up for a forgotten dose.
PX2046/4

If you stop taking Laxido Orange
To get the most benefit from Laxido Orange, always finish the course of
treatment recommended by your doctor or pharmacist. This will make sure
that your constipation is cleared, otherwise the symptoms you are suffering
from may persist.
You must contact a doctor if your symptoms worsen or do not improve after
14 days for chronic constipation, or after 3 days for faecal impaction.
If you have any further questions on the use of this medicine, ask your doctor,
pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody
gets them.
If you experience any of the following side effects, stop taking Laxido Orange
and see your doctor immediately:
- signs of a serious allergic reaction, such as difficulty in breathing, or swelling
of the face, lips, tongue or throat

Reconstituted Laxido Orange solution can be covered and stored in the
refrigerator (2˚C to 8˚C), and should be used within six hours. After six hours,
any unused solution should be discarded.
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 protect the environment.
6. Contents of the pack and other information
What Laxido Orange contains
The active substances are macrogol 3350 (13.125g), sodium chloride
(350.7mg), sodium hydrogen carbonate (178.5mg) and potassium chloride
(46.6mg). The other ingredients are acesulfame potassium (E950) and orange
flavour (containing maltodextrin and propylene glycol (E1520)).
What Laxido Orange looks like and contents of the pack
Laxido Orange is a white powder that is packed in sachets. It has an orange
taste and smell.

- signs of an allergy, such as a rash, reddening of the skin, nettle rash, itching
or shortness of breath

Each sachet contains 13.8g of powder and is packed in cartons containing 2, 8,
10, 20, 30, 50 and 100 sachets. Not all of these pack sizes are marketed.

- signs of a change in your body’s fluid or electrolyte levels, such as swelling
(mainly in the ankles), feeling fatigued, dehydration or increased thirst with
headache. These symptoms may be a sign that the potassium levels in your
blood are higher or lower than normal.

Marketing Authorisation Holder
Galen Limited
Seagoe Industrial Estate
Craigavon
BT63 5UA
UK

The following side effects are also possible:
- abdominal pain
- feeling bloated
- suffering from wind
- indigestion
- soreness of the anus (bottom)
- mild diarrhoea
- nausea
- vomiting
- swelling of your abdomen
- stomach rumbling

Manufacturer
Almac Pharma Services Limited
Almac House
20 Seagoe Industrial Estate
Craigavon
BT63 5QD
UK

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes
any possible side effects not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme at: 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 Laxido Orange
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and
sachet. The expiry date refers to the last day of that month.

This medicinal product is authorised in the Member States of the EEA
under the following names:
Denmark, Belgium, Germany, Spain, Ireland, Iceland, Luxembourg and UK –
Laxido Orange
Finland – Laxido Appelsiini
Portugal – Laxido Laranja
Sweden – Laxido Apelsin
Italy - Laxido
This leaflet was last revised in 10/2015.
Laxido is a trade mark

You should store unopened sachets below 25˚C.

PX2046/4

Do not use this medicine if you notice that any of the sachets is damaged.

Ink Colour:

Black

Fold Configuration:
155mm

PX No:

2046/4

Pharmacode: 20464
Supplied:

220mm

Dimensions: 155 x 220mm

front

back

1

Folded

Folded Size: 110mm x 77.5mm
APPROVED BY:

155mm

Date:

2

77.5mm

Laxido Orange

110mm

PIL:

110mm

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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