LAXIDO ORANGE POWDER FOR ORAL SOLUTION

Active substance: SODIUM HYDROGEN CARBONATE

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

Laxido Orange
Powder for oral solution
Read all of this leaflet carefully because it contains important
information for you.
This medicine is available without prescription. However, you still need to take
Laxido Orange carefully to get the best results from it.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- 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 any of the side effects gets serious, or if you notice any side effect not
listed in this leaflet, please tell your doctor or pharmacist.

Taking other medicines
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, 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 Laxido Orange.
Taking Laxido Orange with food and drink
Food and drink have no influence on the effect of Laxido Orange.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, talk to your doctor before taking Laxido
Orange.
Driving and using machines
Laxido Orange has no effect on the ability to drive or use machinery.
Important information about some of the ingredients of Laxido Orange
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.

In this leaflet:
1. What Laxido Orange is and what it is used for
2. Before you take Laxido Orange
3. How to take Laxido Orange
4. Possible side effects
5. How to store Laxido Orange
6. Further information

Laxido Orange contains 8.13mmol (187mg) of sodium per sachet. This should
be taken into consideration if you are on a controlled sodium diet.

1. WHAT LAXIDO ORANGE IS AND WHAT IT IS USED FOR

Adults, children (aged 12 years and above) and the elderly:
The usual dose for constipation is one sachet taken one to three times daily.
This course of treatment for constipation does not normally last longer than 2
weeks.

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. BEFORE YOU TAKE LAXIDO ORANGE
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 in Laxido Orange
- 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
If any of these applies to you, please talk to your doctor or pharmacist for
further advice.
Take special care with Laxido Orange
Before taking Laxido Orange to treat faecal impaction, you should have this
condition confirmed by your doctor.

3. HOW TO TAKE LAXIDO ORANGE
Always take Laxido Orange exactly as your doctor or
pharmacist has told you. You should check with your doctor
or pharmacist if you are not sure. Laxido Orange should be taken orally.

The usual dose for faecal impaction is eight sachets daily. All eight sachets
must be taken within a six hour period. This course of treatment for faecal
impaction does not normally last longer than 3 days. If you have a heart
condition, do not take more than two sachets (in 250ml of water) in any one
hour.
Laxido Orange should be made up by dissolving the contents of one sachet in a
glass of water (125ml or a quarter pint). 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).
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 you take more Laxido Orange than you should
You may experience severe pains and swelling in your abdomen, or vomiting or
diarrhoea. If this happens, 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.
1017625

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.

6. FURTHER 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)).

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

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.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Laxido Orange can cause side effects, although not
everybody gets them.

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.

If you experience any of the following side effects, stop taking Laxido Orange
and see your doctor immediately:

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

- signs of a serious allergic reaction, such as difficulty in breathing, or swelling
of the face, lips, tongue or throat
- signs of an allergy, such as a rash, reddening of the skin, nettle rash, itching
or shortness of breath
- 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.
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
Co-Pharma Limited
Unit 4
Metro Centre
Tolpits Lane
Watford
Hertfordshire
WD18 9SS
United Kingdom
This leaflet was last approved in 06/2012
Laxido is a trade mark

If any of the side effects becomes serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE LAXIDO ORANGE
Keep out of the reach and sight of children.
Do not use Laxido Orange after the expiry date which is stated on the carton
and sachet. The expiry date refers to the last day of that month.
You should store unopened sachets below 25˚C.

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.
Unused sachets of Laxido Orange should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of unused sachets, which
you no longer require. These measures will help to protect the environment.

1017625

Do not use Laxido Orange if you notice that any of the sachets is damaged.

PACKAGE LEAFLET:
INFORMATION FOR THE USER

Laxido Orange
Powder for oral solution
Read all of this leaflet carefully because it contains important
information for you.
This medicine is available without prescription. However, you still need to take
Laxido Orange carefully to get the best results from it.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- 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 any of the side effects gets serious, or if you notice any side effect not
listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Laxido Orange is and what it is used for
2. Before you take Laxido Orange
3. How to take Laxido Orange
4. Possible side effects
5. How to store Laxido Orange
6. Further information
1. WHAT LAXIDO ORANGE IS AND WHAT IT IS USED FOR
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. BEFORE YOU TAKE LAXIDO ORANGE
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 in Laxido Orange
- 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
If any of these applies to you, please talk to your doctor or pharmacist for
further advice.
Take special care with Laxido Orange
Before taking Laxido Orange to treat faecal impaction, you should have this
condition confirmed by your doctor.

Taking other medicines
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, 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 Laxido Orange.
Taking Laxido Orange with food and drink
Food and drink have no influence on the effect of Laxido Orange.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, talk to your doctor before taking Laxido
Orange.
Driving and using machines
Laxido Orange has no effect on the ability to drive or use machinery.
Important information about some of the ingredients of Laxido Orange
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.
3. HOW TO TAKE LAXIDO ORANGE
Always take Laxido Orange exactly as your doctor or
pharmacist has told you. You should check with your doctor
or pharmacist if you are not sure. Laxido Orange should be taken orally.
Adults, children (aged 12 years and above) and the elderly:
The usual dose for constipation is one sachet taken one to three times daily.
This course of treatment for constipation does not normally last longer than 2
weeks.
The usual dose for faecal impaction is eight sachets daily. All eight sachets
must be taken within a six hour period. This course of treatment for faecal
impaction does not normally last longer than 3 days. If you have a heart
condition, do not take more than two sachets (in 250ml of water) in any one hour.
Laxido Orange should be made up by dissolving the contents of one sachet in a
glass of water (125ml or a quarter pint). 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).
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 you take more Laxido Orange than you should
You may experience severe pains and swelling in your abdomen, or vomiting or
diarrhoea. If this happens, 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.
PX2046/2

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 product, ask your doctor or
pharmacist.

6. FURTHER 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.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Laxido Orange can cause side effects, although not
everybody gets them.

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.

If you experience any of the following side effects, stop taking Laxido Orange
and see your doctor immediately:

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

- signs of a serious allergic reaction, such as difficulty in breathing, or swelling
of the face, lips, tongue or throat
- signs of an allergy, such as a rash, reddening of the skin, nettle rash, itching
or shortness of breath
- 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.
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
This leaflet was last approved in 06/2012
Laxido is a trade mark

If any of the side effects becomes serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE LAXIDO ORANGE
Keep out of the reach and sight of children.
Do not use Laxido Orange after the expiry date which is stated on the carton
and sachet. The expiry date refers to the last day of that month.
You should store unopened sachets below 25˚C.
Do not use Laxido Orange if you notice that any of the sachets is damaged.
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.

PX2046/2

Unused sachets of Laxido Orange should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of unused sachets, which
you no longer require. These measures will help to protect the environment.

Expand view ⇕

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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