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MACILAX 13.8 G 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 user

Macilax
13.8 g 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 or pharmacist has 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 or pharmacist. 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.

What is in this leaflet:
1.

What Macilax is and what it is used for

2.

What you need to know before you take Macilax

3.

How to take Macilax

4.

Possible side effects

5.

How to store Macilax

6.

Contents of the pack and other information

1.

What Macilax is and what it is used for

The name of this medicine is Macilax 13.8 g Powder for Oral Solution. It is a
laxative for the treatment of chronic constipation and of very bad constipation
(called faecal impaction) in adults, adolescents and elderly. It is not
recommended for children below 12 years of age.
It helps you to have a comfortable bowel movement even if you have been
constipated for a long time.

2.

What you need to know before you take Macilax

Do not take Macilax
• if you are allergic 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 perforated gut (bowel) wall
• if you have a blockage in your intestine (gut obstruction, ileus)
• if you have severe inflammatory bowel disease such as ulcerative colitis,
Crohn’s disease or toxic megacolon.
Other medicines and Macilax
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
Some medicines, such as anti-epileptics, may not work as effectively during
use with Macilax.
Macilax with food and drink
Macilax can be taken at any time with or without food or drink.
Pregnancy and breast-feeding
Macilax 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 for advice before taking this medicine.
Driving and using machines
Macilax has no effect on the ability to drive or use machinery.

Macilax contains potassium, sodium and sorbitol
Macilax contains 0.63 mmol (25 mg) potassium per sachet. This should be
taken into consideration if you have reduced kidney function, or if you are on a
controlled potassium diet.
Macilax contains 8.1 mmol (187 mg) sodium per sachet. This should be taken
into consideration if you are on a controlled sodium diet.
The lemon lime flavour in Macilax contains sorbitol. If you have been told by
your doctor that you have an intolerance to some sugars, contact your doctor
before taking this medicinal product.

3.

How to take Macilax

Always take this medicine exactly as described in this leaflet or as your doctor
or pharmacist has told you. Check with your doctor or pharmacist if you are not
sure.
Adults, children (aged 12 years and above) and the elderly:
Chronic constipation (constipation for a long time)
The recommended dose for constipation is one sachet taken one to three times
daily according to your individual response.
Faecal impaction (complete severe constipation)
Before you take this medicine for faecal impaction, it should be confirmed that
you have this condition.
The recommended dose for faecal impaction (complete severe constipation) is
8 sachets daily. The 8 sachets should be taken within a 6 hour period each day.
Treatment may be continued for up to 3 days if required.
Patients with a heart condition:
Do not take more than 2 sachets in one hour.
Use in children (below 12 years of age)
Macilax is not recommended for children under 12 years old. Alternative
products are available for children below 12 years of age.
Method of administration
Open the sachet and pour the contents into a glass. Add about 125 ml of water
to the glass. Stir well until all the powder has dissolved and the solution is
clear or slightly hazy, then drink it. If you are taking Macilax for faecal
impaction it may be easier to dissolve all 8 sachets in 1 litre of water and to

drink the solution evenly spread over a 6 hour period. Reconstituted Macilax
solution should be covered and stored in the refrigerator (2°C to 8°C).
Duration of treatment
Constipation:
This course of treatment for constipation should not normally last longer than
2 weeks.
On your doctor's advice, you may need to take Macilax 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 advise
you to reduce your dose to one sachet taken one or two times daily.
Faecal impaction:
Treatment with Macilax can be up to 3 days.
If you take more Macilax than you should
This can cause severe pain and swelling in your abdomen (stomach), vomiting
(sickness) or diarrhoea. If this happens, contact your doctor or pharmacist.
If you forget to take Macilax
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.
If you stop taking Macilax
To get the most benefit from Macilax, always finish the course of treatment
according to the directions in this package leaflet or as your doctor or
pharmacist has told you. This will make sure that your constipation is cleared,
otherwise the symptoms you are suffering from may persist.
If you have any further questions on the use of this medicine, ask your doctor
or pharmacist.

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
Macilax and see your doctor immediately:
• signs of an allergy, such as skin rash, itching, reddening of the skin, nettle
rash, shortness of breath or difficulty in breathing, or swelling of the face,
lips, tongue or throat

• signs of a change in your body’s fluid or electrolyte levels, such as swelling
(mainly in the ankles), feeling weak, increasingly tired or increased thirst
with headache.
Other side effects include:
• stomach pains
• stomach rumbles
• diarrhoea. You may have mild diarrhoea when starting to take Macilax. This
usually stops if you reduce the number of sachets you take
• vomiting (being sick)
• nausea (feeling sick)
• anal discomfort (uncomfortable sensation around the bottom)
• swollen stomach
• wind
• swollen hands, feet or ankles
• headaches
• indigestion
• high or low levels of potassium in the blood.
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 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 Macilax

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.
Do not use this medicine if you notice that any of the sachets is damaged.
This medicinal product does not require any special storage conditions.
Reconstituted Macilax solution can be covered and stored in the refrigerator
(2°C to 8°C) and should be used within 24 hours. After 24 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 Macilax contains
The active substances are:
macrogol 3350
13.125 g
sodium chloride
0.3507 g
sodium hydrogen carbonate
0.1785 g
potassium chloride
0.0466 g
The other ingredients are silica colloidal anhydrous, saccharin sodium, orange
flavour (Orange flavour contains: flavouring preparations and substances,
natural flavouring substances, maltodextrin, acacia, α-tocopherol) and lemon
lime flavour (Lemon lime flavour contains: natural lemon oil, natural powder
flavour lemon, powder flavour lime, maltodextrin, mannitol, gluconolactone,
sorbitol, acacia, silica colloidal anhydrous).
What Macilax looks like and contents of the pack
Macilax is a white powder.
Each sachet contains 13.8 g of powder and is packed in cartons containing 20,
30 and 50 sachets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
TEVA UK Limited, Eastbourne, BN22 9AG, UK
Manufacturer
Klocke Pharma-Service GmbH:
Straßburger Straße 77
77767 Appenweier
Germany
This leaflet was last revised in 01/2014.
PL 00289/1813
70040-A

297 x 148
248661.01-GB

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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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