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Macrogol Compound Powder For Oral Solution

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Version No.

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Ennogen

Mocrogol ftswifer for Oral Solutionr Leaflet

UK

English

148 * 540 mm lOpt 1 of 2

18-10-13 Coreldraw 12


Colours Used

Black

Keyline


nogen Pharma

PACKAGE LEAFLETS INFORMATION FOR THE USER

Macrogol Compound 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 Macrogol Compound Powder for Oral Solution 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.

■    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Macrogol Compound Powder for Oral Solution is and what it is used for

2.    Before you take Macrogol Compound Powder for Oral Solution

3.    How to take Macrogol Compound Powder for Oral Solution

4.    Possible side effects

5.    How to store Macrogol Compound Powder for Oral Solution

6.    Further information

1.    WHAT MACROGOL COMPOUND POWDER FOR ORAL SOLUTION IS AND WHAT fT IS USED FOR

Macrogol Compound Powder for Oral Solution is a laxative used for the treatment of long term constipation. It Is not recommended for children below 12 years of age. Macrogol 3350 makes your faeces softer and easier to pass, giving you relief from constipation. The electrolytes (salts) help to maintain your body's normal levels of sodium, potassium and water while you are being treated for constipation.

2.    BEFORE YOU TAKE MACROGOL COMPOUND POWDER FOR ORAL SOLUTION

Do not take Macrogol Compound Powder

•    if you are allergic (hypersensitive) to macrogol 3350, sodium chloride, sodium hydrogen carbonate, potassium chloride, or any of the other Ingredients In Macrogol Compound Powder

•    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.

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

Taking other medicines

Some medicines, e.g. antl-eplleptlcs, may not work as effectively during use with Macrogol Compound Powder.

Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines, Including medicines obtained without a prescription.

Taking Macrogol Compound Powder with food and drink

Macrogol Compound Powder can be taken at any time with or without food or drink.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding talk to your doctor before taking Macrogol Compound Powder.

Driving and using machines

Macrogol Compound Powder has no effect on the ability to drive or use machinery.

Important Information about some of the Ingredients of Macrogol Compound Powder

Macrogol Compound Powder contains 0.63 mmol (25 mg) 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.

Macrogol Compound Powder contains 8.1 mmol (187 mg) of sodium per sachet. This should be taken into consideration if you are on a controlled sodium diet.

The lemon lime flavour In Macrogol Compound Powder contains sorbitol (E420). 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 MACROGOL COMPOUND POWDER FOR ORAL SOLUTION

Adults, children (aged 12 years and above) and the elderly:

The usual dose for constipation Is one sachet taken one to three times dally.

How to mix

Open the sachet and pour the contents Into a glass. Add about 125 ml or a quarter pint of water to the glass. Stir well until the powder has dissolved and then drink it.

Duration of treatment

This course of treatment for constipation should not normally last longer than 2 weeks.

If you take more Macrogol Compound Powder than you should

This can cause severe pain and swelling in your abdomen (stomach), or vomiting (sickness) or diarrhoea. If this happens, contact your doctor or pharmacist.

If you forget to take Macrogol Compound Powder

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 tor a forgotten dose.

Customer

Description

Market

Language

Size


Version No.

Date

Software


Ennogen

Mocrogol ftswifer for Oral Solutionr Leaflet

UK

English

148 * 540 mm lOpt 2 of 2

18-10-13 Coreldraw 12


Colours Used

Black

Keyline


If you stop taking Macrogol Compound Powder

To get the most benefit from Macrogol Compound Powder, always finish the course of treatment according to the directions In this package leaflet 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.

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


4.    POSSIBLE SIDE EFFECTS

Like all medicines, Macrogol Compound Powder can cause side effects, although not everybody gets them.

If you experience any of the following side effects, stop taking Macrogol Compound Powder and see your doctor Immediately:

■    signs of an allergy, such as a rash, itching, shortness of breath or difficulty in breathing

•    signs of a change In your body's fluid or electrolyte levels (salt levels), such as swelling (mainly in the ankles), feeling weak, increasingly tired or increased thirst with headache.

The following side effects are also possible:

•    abdominal (stomach) pain

■    mild diarrhoea (when starting to take Macrogol Compound Powder, this usually stops if you reduce the number of sachets you take)

•    nausea (feeling sick)

■    vomiting

•    swelling of your abdomen (feeling bloated)

•    stomach rumbling

•    flatulence (wind)

•    soreness of the anus (bottom).

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 MACROGOL COMPOUND POWDER FOR ORAL SOLUTION

Keep out of the sight and reach of children.

Do not use Macrogol Compound Powder after the expiry date which Is stated on the carton and sachet. The expiry date refers to the last day of that month.

Unopened sachets should not be stored above 25°C

Do not use Macrogol Compound Powder if you notice that any of the sachets are damaged.


Reconstituted Macrogol Compound Powder 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.

Unused sachets of Macrogol Compound Powder 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.

6. FURTHER INFORMATION

What Macrogol Compound Powder contains

The active substances are:


Each sachet contains: 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 colloidal anhydrous silica, saccharin sodium, orange flavour (Orange flavouring contains: flavouring substances and preparations, maltodextiln, acacia gum, alpha-tocopherol) and lemon lime flavour (Lemon lime flavour contains: flavounng preparations, maltodextrin, mannitol, glucondactone, sorbitol (E420), acacia gum, colloidal anhydrous silica).

What Macrogol Compound Powder looks like and contents of the pack

Macrogol Compound Powder is a white powder.

Each sachet contains 13.8 g of powder and is packed in cartons containing 2, 6, 8,10.20, 30, 50, 60 (2x30) and 100 (2x50) sachets.

Not all of these pack sizes are marketed.

Marketing Authorisation Holder

Ennogen Pharma Ltd.

Unit G4, Riverside Industrial Estate,

Riverside Way, Dartford, DA1 5BS.

United Kingdom.

Manufacturer:

Hermes Pharma Ges.m.b.H.

AllgSu 36, 9400 Wolfsberg, Austria


This leaflet was last revised in September 2013