PACKAGE LEAFLET: INFORMATION FOR THE USER

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Compound Macrogol 13.8g 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 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 is and what it is used for

2.    Before you take Macrogol

3.    How to take Macrogol

4.    Possible side effects

5.    How to store Macrogol

6.    Further information

A SANDOZ

What Macrogol is and what it is used for

Compound Macrogol 13.8g Powder for Oral Solution is a laxative used for the treatment of long time 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 beeing treated for constipation.

2 Before you take Macrogol

Important information about some of the ingredients of Macrogol

Compound Macrogol 13.8g Powder for Oral Solution 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.

Compound Macrogol 13.8g Powder for Oral Solution 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 Compound Macrogol 13.8g Powder for Oral Solution 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.

Do not take Macrogol

•    if you are allergic (hypersensitive) to macrogol 3350, sodium chloride, sodium hydrogen carbonate, potassium chloride, or any of the other ingredients in Compound Macrogol 13.8g Powder for Oral Solution

•    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 applies to you, please talk to your doctor or pharmacist for further advice.

Taking other medicines

Some medicines, e.g. anti-epileptics, may not work as effectively during use with Macrogol. 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 with food and drink

Macrogol 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.

Driving and using machines

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

3 How to take Macrogol

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

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

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. Stirr 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 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

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.

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If you stop taking Macrogol

To get the most benefit from Macrogol, 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.

6 Further information

4 Possible side effects

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

If you experience any of the following side effects, stop taking Macrogol 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 (salts 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, 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)

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.

5 How to store Macrogol

Keep out of the reach and sight of children.

Do not use Macrogol 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 store above 25 °C.

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

Reconstituted Macrogol solution can be covered and stored in the refrigerator (2°C to 8°C), and should be used within twenty-four hours. After twenty-four hours, any unused solution should be discarded.

Unused sachets of Macrogol 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.

What Macrogol 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 flavour contains: flavouring substances and flavouring preparations, maltodextrin, acacia gum, alpha-tocopherol and lemon lime flavour (Lemon lime flavour contains: flavouring preparations, maltodextrin, mannitol, gluconolactone, sorbitol (E420), acacia gum, colloidal anhydrous silica).

What Macrogol looks like and contents of the pack

Compound Macrogol 13.8g Powder for Oral Solution contains 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

Sandoz Ltd,

Frimley Business Park, Frimley,

Camberley, Surrey, GU16 7SR, UK.

Manufacturer

Klocke Pharma-Service GmbH,

Strassburger Strasse 77,

77767 Appenweier,

Germany

or

Salutas Pharma GmbH,

Otto-von-Guericke-Allee 1,

39179 Barleben,

Germany

or

Hermes Pharma Ges.m.b.H,

Allgau 36, 9400 Wolfsberg,

Austria.

This leaflet was last revised in 07/2014.

SZ00000LT000

Artwork Proof Box

Ref: V01 6G: Resub of V014G Excipient amendment