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Macrogol Compound Oral Powder 13.8 G Sachet Powder For Oral Solution

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Macrogol Compound Oral Powder

13.8g sachet powder for oral solution

macrogol 3350, sodium chloride, sodium hydrogen carbonate, potassium chloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

This medicine is available without prescription. However, you still need to take Macrogol Compound Oral Powder carefully to get the best results from it.

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist 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 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 after 14 days.


What is in this leaflet:

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

2.    What you need to know before you take Macrogol Compound Oral Powder

3.    How to take Macrogol Compound Oral Powder

4.    Possible side effects

5.    How to store Macrogol Compound Oral Powder

6.    Contents of the pack and other information

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

Macrogol Compound Oral Powder is a laxative used for the treatment of constipation in adults, adolescents and elderly. It is not recommended for children below 12 years of age.

Macrogol Compound Oral Powder helps you to have a comfortable bowel movement even if you have been constipated for a long time. Macrogol Compound Oral Powder also works in very bad constipation called faecal impaction.

You must talk to a doctor if you do not feel better or if you feel worse after 14 days.

2. What you need to know before you take Macrogol Compound Oral Powder

Do not take Macrogol Compound Oral Powder

-    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

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Macrogol Compound Oral Powder. Heart Conditions

Follow the special instructions in section 3 if you are taking Macrogol Compound Oral Powder for faecal impaction.

Other medicines and Macrogol Compound Oral Powder

Some medicines, e.g. anti-epileptics, may not work as effectively during use with Macrogol Compound Oral Powder.

Tell your doctor or pharmacist if you are taking, have taken, or might take any other medicines, including medicines obtained without a prescription.

Macrogol Compound Oral Powder with food and drink

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

Pregnancy, breast-feeding and fertility

Macrogol Compound Oral Powder can be taken during pregnancy and whilst breastfeeding. 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

Macrogol Compound Oral Powder does not affect your ability to drive or use machinery.

Macrogol Compound Oral Powder contains potassium

Macrogol Compound Oral Powder contains 0.63 mmol (25mg) 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 Oral Powder contains sodium

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

Macrogol Compound Oral Powder contains sorbitol (E420)

The lemon lime flavour in Macrogol Compound Oral 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 Oral Powder

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

This medicine can be taken at any time with or without food or drink.

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

Constipation

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

Faecal impaction

A dose of 8 sachets a day of Macrogol Compound Oral Powder is needed for the treatment of faecal impaction. The 8 sachets should be taken within 6 hours for up to 3 days if required. If you have a heart condition do not take more than 2 sachets in any one hour.

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 the Macrogol Compound Oral Powder solution is clear or slightly hazy, then drink it. If you are taking Macrogol Compound Oral Powder for faecal impaction it may be easier to dissolve 8 sachets in 1 litre of water.

Duration of treatment Constipation

Treatment with Macrogol Compound Oral Powder usually lasts for about 2 weeks. If you need to take Macrogol Compound Oral Powder for longer, please see your doctor. If your constipation is caused by an illness such as Parkinson's disease or multiple sclerosis (MS), or if you take medicines that cause constipation your doctor may recommend that you take Macrogol Compound Oral Powder for longer than 2 weeks. Usually for long term treatment that dose can be lowered to either 1 or 2 sachets a day.

Faecal impaction

Treatment with Macrogol Compound Oral Powder can be for up to 3 days.

If you take more Macrogol Compound Oral Powder than you should

You may develop excessive diarrhoea, which can lead to dehydration. If this occurs, stop taking Macrogol Compound Oral Powder and drink plenty of fluids. If you are worried contact your doctor or pharmacist.

If you forget to take Macrogol Compound Oral Powder

Take the dose as soon as you remember to take it. Do not take a double dose to make up for a forgotten dose.

If you stop taking Macrogol Compound Oral Powder

To get the most benefit from Macrogol Compound Oral 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 medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Tell your doctor immediately and stop taking Macrogol Compound Oral Powder if you

• Get a serious allergic reaction which causes difficulty in breathing, or swelling of the face, lips, tongue or throat.

Other side effects include:

Allergic reactions which may cause a skin rash, itching, reddening of the skin or a nettle rash, swollen hands, feet or ankles, headaches and high and low levels of potassium in the blood.

Sometimes you may have indigestion, stomach ache or rumbles.

You may also feel bloated, suffer from wind, feel sick or vomit, may also experience soreness of the anus (bottom) and may have mild diarrhoea when starting to take Macrogol Compound Oral Powder. These side effects generally get better if you reduce the amount of Macrogol Compound Oral Powder you take.

If any of the above are troublesome or last more than a few days or if you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

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 Oral Powder

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 after EXP. The expiry date refers to the last day of that month.

Do not store above 25 °C.

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

Reconstituted Macrogol Compound Oral 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.

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 Macrogol Compound Oral 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 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 Compound Oral Powder looks like and contents of the pack

Macrogol Compound Oral 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

Neopharma Limited 57 High Street Odiham Hampshire RG29 1LF


Manufacturer

Hermes Pharma Ges.m.b.H. Allgau 36 9400Wolfsberg Austria

Klocke Pharma-Service GmbH Strassburger Strasse 77 77767 Appenweier Germany


This leaflet was last revised in August 2015