Macrogol 13.8 G Sachet Sugar Free Powder For Oral Solution
healthcare
PACKAGE LEAFLET: INFORMATION FOR THE USER
Macrogol 13.8 g Sachet,
Sugar Free 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 after 14 days.
What is in this leaflet
1. What Macrogol is and what it is used for
2. What you need to know before you take Macrogol
3. How to take Macrogol
4. Possible side effects
5. How to store Macrogol
6. Contents of the pack and other information
The full name of your medicine is Macrogol 13.8 g Sachet, Sugar Free Powder for Oral Solution. In this leaflet the shorter name Macrogol is used.
1. WHAT MACROGOL IS AND WHAT IT IS USED FOR
Macrogol 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.
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
Do not take Macrogol
• 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 apply to you, please talk to your doctor or pharmacist for further advice.
Other medicines and Macrogol
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Some medicines, e.g. anti-epileptics, may not work as effectively during use with Macrogol.
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, 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 has no effect on the ability to drive or use machinery.
Macrogol contains potassium, sodium and sorbitol (E420)
Macrogol 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 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 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
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:
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. 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 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.
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 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 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 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, website: 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
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 store unopened sachets above 25°C.
Do not use Macrogol if you notice that any of the sachets are damaged.
Reconstituted Macrogol 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 contains
The active substances are: macrogol 3350, sodium chloride, sodium hydrogen carbonate and potassium chloride.
Each sachet contains:
sodium hydrogen carbonate 0.1785 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 13.8 g Sachet, Sugar Free Powder for Oral Solution looks like and contents of the pack
Macrogol 13.8 g Sachet, Sugar Free Powder for Oral Solution 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
Alissa Healthcare Research Limited
Unit 5, Fulcrum 1
Solent Way, Whiteley
Fareham, Hampshire
United Kingdom
PO15 7FE
Manufacturers
Klocke Pharma-Service GmbH Strassburger Strasse 77 77767 Appenweier Germany
Hermes Pharma Ges.m.b.H.
Allgau 36 9400 Wolfsberg Austria