Macrogol Compound Powder For Oral Solution
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Qugo
Powder for Oral Solution
Read all ofthis leaflet carefully before you start taking this medicine because it contains important information foryou.
Always take this medicine exactly as described in this leaflet or as your doctor, or pharmacist or nurse has told you to.
• 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 or nurse. 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 Qugo is and what it is used for
2. What you need to know before you take Qugo
3. How to take Qugo
4. Possible side effects
5. How to store Qugo
6. Contents of the pack and other information
1. WHAT QUGO IS AND WHAT IT IS USED FOR
Qugo is a laxative used for the treatment of long term constipation. It is not recommended for children below 12 years of age. Qugo contains Macrogol 3350, sodium chloride, sodium hydrogen carbonate and potassium chloride. Macrogol 3350 makes your faeces softer and easier to pass, giving you relieffrom constipation. The electrolytes (salts) help to maintain your body's normal levels of sodium, potassium and waterwhile you are being treated for constipation.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE QUGO Do not take Qugo
• if you are allergic (hypersensitive) to macrogol 3350, sodium chloride, sodium hydrogen carbonate, potassium chloride, or any ofthe other ingredients in Qugo (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 Qugo
Please tell your doctor or pharmacist if you are taking, have recently taken or might take, any other medicines including medicines obtained without a prescription.
Some medicines, e.g. anti-epileptics, may not work as effectively during use with Qugo.
Qugo with food and drink
Qugo 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 Qugo. Driving and using machines
Qugo has no effect on the ability to drive or use machinery.
Qugo contains potassium, sodium and sorbitol
Qugo contains 0.63 mmol (25 mg) of potassium per sachet. This should be taken into consideration ifyou take more than one sachet daily and you have reduced kidney function, or ifyou are on a controlled potassium diet.
Qugo contains 8.1 mmol (187 mg) of sodium per sachet. This should be taken into consideration ifyou are on a controlled sodium diet.
The lemon lime flavour in Qugo contains sorbitol (E420). Ifyou 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 QUGO
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 ofwater to the glass. Stir well until the powder has dissolved and then drink it.
Duration oftreatment
This course of treatment for constipation should not normally last longer than 2 weeks.
If you take more Qugo than you should
This can cause severe pain and swelling in your abdomen (stomach), orvomiting (sickness) or diarrhoea. If this happens, contact your doctor or pharmacist.
If you forget to take Qugo
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 Qugo
To get the most benefit from Qugo, 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. POSSIBLESIDEEFFECTS
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 Qugo 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 Qugo, this usually stops if you reduce the number of sachets you take)
• nausea (feeling sick)
• vomiting
• swelling ofyour abdomen (feeling bloated)
• stomach rumbling
• flatulence (wind)
• sorenessoftheanus(bottom).
Reporting ofside 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 QUGO
Keep out of the sight and reach of children.
Do not use Qugo 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 250C.
Do not use Qugo if you notice that any of the sachets are damaged.
Reconstituted Qugo 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 Qugo 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. CONTENTS OF THE PACK AND OTHER INFORMATION
What Qugo contains
The active substances are:
Each sachet contains: macrogol3350 13.125 g
sodium hydrogen carbonate 0.1785 g
The other ingredients are colloidal anhydrous silica, saccharin sodium, orange flavour (Orange flavouring contains: flavouring substances and preparations, maltodextrin, acacia gum, alpha-tocopherol) and lemon lime flavour (Lemon lime flavourcontains: flavouring preparations, maltodextrin, mannitol, gluconolactone, sorbitol (E420), acacia gum, colloidal anhydrous silica).
What Qugo looks like and contents of the pack
Qugo 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 ofthese 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.
Allgau 36 9400 Wolfsberg Austria