Compound Macrogol 13.8g Powder For Oral Solution
PACKAGE LEAFLET: INFORMATION FOR THE USER
SZ00000LT000
macrogol 3350/ sodium chloride / sodium hydrogen carbonate / potassium chloride
Read all of this leaflet carefully to get the best results from it 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 for chronic constipation.
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
Compound Macrogol 13.8g Powder for Oral Solution is a laxative used for the treatment of constipation, (especially if constipation lasts a long time) in adults, adolescents and the elderly. 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.
Do not take Macrogol
• if you are allergic to macrogol 3350, sodium chloride, sodium hydrogen carbonate, potassium chloride, or any of the other ingredients in 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
Talk to your doctor or pharmacist before taking
this medicine.
work as effectively during use with Macrogol. Therefore, other medicines should not be taken orally for one hour before and for one hour after taking this medicine.
Pregnancy and breast-feeding
Macrogol can be taken during pregnancy and whilst breast-feeding. If you are pregnant or breast-feeding, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
This medicine does not affect your ability to drive or use machines.
Macrogol contains potassium, sodium and sorbitol
This medicine 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.
This medicine 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 this medicine 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.
Warnings and precautions
If you feel weak, breathless, very thirsty with a headache, have difficulty breathing when lying down or get swollen ankles stop taking this medicine and tell your doctor immediately.
Children
Do not give this medicine to children below 12 years of age.
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
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Constipation
A dose of Macrogol is 1 sachet dissolved in 125 ml (1/4 pint) of water. Take this 1-3 times a day according to the severity of your constipation. Treatment with this medicine usually lasts for about 2 weeks. If you need to take this medicine for longer, please see your doctor.
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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 this medicine for longer than 2 weeks. If you need to take this medicine for longer, please see your doctor. Usually for long term treatment the dose can be lowered to either 1 or 2 sachets a day.
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 all the powder has dissolved and the solution is clear or slightly hazy, then drink it.
This medicine should be taken orally.
Children
Do not give this medicine to children below 12 years of age.
If you take more Macrogol than you should
This can cause severe pain and bloated stomach, vomiting (sickness) or diarrhoea. Excessive diarrhoea can lead to dehydration. If this occurs, stop taking this medicine and drink plenty of fluids. If you are worried contact your doctor or pharmacist.
If you forget to take Macrogol
Take the dose as soon as you remember to take it.
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:
• If you get signs of an allergy, such as a rash, itching, reddening of the skin, shortness of breath, difficulty in breathing, or swelling of the face, lips, tongue or throat.
• If you get signs of a change in your body’s fluid or electrolyte levels (salts levels), such as swelling (mainly in the ankles), feeling weak, dehydration, increasingly tired or increased thirst with headache. These symptoms may be a sign that the potassium levels in your blood are higher or lower than normal.
Other side effects include:
• swollen hands, feet or ankles
• headaches
• indigestion, stomach ache or rumbles
• feel bloated, suffer from wind, feel sick or vomit
• soreness of the anus (bottom)
• diarrhoea (when starting to take this medicine) These side effects generally get better if you reduce the amount of Macrogol you take.
The frequencies of these side effects are not known (cannot be estimated from the available data).
Reporting of side effects
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: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
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 above 25 °C.
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.
Do not use this medicine if you notice that any of the sachets are damaged.
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
What Macrogol contains
The active substances are:
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 (E414), alpha-tocopherol (E307)) and lemon lime flavour (Lemon lime flavour contains: natural lemon oil, natural powder lemon flavour, powder lime flavour, maltodextrin, mannitol (E421), gluconolactone (E575), sorbitol (E420), acacia gum (E414), colloidal anhydrous silica (E551)).
What Macrogol looks like and contents of the pack
Macrogol is a free flowing 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 10/2015.
SZ00000LT000
Artwork Proof Box
Ref: V022: Update in line with reference product
|
Proof no. 007.0 |
Date prepared: 09/10/2015 |
Font size: 8pt | |
|
Colours: |
Fonts: | ||
|
■ Black |
□ |
Helvetica | |
|
□ |
□ | ||
|
Dimensions: 148 x 297 |
mm | ||