Dulcobalance
macrogol 4000
10g powder for oral solution
Read all of this leaflet carefully because it contains important information for you. This medicine is available without prescription. You need to take Dulcobalance as instructed in this leaflet 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.
- Talk to your pharmacist or doctor if your symptoms worsen or do not improve within seven days treatment.
- If a side effect occurs and gets troublesome, or seems serious to you, or if you experience a side effect not listed in this leaflet, please tell your pharmacist or doctor.
In this leaflet:
- 1. What Dulcobalance is and what it is used for
- 2. Before you take Dulcobalance
- 3. How to take Dulcobalance
- 4. Possible side effects
- 5. How to store Dulcobalance
- 6. Further information
What Dulcobalance Is And What It Is Used For
Dulcobalance contains a medicine called macrogol 4000. This belongs to a group of medicines called osmotic laxatives.
- Dulcobalance is used to relieve constipation in adults and children 8 years and over. It adds water to your stools, which helps to overcome sluggish bowels.
- Dulcobalance is a powder that you dissolve in water and drink.
- Dulcobalance usually takes 24 to 48 hours to work.
- Dulcobalance is not absorbed into the bloodstream or changed by the body.
What is constipation?
Normal and regular bowel movement is important for most people. However, what is “normal and regular” varies from person to person. Some may have a bowel movement every day, others less often. Whatever it is like for you, it is best that your bowel movement has a regular pattern.
- Constipation is an occasional problem for some people; for others, it may happen more often.
- It happens when the normal muscle action in the bowel (large intestine) slows down. This can mean that material is not easily eliminated from the body.
The cause of constipation is often not known. It can be associated with:
- Sudden change of diet
- Not drinking enough fluid (e.g. water)
- A diet with not enough fibre
- Loss of “tone” of the bowel muscles in older people
- Pregnancy
- Medicines such as morphine or codeine
- Having to stay in bed for a long time
- Lack of exercise
These healthy tips are recommended to try to prevent constipation happening:
- Eat a balanced diet including fresh fruit and vegetables
- Drink enough water so that you do not become dehydrated
- Keep up your exercise and stay fit
- Make time to empty your bowels when your body tells you
Before You Take Dulcobalance
Do not take Dulcobalance if:
- You are allergic (hypersensitive) to macrogol or any of the other ingredients in this product (listed in Section 6)
- You are intolerant to or cannot digest some sugars (as the flavouring contains a small amount of sorbitol which is converted to fructose)
- You have stomach pain without knowing the cause
- You have a bowel condition called “ileus”
- You have a blocked bowel (intestinal obstruction)
- You have had a hole (perforation) in your bowel wall
- You have inflammation of the bowel (small or large intestine), such as ulcerative colitis or Crohn’s disease
Do not take this medicine if any of the above applies to you. If you are not sure, talk to your pharmacist or doctor before taking the medicine.
Take special care
If you regularly suffer from diarrhoea, check with your pharmacist or doctor before taking Dulcobalance. This is especially important if you are elderly, have liver or kidney problems, or if you are taking water tablets (diuretics). This can lead to low sodium and potassium levels in your blood, or to dehydration.
Taking other medicines
Dulcobalance will not affect any other medicines that you take.
Pregnancy and breast-feeding
You should always ask your pharmacist or doctor for advice before taking any medicine if you are pregnant or breast-feeding. Dulcobalance may be taken during pregnancy and when breast-feeding on the advice of a pharmacist or doctor.
Important information about some of the ingredients of Dulcobalance
- Do not take this medicine if you have been told by your doctor that you cannot tolerate or digest some sugars. This medicine contains a small amount of sugar called sorbitol, which is converted to fructose.
- Dulcobalance can be used if you are diabetic, or if you are on a galactose-free diet.
How To Take Dulcobalance
Talk to your pharmacist or doctor if your symptoms worsen or do not improve within seven days treatment.
If you need laxatives every day, or if you have abdominal pain which does not go away, you should see your doctor.
Taking this medicine
Adults and Children 8 years and over
- Start by taking one to two sachets each day.
- Adjust your dose as needed. This may range from one sachet every other day (especially in a child) up to two sachets each day.
- It is best to take this medicine in the morning.
- Dissolve the powder from the sachet(s) in a glass of water, and then drink the whole contents of the glass.
- If you are taking two sachets, it is best to take them together in one glass of water.
- Dulcobalance usually takes 24 to 48 hours to work.
- When your bowel movements return to their normal pattern, you can stop taking this medicine.
Children should not be given this medicine for more than 3 months.
Dulcobalance Side Effects
Like all medicines, Dulcobalance can cause a side effect, although most people do not have a problem. The following side effects may happen with this medicine:
Stop taking Dulcobalance and see a doctor straight away if you notice any of the following side effects. You may need urgent medical treatment:
- Rash, itching and swelling of your face, or a more serious reaction causing difficulty in breathing or dizziness (anaphylactic shock). You may be having an allergic reaction to the medicine.
- Diarrhoea that lasts for a long time or is severe. This can lead you to get dehydrated and have low body salts, especially if you are elderly.
Common (affect less than 1 in 10 people)
- Abdominal pain and swelling.
- Feeling sick (nausea).
- Diarrhoea. This should go away if you lower the dose or stop taking this medicine.
Uncommon (affect less than 1 in 100 people)
- Being sick (vomiting).
- Urgent need to go to the toilet (defaecate).
- Bowel incontinence.
If a side effect occurs and gets troublesome, or seems serious to you, or if you experience a side effect not listed in this leaflet, please tell your pharmacist or doctor.
How To Store Dulcobalance
- Keep this medicine out of the sight and reach of children.
- Do not take this medicine after the expiry date which is printed on the base of the carton.
- Dulcobalance does not require any special storage conditions.
- Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.
Further Information
What Dulcobalance contains
- Each sachet contains 10g of macrogol 4000.
- The other ingredients are saccharin sodium, and the orange-grapefruit flavour which contains orange and grapefruit oils, concentrated orange juice, citral, acetaldehyde, linalol, ethyl butyrate, alpha terpineol, octanal, beta and gamma hexenol, maltodextrin, gum arabic, sorbitol (E420).
What Dulcobalance looks like and contents of the pack
- Dulcobalance is an almost white powder that smells and tastes of orange-grapefruit, for making up into a drink.
- Dulcobalance is available in a pack of 10 sachets.
The Marketing Authorisation is held by
Dulcobalance is manufactured for Boehringer Ingelheim Limited by
Date of preparation of this leaflet: July 2009.
Registered trade mark
© Boehringer Ingelheim Limited 2009
89 675.01 RV
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