Macrogol Apple Flavour 4g Powder For Oral Solution
PACKAGE LEAFLET: INFORMATION FOR THE USER
MACROGOL APPLE FLAVOUR 4 g powder for oral solution
Read all of this leaflet carefully before your child starts taking this medicine because it contains important information for you.
Always use 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 your child gets any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
- You must talk to a doctor if you do not feel better or if you feel worse after 7 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
1. What MACROGOL is and what it is used for
MACROGOL APPLE FLAVOUR is 4g sachets for use in children from 6 months to 8 years. There are also 10g sachets available for children from 8 years and adults (MACROGOL GRAPEFRUIT FLAVOUR and MACROGOL LEMON FLAVOUR).
MACROGOL contains a medicine called macrogol 4000. This belongs to a group of medicines called osmotic laxatives.
• MACROGOL APPLE FLAVOUR is used to relieve constipation in children from 6 months to 8 years. It carries water to your stools, which loosens and increases stool volume, helping to overcome sluggish bowels. It works only at the site of the problem, in the bowel, by a hydrating action to reactivate your normal rhythm.
• MACROGOL is a powder that you dissolve in water and drink.
• MACROGOL usually takes 24 to 48 hours to work.
• MACROGOL 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 prompts you
2. What you need to know before you take MACROGOL
Do not take MACROGOL if:
- your child is allergic (hypersensitive) to macrogol or any of the other ingredients of this medicine (listed in Section 6)
- your child has stomach pain without knowing the cause
- your child has a bowel condition called “ileus”
- your child has a blocked bowel (intestinal obstruction)
- your child has had a hole (perforation) in his/her bowel wall
- your child has inflammation of the bowel (small or large intestine), such as ulcerative colitis or Crohn’s disease
Do not use this medicine if any of the above applies to your child. If you are not sure, talk to your pharmacist or doctor before taking this medicine.
Warnings and precautions
If your child regularly suffers from diarrhoea, check with your pharmacist or doctor before taking MACROGOL. This is especially important if your child has liver or kidney problems, or if he/she is taking water tablets (diuretics). This can lead to low sodium and potassium levels in his/her blood, or to dehydration.
Other medicines and MACROGOL
MACROGOL will not affect any other medicines that your child takes.
Pregnancy and breast-feeding
MACROGOL can be taken during pregnancy and whilst breast-feeding, but as with all medicines, ask for advice from your pharmacist or doctor beforehand.
Ask your doctor or pharmacist for advice before taking any medicine.
Important information about some of the ingredients of MACROGOL:
MACROGOL APPLE FLAVOUR: This product contains small amount of sucrose. If you have been told by your doctor that your child has an intolerance to some sugars, contact your doctor before taking this medicinal product.
MACROGOL APPLE FLAVOUR contains 50.4mg of sucrose in 4 g sachets.
This product can be used if your child is diabetic.
MACROGOL APPLE FLAVOUR contains 3.9mg of wheat starch in 4 g sachets. Suitable for people with coeliac disease. Patients with wheat allergy (different from coeliac disease) should not take this medicine.
3. How to take MACROGOL
Talk to your pharmacist or doctor if your symptoms worsen or do not improve within seven days treatment.
Do not use MACROGOL without medical advice for more than two weeks because constipation can also be a symptom of serious diseases.
If your child needs laxatives every day, or if he/she has abdominal pain which does not go away, you should see your doctor.
Taking this medicine
Children aged 6 months to 8 years
Children from 6 months to 1 year: 1 sachet (4g) per day.
Children from 1 to 4 years: 1-2 sachets (4-8g) per day.
Children from 4 to 8 years: 2-4 sachets (8-16g) per day.
• Start by using 1 sachet each day, dissolved in a glass of water.
• Adjust the dose as needed. This may range from one sachet every other day up to four sachets each day. Do not exceed the maximum daily doses which are listed above.
• Continue to take MACROGOL until your child’s bowel movements return to normal.
• MACROGOL works gradually within 24 to 48 hours.
• It is best to take this medicine in the morning. If a dose is higher than one sachet per day, the dose should be taken twice a day, once in the morning and once in the evening.
• Dissolve the powder from the sachet(s) in at least 50ml of water, and then your child drinks the whole contents.
Children should not be given this medicine for more than 3 months.
Children under the age of 8 years can use MACROGOL after receiving the advice of a health care professional who will evaluate the suitability of the product use.
Appearance of the product after reconstitution: Almost white to lightly yellowish opalescent solution.
If your child takes more MACROGOL than he/she should
Contact your doctor or pharmacist for advice.
If you forget to use MACROGOL
Do not use a double dose to make up for a forgotten dose.
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. The following side effects may happen with this medicine.
Children
Common (affect less than 1 in 10 people)
• Abdominal pain.
• Diarrhoea. This should go away if you lower the dose or stop taking this medicine. Diarrhoea can cause soreness around the anus (back passage).
Uncommon (affect less than 1 in 100 people)
• Being sick (vomiting).
• Bloating.
• Feeling sick (nausea).
Unknown (cannot be estimated from the available data)
• Hypersensitivity reactions (rash, itching and swelling of your face, or a more serious reaction causing difficulty in breathing or dizziness (anaphylactic shock).
Reporting of side effectsIf 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.
5. How to store MACROGOL
Keep this medicine out of the sight and reach of children.
MACROGOL does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the package. The expiry date refers to the last day of that month.
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
Each sachet contains 4g of macrogol 4000.
The other ingredients are Saccharin sodium dihydrate (E 954), Silica, colloidal anhydrous MACROGOL APPLE FLAVOUR also contains apple flavour powder (Sucrose, Wheat starch, Aroma, Silica colloidal hydrated).
What MACROGOL looks like and contents of the pack
MACROGOL APPLE FLAVOUR is an almost white to slightly yellowish powder with an odour and taste of apple, for making up into a drink.
Size of packing
MACROGOL 4g sachets are available in a pack of 12 sachets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Zentiva, One Onslow Street, Guildford, Surrey, GU1 4YS, UK.
Manufacturer
Zentiva k.s., Ulica Kabelovny 130, Dolni Mecholupy Prague 10,
CZ-102 37 Czech Republic