Macilax Paediatric 6.9 G Powder For Oral Solution
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TEVA UK LIMITED | ||
1. What Macilax Paediatric is and what it is used for
The name of this medicine is Macilax Paediatric 6.9 g Powder For Oral Solution. It is a laxative for the treatment of chronic constipation in children aged 2 to 11 years and for the treatment of very bad constipation (called faecal impaction) in children aged 5 to 11 years.
It helps your child to have a comfortable bowel movement even if your child has been constipated for a long time.
Macilax Paediatric contains potassium, sodium and sorbitol
Macilax Paediatric contains 0.3 mmol (12 mg) potassium per sachet. This should be taken into consideration if your child has reduced kidney function, or if your child is on a controlled potassium diet.
Macilax Paediatric contains 4.1 mmol (94 mg) sodium per sachet. This should be taken into consideration if your child is on a controlled sodium diet.
The lemon lime flavour in Macilax Paediatric contains sorbitol. If you have been told by your doctor that your child has an intolerance to some sugars, contact your doctor before giving this medicinal product.
Read all of this leaflet carefully before you give this medicine to
your child because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for your child only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as your child's.
• If your child gets any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Macilax Paediatric is and what it is used for
2. What you need to know before you use Macilax Paediatric
3. How to use Macilax Paediatric
4. Possible side effects
5. How to store Macilax Paediatric
6. Contents of the pack and other information
2 What you need to know before you use 2. Macilax Paediatric
Do not give Macilax Paediatric to your child
• if your child is 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 your child has a perforated gut (bowel) wall
• if your child has a blockage in the intestine (gut obstruction, ileus)
• if your child has severe inflammatory bowel disease such as ulcerative colitis, Crohn's disease or toxic megacolon.
Warnings and precautions
Talk to your doctor or pharmacist before giving Macilax Paediatric to your child, if your child has a heart or kidney problem, an impaired gag reflex or reflux oesophagitis (heart-burn caused by back-flow of stomach contents into the oesophagus).
Other medicines and Macilax Paediatric
Tell your doctor or pharmacist if your child is taking, has recently taken or might take any other medicines.
Some medicines, such as anti-epileptics, may not work as effectively during use with Macilax Paediatric.
When taking large volumes of Macilax Paediatric (e.g. for faecal impaction), your child should not take other medicines within one hour of taking Macilax Paediatric.
Macilax Paediatric with food and drink
Macilax Paediatric can be given at any time with or without food or drink. Driving and using machines
Macilax Paediatric has no effect on the ability to drive or use machinery.
3. How to use Macilax Paediatric
Always give this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Chronic constipation (constipation for long time):
The dose of Macilax Paediatric depends on the age of the child and their response to treatment.
As a starting dose, children aged 2 to 6 years should be given 1 sachet each day.
Children aged 7 to 11 years should be given 2 sachets each day.
• Your doctor may tell you to increase the number of sachets taken until your child has a soft bowel movement. The dose will not usually exceed 4 sachets per day.
It is not necessary to take all of the drink at one time: if the child prefers it, half the drink can be taken in the morning and half in the evening.
Faecal impaction (complete severe constipation):
Before your child takes Macilax Paediatric for faecal impaction, it should be confirmed medically that your child has this condition.
A course of treatment is as follows:
|
Number of sachets | |||||||
|
Age (years) |
Day 1 |
Day 2 |
Day 3 |
Day 4 |
Day 5 |
Day 6 |
Day 7 |
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5 - 11 |
4 |
6 |
8 |
10 |
12 |
12 |
12 |
The daily number of sachets should be taken one at a time, all consumed within 12 hours (e.g. 8 am to 8 pm). Treatment can be stopped when the medicine has worked. This is shown by the child passing large volumes of stool and/or watery diarrhoea.
Method of administration
• Open the sachet and pour the contents into a glass. Add % glass (about 62.5 ml) of water to the glass. Stir well until all the powder has dissolved and the solution is clear or slightly hazy, then give it to your child to drink.
• If your child is taking Macilax Paediatric for faecal impaction it may be easier to dissolve 12 sachets in 750 ml of water and to administer the solution evenly spread over a 12 hour period. Reconstituted Macilax Paediatric solution should be covered and stored in the refrigerator (2°C to 8°C).
Duration of treatment
• Chronic constipation: Treatment needs to be for a prolonged period of time, at least 6 to 12 months.
• Faecal impaction: Treatment can be for up to 7 days.
If your child takes more Macilax Paediatric than they should
This can cause severe pain and swelling in the abdomen (stomach), vomiting
(sickness) or diarrhoea. If this happens, contact your doctor or pharmacist.
If you forget to give Macilax Paediatric
If you forget to give a dose, give it as soon as you remember and then continue
on as before. Do not give 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.
If your child experiences any of the following side effects, tell your
doctor immediately and stop giving Macilax Paediatric to your child:
• signs of an allergy, such as skin rash, itching, reddening of the skin, nettle rash, shortness of breath or difficulty in breathing, or swelling of the face, lips, tongue or throat
• signs of a change in your child's fluid or electrolyte levels, such as swelling (mainly in the ankles), feeling weak, increasingly tired or increased thirst with headache.
Very common side effects (may affect more than 1 in 10 people):
• stomach pains
• stomach rumbles.
Common side effects (may affect up to 1 in 10 people):
• diarrhoea. If your child is being treated for chronic constipation, diarrhoea will usually improve when the dose is reduced
• vomiting (being sick)
• nausea (feeling sick)
• anal discomfort (uncomfortable sensation around the bottom).
Uncommon side effects (may affect up to 1 in 100 people):
• swollen stomach
• wind.
Rare side effects (may affect up to 1 in 1,000 people):
• allergic reactions, which may include breathlessness or difficulty in breathing.
Frequency not known (frequency cannot be estimated from the available data):
• swelling of the face, lips or throat
• skin rash (hives), itching, reddening of the skin or a nettle rash
• swollen hands, feet or ankles
• headaches
• indigestion
• high or low levels of potassium in the blood.
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 at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
Reconstituted Macilax Paediatric 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 Macilax Paediatric contains
The active substances are:
macrogol 3350 6.563 g
sodium chloride 175.4 mg
sodium hydrogen carbonate 89.3 mg
potassium chloride 23.3 mg
5. How to store Macilax Paediatric
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 use this medicine if you notice that any of the sachets is damaged. This medicinal product does not require any special storage conditions.
The other ingredients are silica colloidal anhydrous, saccharin sodium, orange flavour (Orange flavour contains: flavouring preparations and substances, natural flavouring substances, maltodextrin, acacia, a-tocopherol) and lemon lime flavour (Lemon lime flavour contains: natural lemon oil, natural powder flavour lemon, powder flavour lime, maltodextrin, mannitol, gluconolactone, sorbitol, acacia, silica colloidal anhydrous).
What Macilax Paediatric looks like and contents of the pack Macilax Paediatric is a white powder.
Each sachet contains 6.9 g of powder and is packed in cartons containing 30 and 50 sachets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder
TEVA UK Limited, Eastbourne, BN22 9AG, UK.
Manufacturer
Klocke Pharma-Service GmbH:
StraBburger StraBe 77 77767 Appenweier Germany
This leaflet was last revised in 01/2014 297°4348
PL 00289/1816 248638.01-GB