Informations for option: Compound Macrogol 6.9g Powder For Oral Solution, show other option

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1. Compound Macrogol 6.9g Powder For Oral Solution
2. Compound Macrogol 6.9g Powder For Oral Solution

PACKAGE LEAFLET: INFORMATION FOR THE USER

< INVENTED NAME > Powder for Oral Solution

Read all of this leaflet carefully before you give this medicine to your child.

•    Keep this leaflet. You may need to read it again.

•    If you have further questions, ask your doctor or pharmacist.

•    This medicine has been prescribed for your child. Do not pass it on to others. It harm them, even if their symptoms are the same as your child’s.

• If any of the side effects gets serious, or if you notice any side effects not listed leaflet, please tell your doctor or your pharmacist.

In this leaflet:

1.    What < Invented Name > is and what it is used for

2.    Before you give < Invented Name >

3.    How to give < Invented Name >

4.    Possible side effects

5.    How to store < Invented Name >

6.    Further Information

The name of this medicine is < Invented Name, 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 they have been constipated for a long time.

2. Before you use < Invented Name >

Do not give < Invented Name > if your doctor has told you that your child has:

•    an allergy to any of the ingredients listed in section 6.

•    a perforated gut wall.

•    a blockage in their intestine (gut obstruction, ileus)

•    severe inflammatory bowel disease like ulcerative colitis, Crohn’s disease or toxic megacolon.

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), you should talk to your doctor before giving < Invented Name >.

Taking other medicines

Some medicines e.g. anti-epileptics, may not work effectively during use with < Invented Name >. Tell your doctor about any other medicines your child is taking. When taking large volumes of < Invented Name > (e.g. for faecal impaction), your child should not take other medicines within one hour of taking < Invented Name >.

Taking < Invented Name > with food and drink

This medicine can be given at any time with or without food.

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Pregnancy and breast-feeding

If your child is pregnant or breast feeding talk to your doctor before giving < Invented Name >. Driving and using machines

< Invented Name > has no effect on the ability to drive or use machines.

3. How to use < Invented Name >

Always give < Invented Name > exactly as your doctor or pharmacist has told you. You should check with your doctor or pharmacist if you are not sure.

Chronic Constipation:

The dose of < Invented Name > depends on the age of the child and their response to treatment.

•    Asa starting dose, children aged 2 to 6 years should be given 1 sachet each day.

•    Children aged 7 to 11 years should be give 2 sachets each day.

•    Your doctor may tell you to increase the number of sachets taken until your child has a soft bowel movement. This does not normally need more than 4 sachets taken in one 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:

Before your child takes < Invented Name > for faecal impaction, it should be confirmed medically that your child has this condition.

The daily number of sachets should be taken in divided doses, all consumed within 12 hours (e.g. 8am to 8pm). 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 62.5ml) of water to the glass. Stir well until all the powder has dissolved.

•    For the treated for faecal impaction it may be easier to dissolve 12 sachets in 750ml of water.

Duration of Treatment

•    Chronic constipation: Treatment needs to be for a prolonged period of time, at least 6 -12 months.

•    Faecal impaction: Treatment can be up to 7 days.

If your child takes more < Invented Name > than they should

Your child may develop diarrhoea. Stop giving < Invented Name > until it clears and then start again at a lower does. If you are worried contact your doctor or pharmacist.

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If you forget to give < Invented Name >

Give the dose as soon as you remember.

Like all medicines, < Invented Name > can cause side effects, although not everybody gets them.

Tell your doctor immediately and stop giving < Invented Name > if your child:

•    feels weak, is breathless or has difficulty in breathing, is very thirsty with a headache or gets puffy ankles.

Very common side effects (more than 1 person in 10):

If your child is being treated for chronic constipation your child may:

•    get stomach pain or rumbles, or have diarrhoea but this will usually improve when the dose is reduced

If your child is being treated for faecal impaction your child may:

•    be sick, have a swollen stomach or stomach pain or have soreness around the bottom.

Common side effects (more than 1 in 100 but less than 1 in 10 people):

If your child is being treated for chronic constipation your child may:

•    feel sick or actually get sick, have a swollen stomach or suffer from wind or soreness around the bottom.

If your child is being treated for faecal impaction your child may:

•    feel sick, have mild diarrhoea or have stomach rumbles.

Rare side effects (less than 1 person in 10000):

•    allergic reactions, which may include an itchy skin rash (hives), breathlessness or difficult in breathing.

If any of the side effects gets serious or last more than a few days, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. How to store < Invented Name >

Keep out of the reach and sight of children.

Do not use < Invented Name > after the expiry date which is stated on the carton and sachet. The expiry date refers to the last day of that month.

Once you have made up < Invented Name > in water, if your child cannot drink it straight away keep it covered and in the fridge (2 - 8°C). Throw away any solution not used within a 24 hour period.

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 to protect the environment.

6. Further Information What < Invented Name > contains

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The active substances are macrogol 3350 (6.563g), sodium chloride (175.4mg), sodium hydrogen carbonate (89.3mg) and potassium chloride (23.3mg).

The other ingredients are lemon flavour and acesulfame potassium (E950) as a sweetener. The lemon flavour contains the following ingredients: acacia gum (E414) and flavouring.

What < Invented Name > looks like and contents of the pack

< Invented Name > is a white powder packed in sachets. It is available in boxes of 2, 6, 8, 10, 20, 30, 40, 50, 60 or 100 sachets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

The marketing authorisation holder is <to be completed nationally>.

The manufacturer is <to be completednationally>.

This medicinal product is authorised in the Member States of the EEA under the following names:

United Kingdom	Compound Macrogol 6.9g powder for oral solution
Belgium	Macrosol + Electrolytes Junior Teva, poeder voor drank	„ - Deleted: Curapeg Junior
Germany	Macrogol-ratiopharm Junior 6.9g, Pulver zur Herstellung einer Losung zum Einnehmen
Spain	Yaprel pediatrico 6.9g polvo para solucion oral

This leaflet was last approved in MM/YYYY

< To be completed nationally>

Approved by:

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REG0065876 Version 1.11 Approved Page 5of5