Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Pregnancy and breast-feeding L The name of this medicine is Compound Macrogol Compound Macrogol Paediatric can be given during —r 6.86 g Paediatric powder for oral solution. pregnancy and whilst breast feeding. If your child It is a laxative for the treatment of chronic is pregnant or breastfeeding, ask your doctor before iving this medicine. constipation in children aged 2 to 11 years and for giving the treatment of very bad constipation (called faecal | Compound Macrogol Paediatric contains about impaction) in children aged 5 to 11 years. Compound 93.4 mg sodium (main component of cooking/table Macrogol Paediatric also prevents re-impaction after Salt) per sachet. This is equivalent to 4.6% of the successful disimpaction in children 2 to 11 years of age. recommended maximum daily dietary intake of Compound Macrogol Paediatric helps your child to sodium for an adult. have a comfortable bowel movement even if they
How to give Compound Macrogol Paediatric have been constipated for a long time. Always give this medicine exactly as described in . this leaflet or as your doctor or pharmacist has told 2. What do you need to know before you give you. Check with your doctor or pharmacist if you Compound Macrogol Paediatric are not sure. ne mr Bive Compound Macrogol Paediatric ifyour This medicine can be given at any time with or octor has told you that your child fas: without food or drink. - a blockage in their intestine (gut obstruction, ileus) . oo. - aperforated gut wall Chronic constipation: - severe inflammatory bowel disease like ulcerative The dose of Compound Macrogol P aediatric colitis, Crohn's disease or toxic megacolon depends on the age of the child and their response to - anAllergy to macrogol, sodium chloride, sodium treatment. ine d hild 42 to6 bicarbonate, potassium chloride, or any of the other ~ Asa starting lose, children aged 2 to 6 years ingredients in this medicine (listed in section 6). should be given 1 sachet each day. it hild has a heart or kid bl - Children aged 7 to 11 should be given 2 sachets If your child has a heart or kidney problem, an each day. impaired gag reflex or reflux oesophagitis (heart-burn . caused by back-flow of stomach contents into the Your doctor may tell you to increase the number oesophagus), you should talk to your doctor before of sachets taken until your child has a soft bowel giving Compound Macrogol Paediatric movement. If the dose does need increasing, this . 7 should be done every other day. Normally, no more ir breath tctine tied dehodatontgmmane than 4 sachets are required to be taken in one day. include increasing thirst, dry mouth and weakness) It 1s not necessary to take all of the drink at one or heart problems you should stop taking Compound ae if me child prefers it ma me drink can be Macrogol Paediatric and contact your doctor taken in the morning and half in the evening. immediately. Faecal impaction: Warnings and precautions Before your child takes Compound Macrogol When taking Compound Macrogol Paediatric you P aediatr " tor faced then read pe should continue to take plenty of fluids. The fluid confirmed medically that your child has this content of Compound Macrogol Paediatric should condition. not replace your regular liquid intake. A course of treatment with Compound Macrogol Avoid mixing Compound Macrogol Paediatric and Paediatric is as follows: starch-based food thickeners if you have difficulties 160 x 300 mm Font: Times New Roman 9 pt Front Page
Number of Compound Macrogol Paediatric sachets
Age | Day | Day | Day | Day | Day | Day | Day (years) 1 2 3 4 5 6 7
5-11 4 6 8 10 | 12 | 12 | 12
The daily number of sachets should be taken in
divided doses, all taken within 12 hours (e.g.
8am — 8pm). Treatment can be stopped when
the medicine has worked. This is shown by
your child passing large volumes of stool and/or
watery diarrhoea.
Method of Administration
- Open the sachet and pour the contents into a glass.
- Add 4 glass (about 62.5ml) of water.
- Stir well until all the powder has dissolved and the Compound Macrogol Paediatric solution is clear or slightly hazy, then give it to your child to drink.
Duration of treatment
Chronic constipation:
Treatment needs to be for a prolonged period of time,
at least 6 — 12 months.
Faecal impaction: Treatment with Compound Macrogol Paediatric can be for up to 7 days.
If your child takes more Compound Macrogol Paediatric than they should:
Your child may develop excessive diarrhoea. If this occurs, stop taking Compound Macrogol Paediatric and drink plenty of fluids. If you are worried contact your doctor or pharmacist.
If you forget to give Compound Macrogol Paediatric:
Give the dose as soon as you remember.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor immediately and stop giving
Compound Macrogol Paediatric if your child:
- gets a serious allergic reaction which causes difficulty in breathing or swelling of the face, lips, tongue or throat.
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
- vomiting (being sick)
- nausea (feeling sick)
- anal discomfort (uncomfortable sensation around the bottom).
If your child is being treated for chronic constipation,
diarrhoea will usually improve when the dose is
reduced.
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)
(low levels of potassium, low levels of sodium).
Other side effects reported include:
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.
If any of the above become serious or last more than a few days or if you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
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.
Do not use this medicine after the expiry date which is stated on the sachet and carton. The expiry date refers to the last day of that month.
Once you have made up Compound Macrogol Paediatric 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.
Do not throw away any medicines via wastewater
or household waste. Ask your pharmacist how to throw away any medicines you no longer use. These measures will help protect the environment.
What Compound Macrogol Paediatric contains: Each 6.86g sachet of Compound Macrogol Paediatric contains the following:
Macrogol 3350 6.563 g
Sodium chloride 175.4 mg
Sodium bicarbonate 89.3 mg — Potassium chloride 23.30 mg =
The other ingredients are acesulfame potassium and orange flavor.
i Be Odi TTTSTT OTT es
When it is made into a drink with 4 glass (62.5ml) of — water, each sachet gives the equivalent of: a Sodium 65 millimoles/litre ~~ Chloride 53 millimoles/litre Potassium 5.4 millimoles/litre Bicarbonate 17 millimoles/litre
What Compound Macrogol Paediatric looks like and contents of the pack
Compound Macrogol Paediatric is a white crystalline powder which comes in single dose sachets. Boxes of 6, 8, 10, 20, 30, 40, 50, 60 or 100 sachets are available.
Not all pack sizes will be marketed.
Marketing Authorisation Holder and Manufacturer:
Strides Pharma UK Ltd.
Unit 4, Metro Centre, Tolpits Lane, Watford,
- allergic reactions, which may include, Hertfordshire, WD18 9SS, g
breathlessness or difficulty in breathing. United Kingdom. 2 Not known (frequency cannot be estimated from This leaflet was last revised in 11/2021. the available data): - change in your body's fluid or electrolyte levels
I1atl Odi ee Be ee 160 x 300 mm Font: Times New Roman 9 pt Back Page
Strigol Orange Flavour 6.86 g and Compound Macrogol 6.86g Paediatric powder for oral solution comes as powder containing 6.86 g. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Strigol Orange Flavour 6.86 g and Compound Macrogol 6.86g Paediatric powder for oral solution is macrogol 3350.
This leaflet reproduces the patient information leaflet approved for Strigol Orange Flavour 6.86 g and Compound Macrogol 6.86g Paediatric powder for oral solution, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
For the treatment of chronic constipation in children 2 to 11 years of age.
For the treatment of faecal impaction in children from the age of five years, defined as refractory constipation with faecal loading of the rectum and/or colon.
For the prevention of re-impaction after successful disimpaction in children 2 to 11 years of age.
Posology
Chronic constipation
The usual starting dose is 1 sachet daily for children aged 2 to 6 years, and 2 sachets daily for children aged 7 – 11 years. The dose should be adjusted up or down as required to produce regular soft stools. If the dose needs increasing this is best done every second day. The maximum dose needed does not normally exceed 4 sachets a day.
Treatment of children with chronic constipation needs to be or a prolonged period (at least 6 – 12 months). However, safety and efficacy of Compound Macrogol Paediatric has only been proved for a period of up to three months. Treatment should be stopped gradually and resumed if constipation recurs.
Faecal impaction
A course of treatment for faecal impaction with Compound Macrogol Paediatric is for up to 7 days as follows:
Daily dosage regimen:
| Number of Compound Macrogol Paediatric sachets | |||||||
| Age (years) | Day 1 | Day 2 | Day 3 | Day 4 | Day 5 | Day 6 | Day 7 |
| 5 - 11 | 4 | 6 | 8 | 10 | 12 | 12 | 12 |
The daily number of sachets should be taken in divided doses, all consumed within a 12 hour period.
The above dosage regimen should be stopped once disimpaction has occurred. An indicator of disimpaction is the passage of a large volume of stools. After disimpaction it is recommended that the child follows an appropriate bowel management program to prevent reimpaction (dosing for prevention of re-impaction should be as for patients with chronic constipation; see above).
Compound Macrogol Paediatric is not recommended for children below five years of age for the treatment of faecal impaction, or in children below two years of age for the treatment of chronic constipation. For patients of 12 years and older it is recommended to use Compound Macrogol Paediatric.
Patients with impaired cardiovascular function:
There are no clinical data for this group of patients. Therefore Compound Macrogol Paediatric is not recommended for treating faecal impaction in children with impaired cardiovascular function.
Patients with renal insufficiency:
There are no clinical data for this group of patients. Therefore Compound Macrogol Paediatric is not recommended for treating faecal impaction in children with impaired renal function.
Method of administration
Each sachet should be dissolved in 62.5 ml (quarter of a glass) of water. The correct number of sachets may be reconstituted in advance and kept covered and refrigerated for up to 24 hours. For example, for use in faecal impaction, 12 sachets can be made up into 750 ml of water.
Intestinal perforation or obstruction due to structural or functional disorder of the gut wall, ileus, severe inflammatory conditions of the intestinal tract, such as Crohn's disease and ulcerative colitis and toxic megacolon.
Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.
Medicinal products in solid dose form taken within one hour of administration of large volumes of macrogol preparations (as used when treating faecal impaction) may be flushed from the gastrointestinal tract and not absorbed.
Macrogol raises the solubility of medicinal products that are soluble in alcohol and relatively insoluble in water.
There is a possibility that the absorption of other medicinal products could be transiently reduced during use with Compound Macrogol Paediatric (see section 4.4).There have been isolated reports of decreased efficacy with some concomitantly administered medicinal products, e.g. anti-epileptics.
Compound Macrogol Paediatric may result in as potential interactive effect when used with starch-based food thickeners. The polyethylene glycol (PEG) ingredient counteracts the thickening effect of starch, effectively liquefying preparations that need to remain thick for people with swallowing problems.
Pregnancy
There are limited amount of data from the use of Compound Macrogol Paediatric in pregnant women. Studies in animals have shown indirect reproductive toxicity (see section 5.3). Clinically, no effects during pregnancy are anticipated, since systemic exposure to macrogol 3350 is negligible.
Compound Macrogol Paediatric can be used during pregnancy.
Breastfeeding
No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breast-feeding woman to Macrogol 3350 is negligible.
Compound Macrogol Paediatric can be used during breast-feeding.
Fertility
There are no data on the effects of Compound Macrogol Paediatric on fertility in humans. There were no effects on fertility in studies in male and female rats (see section 5.3).
Compound Macrogol Paediatric has no or negligible influence on the ability to drive and use machines.
Severe abdominal pain or distension can be treated by nasogastric aspiration. Extensive fluid loss by diarrhoea or vomiting may require correction of electrolyte disturbances.
Ask anything about Strigol Orange Flavour 6.86 g and Compound Macrogol 6.86g Paediatric powder for oral solution. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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