Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Strigol Orange Flavour 6.86 g Paediatric Powder for oral solution
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Potassium chloride, Sodium chloride, Sodium bicarbonate, Macrogol 3350 may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for The name of this medicine is Strigol Orange Flavour 6.86 g Paediatric 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. Strigol Orange Flavour Paediatric also prevents re-impaction after successful disimpaction in children 2 to 11 years of age. Strigol Orange Flavour Paediatric helps your child to have a comfortable bowel movement even if they have been constipated for a long time. 2. What do you need to know before you give Strigol Orange Flavour Paediatric Do not give Strigol Orange Flavour Paediatric if your doctor has told you that your child has:
- a blockage in their intestine (gut obstruction, ileus)
- a perforated gut wall
- severe inflammatory bowel disease like ulcerative colitis, Crohn's disease or toxic megacolon
- an Allergy to macrogol, sodium chloride, sodium bicarbonate, potassium chloride, or any of the other ingredients in this medicine (listed in section 6).
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Strigol Orange Flavour 6.86 g Paediatric powder for oral solution macrogol 3350, sodium chloride, sodium bicarbonate, potassium chloride
Strigol Orange Flavour 6.86 g Paediatric powder for oral solution
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Strigol Orange Flavour 6.86 g Paediatric powder for oral solution
Package leaflet: Information for the Patient
and starch-based food thickeners if you have difficulties with swallowing. This may result in a watery liquid which could get into your lungs and cause pneumonia if you can't swallow properly. Strigol Orange Flavour Paediatric contains 0.3106 mmol (12.11 mg) of potassium per sachet. This should be taken into consideration if the patient takes more than one sachet daily and has reduced kidney function or is on a controlled potassium diet. Other medicines and Strigol Orange Flavour Paediatric Tell your doctor or pharmacist if your child is taking or has recently taken or might take any other medicines. Some medicines, e.g. anti-epileptics, may not work as effectively during use with Strigol Orange Flavour Paediatric. When taking large volumes of Strigol Orange Flavour Paediatric (e.g. for faecal impaction), your child should not take other medicines within one hour of taking Strigol Orange Flavour Paediatric. Strigol Orange Flavour Paediatric with food and drink This medicine can be taken at any time with or without food or drink. If you need to thicken fluids in order to swallow them safely, Strigol Orange Flavour Paediatric may counteract the effect of the thickener. Pregnancy and breast-feeding Strigol Orange Flavour Paediatric can be given during pregnancy and whilst breast feeding. If your child is pregnant or breastfeeding, ask your doctor before giving this medicine. Strigol Orange Flavour Paediatric contains about 93.4 mg sodium (main component of cooking/table salt) per sachet. This is equivalent to 4.6% of the recommended maximum daily dietary intake of sodium for an adult.
How to take it
Strigol Orange Flavour Paediatric Always give this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. This medicine can be given at any time with or without food or drink. Chronic Constipation: The dose of Strigol Orange Flavour 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 should be given 2 sachets each day.
If your child has a heart or kidney problem, an impaired gag reflex or reflux oesophagitis (heartburn caused by back-flow of stomach contents into the oesophagus), you should talk to your doctor before giving Strigol Orange Flavour Paediatric.
Your doctor may tell you to increase the number of sachets taken until your child has a soft bowel movement. If the dose does need increasing, this should be done every other day. Normally, no more than 4 sachets are required to be taken in one day.
If you develop side effects such as swelling, shortness of breath, feeling tired, dehydration (symptoms include increasing thirst, dry mouth and weakness) or heart problems you should stop taking Strigol Orange Flavour Paediatric and contact your doctor immediately.
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.
Warnings and precautions When taking Strigol Orange Flavour Paediatric you should continue to take plenty of fluids. The fluid content of Strigol Orange Flavour Paediatric should not replace your regular liquid intake.
Faecal impaction: Before your child takes Strigol Orange Flavour Paediatric for faecal impaction, it should be confirmed medically that your child has this condition. A course of treatment with Strigol Orange Flavour Paediatric is as follows:
Avoid mixing Strigol Orange Flavour Paediatric
155 x 350 mm
FRONT SIDE
Strigol Orange Flavour – Pack Insert – SPUK – Submission Dimension: 155 x 350 mm Folded Dimension: 30 x 50 mm (with glue) Market: SPUK Version: 01 Date: 23.02.2024
Artwork for Submission purpose: UK Market
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 1⁄4 glass (about 62.5ml) of water.
- Stir well until all the powder has dissolved and the Strigol Orange Flavour 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 Strigol Orange Flavour Paediatric can be for up to 7 days. If your child takes more Strigol Orange Flavour Paediatric than they should: Your child may develop excessive diarrhoea. If this occurs, stop taking Strigol Orange Flavour Paediatric and drink plenty of fluids. If you are worried contact your doctor or pharmacist. If you forget to give Strigol Orange Flavour Paediatric: Give the dose as soon as you remember.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Tell your doctor immediately and stop giving Strigol Orange Flavour 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
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 Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
How to store it
Strigol Orange Flavour 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 sachet and carton. The expiry date refers to the last day of that month. Once you have made up Strigol Orange Flavour 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 house hold waste. Ask your pharmacist how to throw away of medicines you no longer use. These measures will help protect the environment.
Contents of the pack and other information
What Strigol Orange Flavour Paediatric contains: Each 6.86g sachet of Strigol Orange Flavour 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. When it is made into a drink with 1⁄4 glass (62.5ml) of water, each sachet gives the equivalent of: Sodium 65 millimoles/litre Chloride 53 millimoles/litre Potassium 5.4 millimoles/litre Bicarbonate 17 millimoles/litre What Strigol Orange Flavour Paediatric looks like and contents of the pack Strigol Orange Flavour Paediatric is a white crystalline powder in single-dose sachets with orange odour. 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:
Rare side effects (may affect up to 1 in 1000 people)
- allergic reactions, which may include, breathlessness or difficulty in breathing.
Strides Pharma UK Ltd. Unit 4 The Metro Centre, Dwight Road, Watford, WD18 9SS United Kingdom
Not known (frequency cannot be estimated from the available data):
- change in your body's fluid or electrolyte levels (low levels of potassium, low levels of sodium)
This leaflet was last revised in 02/2024.
Other side effects reported include: Skin rash (hives), itching, reddening of the skin
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Number of Strigol Orange Flavour Paediatric sachets Day Day Day Day Day Day Day Age 2 3 4 5 6 7 (years) 1 5-11 4 6 8 10 12 12 12
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Strigol Orange Flavour – Pack Insert – SPUK – Submission Dimension: 155 x 350 mm Folded Dimension: 30 x 50 mm (with glue) Market: SPUK Version: 01 Date: 23.02.2024
Frequently asked questions about Strigol Orange Flavour 6.86 g Paediatric Powder for oral solution
How do I take Strigol Orange Flavour 6.86 g Paediatric Powder for oral solution?
Strigol Orange Flavour 6.86 g Paediatric Powder for oral solution comes as oral solution containing 6.86g. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Strigol Orange Flavour 6.86 g Paediatric Powder for oral solution?
The active substance in Strigol Orange Flavour 6.86 g Paediatric Powder for oral solution is potassium chloride, sodium chloride, sodium bicarbonate, macrogol 3350.
Are there equivalent medicines to Strigol Orange Flavour 6.86 g Paediatric Powder for oral solution?
Medicines with the same active substance, strength and form include: STRIGOL Paediatric 6.86 g powder for oral solution – Lemon. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Strigol Orange Flavour 6.86 g 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.
Can I get Strigol Orange Flavour 6.86 g Paediatric Powder for oral solution without a prescription?
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.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: potassium chloride, sodium chloride, sodium bicarbonate, macrogol 3350
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
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.
4.2. Posology and method of administration
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.
4.3. Contraindications
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.
4.4. Special warnings and precautions for use
The fluid content of Compound Macrogol Paediatric when re-constituted with water does not replace regular fluid intake and adequate fluid intake must be maintained.
Avoid mixing PEG laxatives and starch-based thickeners in patients with dysphagia, considered at risk of aspiration.
Diagnosis of faecal impaction/faecal loading of the rectum should be confirmed by the physical or radiological examination of the abdomen and rectum.
Rarely symptoms indicating shifts of fluid/electrolytes e.g. oedema, shortness of breath, increasing fatigue, dehydration and cardiac failure have been reported in adults when using preparations containing macrogol. If this occurs Compound Macrogol Paediatric should be stopped immediately, electrolytes measured, and any abnormality should be treated appropriately.
When used in high doses to treat faecal impaction this medicinal product should be administered with caution to patients with impaired gag reflex, reflux oesophagitis or diminished levels of consciousness.
In case of diarrhoea, caution should be exercised, particularly in patients who are at higher risk for water -electrolyte balance disorders (e.g. the elderly, patients with impaired hepatic or renal function or patients taking diuretics) and electrolyte control should be considered.
Compound Macrogol Paediatric solution when reconstituted has no calorific value.
The absorption of other medicinal products could transiently be reduced due to an increase in gastro-intestinal transit rate induced by Compound Macrogol Paediatric (see section 4.5).
Compound Macrogol Paediatric contains 0.3106 mmol (12.11 mg) of potassium per sachet. This should be taken into consideration if the patient takes more than one sachet daily and has reduced kidney function, or is on a controlled potassium diet.
Compound Macrogol Paediatric contains about 93.4 mg sodium (main component of cooking/table salt) per sachet. This is equivalent to 4.6% of the recommended maximum daily dietary intake of sodium for an adult.
4.5. Interaction with other medicinal products and other forms of interaction
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.
4.6. Fertility, pregnancy and lactation
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).
4.7. Effects on ability to drive and use machines
Compound Macrogol Paediatric has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
Reactions related to the gastrointestinal tract occur most commonly.
These reactions may occur as a consequence of expansion of the contents of the gastrointestinal tract, and an increase in motility due to the pharmacologic effects of Compound Macrogol Paediatric.
In the treatment of chronic constipation, diarrhoea or loose stools normally respond to a reduction in dose.
Diarrhoea, abdominal distension, anal discomfort and mild vomiting are more often observed during the treatment for faecal impaction. Vomiting may be resolved if the dose is reduced or delayed.
The frequency of the adverse reactions listed below is defined using the following convention: very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1000); and very rare (<1/10,000); not known (cannot be estimated from the available data).
System Organ Class
Frequency
Adverse event
Immune system disorders
Rare
Anaphylaxis.
Not known
Angioedema, dyspnoea, rash, erythema, urticaria and pruritus.
Metabolism and nutrition disorders
Not known
Dehydration, electrolytes disorders (hypokalemia, hyponatraemia, hyperkalaemia)
Nervous system disorders
Not known
Headache.
Gastrointestinal disorders
Very common
Abdominal pain, borborygmi.
Common
Diarrhoea vomiting, nausea, anal discomfort.
Uncommon
Abdominal distension, flatulence.
Not known
Dyspepsia and peri-anal inflammation.
General disorders and administration site conditions
Not known
Peripheral oedema.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
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 about this leaflet
Ask anything about Strigol Orange Flavour 6.86 g 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.