Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
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 Macrogol 3350, Sodium bicarbonate, Sodium chloride, Potassium chloride may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
for The name of this medicine is Strigol Orange Flavour 13.72g powder for oral solution. It is a laxative for the treatment of chronic constipation in adults, adolescents and elderly and for the treatment of very bad constipation (called faecal impaction). It is not recommended for children below 12 years of age. Strigol Orange Flavour helps you to have a comfortable bowel movement even if you have been constipated for a long time.
Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
e Strigol Orange Flavour Do not take Strigol Orange Flavour:
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Strigol Orange Flavour 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 may counteract the effect of the thickener.
Strigol Orange Flavour can be taken during pregnancy and whilst breast-feeding. Driving and using machines Strigol Orange Flavour does not affect your ability to drive or use machines. Strigol Orange Flavour contains 186.87 mg sodium (main component of cooking/ table salt) per sachet. This is equivalent to 9.3% of the recommended maximum daily dietary intake of sodium for an adult.
Strigol Orange Flavour Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. This medicine can be taken at any time with or without food or drink. Chronic Constipation: For adults, adolescents and the elderly the recommended dose is 1 sachet, 1-3 times a day according to the severity of your constipation. Faecal impaction: Before you take Strigol Orange Flavour for faecal impaction, your doctor must check to confirm that you have this condition. For adults, adolescents and the elderly the recommended dose is 8 sachets a day. All the 8 sachets should be taken within 6 hours, and for up to 3 days if required. If you have a heart conditions do not take more than 2 sachets per one hour.
Front Page
Font: Times New Roman 9 pt
Strigol Orange flavour 13.72g powder for oral solution
Strides Pharma UK Ltd.
Pack Insert —
160 x 300 mm 1046253 Black
PC-TSG/2021/369 – Record Number: 305208 and 326106 Front & Back Printing. To be supplied in folded size: 80 x 75 mm 60 GSM Paper. Printing clarity to be clear & sharp. NA
1041686 1 2.0
If you are taking Strigol Orange Flavour for faecal impaction it may be easier to dissolve 8 sachets in 1 litre of water. Duration of treatment Chronic constipation: Treatment with Strigol Orange Flavour usually lasts for about 2 weeks. If you need to take Strigol Orange Flavour for longer, please see your doctor. If your constipation is caused by an illness such as Parkinson's disease or multiple sclerosis (MS), or if you take medicines that cause constipation your doctor may recommend that you take Strigol Orange Flavour for longer than 2 weeks. Usually for long term treatment the dose can be lowered to either 1 or 2 sachets a day. Faecal impaction: Treatment with Strigol Orange Flavour can be for up to 3 days. If you take more Strigol Orange Flavour than you should You may develop excessive diarrhoea, which can lead to dehydration. If this occurs, stop taking Strigol Orange Flavour and drink plenty of fluids. If you are worried contact your doctor or pharmacist. If you forget to take Strigol Orange Flavour Take the dose as soon as you remember. 4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. Tell your doctor immediately and stop taking Strigol Orange Flavour if you:
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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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting
you can help provide more information on the safety of this medicine.
Strigol Orange Flavour 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. The expiry date refers to the last day of that month. Unopened sachet: No special storage conditions. Once you have made up Strigol Orange Flavour in water, if you 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 Strigol Orange Flavour contains Each 13.72 g sachet of Strigol Orange Flavour contains the following: Macrogol 3350 Sodium chloride
13.125 g 350.7 mg
Sodium bicarbonate
178.5 mg
Potassium chloride
46.6 mg
The other ingredients are Acesulfame potassium and orange flavor. When it is made into a drink with 125 millilitres of water, each sachet gives the equivalent of: Sodium Chloride Potassium Bicarbonate
65 millimoles/litre 53 millimoles/litre 5.4 millimoles/litre 17 millimoles/litre
What Strigol Orange Flavour looks like and contents of the pack Strigol Orange Flavour 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: Strides Pharma UK Ltd. Unit 4, Metro Centre, Tolpits Lane, Watford, Hertfordshire, WD18 9SS, United Kingdom. This leaflet was last revised in 11/2021.
1046253
Method of Administration
Back Page
Font: Times New Roman 9 pt
Strigol Orange flavour 13.72g powder for oral solution
Strides Pharma UK Ltd.
Pack Insert —
160 x 300 mm 1046253 Black
PC-TSG/2021/369 – Record Number: 305208 and 326106 Front & Back Printing. To be supplied in folded size: 80 x 75 mm 60 GSM Paper. Printing clarity to be clear & sharp. NA
1041686 1 2.0
Strigol Orange 13.72 g powder for oral solution comes as oral solution containing 13.72g. 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 13.72 g powder for oral solution is macrogol 3350, sodium bicarbonate, sodium chloride, potassium chloride.
Medicines with the same active substance, strength and form include: STRIGOL 13.72 g powder for oral solution. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Strigol Orange 13.72 g 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 adults and children above 12 years. STRIGOL is also effective in resolving faecal impaction, defined as refractory constipation with faecal loading of the rectum and/or colon in adults and children above 12 years.
Posology
Chronic constipation
A course of treatment for constipation with STRIGOL does not normally exceed 2 weeks, although this can be repeated if required.
As for all laxatives, prolonged use is not usually recommended. Extended use may be necessary in the care of patients with severe chronic or resistant constipation, secondary to multiple sclerosis or Parkinson's disease, or induced by regular constipating medication in particular opioids and antimuscarinics.
Adults, adolescents and the elderly: 1 –3 sachets daily in divided doses, according to individual response.
For extended use, the dose can be adjusted down to 1 or 2 sachets daily.
Paediatric population
Children (below 12 years old): Not recommended. Alternative STRIGOL Paediatric powder for oral solution 6.86 g product is available for children.
Faecal impaction
A course of treatment for faecal impaction with Macrogol does not normally exceed 3 days.
Adults, adolescents and the elderly: 8 sachets daily, all of which should be consumed within a 6 hour period.
Paediatric population
Children (below 12 years old): Not recommended. Alternative STRIGOL Paediatric powder for oral solution 6.86 g product is available for children.
Patients with impaired cardiovascular function: For the treatment of faecal impaction the dose should be divided so that no more than two sachets are taken in any one hour.
Patients with renal insufficiency: No dosage change is necessary for treatment of either constipation or faecal impaction.
Method of administration
Each sachet should be dissolved in 125 ml water. For use in faecal impaction 8 sachets may be dissolved in 1 litre 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.
The fluid content of Compound Macrogol when re-constituted with water does not replace regular fluid intake and adequate fluid intake must be maintained.
Diagnosis of impaction/faecal loading of the rectum should be confirmed by physical or radiological examination of the abdomen and rectum.
Mild adverse drug reactions are possible as indicated in Section 4.8. If patients develop any symptoms indicating shifts of fluids/electrolytes (e.g. oedema, shortness of breath, increasing fatigue, dehydration, cardiac failure) Compound Macrogol should be stopped immediately and electrolytes measured, and any abnormality should be treated appropriately.
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.
If patients develop any symptoms indicating shifts of fluid/ electrolytes (e.g. oedema, shortness of breath, increasing fatigue, dehydration, cardiac failure) Macrogol should be stopped immediately, electrolytes measured, and any abnormality treated appropriately.
The absorption of other medicinal products could transiently be reduced due to an increase in gastro-intestinal transit rate induced by Compound Macrogol (see section 4.5).
Compound Macrogol contains 0.6213 mmol (24.230) 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.
This medicinal product contains 186.87 mg (8.125 mmol) sodium per dose, equivalent to 9.3% of the WHO recommended maximum daily intake for sodium. When used long term for constipation the maximum daily dose of this product is equivalent to 28% of the WHO recommended maximum daily intake for sodium. STRIGOL is considered high in sodium. This should be particularly taken into account for those on a low salt diet.
In patients with swallowing problems, who need the addition of a thickener to solutions to enhance an appropriate intake, interactions should be considered, see section 4.5.
Avoid mixing PEG laxatives and starch-based thickeners in patients with dysphagia, considered at risk of aspiration
Paediatric population
There is no clinical data on the use of Compound Macrogol 13.72 g, powder for oral solution in children, therefore it should not be used in children below 12 years of age.
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 STRIGOL (see section 4.4). There have been isolated reports of decreased efficacy with some concomitantly administered medicinal products, e.g. anti-epileptics.
STRIGOL may result in a 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 STRIGOL 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.
STRIGOL 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.
STRIGOL can be used during breast-feeding.
Fertility
There are no data on the effects of STRIGOL on fertility in humans. There were no effects on fertility in studies in male and female rats (see section 5.3).
STRIGOL has no or negligible influence on the ability to drive and use machines.
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. Mild diarrhoea usually responds to dose reduction.
The frequency of the adverse effects is not known as it cannot be estimated from the available data.
System Organ Class
Adverse Event
Immune system disorders
Allergic reactions, including anaphylactic reactions, dyspnoea and skin reactions (see below)
Skin and subcutaneous tissue disorders
Allergic skin reactions including angioedema, urticaria, pruritus, rash, erythema.
Metabolism and nutrition disorders
Electrolyte disturbances, particularly hyperkalaemia and hypokalaemia.
Nervous system disorders
Headache
Gastrointestinal disorders
Abdominal pain, diarrhoea, vomiting, nausea, dyspepsia, abdominal distension, borborygmi, flatulence and anorectal discomfort.
General disorders and administration site conditions
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.
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 13.72 g 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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