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 Potassium chloride, Sodium chloride, Sodium hydrogen carbonate, Macrogol 3350 may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
for
Laxido Paediatric Plain contains macrogol 3350 and the electrolytes sodium chloride, sodium hydrogen carbonate and potassium chloride. Laxido Paediatric Plain is a laxative used for the treatment of chronic constipation in children aged 1 to 11 years. It is also used to treat a build up of hard faeces in the bowel in children aged 5 to 11 years, which may be a result of long-term constipation (this is known as faecal impaction). Macrogol 3350 makes your child's faeces softer and easier to pass, giving them relief from constipation. The electrolytes help to maintain the body's normal levels of sodium, potassium and water while your child is being treated for constipation. 2.
e Laxido Paediatric Plain
Do not give Laxido Paediatric Plain if your doctor has told you that your child: is allergic to macrogol 3350, sodium chloride, sodium hydrogen carbonate or potassium chloride has a perforation in the wall of their intestine has a blockage in their intestine has paralysis of the intestine (for example, your child's intestines may stop working due to intestinal surgery or severe infection) has ulcerative colitis, Crohn's disease or toxic megacolon. If any of these applies to your child, please talk to their doctor or pharmacist for further advice.
1.3.1 Package Leaflet
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Warnings and precautions Before giving Laxido Paediatric Plain to your child for faecal impaction, it should be confirmed by their doctor that your child has this condition. If your child has a heart or kidney problem, an impaired gag reflex, reflux oesophagitis (heartburn caused by back-flow of stomach contents in the oesophagus) or reduced consciousness, you should talk to their doctor before giving Laxido Paediatric Plain. When taking Laxido Paediatric Plain you should continue to take plenty of fluids. The fluid content of Laxido Paediatric Plain should not replace your regular liquid intake. Other medicines and Laxido Paediatric Plain Tell their doctor or pharmacist if your child is taking, has recently taken, or might take any other medicines. Some medicines, e.g. anti-epileptics, may not work as effectively if they are taken at the same time as Laxido Paediatric Plain. When taking large volumes of Laxido Paediatric Plain (e.g. for faecal impaction), your child should not take other medicines within one hour of taking Laxido Paediatric Plain. If you need to thicken fluids in order to swallow them safely, Laxido Paediatric Plain may counteract the effect of the thickener. Laxido Paediatric Plain with food, drink and alcohol Food and drink have no influence on the effect of Laxido Paediatric Plain. Pregnancy, breast-feeding and fertility Laxido Paediatric Plain can be given during pregnancy and whilst breast-feeding. Ask your pharmacist or doctor for advice before giving Laxido Paediatric Plain. Driving and using machines Laxido Paediatric Plain has no effect on the ability to drive or use machinery. Laxido Paediatric Plain contains potassium and sodium This medicine contains 0.34 mmol (13 mg) of potassium per sachet. This should be taken into consideration if you give your child more than three sachets daily and they have reduced kidney function or if they are on a controlled potassium diet. This medicine contains 93 mg of sodium (main component of cooking/table salt) in each sachet. This is equivalent to approximately 4.6% of the recommended maximum daily dietary intake of sodium for an adult. 3.
Laxido Paediatric Plain
Always give this medicine exactly as the doctor or pharmacist has told you. Check with the doctor or pharmacist if you are not sure. Laxido Paediatric Plain should be taken orally. Chronic constipation The recommended dose for chronic constipation depends on the age of the child and their response to treatment.
1.3.1 Package Leaflet
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As a starting dose, children aged 1 to 6 years should be given 1 sachet each day and children aged 7 to 11 years should be given 2 sachets each day. The 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. For children below 2 years of age, no more than 2 sachets should be taken in one day. For children 2 to 11 years, normally, no more than 4 sachets are required to be 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 A course of treatment with Laxido Paediatric Plain is as follows: Age (years) 5 to 11
Day 1
Number of Laxido Paediatric Plain sachets Day 2 Day 3 Day 4 Day 5
Day 6
Day 7
4
6
12
12
8
10
12
The daily number of sachets should be taken in divided doses, all taken within 12 hours (e.g. 8am to 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. How to mix Laxido Paediatric Plain should be made up by dissolving the contents of one sachet in a quarter glass of water (62.5 ml). Stir well until all the powder has dissolved and the Laxido Paediatric Plain solution is clear or slightly hazy, then give it to your child to drink. If you like you can add a flavour such as orange squash to the drink. If your child is taking Laxido Paediatric Plain for faecal impaction it may be easier to dissolve 12 sachets in 750 ml of water. In this case, the reconstituted solution must be stored in accordance with the relevant instructions provided in section 5. Duration of treatment Chronic constipation The course of treatment for chronic constipation needs to be for a prolonged period of time, at least 6 to 12 months. Faecal impaction The course of treatment for faecal impaction can be for up to 7 days. If your child takes more Laxido Paediatric Plain than they should Your child may experience severe pains and swelling in their abdomen, or vomiting or diarrhoea. If this happens, contact their doctor or pharmacist. If you forget to give Laxido Paediatric Plain If you forget to give your child 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.
1.3.1 Package Leaflet
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If you stop giving Laxido Paediatric Plain To get the most benefit from Laxido Paediatric Plain, always make sure that your child finishes the course of treatment recommended by their doctor, pharmacist or nurse. This will make sure that your child's constipation is cleared, otherwise the symptoms they are suffering from may persist. If you have any further questions on the use of this medicine, ask the doctor, pharmacist or nurse. 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, stop giving Laxido Paediatric Plain and see their doctor immediately:
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.
1.3.1 Package Leaflet
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5.
Laxido Paediatric Plain
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. You should store unopened sachets below 25 °C. Reconstituted Laxido Paediatric Plain 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 use this medicine if you notice that any of the sachets are damaged. 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.
What Laxido Paediatric Plain contains The active substances in each sachet are macrogol 3350 (6.563 g), sodium chloride (175.4 mg), sodium hydrogen carbonate (89.3 mg) and potassium chloride (25.1 mg). Laxido Paediatric Plain does not contain any other ingredients. It does not contain any colours, flavours or sweeteners. What Laxido Paediatric Plain looks like and contents of the pack Laxido Paediatric Plain is a white powder for oral solution that is packed in sachets. Each sachet contains 6.9 g of powder and is packed in cartons containing 2, 6, 8, 10, 20, 30, 50 and 100 sachets. Not all of these pack sizes are marketed. Marketing Authorisation Holder Galen Limited Seagoe Industrial Estate Craigavon BT63 5UA UK Manufacturer Almac Pharma Services Limited Almac House 20 Seagoe Industrial Estate Craigavon BT63 5QD UK
1.3.1 Package Leaflet
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Almac Pharma Services (Ireland) Limited Finnabair Industrial Estate Dundalk Co Louth A91 P9KD Ireland This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names: Ireland and United Kingdom (Northern Ireland) – Laxido Paediatric Plain Portugal – Laxido Mini Belgium and Luxembourg – Laxido Junior Neutral Sweden – Laxido Junior This leaflet was last revised in 09/2021.
1.3.1 Package Leaflet
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Laxido Paediatric Plain 6.9 g, powder for oral solution comes as oral solution containing 6.9g. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Laxido Paediatric Plain 6.9 g, powder for oral solution is potassium chloride, sodium chloride, sodium hydrogen carbonate, macrogol 3350.
Medicines with the same active substance, strength and form include: CosmoCol Half 6.9g powder for oral solution, CosmoCol Paediatric 6.9g powder for oral solution, Movicol® Paediatric Plain 6.9 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 Laxido Paediatric Plain 6.9 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.
Laxido Paediatric Plain is indicated for the treatment of chronic constipation in children aged 1 to 11 years.
Laxido Paediatric Plain is indicated for the treatment of faecal impaction in children from the age of 5 years, defined as refractory constipation with faecal loading of the rectum and/or colon.
Laxido Paediatric Plain is for oral use.
Posology
Chronic constipation:
The usual starting dose is 1 sachet daily for children aged 1 to 6 years, and 2 sachets daily for children aged 7 to 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. For children below 2 years of age, the maximum recommended dose should not exceed 2 sachets a day. For children aged 2 to 11 years, the maximum recommended dose needed does not normally exceed 4 sachets a day.
Treatment of children with chronic constipation needs to be for a prolonged period (at least 6 to 12 months). However, safety and efficacy have only been proven for a period of up to 3 months. Treatment should be stopped gradually and resumed if constipation recurs.
Faecal impaction:
A course of treatment for faecal impaction with Laxido Paediatric Plain is for up to 7 days as follows:
Daily dosage regimen:
Number of Laxido Paediatric Plain sachets
Age (years)
Day 1
Day 2
Day 3
Day 4
Day 5
Day 6
Day 7
5 to 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 re-impaction (dosing for prevention of re-impaction should be as for patients with chronic constipation; see above.)
Laxido Paediatric Plain is not recommended for children below 5 years of age for the treatment of faecal impaction, or in children below 1 year of age for the treatment of chronic constipation. For patients of 12 years and older it is recommended to use Laxido.
Patients with impaired cardiovascular function: There are no clinical data for this group of patients. Therefore Laxido Paediatric Plain 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 Laxido Paediatric Plain 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, to make a clear or slightly hazy solution. 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.
Hypersensitivity to the active substances.
Laxido Paediatric Plain is contraindicated in intestinal obstruction or perforation caused by functional or structural disorder of the gut wall, ileus and in patients with severe inflammatory conditions of the intestinal tract (e.g. ulcerative colitis, Crohn's disease and toxic megacolon).
The fluid content of Laxido Paediatric Plain when re-constituted with water does not replace regular fluid intake and adequate fluid intake must be maintained.
The faecal impaction diagnosis should be confirmed by appropriate physical or radiological examination of the rectum and abdomen.
Mild adverse drug reactions are possible as indicated in Section 4.8. 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 Laxido Paediatric Plain 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.
Laxido Paediatric Plain 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 Laxido Paediatric Plain (see section 4.5).
This medicinal product contains 93 mg of sodium per sachet, equivalent to approximately 4.6% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
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.
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 gastro-intestinal 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 Laxido Paediatric Plain (see section 4.4). There have been isolated reports of decreased efficacy with some concomitantly administered medicinal products, e.g. anti-epileptics.
Laxido Paediatric Plain may result in a potential interactive effect if used with starch-based food thickeners. The macrogol ingredient counteracts the thickening effect of starch, effectively liquefying preparations that need to remain thick for people with swallowing problems.
Pregnancy
There is a limited amount of data from the use of the Laxido formulation 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.
Laxido Paediatric Plain can be used during pregnancy.
Breast-feeding
No effects on the breast-fed newborn/infant are anticipated since the systemic exposure of the breast-feeding woman to macrogol 3350 is negligible.
Laxido Paediatric Plain can be used during breast-feeding.
Fertility
There are no data on the effects of the Laxido formulation on fertility in humans. There were no effects on fertility in studies in male and female rats (see section 5.3).
Laxido Paediatric Plain has no influence on the ability to drive and use machines.
Reactions related to the gastro-intestinal tract occur most commonly.
These reactions may occur as a consequence of expansion of the contents of the gastro-intestinal tract, and an increase in motility due to the pharmacological effects of Laxido Paediatric Plain.
In the treatment of chronic constipation, diarrhoea or loose stools normally respond to a reduction in dose.
Diarrhoea, abdominal distension, anorectal 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 (≥ 1/1000, <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
Allergic reactions including anaphylactic reaction.
Not known
Dyspnoea and skin reaction (see below).
Skin and subcutaneous tissue disorders
Not known
Allergic skin reactions including angioedema, urticaria, pruritus, rash, erythema.
Metabolism and nutrition disorders
Not known
Electrolyte disturbances, particularly hyperkalaemia and hypokalaemia.
Nervous system disorders
Not known
Headache.
Gastro-intestinal disorders
Very common
Abdominal pain, borborygmi.
Common
Diarrhoea, vomiting, nausea and anorectal 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 website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Severe distension or pain can be treated using nasogastric aspiration. Vomiting or diarrhoea may induce extensive fluid loss, possibly leading to electrolyte disturbances that should be treated appropriately.
Ask anything about Laxido Paediatric Plain 6.9 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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