Indication for macrogol sachets
This medicine is indicated for the symptomatic treatment of constipation in adults and children aged 8 and over. MACROGOL 4000 ZYDUS 10 g should be used only as a temporary treatment for constipation, for a period not exceeding 3 months in children, in conjunction with appropriate dietary and hygienic measures.
How to take this medicine
Take by mouth. The contents of the sachets should be dissolved in a glass of water just before administration
Dosage and frequency of administration
FOR ADULTS AND CHILDREN AGED 8 AND OVER. The dose is 1 to 2 sachets per day, preferably taken as a single dose in the morning. The daily dose should be adjusted according to the clinical effects obtained: it may range from 1 sachet every other day (particularly in children) to 2 sachets per day. In children, the duration of treatment should not exceed 3 months.
Composition
The active substance is: Macrogol 4000 ............................................................................................................................... 10,000 g For one sachet. The other ingredients are: Saccharin sodium and orange-grapefruit flavour*. *Composition of orange-grapefruit flavour: orange and grapefruit essential oils, citral, acetic aldehyde, linalool, ethylbutyrate, alpha terpineol, octanal, cis 3 hexenol, buthyldroxyanisole (E320), maltodextrin, gum arabic (E414), sorbitol (E420), sulphur dioxide (E220).
Packaging
This medicine comes in the form of a powder for drinkable solution in a sachet. Box of 20 sachets.
Precautions for use
Special warnings Be careful with MACROGOL 4000 ZYDUS 10 g, powder for drinkable solution in sachet: Before administering this treatment to your child, you must consult a doctor to rule out any organic cause of constipation. After 3 months of treatment, a clinical assessment of your child's constipation should be carried out by your doctor. Due to the presence of sorbitol, this medicine must not be used in cases of fructose intolerance (hereditary metabolic disease). In the event of diarrhoea, appropriate monitoring should be instituted in patients at risk of hydro-electrolyte disorders. This medicine contains macrogol (= P.E.G. = polyethylene glycol). Very rare allergic reactions (rash, urticaria, oedema) have been reported with products containing macrogol. This medicine contains sulphur dioxide and may cause severe allergic reactions and respiratory discomfort. This medicine contains sorbitol. Its use is not recommended in patients with sorbitol intolerance (rare hereditary disease). Special precautions Not applicable.
Contraindications
Never take MACROGOL 4000 ZYDUS 10 g, powder for drinkable solution in a sachet: - In case of allergy (rash, urticaria, oedema) to macrogol (= P.E.G. = polyethylene glycol), or to one of the excipients contained in MACROGOL 4000 ZYDUS 10 g. - In the case of certain diseases of the colon and intestine (haemorrhagic rectocolitis, Crohn's disease, etc.). - In cases of suspected intestinal obstruction or abdominal pain of undetermined cause. - In cases of digestive perforation or risk of digestive perforation.
Interactions with other medicines
Use of other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding
This medicine should only be used during pregnancy on the advice of a doctor. In the event of pregnancy occurring during treatment, consult a doctor, who alone can judge whether it is necessary to continue treatment. This medicine may be used during breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine.
Possible undesirable effects
Like all medicines, MACROGOL 4000 ZYDUS 10 g, powder for oral solution in a sachet is likely to have undesirable effects, although not everyone is subject to them. - diarrhoea, which may cause urinary urgency and faecal incontinence, - abdominal pain, bloating, - nausea, vomiting, - very rare cases of allergic reactions such as rashes, urticaria and oedema (facial oedema, angioedema). Taking too large a dose may cause diarrhoea, which generally resolves on reduction of dosage or temporary discontinuation of treatment. Diarrhoea may cause perianal pain. If you notice any side effects not mentioned in this leaflet, or if any side effects become serious, please tell your doctor or pharmacist.
Instructions in case of overdose
If you have taken more MACROGOL 4000 ZYDUS 10 g, powder for oral solution in a sachet, than you should have: consult your doctor or pharmacist immediately.
Storage conditions
There are no special storage precautions.Possible undesirable effects
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