Omnilax contains the active substance macrogol 4000 and belongs to a group of pharmaceuticals called osmotic active laxatives. They work by increasing the fluid volume of the stool, which helps with problems caused by very slow bowel movements.
Omnilax is prescription medicine for the symptomatic treatment of constipation in both adults and children who are 6 months and older.
Medical information and reporting of adverse events
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Functional constipation in children aged 6 months to 8 years. An organic disorder should have been ruled out by a physician before initiation of treatment, especially in the age group below 2 years of age. Omnilax should be a temporary adjuvant treatment to lifestyle and dietary management appropriate for constipation. Maximum treatment duration is 3 months. If symptoms persist despite dietary changes, an underlying cause should be suspected and treated.
Omnilax 4 g (macrogol 4000), powder for oral solution in sachet. Drug for constipation, osmotically acting laxative.
Rx, (F). Indication: Functional constipation in children aged 6 months to 8 years. An organic disorder should have been ruled out by a physician before initiation of treatment, especially in the age group below 2 years of age. Omnilax should be a temporary adjuvant treatment to lifestyle and dietary management appropriate for constipation. Maximum treatment duration is 3 months. If symptoms persist despite dietary changes, an underlying cause should be suspected and treated.
Contraindications: Severe inflammatory bowel disease or toxic megacolon associated with symptomatic stenosis. Gastrointestinal perforation or risk of gastrointestinal perforation, ileus or suspected intestinal blockage or symptomatic stenosis. Abdominal pain without known cause.
Warning and precautions: The treatment of constipation with any medicinal product is only an adjuvant to a healthy lifestyle and diet. Neurologically impaired children with oromotor dysfunction are particularly at risk of aspiration. For further information and price see Fass.se.
Pro Health Pharma Sweden AB, Helsingborg
info@prohealthpharma.se
Date of latest revision of SmPC 07/2021. Revised 02/2022.
Omnilax 10 g (macrogol 4000), powder for oral solution in sachet. Osmotically acting laxative.
(Rx), F. Indication: Functional constipation in adults and children aged 8 years and above. An organic disorder should have been ruled out before initiation of treatment. Omnilax should be a temporary adjuvant treatment to lifestyle and dietary management appropriate for constipation, with a maximum 3-month treatment duration in children. If symptoms persist despite dietary changes, an underlying cause should be suspected and treated.
Contraindications: Severe inflammatory bowel disease or toxic megacolon. Gastrointestinal perforation or risk of gastrointestinal perforation, ileus or suspected intestinal blockage or symptomatic stenosis. Abdominal pain without known cause.
Warning and precautions: The treatment of constipation with any medicinal product is only an adjuvant to a healthy lifestyle and diet. Neurologically impaired children with oromotor dysfunction are particularly at risk of aspiration. For further information and price see Fass.se.
Pro Health Pharma Sweden AB, Helsingborg
info@prohealthpharma.se
Date of latest revision of SmPC 03/2020. Revised 02/2022.
Functional constipation in adults and children aged 8 years and above. An organic disorder should have been ruled out before initiation of treatment. Omnilax should be a temporary adjuvant treatment to lifestyle and dietary management appropriate for constipation, with a maximum 3-month treatment duration in children. If symptoms persist despite dietary changes, an underlying cause should be suspected and treated.
For the treatment of chronic constipation. Also effective in dissolving fecalom, defined as difficult-to-treat constipation with accumulation of faeces in the rectum and/or colon.
Omnicol (macrogol 3350, sodium chloride, sodium bicarbonate, potassium chloride), powder for oral solution in sachet. Osmotically acting laxative.
(Rx), F. Indication: For the treatment of chronic constipation. Also effective in dissolving fecalom, defined as difficult-to-treat constipation with accumulation of faeces in the rectum and/or colon.
Contraindications: Intestinal perforation or obstruction caused by structural or functional disorder in the intestinal wall (ileus), severe inflammatory conditions of the intestinal tract, such as Crohn’s disease, ulcerative colitis, or toxic megacolon. Hypersensitivity to any of the active substances or excipients.
Warning and precautions: Treatment is not recommended for children below 12 years of age. Adequate fluid intake must be maintained. If patients develop symptoms suggestive of fluid/electrolyte disturbances (e.g., edema, shortness of breath, increasing fatigue, dehydration, cardiac failure), treatment with Omnicol should be stopped immediately. Omnicol contains sodium. Special consideration should be taken for patients on a low salt (sodium) diet. For further information and price see Fass.se.
Pro Health Pharma Sweden AB, Helsingborg,
info@prohealthpharma.se
Date of latest revision of SmPC: 2022-10-13. Revised 01/2023.
Omnicol Junior (macrogol 3350, sodium chloride, sodium bicarbonate, potassium chloride), powder for oral solution in sachet. Drug for constipation, osmotically acting laxative.
Rx, (F) Indication: For the treatment of chronic constipation in children aged 1 to 11 years. For dissolving fecalom in children from 5 years. Fecalom is defined as difficult-to-treat constipation with accumulation of faeces in the rectum and/or colon. Treatment should be discontinued and resumed if constipation symptoms recur.
Contraindications: Severe inflammatory bowel disease or toxic megacolon. Intestinal perforation or obstruction caused by structural or functional disturbance in the intestinal wall (ileus).
Warning and precautions: Adequate fluid intake must be maintained. If patients develop symptoms suggestive of fluid/electrolyte disturbances (eg edema, shortness of breath, increasing fatigue, dehydration or heart failure), treatment with Omnicol Junior should be stopped immediately. When using high doses in the treatment of fecalom, this medicine should be administered with caution to patients with vomiting reflex, reflux oesophagitis or impaired consciousness. Treatement of fecalom in children with impaired cardiovascular function or renal impaiment is not recommended. For further information and price see Fass.se.
Pro Health Pharma Sweden AB, Helsingborg,
info@prohealthpharma.se
Date of latest revision of SmPC 03/2022. Revised 07/2022.
For the treatment of chronic constipation in children aged 1 to 11 years. For dissolving fecalom in children from 5 years. Fecalom is defined as difficult-to-treat constipation with accumulation of faeces in the rectum and/or colon. Treatment should be discontinued and resumed if constipation symptoms recur.
Pro Health Pharma is a niche generic pharmaceutical company within the gastroenterology area. We focus on development and marketing of pharmaceuticals for constipation and provide cost-efficient medicines of highest quality. By delivering affordable medicines to pharmacies, our goal is to improve health economy for patients and society.
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