FYBOGEL ORANGE

If there has been no bowel movement after three days of treatment a doctor or healthcare professional should be consulted. 4 ‘Special warnings and precautions for use’) Posology Adults: One sachet, morning and evening Elderly: There is no indication that dosage needs to be modified for the elderly.

4 ‘Special warnings and precautions for use’). The effects start 12-24 hours later. 4). The granules should be stirred into a glass of water and taken as soon as possible, preferably after meals. The product should be taken during the day at least ½ to 1 hour before or after intake of other medicine and should not be taken immediately before going to sleep When preparing the product for administration, it is important to try to avoid inhaling any of the powder in order to minimize the risk of sensitisation to the active ingredient.

). It is recommended to assess clinically the possible sensitization of individuals at risk and, if justified, to perform specific diagnostic tests. 3 Contraindications). Paediatric Population Use is not recommended in children below 6 years of age due to insufficient data on safety and efficacy.

Laxative bulk producers should be used before using other purgatives if change of nutrition is not successful. 5. Interactions with other Medicinal Products and other Forms of Interaction Enteral absorption of concomitantly administered medicines such as minerals, vitamins (B12), cardiac glycosides, coumarin derivatives, carbamazepine and lithium may be delayed.

For this reason the product should not be taken ½ to 1 hour before or after intake of other medicinal products. Diabetic patients should take ispaghula husk only under medical supervision because adjustment of anti-diabetic therapy may be necessary.

Use of ispaghula husk concomitantly with thyroid hormones requires medical supervision because the dose of the thyroid hormones may have to be adjusted. 6 Fertility, pregnancy and lactation Pregnancy There are limited amount of data (less than 300 pregnancy outcomes) from the use of ispaghula husk in pregnant women.

3 Preclinical safety data). Breast-feeding The use of ispaghula husk may be considered during pregnancy and lactation, if necessary and if change of nutrition is not successful. 7. Effects on Ability to Drive and Use Machines Fybogel Orange has no or negligible influence on the ability to drive and use machines.

4 Special warnings and precautions for use). Adverse events which have been associated with ispaghula husk are given below, tabulated by system organ class and frequency.

Frequencies are defined as:

Very common (≥1/10); Common (≥1/100 and <1/10); Uncommon (≥1/1000 and <1/100); Rare (≥1/10,000 and <1/1000); Very rare (< 1/10,000); Not known (cannot be estimated from the available data). Within each frequency grouping, adverse events are presented in order of decreasing seriousness System Organ Class Frequency Adverse Events Immune System Disorders Not known Hypersensitivity disorders1,2 Eye Disorders Not known Conjunctivitis2 Respiratory, Thoracic and Mediastinal Disorders Not known Rhinitis2 Gastrointestinal Disorders Not known Flatulence, abdominal distension, intestinal obstruction, oesophageal obstruction, faecal impaction3 Skin and Subcutaneous Tissue Disorders Not known Skin Rash2 Description of Selected Adverse Reactions 1 Including rash, anaphylaxis, pruritus, and bronchospasm 2 Ispaghula/psyllium husk contains potent allergens.

), Patients with a sudden change in bowel habit that has persisted more than two weeks. Undiagnosed rectal bleeding and failure to defecate following the use of a laxative. Fybogel Orange is contra-indicated in patients suffering from abnormal constrictions in the gastro-intestinal tract, with diseases of the oesophagus and cardia, intestinal obstruction, faecal impaction, natural or drug-induced reduction of gut motility and colonic atony such as senile mega-colon.

Patients who have difficulty in swallowing or any throat problems. 4 Special Warnings and Special Precautions for Use The product should not be taken dry and should always be taken mixed with fluid (5 fluid ounces or 150 mL of water or other liquid per sachet).

Ispaghula husk should not be used by patients with faecal impaction and symptoms such as abdominal pain, nausea and vomiting unless advised by a doctor because these symptoms can be signs of potential or existing intestinal blockage (ileus).

If abdominal pain occurs or in cases of any irregularity of faeces, the use of psyllium seed should be discontinued and medical advice must be sought. When taken with inadequate fluid amounts, bulk forming agents can cause obstruction of the throat and oesophagus with choking and intestinal obstruction.

Symptoms can be chest pain, vomiting, or difficulty in swallowing or breathing. The treatment of debilitated patients and / or elderly patients requires medical supervision. g. opioids) and then only under medical supervision. The last dose should not be taken immediately before going to sleep since impaired or reduced gastric motility may impair the intestinal passage and then cause sub-obstruction.

This medicine contains 16mg aspartame in each sachet. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.

1 (See Section