). It is recommended to assess clinically the possible sensitisation 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. Interaction 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. 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 Lemon 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.
The exposure to these allergens is possible through oral administration, contact with the skin and, in the case of powder formulations, also by inhalation. As a consequence to this allergic potential, individuals exposed to the product can develop hypersensitivity reactions such as rhinitis, conjunctivitis, bronchospasm and in some cases, anaphylaxis.
Cutaneous symptoms such as exanthema and/or pruritus have also been reported. 3 A small amount of flatulence and abdominal distension may sometimes occur during the first few days of treatment, but should diminish during continued treatment.
Abdominal distension and risk of intestinal or oesophageal obstruction and faecal impaction may occur, particularly if swallowed with insufficient fluid. 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. uk/yellowcard.