FYBOGEL MEBEVERINE

4).

Posology Adults and children over 12:

One sachet morning and evening, taken half an hour before meals. A third dose may be taken before the midday meal if necessary.

Elderly:

There is no indication that the dose need be modified for the elderly. 4). 4) The contents of one sachet should be stirred into a glass of cold water (150 ml minimum) and drunk immediately. The product should be taken during the day at least ½ to 1 hour before or after intake of other medicines and should not be taken immediately before going to sleep.

Effects may take 12-24 hours. 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.

The list of the following adverse effects relates to those experienced with ispaghula husk and mebeverine hydrochloride at OTC doses, in short term use. In the treatment of chronic conditions, under long-term treatment, additional adverse effects may occur.

4). The frequency is not known. Adverse events which have been associated with ispaghula husk or mebeverine 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, urticaria, anaphylactic reaction, pruritus, bronchospasm, rhinitis and angioedema.

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 Flatulence and abdominal distension (bloating) may be experienced during the first few days of treatment, but should diminish during continued treatment.

The use is not recommended in children below 12 years of age due to insufficiency data on efficacy. Laxative bulk producers should be used before using other purgatives if change of nutrition is not successful. Fybogel Mebeverine should not be taken in the dry form and should always be taken mixed with fluid (5 fluid ounces or 150 mL of water or other liquid per sachet).

Gastrointestinal obstruction or impaction have been reported with hydrophilic mucilloid preparations when taken with insufficient liquid, contrary to administration instructions. 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 ispaghula husk 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. 5). This product should not be taken immediately before going to bed as reduced gastric motility may impair intestinal passage and cause obstruction.

This medicine contains 16 mg aspartame in each unit dose (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.

Consult your doctor if you have developed new symptoms, or if your symptoms worsen, or if they do not improve after two weeks of treatment. g. healthcare workers and caregivers) allergic sensitisation may occur due to inhalation; this is more frequent in atopic individuals.

1. 4). 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. Patients suffering from abnormal constrictions in the gastro-intestinal tract, with diseases of the oesophagus and cardia, potential or existing intestinal blockage (ileus), paralysis of the intestine or megacolon.

Patients who have difficulty in swallowing or any throat problems.