ISPAGEL ORANGE

Posology Adults and children over 12 years:

One sachet morning and evening.

Elderly:

There is no indication that dosage needs to be modified for the elderly.

Children aged 12 years and under:

Ispagel® Orange should not be used in children aged 12 years and under. Other pharmaceutical forms may be more appropriate for administration to this population. The last dose should not be taken immediately before going to sleep. If there has been no bowel movement after three days of treatment the doctor should be consulted.

Method of Administration Ispagel Orange is intended for oral use as a suspension in a drink of water. The granules should be stirred into a glass of 150 ml of cold water and taken as soon as the effervescence subsides, preferably after meals.

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 sensitization to the active ingredient.

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, anaphylaxia.

Cutaneous symptoms as exanthema and/or pruritus have also been reported. 4). 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.

e. healthcare workers, caregivers) allergic sensitization may occur due to inhalation, this is more frequent in atopic individuals. 8). It is recommended to assess clinically the possible sensitization of individuals at risk and, if justified, to perform specific diagnostic tests.

3). If symptoms persist longer than 3 days, the patient should consult a doctor or healthcare professional. 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.

Adequate fluid intake should be maintained. Therefore, the product should not be taken dry and should always be taken with at least 150 mL of water or other liquid. 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.

Paediatric Population Use is not recommended in children below 12 years of age. Laxative bulk producers should be used before using other purgatives if change of nutrition is not successful. 00 mg of aspartame, a source of phenylalanine.

1. 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. Ispagel Orange is contra-indicated in patients suffering from abnormal constrictions in the gastro-intestinal tract, with diseases of 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