Ispagel Orange
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ispagel Orange
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
A unit dose (one sachet or two level 5 ml spoonfuls) contains 3.5 g ispaghula husk. Excipient with known effect: Also contains aspartame (E951).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Effervescent granules for oral suspension
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
The treatment of patients requiring a high fibre regime: for example, for the relief of constipation, including constipation in pregnancy and the maintenance of regularity; for the management of bowel function in patients with colostomy, ileostomy, haemorrhoids, anal fissure, chronic diarrhoea associated with diverticular disease, irritable bowel syndrome and ulcerative colitis.
4.2 Posology and method of administration
Posology
Adults and children over 12 years: One sachet or two level 5ml spoonfuls morning and evening.
Elderly: There is no indication that dosage needs to be modified for the elderly.
Children aged 6 to 12 years: Half to one level 5 ml spoonful, depending on age and size, morning and evening.
Children under 6 years: To be taken only when prescribed by a doctor, half to one level 5 ml spoonful depending on age and size, morning and evening.
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.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Ispagel Orange is contra-indicated in cases of intestinal obstruction, faecal impaction. Natural or drug-induced reduction of gut motility and colonic atony such as senile mega-colon.
4.4 Special warnings and precautions for use
Warning on hypersensitivity reactions: In individuals with continued occupational contact to powder of Plantago ovata seeds (i.e. healthcare workers, caregivers) allergic sensitization may occur due to inhalation, this is more frequent in atopic individuals. This sensitization usually leads to hypersensitivity reactions which could be serious (see section 4.8). It is recommended to assess clinically the possible sensitization of individuals at risk and, if justified, to perform specific diagnostic tests. In case of proven sensitization leading to hypersensitivity reactions, exposure to the product should be stopped immediately and avoided in the future (see section 4.3).
If symptoms persist consult a doctor.
Adequate fluid intake should be maintained. Therefore, they 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.
Important information regarding the ingredients of this medicine
This medicine contains aspartame, a source of phenylalanine. Ispagel Orange should not be given to patients with phenylketonuria, as it may be harmful.
4.5 Interaction with other medicinal products and other forms of interaction
Ispaghula husk and other bulk-forming laxatives may delay or reduce the gastrointestinal absorption of other drugs such as cardiac glycosides, coumarin derivatives, lithium, or vitamins (such as vitamin B12) and minerals (such as calcium, iron, or zinc).
4.6 Fertility, pregnancy and lactation
Ispagel Orange may be used during pregnancy and lactation since the ispaghula husk is not absorbed from the gastrointestinal tract.
4.7 Effects on ability to drive and use machines
None
4.8 Undesirable effects
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. Special attention should be given to individuals manipulating the powder formulations routinely (see section 4.4).
A small amount of flatulence and abdominal distension may sometimes occur. 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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
4.9 Overdose
In the event of an overdose, abdominal discomfort and flatulence may occur which should be treated conservatively and an adequate fluid intake maintained, particularly if the granules have been taken without water contrary to administration instructions.
PHARMACOLOGICAL PROPERTIES
5
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Bulk producer
ATC Code: A06A C01
Ispaghula husk is capable of absorbing up to 40 times its own weight of water in vitro and part of its activity can be attributed to its action as a simple bulking agent. In addition colonic bacteria are believed to use the hydrated material as a metabolic substrate. This results in an increase in the bacterial cell mass with a consequent softening of the faeces.
5.2 Pharmacokinetic properties
The mode of action of Ispaghula husk is physical and does not depend on absorption into the systemic circulation.
5.3 Preclinical safety data
No preclinical findings relevant to the prescriber have been reported.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sodium bicarbonate
Orange flavour P-carotene 10%
Aspartame E951 Citric acid anhydrous Riboflavin 5 sodium phosphate.
6.2 Incompatibilities
None known
6.3 Shelf life
3 years
6.4 Special precautions for storage
Do not store above 25°C. Store in the original package.
6.5 Nature and contents of container
Sachets of 3, 10, 30 or 60 enclosed in a carton
Not all pack sizes may be marketed.
6.6 Special precautions for disposal and other handling
Ispagel Orange granules are to be dispersed in water forming a drink.
7 MARKETING AUTHORISATION HOLDER
Bristol Laboratories Limited
Unit 3, Canalside,
Northbridge road,
Berkhamsted, HP4 1EG United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 17907/0397
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 17/04/2000
Date of last renewal: 07/12/2005
10
DATE OF REVISION OF THE TEXT
09/01/2015