Document: document 1 change

• document 0
• document 1

---

SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Ispagel Orange

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Ispaghula Husk granules 3.5g

For a full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Effervescent Granules for Oral Suspension.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

For the treatment of constipation, for use in patients with colostomy, ileostomy, haemorroids, anal fissure, chronic diarrhoea associated with diverticular disease, irritable bowel syndrome, and as adunctants in ulcerative colitis.

4.2 Posology and method of administration For Constipation.

Adults: One sachet one to three times daily, mixed in at least 150 ml of liquid, followed by additional liquid.

Children 6 - 12 years half the adult dose; children under 6 years consult a physician. Ispagel Orange should be taken with an adequate intake of fluid and not before bedtime.

4.3 Contraindications

Ispagel Orange should not be given to patients with intestinal obstruction or conditions likely to lead to this, abdominal pain, nausea or vomiting, colonic atony such as senile megacolon, difficulty in swallowing, faecal impaction, or known hypersensitivity to ispaghula. Patients suffering from phenylketonurea should not take this product.

4.4 Special warnings and precautions for use

If symptoms persist consult your doctor. Due to its aspartame content Ispagel Orange should not be given to patients with phenylketonuria.

Ispaghula should not be given to patients with natural or drug induced failure of gut motility.

Taking this product without adequate fluid may cause it to swell and block the throat or oesophagus and may cause choking. This product should not be taken if there is difficulty in swallowing. If chest pain, vomiting, or difficulty in swallowing or breathing is experienced after taking this product, immediate medical attention should be sought. Inhaled or ingested ispaghula powder may cause an allergic reaction in people sensitive to ispaghula. Calcium and iron absorption as well as vitamins and mineral absorption may be impaired.

4.5 Interaction with other medicinal products and other forms of interaction

Since ispaghula decreases transit time, there is a theoretical possibility of decreased gastrointestinal absorption of other drugs.

4.6 Fertility, Pregnancy and lactation

Controlled studies in pregnant and lactating women are not available, but the product has been in wide use for many years without apparent ill consequences and animal studies have shown no hazard. Ispaghula is not thought to be absorbed nor is it thought to enter breast milk.

4.7 Effects on ability to drive and use machines

None known.

4.8 Undesirable effects

Abdominal discomfort and Flatulence Gastrointestinal obstruction, impaction. Allergic reactions have occurred following inhalation by persons sensitive to ispaghula powder

Allergy is more common in those people who are allergic to aspirin.

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.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

None.

5.2 Pharmacokinetic properties

None.

5.3 Preclinical safety data

No relevant data are available

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sodium bicarbonate_

Orange Flavour_

ft-carotene10%_

Aspartame_

Citric Acid Anhydrous_

Riboflavine 5 sodium phosphate

6.2 Incompatibilities

None known

6.3 Shelf life

3 years.