Cholestagel

Posology Combination therapy The recommended dose of Cholestagel for combination with a statin with or without ezetimibe is 4 to 6 tablets per day. The maximum recommended dose is 6 tablets per day taken as 3 tablets twice per day with meals or 6 tablets taken once per day with a meal.

Clinical trials have shown that Cholestagel and statins can be co-administered or dosed apart, and that Cholestagel and ezetimibe can be co- administered or dosed apart. Monotherapy The recommended starting dose of Cholestagel is 6 tablets per day taken as 3 tablets twice per day with meals or 6 tablets once per day with a meal.

The maximum recommended dose is 7 tablets per day. During therapy, the cholesterol-lowering diet should be continued, and serum total-C, LDL-C and triglyceride levels should be determined periodically during treatment to confirm favourable initial and adequate long-term responses.

5). Elderly population There is no need for dose adjustment when Cholestagel is administered to elderly patients. Paediatric population The safety and efficacy of Cholestagel in children aged 0 to 17 years have not yet been established.

1 but no recommendation on a posology can be made. Method of administration Cholestagel tablets should be taken orally with a meal and liquid. The tablets should be swallowed whole and not broken, crushed or chewed.

Summary of the safety profile The most frequently occurring adverse reactions are flatulence and constipation, found within the gastrointestinal disorders system organ class. Tabulated list of adverse reactions In controlled clinical studies involving approximately 1400 patients and during post-approval use, the following adverse reactions were reported in patients given Cholestagel.

The reporting rate is classified as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).

Nervous system disorders Common:

Headache Gastrointestinal disorders Very common: Flatulence*, constipation* Common: Vomiting, diarrhoea*, dyspepsia*, abdominal pain, abnormal stools, nausea, abdominal distension Uncommon: Dysphagia Very rare: Pancreatitis Not known: Intestinal obstruction*,** Musculoskeletal and connective tissue disorders Uncommon: Myalgia Investigations Common: Serum triglycerides increased Uncommon :Serum transaminases increased * see section below for further information ** adverse reactions from post-marketing experience Description of selected adverse events The background incidence of flatulence and diarrhoea were higher in patients receiving placebo in the same controlled clinical studies.

Only constipation and dyspepsia were reported by a higher percentage among those receiving Cholestagel, compared with placebo. The incidence of intestinal obstruction is likely to be increased among patients with a history of bowel obstruction or removal.

7 Cholestagel in combination with statins and in combination with ezetimibe was well tolerated and the adverse reactions observed were consistent with the known safety profile of statins or ezetimibe alone. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

, poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease) are considered, these should be diagnosed and properly treated. 5). Patients starting on ciclosporin already taking Cholestagel should have their ciclosporin blood concentrations monitored as normal and their dose adjusted as normal.

Patients starting on Cholestagel already taking ciclosporin should have their blood concentrations monitored prior to combination therapy and frequently monitored immediately starting co-therapy with the ciclosporin dose adjusted accordingly.

It should be noted that stopping Cholestagel therapy will result in increased ciclosporin blood concentrations. Therefore, patients taking both ciclosporin and Cholestagel should have their blood concentrations monitored prior to and frequently after when Cholestagel therapy is stopped with their ciclosporin dose adjusted accordingly.

4 mmol/L due to the triglyceride increasing effect with Cholestagel. 4 mmol/L, since such patients were excluded from the clinical studies. The safety and efficacy of Cholestagel in patients with dysphagia, swallowing disorders, severe gastrointestinal motility disorders, inflammatory bowel disease, liver failure or major gastrointestinal tract surgery have not been established.

Consequently, caution should be exercised when Cholestagel is used in patients with these disorders. Constipation Cholestagel can induce or worsen present constipation. The risk of constipation should especially be considered in patients with coronary heart disease and angina pectoris.

5). Oral contraceptives Cholestagel can affect the bioavailability of the oral contraceptive pill when administered simultaneously. 5).

1 • Bowel or biliary obstruction