Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Allergan Pharmaceuticals International Limited, Clonshaugh Business & Technology Park Dublin 17, D17 E400, Ireland
Constella is indicated for the symptomatic treatment of moderate to severe irritable bowel syndrome with constipation (IBS-C) in adults.
The recommended dose is one capsule (290 micrograms) once daily. Physicians should periodically assess the need for continued treatment. The efficacy of linaclotide has been established in double-blind placebo-controlled studies for up to 6 months. If patients have not experienced improvement in their symptoms after 4 weeks of treatment, the patient should be re-examined and the benefit and risks of continuing treatment reconsidered.
No dose adjustments are required for patients with hepatic or renal impairment (see section 5.2).
For elderly patients, although no dose adjustment is required, the treatment should be carefully monitored and periodically re-assessed (see section 4.4).
The safety and efficacy of Constella in children aged 0 to18 years have not yet been established. No data are available.
This medicinal product should not be used in children and adolescents (see sections 4.4 and 5.1).
Oral use. The capsule should be taken at least 30 minutes before a meal (see section 4.5).
An overdose may result in symptoms resulting from an exaggeration of the known pharmacodynamic effects of the medicinal product, mainly diarrhoea. In a study in healthy volunteers receiving a single dose of 2,897 micrograms (up to 10-fold the recommended therapeutic dose) the safety profile in these subjects was consistent with that in the overall population, with diarrhoea being the most commonly reported adverse event.
Should an overdose occur, the patient should be treated symptomatically and supportive measures instituted as required.
Unopened bottle for 28, 90 and multipack containing 112 (4 packs of 28) capsules: 3 years.
Unopened bottle for 10 capsules: 2 years.
After first opening: 18 weeks.
Do not store above 30°C. Keep the bottle tightly closed in order to protect from moisture.
The bottle contains one or more sealed canisters containing silica gel to keep the capsules dry. Keep the canisters in the bottle.
White high density polyethylene (HDPE) bottle with a tamper evident seal and a child-resistant closure, together with one or more desiccant canisters containing silica gel.
Pack sizes: 10, 28 or 90 capsules and multipacks containing 112 (4 packs of 28) capsules. Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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