Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: Opella Healthcare UK Limited, trading as Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, United Kingdom
Prevention and treatment of chronic constipation. Prevention of hard, dry stools and reduction of straining at stools in the presence of conditions like haemorrhoids or anal fissures.
Up to maximum of 500 mg should be taken daily in divided doses.
Treatment should be commenced with large doses such as 100 mg three times daily, which should be adapted to the treatment response.
Dulcoease is not recommended for use in children under the age of 12 years.
The patient should be advised to consult a physician when constipation persists or worsens during treatment or when laxatives are needed for a long period of time.
Oral use. The capsules should be swallowed whole with a glass of water.
No specific dose adjustment is necessary for elderly patients.
Overdose may cause excessive loss of fluid and electrolytes which require replacement.
PVC/PVdC blister packs with aluminium foil: 18 months.
Polyethylene/polypropylene containers: 36 months.
Do not store above 25°C.
Store in the original package in order to protect from moisture.
PVC/PVdC blister packs with aluminium foil containing 10, 20, 30, 40, or 50 capsules.
Polyethylene/polypropylene containers, e.g.: securitainers/tampertainers containing 30, 100 and 250 capsules.
Not all pack sizes may be marketed.
No special requirements.
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