DULCOEASE Capsule, soft (2021)

Βιβλιογραφική αναφορά

Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή

Περιεχόμενα

Name of the medicinal product

Dulcoease 100 mg Capsules.

Qualitative and quantitative composition

Docusate sodium 100 mg. <u>Excipients of known effect:</u> Sorbitol Sunset yellow (E110)

Pharmaceutical form

Capsule, soft. A two colour (opaque white and opaque yellow) soft, oval, gelatin capsule with a clear, colourless liquid fill.

Therapeutic indications

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.

Posology and method of administration

Adults and children 12 years and above 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 ...

Contraindications

Dulcoease is contraindicated in patients with: hypersensitivity to docusate or to any of the excipients abdominal pain if not constipation-related nausea and vomiting intestinal obstruction

Special warnings and precautions for use

Organic disorders should be excluded prior to the administration of any laxative. Each 100 mg capsule contains approximately 19.3 mg of sorbitol, resulting in 96.5 mg sorbitol per maximum recommended daily ...

Interaction with other medicinal products and other forms of interaction

Dulcoease should not be taken concurrently with mineral oil laxatives such as liquid paraffin.

Fertility, pregnancy and lactation

Pregnancy There are no adequate data from the use of the drug in pregnant women. The potential risk for humans is unknown. Nonclinical studies are insufficient with respect to effects on pregnancy and ...

Effects on ability to drive and use machines

None known.

Undesirable effects

The following CIOMS frequency rating is used, when applicable: Very common ≥10%; Common ≥1 and <10%; Uncommon ≥0.1 and <1%; Rare ≥0.01 and <0.1%; Very rare <0.01%; Not known (cannot be estimated from available ...

Overdose

Overdose may cause excessive loss of fluid and electrolytes which require replacement.

Pharmacodynamic properties

Laxatives, softeners, emollients ATC code: A06AA02 Docusate sodium is an anionic wetting agent, which acts as a faecal softener by lowering the surface tension and allowing penetration of accumulated hard ...

Pharmacokinetic properties

Docusate sodium exerts its clinical effect in the gastrointestinal tract. There is some evidence that docusate sodium is absorbed and is excreted in the bile. There is also evidence that docusate sodium ...

Preclinical safety data

None stated.

List of excipients

Macrogol 400 Propylene glycol Gelatin 195 bloom Purified water Sorbitol special (E420) Glycerol Titanium dioxide E171 Quinoline yellow E104 Sunset yellow E110

Incompatibilities

Not applicable.

Shelf life

PVC/PVdC blister packs with aluminium foil: 18 months. Polyethylene/polypropylene containers: 36 months.

Special precautions for storage

Do not store above 25°C. Store in the original package in order to protect from moisture.

Nature and contents of container

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 ...

Special precautions for disposal and other handling

No special requirements.

Marketing authorization holder

Opella Healthcare UK Limited, trading as Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, United Kingdom

Marketing authorization number(s)

PL 53886/0022

Date of first authorization / renewal of the authorization

06/10/2010

Date of revision of the text

01/11/2021

Πηγαίο έγγραφο

Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:

application/pdf