SENOKOT Syrup (2018)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Senokot 7.5 mg/5 ml Syrup.
Qualitative and quantitative composition
Each 5 ml of Senokot Syrup contains calcium sennosides equivalent to 7.5 mg per 5 ml total sennosides (calculated as sennoside B). Also contains maltitol syrup (E965), methyl parahydroxybenzoate (E218), ...
Pharmaceutical form
Syrup. Amber, slightly viscous liquid.
Therapeutic indications
As a laxative for the relief of occasional or non-persistent constipation.
Posology and method of administration
Senokot 7.5 mg/5 ml Syrup is for oral administration. The correct individual dose is the smallest required to produce a comfortable soft-formed motion. <u>Adults, including the elderly and children over ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients. Not to be used the same time as other laxative agents. Cases of intestinal obstructions and stenosis, atony, appendicitis, inflammatory ...
Special warnings and precautions for use
If there is no bowel movement after three days, a doctor should be consulted. If laxatives are needed every day or abdominal pain persists, a doctor should be consulted. If laxatives are needed every day ...
Interaction with other medicinal products and other forms of interaction
Hypokalaemia (resulting from long-term laxative abuse) potentiates the action of cardiac glycosides and interacts with antiarrhythmic medicinal products with medicinal products which induce reversion to ...
Fertility, pregnancy and lactation
Pregnancy There are no reports of undesirable or damaging effects during pregnancy and on the foetus when used at the recommended dosage. However, as a consequence of experimental data concerning a genotoxic ...
Effects on ability to drive and use machines
No studies on the effect on the ability to drive and use machines have been performed.
Undesirable effects
Adverse events which have been associated with sennosides at OTC doses in short-term use are given below, tabulated by system organ class and frequency. In the treatment of chronic condition, under long-term ...
Overdose
Symptoms Where diarrhoea is severe, conservative measures are usually sufficient; generous amounts of fluid, especially fruit drinks, should be given. The major symptoms of overdose/abuse are griping pain ...
Pharmacodynamic properties
<b>Pharmaco-therapeutic group:</b> contact laxatives <b>ATC-code:</b> A06AB The sugar moiety of the sennosides is removed by bacteria in the large intestine releasing the active anthrone fraction. This ...
Pharmacokinetic properties
The action of the sennosides is colon specific and does not depend upon systemic absorption. The β-Ο-linked glycosides (sennosides) are neither absorbed in the upper gut nor split by human digestive enzymes. ...
Preclinical safety data
There are no new, systematic preclinical tests for senna leaves or preparations thereof. Data derive from investigations with senna pods. Since the spectrum of constituents of senna leaf and fruit is comparable ...
List of excipients
Potassium sorbate E202 Methyl parahydroxybenzoate E218 Propyl parahydroxybenzoate E216 Maltitol liquid E965 Xanthan gum Anti-foam (Medical C) emulsion Prune flavour Citric acid anhydrous Purified water ...
Incompatibilities
None known.
Shelf life
13 months.
Special precautions for storage
Do not store above 25°C. Do not freeze.
Nature and contents of container
Glass bottle with a polypropylene cap with a polyethylene tamper-evident band with an expanded polyethylene wad containing 100, 150 or 200 ml syrup.
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Reckitt Benckiser Healthcare (UK) Limited, Dansom Lane, Hull, HU8 7DS, United Kingdom
Marketing authorization number(s)
PL 00063/0123
Date of first authorization / renewal of the authorization
8<sup>th</sup> April 2005
Date of revision of the text
11/07/2018
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