Šalis: Izraelis
kalba: anglų
Šaltinis: Ministry of Health
SENNAE FOLIUM
NEOPHARM (ISRAEL) 1996 LTD
A06AB06
TEA
SENNAE FOLIUM 75 %
PER OS
Required
MIDRO AG, SWITZERLAND
SENNA GLYCOSIDES
SENNA GLYCOSIDES
Laxative.
2020-03-31
MIDRO ® TEA _MIDRO _ _ _ 1 N AME OF THE M EDICINAL P RODUCT Midro Tea 2 Q UALITATIVE AND Q UANTITATIVE C OMPOSITION _Active substance: Sennae folium _(senna leaf). For excipients, see 6.1. 1 g tea contains 750 mg senna leaves, corresponding to 19–21 mg hydroxyanthracene derivatives calculated as sennoside B. 3 P HARMACEUTICAL F ORM Tea 4 C LINICAL P ARTICULARS 4.1 THERAPEUTIC INDICATIONS Laxative 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults and children aged 12 years and older: take 0.5 to 1.5 g (e.g. to 1 measuring spoonfuls or to 1 sachet) in the evening, preferably 1 hour before bedtime, by chewing and/or swallowing with some water. The daily dose may vary from one individual to another. Treatment should normally start with a small dose (e.g. measuring spoonful or sachet), which should be increased according to need. The maximum daily dose must not exceed 30 mg hydroxyanthracene derivatives, which corresponds to 1 measuring spoonfuls or 1 sachet. The correct individual dose is the smallest dose needed to obtain soft and well- formed stools. The product may be taken only occasionally and for no longer than 1 to 2 weeks. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Diseases of the gastrointestinal tract (acute bowel inflammation, such as Crohn’s disease and ulcerative colitis, strictures of the gastrointestinal system, intestinal obstruction or suspected appendicitis, abdominal pain of unknown origin); severe dehydration with fluid and electrolyte losses; hypersensitivity to the active substance or to any of the excipients according to the composition. Children under 12 years. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE The long-term use of laxatives must be avoided. Abuse with subsequent loss of fluid and electrolytes can have undesirable consequences such as: dependence, possibly accompanied by the need to increase the dose, fluid and electrolyte imbalance (mainly hypokalaemia), as well as colonic atony with functional restriction I Perskaitykite visą dokumentą
MIDRO ® TEA ________________________________________________________________________________________________________________ _MIDRO _ _________________________________________________________________________________________________________________ NAME OF THE MEDICINAL PRODUCT Midro Tea _ _ _COMPOSITION_ _Active substance: Sennae folium_ (senna leaf). _Excipients: _caraway fruit, peppermint leaf, liquorice root, common mallow flowers, larkspur flowers. _ _ _PHARMACEUTICAL FORM AND AMOUNT OF ACTIVE SUBSTANCE PER UNIT_ 1 g tea contains 750 mg senna leaves, corresponding to 19–21 mg hydroxyanthracene derivatives calculated as sennoside B. _ _ Therapeutic _INDICATIONS_ Laxative _ _ _POSOLOGY/METHOD OF ADMINISTRATION_ Adults and children aged 12 years and older: take 0.5 to 1.5 g (e.g. ¼ to 1½ measuring spoonfuls or ½ to 1 sachet) in the evening, preferably 1 hour before bedtime, by chewing and/or swallowing with some water. The daily dose may vary from one individual to another. Treatment should normally start with a small dose (e.g. ¼ measuring spoonful or ½ sachet), which should be increased according to need. The maximum daily dose must not exceed 30 mg hydroxyanthracene derivatives, which corresponds to 1½ measuring spoonfuls or 1 sachet. The correct individual dose is the smallest dose needed to obtain soft and well- formed stools. The product may be taken only occasionally and for no longer than 1 to 2 weeks. _ _ _CONTRAINDICATIONS_ Diseases of the gastrointestinal tract (acute bowel inflammation, such as Crohn’s disease and ulcerative colitis, strictures of the gastrointestinal system, intestinal obstruction or suspected appendicitis, abdominal pain of unknown origin); severe dehydration with fluid and electrolyte losses; hypersensitivity to the active substance or to any of the excipients according to the composition. Children under 12 years. _ _ _WARNINGS AND PRECAUTIONS_ The long-term use of laxatives must be avoided. Abuse with subsequent loss of fluid and electrolytes can have undesirable conse Perskaitykite visą dokumentą