MIDRO TEA

Country: Ísrael

Tungumál: enska

Heimild: Ministry of Health

Virkt innihaldsefni:

SENNAE FOLIUM

Fáanlegur frá:

NEOPHARM (ISRAEL) 1996 LTD

ATC númer:

A06AB06

Lyfjaform:

TEA

Samsetning:

SENNAE FOLIUM 75 %

Stjórnsýsluleið:

PER OS

Gerð lyfseðils:

Required

Framleitt af:

MIDRO AG, SWITZERLAND

Meðferðarhópur:

SENNA GLYCOSIDES

Lækningarsvæði:

SENNA GLYCOSIDES

Ábendingar:

Laxative.

Leyfisdagur:

2020-03-31

Upplýsingar fylgiseðill

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

Vara einkenni

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