MIDRO TEA

Država: Izrael

Jezik: angleščina

Source: Ministry of Health

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Navodilo za uporabo Navodilo za uporabo (PIL)
09-08-2022
Lastnosti izdelka Lastnosti izdelka (SPC)
04-08-2016

Aktivna sestavina:

SENNAE FOLIUM

Dostopno od:

NEOPHARM (ISRAEL) 1996 LTD

Koda artikla:

A06AB06

Farmacevtska oblika:

TEA

Sestava:

SENNAE FOLIUM 75 %

Pot uporabe:

PER OS

Tip zastaranja:

Required

Izdeluje:

MIDRO AG, SWITZERLAND

Terapevtska skupina:

SENNA GLYCOSIDES

Terapevtsko območje:

SENNA GLYCOSIDES

Terapevtske indikacije:

Laxative.

Datum dovoljenje:

2020-03-31

Navodilo za uporabo

                                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
                                
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Lastnosti izdelka

                                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
                                
                                Preberite celoten dokument
                                
                            

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