TESALIN

Krajina: Izrael

Jazyk: angličtina

Zdroj: Ministry of Health

Aktívna zložka:

PETASINS

Dostupné z:

RAFA LABORATORIES LTD

Forma lieku:

TABLETS

Zloženie:

PETASINS 8 MG

Spôsob podávania:

PER OS

Typ predpisu:

Required

Výrobca:

MAX ZELLER SOHNE AG, SWITZERLAND

Terapeutické indikácie:

For the treatment of symptoms of allergic rhinitis (hay-fever) as well as related symptoms in eyes, nose and throat.

Dátum Autorizácia:

2019-05-15

Príbalový leták

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS)
– 1986
This medicine is dispensed without a doctor's prescription
TESALIN
FILM-COATED TABLETS
ACTIVE INGREDIENT:
Each tablet of Tesalin contains: 8 mg petasins. The extract is
produced from the leaves of the
_Petasites hybridus (L.) _plant.
For the list of the additional ingredients, please see section 6.
See also 'Important information about some of the medicine's
ingredients' in section 2.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE.
This leaflet contains concise information about the medicine. If you
have any further
questions, refer to your doctor or pharmacist.
This medicine was prescribed for treating your condition. Do not pass
it on to others. It may
harm them, even if it seems to you that their illness/medical
condition is similar to yours.
1. WHAT IS THE MEDICINE INTENDED FOR?
The medicine is intended for the treatment of symptoms of allergic
rhinitis (hay fever) and
related symptoms in eyes, nose and throat.
THERAPEUTIC GROUP:
Herbal medicine for treatment of hay fever symptoms.
2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:
You are sensitive (allergic) to the active ingredient or to any of the
additional ingredients the
medicine contains (for the list of the additional ingredients, please
see section 6.)
SPECIAL WARNINGS REGARDING THE USE OF THE MEDICINE:
BEFORE STARTING THE TREATMENT WITH TESALIN, TELL YOUR DOCTOR:
•
If you suffer or have suffered in the past from liver problems.
•
If you suffer or have suffered in the past from kidney problems.
•
If you suffer from any allergies.
•
If you suffer from other illnesses or from any medical problem.
ADDITIONAL WARNINGS:
Very rare cases of liver damage (including serious damage), related to
use of the plant root
extracts have been reported. Tesalin contains an extract from the
plant's leaves, but a possible
negative effect on the liver (liver damage) cannot be ruled out.
Therefore, if there is an existing
liver problem, use with cautio

Súhrn charakteristických

1
Tesalin -DL-May 2019 _01
This leaflet format has been determined by the Ministry of Health and
the content thereof has been
checked and approved
in May 2019
1.
NAME OF THE MEDICINAL PRODUCT
Tesalin, tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
P. hybridus leaf native extract Ze 339 corresponding to 8.0mg petasins
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film coated tablet.
_ _
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of symptoms of allergic rhinitis (hay-fever) as well
as related symptoms in
eyes, nose and throat.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults and adolescents from 12 years of age: 2 film coated tablets
distributed over the day.
In cases of high pollen exposure the dosage may be increased to 3
times 1 film coated tablet
per day if needed. The film coated tablet should be swallowed unchewed
with some water.
The tablet intake does not depend on day-time or meals.
The safety and efficacy have not been established in children younger
than 12 years.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substances or to any of the excipients
listed in section 6.1.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
2
Very rare cases of liver damage, including some serious cases, have
been observed
in
association with preparations containing a CO
2
-extract made from roots of
_Petasites hybridus_
.
However, a liver damaging effect cannot be excluded for the CO
2
-extract made from leaves of
_Petasites hybridus _
(Ze 339), which is contained in Tesalin. During treatment, doctors and
patients should therefore look at early signs of liver damage such as
upper abdominal pain,
loss of appetite, jaundice, ocular icterus et al.
There are no own clinical trial results available with patients having
a reduced liver or kidney
function. For these patients it is therefore advised that the
preparation should be taken with
caution and under medical supervision.
The safety and efficacy have not been established yet in children
younger