TINDEN DROPS

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

DIMETINDENE MALEATE

Available from:

TRIMA ISRAEL PHARMACEUTICAL PRODUCTS MAABAROT LTD

ATC code:

R06AB03

Pharmaceutical form:

ORAL DROPS

Composition:

DIMETINDENE MALEATE 1 MG / 1 ML

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

TRIMA ISRAEL PHARMACEUTICAL PRODUCTS MAABAROT LTD, ISRAEL

Therapeutic area:

DIMETINDENE

Therapeutic indications:

Antipruritic, antihistaminic and antiallergic.

Authorization date:

2023-06-30

Patient Information leaflet

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) - 1986
The dispensing of this medicine requires a doctor’s
prescription
TINDEN DROPS
ACTIVE INGREDIENT AND ITS QUANTITY PER DOSAGE UNIT:
1 ml contains 1 mg dimetindene maleate
(each drop contains 0.05 mg)
dimetindene maleate 1 mg/ml
Inactive ingredients and allergens: See chapter 2, section:
‘Important information about some of this medicine’s
ingredients’ and chapter 6: ‘Additional information’.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START
USING THIS MEDICINE. This leaflet contains concise
information about this medicine. If you have any further
questions, consult your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass
it on to others. It may harm them, even if it seems to you
that their medical condition is similar to yours.
The medicine is not intended for infants below the age
of 1 month.
1. WHAT IS THIS MEDICINE INTENDED FOR?
TINDEN DROPS is an anti pruritic, antihistamine and anti
allergic medicine.
THERAPEUTIC GROUP: The medicine belongs to the anti
histamines class.
TINDEN DROPS are intended for oral use.
2. BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE:
If you are sensitive (allergic) to the active ingredient
dimetindene
maleate
or
to
any
of
the
other
ingredients
that
this
medicine
contains
.
In infants below the age of 1 month, especially
preterm infants.
In such cases, talk to your doctor or pharmacist since
this means that TINDEN DROPS is not suitable for you.
SPECIAL WARNINGS REGARDING USING THIS MEDICINE
BEFORE YOU START TAKING TINDEN DROPS, TELL YOUR DOCTOR
IF YOU SUFFER FROM:
glaucoma
urinary retention (for example, due to enlargement of
the prostate gland)
epilepsy
chronic obstructive pulmonary disease or any other illness
CHILDREN AND ADOLESCENTS
TINDEN
DROPS
should
be
used
in
young
children
aged 1 month to 1 year only according to the doctor’s
recommendation. Do not exceed the recommended dose.
The sedative effect may be accompanied by pauses
in breathing during s