FENISTIL DROPS

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

DIMETINDENE MALEATE

Available from:

GSK CONSUMER HEALTHCARE, ISRAEL LTD

ATC code:

R06AB03

Pharmaceutical form:

DROPS

Composition:

DIMETINDENE MALEATE 1 MG/ML

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

NOVARTIS CONSUMER HEALTH SA, SWITZERLAND

Therapeutic group:

DIMETINDENE

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 medicine is dispensed with a doctor's prescription only
Fenistil Drops 1 mg/ml
Active ingredient and its quantity in a dosage unit:
Each 1 ml contains: Dimethindene Maleate 1 mg/ml (each drop contains:
0.05 mg).
For a list of inactive ingredients and allergens in the preparation
– please see section 6.
Read the entire leaflet carefully before using the medicine. This
leaflet contains concise
information about the medicine. If you have additional questions,
refer to the doctor or the
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. This medicine is
not intended for children under
the age of 1 month.
1. What is the medicine intended for?
Anti-pruritic, anti-histamine and anti-allergic.
Therapeutic class: the medicine belongs to a group of preparations
that bind to the histamine H1
receptor.
Fenistil Drops inhibits the action of histamine, which is one of the
substances released during allergic
reactions. Fenistil Drops relieves itch and skin irritation caused by
allergic reactions, reduces edema
(a pathological accumulation of fluids in the skin or in the mucous
membranes) and relieves
symptoms of allergic rhinitis, such as runny nose and watery eyes as
well as sneezing.
2. Before using the medicine
Do not use this medicine:

If you are sensitive (allergic) to the active ingredient or any of the
additional components the
medicine contains (see section 6).

In babies under 1 month of age, especially in preterm infants.
Special warnings regarding the use of the medicine
Before treatment with Fenistil Drops, inform the doctor if you have:

Glaucoma

Urinary retention (e.g., enlarged prostate)

Epilepsy

Chronic obstructive pulmonary disease (COPD) or another disease
The elderly:
A doctor should be consulted before starting treatment with the
medicine, since side effects such as
restlessness

Summary of Product characteristics

1
FENISTIL
® DROPS
_ _
_COMPOSITION _
_Active substance: _Dimethindene maleate.
_Excipients: _
Purified Water, Propylene Glycol, Disodium Phosphate dodecahydrate,
Citric Acid
Monohydrate, Benzoic acid, Disodium edetate, Saccharin sodium
1 ml Fenistil drops contains 2.24 mg of sodium
_PHARMACEUTICAL FORM AND QUANTITY OF THE ACTIVE SUBSTANCE PER UNIT _
Oral drops, solution
1 mL (=20 drops) contains: 1 mg of dimethindene maleate.
_ _
_INDICATIONS/POSSIBLE USES _
Antipruritic, antihistaminic and antiallergic.
_ _
_POSOLOGY/METHOD OF ADMINISTRATION _
_Adults and adolescents over 12 years of age: _
The daily recommended dose is 3 to 6 mg of dimethindene maleate
divided into 3 doses;
this corresponds to:
_Drops 1 mg/ml:_ 20-40 drops, 3x per day.
In patients with a tendency to drowsiness, it is recommended to
prescribe 40 drops
before bedtime, and 20 drops in the morning at breakfast.
_ _
_Children: _
In small children from 1 month to 1 year of age, Fenistil Drops should
only be used
according to a doctor's recommendations and upon strict medical
indication for
antihistamines. The recommended dose should not be exceeded.
Caution should be used when administering drops to children under 1
year of age. The
sedative effect may be associated with episodes of sleep apnoea.
The recommended daily dose is 0.1 mg/kg of body weight per day (this
corresponds to 2
drops per kg of body weight per day, divided into 3 doses).
The usual daily doses for children from 1 month to 12 years of age and
based on body
weight, are therefore the following:_ _
_ _
Age/Weight _ _
Dose in mg _ _
Dose in drops _ _
_ _
1 month to 1 year/ 4.5-15 kg_ _
0.15-0.5 mg three times per day
3-10 drops three times per day
1-3 years/15-22.5 kg
0.5-0.75 mg three times per day
10-15 drops three times per day
3-12 years/22.5-30 kg
0.75-1 mg three times per day
15-20 drops three times per day
20 drops = 1 mL = 1 mg of dimethindene maleate.
1 drop = 0.05 mg of dimethindene maleate._ _
2
_ _
Fenistil Drops_ _cannot withstand high temperatures; before feeding
pour the