Balkis 0.1% Nasal Drops

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

BENZALKONIUM CHLORIDE, XYLOMETAZOLINE HYDROCHLORIDE

Available from:

Dolorgiet GmbH & Co. KG Otto-von-Guericke-Str. 1, 53757 Sankt Augustin / Bonn, Germany

ATC code:

R01AA07

INN (International Name):

BENZALKONIUM CHLORIDE 0.5 mg/ml XYLOMETAZOLINE HYDROCHLORIDE 0.1 % (W/V)

Pharmaceutical form:

NASAL DROPS, SOLUTION

Composition:

BENZALKONIUM CHLORIDE 0.5 mg/ml XYLOMETAZOLINE HYDROCHLORIDE 0.1 % (W/V)

Prescription type:

OTC

Therapeutic area:

NASAL PREPARATIONS

Authorization status:

Withdrawn

Authorization date:

2006-11-24

Patient Information leaflet

PACKAGE INSERT 

LOCAL VASOCONSTRICTOR 

BALKIS® 0.05 % NASAL DROPS 

Active Ingredient: Xylometazoline 

COMPOSITION: 1 ml (30 drops approx.) contains: 
_Active ingredient :_ xylometazoline hydrochloride 0.5 mg,
benzalkonium chloride 0.2 mg. 
_Excipients :_ sodium monohydrogen phosphate, potassium dihydrogen
phosphate, sodium 
chloride, water. 

PHARMACOTHERAPEUTIC GROUP : 
Xylometazoline has vasoconstrictive properties and thus exerts a
detumescent effect on the 
mucosa. 

INDICATIONS: 
For the relief of nasal congestion caused by common cold, for
the relief of nasal congestion in 
case of paroxysmal vasomotor rhinitis (rhinitis vasomotorica), for
the decongestion of the 
mucosa in case of rhinitis allergica. 
Balkis 0.05 % Nasal Drops are intended for the use in children
from 2 to 6 years. 

CONTRAINDICATIONS: 
Hypersensitivity to the active ingredient, dry inflammation of the
nasal mucosa (rhinitis sicca), 
babies and infants under 2 years of age, a careful consideration of
the benefit-risk ratio is 
required in case of glaucoma, particularly narrow-angle glaucoma.
A careful consideration of 
the benefit-risk ratio is indicated in case of
severe cardiovascular diseases (e. g. coronary 
heart disease, hypertension), phaeochromocytoma and metabolic
disturbances (e. g. 
hyperthyroidism, diabetes). The same is valid for patients treated
with monamine oxidase 
inhibitors and other potentially hypertensive drugs. Due
to the content of the preservative 
benzalkonium chloride Balkis 0.05 % Nasal Drops must no be
administered in case of 
hypersensitivity to this substance. 
Pregnancy and lactation: Balkis 0.05 % are not recommended for
the use in pregnant women, 
as there are no adequate and well-controlled studies concerning
the effect on the human fetus. 
It is not
known whether the active ingredient xylometazoline is excreted in
human milk. 
Therefore, the drug�

Summary of Product characteristics

Page 1 of 6

SUMMARY OF PRODUCT CHARACTERISTICS 

1. 
NAME OF THE MEDICINAL PRODUCT 

Balkis 0.1 % Nasal Drops 
Balkis 0.05 % Nasal Drops 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Balkis® 0.1 % Nasal Drops 
1 ml of nasal Nasal Drops, solution (^ about 30 drops) contains
1.0 mg of 
xylometazoline hydrochloride; 0.2 mg of benzalkonium chloride 

Balkis® 0.05 % Nasal Drops  
1 ml of Nasal Drops, solution(^ about 30 drops) contains 0.5
mg of 
xylometazoline hydrochloride; 0.2 mg of benzalkonium chloride 

For a full list of excipients, see section 6.1 

3. PHARMACEUTICAL 
FORM 

Nasal drops, solution  

4. CLINICAL 
PARTICULARS 

4.1 THERAPEUTIC 
INDICATIONS 

For the relief of nasal congestion caused by common cold, paroxysmal
vasomotor rhinitis  
(rhinitis varomotorica) and rhinitis allergica. 

Balkis® 0.1 % Nasal Drops are intended for the use in adults
and school children above 6 
years of age. 

    Balkis® 0.05 % Nasal Drops are intended for children from 2
to 6 years of age. 

4.2  POSOLOGY AND METHOD OF ADMINISTRATION 

    Balkis® 0.1 % Nasal Drops 
Unless otherwise prescribed, adults and school children above 6 years
of age, give, if 
necessary, 1 – 2 drops of Balkis® 0.1 % Nasal Drops into each
nostril up to 3 times daily. 
The dosage depends on the individual sensitivity and the clinical
effect. 

    Balkis® 0.05 % Nasal Drops 
Unless otherwise prescribed, give, if necessary, in children
from the age of 2 – 6 years of age, 
1 – 2 Nasal Drops of Balkis® 0.05 % Nasal Drops into each nostril
up to 3 times daily.  

The use of xylometazoline 0.1 % Nasal Drops and 0.05 % Nasal Drops
should be restricted to 
5 days, unless otherwise prescribed. 
Page 2 of 6

  Renewed application only after an interruption of several
days.  

As a general principle, the physician should be consulted concerning
the duration