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Product Prescribing Information
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BALKIS


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  • Prescription Information
  • Composition


    Balkis® 0.1 % Nasal Drops:

    1 ml of Nasal Drops, solution (≜ about 30 drops) contains:

    Active ingredient: 

    Xylometazoline hydrochloride                            1.0 mg 

    Inactive ingredient: (as preservative agent)

    Benzalkonium chloride                                        0.2 mg

    Balkis® 0.05 % Nasal Drops: 

    1 ml of Nasal Drops, solution (≜ about 30 drops) contains: 

    Active ingredient:

    Xylometazoline hydrochloride                           0.5 mg

    Inactive ingredient: (as preservative agent)

    Benzalkonium chloride                                        0.2 mg

    Excipients: Sodium monohydrogen phosphate, potassium dihydrogen phosphate, sodium chloride, water (purified).


    Therapeutic Indications


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

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

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


    Dosage and Administration


    Balkis® 0.1 %/0.05 % Nasal Drops are determined for nasal application.

    Bring one drop of the solution in each nostril 2-3 times daily. 

    The single dose for Balkis® 0.1 %/0.05 % Nasal Drops must not be administered more than three-times daily. 

    Balkis® 0.1 %/0.05 % Nasal Drops must not be applied longer than 7 days.

    Do not apply higher doses than recommended.


    Contraindications


    This pharmaceutical product must not be used in case of:

    Hypersensitivity to the active substance or to any of the excipients.

    Dry inflammation of the nasal mucosa (rhinitis sicca).

    State after transsphenoidal hypophysectomy or other operations, which lay open the dura mater.

    Balkis® 0.1 % Nasal Drops, additionally, is contraindicated in infants under 6 years of age.

    Balkis® 0.05 % Nasal Drops, additionally, is contraindicated in nurslings and infants up to 2 years of age.


    Warnings and Precautions


    Single reports suggest side effects (especially apnoea) in case of use of therapeutic doses in this age group. Exceeded doses have to be avoided imperatively.

    A careful consideration of the benefit-risk ratio is indicated in case of:

    Patients treated with monoamine oxidase inhibitors and other potentially hypertensive drugs.

    Glaucoma, particularly narrow-angle glaucoma.

    Severe cardiovascular diseases (e. g. coronary heart disease, hypertension).

    Phaeochromocytoma.

    Metabolic disturbances (e. g. hyperthyroidism, diabetes mellitus).

    Porphyria.

    Prostatic hyperplasia.

    Especially in case of longer application and overdosage of sympathomimetic agents, the efficacy may abate. The consequences of a misuse of decongesting rhinologic agents may be:

    A reactive hyperaemia of the nasal mucosa (rhinitis medicamentosa).

    Atrophy of the nasal mucosa (atrophic rhinitis).

    It may be considered in mild cases to withdraw the sympathomimetic agent initially in one nostril and to change to the other side when the symptoms have abated in order to maintain the nasal respiration at least partly.

    Warnings:

    The preserving agent (Benzalkonium chloride) included in Balkis® may, especially in case of long-term administration, cause a swelling of the nasal mucous membrane. In case such a reaction is suspected (continuously stiffed up nose), a pharmaceutical product for the use in the nose without preserving agent should – as far as possible – be administered. If such medicinal products for the use in the nose without preserving agent are not available, a different dosage form should be considered.


    Drug Interactions


    Combined application of Xylometazoline and:

    Tricyclic antidepressants,

    Monoaminooxidase-inhibitors of the tranylcypromine-type,

    Vasopressor agents,

    May result in an increase in blood pressure. Therefore a combined application should be abstained from.


    Pregnancy and Lactation


    Pregnancy:

    Data on a limited number of pregnant women in the first trimester do not suggest any side effects of xylometazoline concerning pregnancy or health of the fetus/newborn. No relevant epidemiological data have been available so far. Animal experiments showed reproduction toxicity above the therapeutic dose level. 

    In pregnancy, Balkis® 0.1 %/0.05 % Nasal Drops should be applied only after a careful consideration of the benefit/risk ratio. As an overdosage might impair the blood supply of the unborn child, the recommended dosage may not be exceeded during the pregnancy.

    Lactation:

    It is not known whether xylometazoline penetrates into the breast milk. Therefore, Balkis® 0.1 %/0.05 % Nasal Drops should be applied only after a careful consideration of the benefit/risk ratio. As an overdosage might decrease the milk production, the recommended dosage must not be exceeded during lactation.


    Effects on ability to drive and to use machines


    Balkis® 0.1 %/0.05 % Nasal Drops have no influence on the ability to drive and to use machines.




    Undesirable Effects


    The following categories are taken as a basis for the frequency data of side effects:

    Very common (>1/10); Common (>1/100 to < 1/10); Uncommon (>1/1.000 to < 1/100); Rare (>1/10,000 to < 1/1.000);

    Very rare (<1/10,000); Not known (cannot be estimated from the available data).

    Nervous system disorders:

    Very rare: Agitation, insomnia, fatigue (drowsiness, sedation), headaches, hallucinations (primarily in children).

    Cardiac disorders:

    Rare: Palpitations, tachycardia, hypertension.

    Very rare: Arrhythmia.

    Respiratory, Thoracic and Mediastinal disorders:

    Common: Burning and desiccation of the nasal mucosa, sneezing.

    Uncommon: After abating of the efficacy, increased congesting swelling of the muscosa, nose bleed.

    Musculoskeletal and Connective tissue disorders:

    Very rare: Convulsions (especially in children).

    Immune system disorders:

    Uncommon: Hypersensitivity reactions (Quincke´s edema, skin rash, pruritits).


    Overdose


    The clinical picture of an intoxication with imidazole derivates can be confusing, as phases of stimulation may change with phases of a suppression of the central nervous system and of the cardiovascular system.

    Symptoms of a stimulation of the central nervous system are: anxiety, agitation, hallucinations and convulsions.

    Symptoms of an inhibition of the central nervous system are: decrease of the body temperature, lethargy, drowsiness and coma.

    The following further symptoms may occur: Miosis, mydriasis, perspiration, fever, pallor, cyanosis, nausea, tachycardia, bradycardia, cardiac arrhythmia, cardiac arrest, hypertension, shock-like hypotension, pulmonary edema, respiratory disturbances and apnea.

    Especially in children, dominating central nervous effects with convulsions and coma, bradycardia, apnea as well as hypertension occur frequently which may be alternated by hypotension.

    Therapeutic measures in case of overdose:                                                                                                           

    An intensive therapy in hospital is indicated in case of severe overdosage.                                                                          

    Charcoal (absorbent) or sodium sulphate (laxative) should be given or a gastric lavage (in case of great amounts) carried out immediately as xylometazoline might be absorbed fast. A non-selective alpha-blocker can be given in order to lower the blood pressure.  

    Vasopressions are contraindicated. If necessary, antipyretic, anticonvulsive and oxygen therapy.


    Pharmacological Properties


    Pharmacodynamic properties:

    Pharmacotherapeutic group: Rhinologic agents, alpha-symphatomimetic agent.

    Xylometazoline, an imidazole derivate is a sympathomimetic having an alpha-adrenergic effect. Its effect is vasoconstricting and results in a decongestion of the mucosae. The onset of action generally occurs within 5-10 minutes and results in a relief of nasal respiration due to decongestion of the mucosa and an improved outflow of secretion.

    Pharmacokinetic properties:

    The onset of action of Balkis® 0.1 %/0.05 % Nasal Drops occurs within a few minutes and lasts for several hours (6 – 8 hours) on an average.

    Occasionally, after intranasal application, the absorbed amount may be sufficient to cause systemic effects such as in the central nervous system and in the cardiovascular system.

    Data from pharmacokinetic tests in the human being are not available.


    Storage


    Store at a temperature not exceeding 30°C.

    This pharmaceutical product must not be used after the expiry date.


    Packaging


    Balkis® 0.1 % Nasal Drops: 10 ml dropper bottle.

    Balkis® 0.05 % Nasal Drops: 10 ml dropper bottle.





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