Tixocortol pivalate спрей для носа инструкция на русском

Patient Information leaflet

                                Page 1 of 5
 
 
 
 
PIVALONE 
Tixocortol Pivalate Nasal Suspension 
 
CAREFULLY SHAKE THE BOTTLE BEFORE USE 
 
 
COMPOSITION 
Tixocortol
pivalate…………………………………………………………………………………. 1.000g 
N-cetylpyridinium
chloride………………………………………………………………………… 0.020g 
Excipient to…………………………………………………………………………………………… 100g 
 
Bottle containing 10ml of suspension. 
 
PHARMACEUTICAL FORM 
1% tixocortol pivalate nasal suspension (10 ml nasal
spray bottle) 
 
THERAPEUTIC PROPERTIES 
Tixocortol pivalate: local anti-inflammatory corticoid devoid
of systemic effects. 
 
INDICATIONS 
Allergic rhinitis 
Seasonal rhinitis 
Acute congestive rhinitis 
Chronic congestive rhinitis 
Vasomotor rhinitis 
 
CONTRAINDICATIONS 
Antecedent allergy to the product.  
Epistaxis 
Existence of viral or fungal infections during treatment and
existence of significant local 
superinfection 
 
DOSAGE AND ADMINISTRATION 
1 to 2 pulverizations in each nostril 2 to 4 times a day. Do not
exceed the prescribed dose. 
 
SPECIAL WARNINGS AND PRECAUTIONS FOR USE 
To be used after carefully blowing or cleaning the nose. 
 
In the event of systemic signs of bacterial
infection, treatment with a systemic antibiotic must be 
considered. 
 
Events of epidural lipomatosis, central serous
chorioretinopathy and pheochromocytoma crisis 
have been associated with systemic administration
of corticosteroids. Long-term administration 
of inhaled or topical corticosteroid formulations may also be
associated with these potential 
systemic effects. 
Page 2 of 5
 
 
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES 
This medication would not be expected to impair the
ability to drive or use machines. 
 
SIDE EFFECTS 
ADVERSE REACTIONS TABLE 
SYSTEM ORGAN CLAS
                                
                                Read the complete document
                                
                            

Summary of Product characteristics

                                PIVALONE
Tixocortol Pivalate Nasal Suspension
CAREFULLY SHAKE THE BOTTLE BEFORE USE
COMPOSITION
Tixocortol
pivalate……………………………………………………………………
1.000 g
N-cetylpyridinium
chloride……………………………………………………………0.020
g
Excipient
to………………………………………………………………………………100
g
Bottle containing 10 ml of suspension.
PHARMACEUTICAL FORM
1% tixocortol pivalate nasal suspension (10 ml nasal spray bottle)
THERAPEUTIC PROPERTIES
Tixocortol pivalate: local anti-inflammatory corticoid devoid of
systemic effects.
INDICATIONS
Allergic rhinitis
Seasonal rhinitis
Acute congestive rhinitis
Chronic congestive rhinitis
Vasomotor rhinitis
CONTRAINDICATIONS
Antecedent allergy to the product.
Epistaxis
Existence of viral or fungal infections during treatment and existence
of significant local
superinfection
DOSAGE AND ADMINISTRATION
1 to 2 pulverizations in each nostril 2 to 4 times a day. Do not
exceed the prescribed dose.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
To be used after carefully blowing or cleaning the nose.
In the event of systemic signs of bacterial infection, treatment with
a systemic antibiotic must
be considered.
Events of epidural lipomatosis, central serous chorioretinopathy and
pheochromocytoma
crisis have been associated with systemic administration of
corticosteroids. Long-term
administration of inhaled or topical corticosteroid formulations may
also be associated with
these potential systemic effects.
Visual disturbance may be reported with systemic and topical
corticosteroid use. If a patient
presents with symptoms such as blurred vision or other visual
disturbances, the patient should
be considered for referral to an ophthalmologist for evaluation of
possible causes which may
include cataract, glaucoma or rare diseases such as central serous
chorioretinopathy (CSCR)
which have been reported after use of systemic and topical
corticosteroids.
EFFECTS ON ABILITY TO DRIVE AND U
                                
                                Read the complete document
                                
                            

pivalone Dosage

Pivalone nasal spray  Generic drug of the therapeutic class: Otorhinolaryngology
active ingredients: Tixocortol

This drug is indicated in inflammatory and allergic manifestations of the rhino-pharynx: allergic rhinitis, seasonal rhinitis, acute and chronic congestive rhinitis, vaso-motor rhinitis

pivalone indication and Uses

pivalone Dosage

How it works pivalone

1. Local corticosteroid: anti-allergic (Allergology Medicines), anti-inflammatory.
2. Tixocortol pivalate is a corticosteroid with no systemic effects. It has the local efficacy of the reference corticosteroids, but it is devoid of remote action from the application site.
3. Administration in humans, 130 times the daily therapeutic dose, does not cause any systemic glucocorticoid effect.
4. The form PIVALONE Nasal Suspension respects the nasal drainage by the ciliary beat of the pituitary mucosa.

pivalone Side Effects

Like all medicines, PIVALONE 1 PERCENT, nasal suspension is likely to have side effects, although not everybody gets them.

1. Local intolerance reactions (tingling, etc.) may occur at the beginning of treatment.
2. Rare local reactions, either type of dryness of the nasal mucosa or allergic type, local cutaneous manifestations, edema (infiltration of liquid into the superficial tissues of the face and / or mucous membranes and exceptionally laryngeal) have been reported. They give in when the treatment is stopped.
3. Very rarely: possibility of glaucoma (increased pressure inside the eye), cataracts (opacification of the lens of the eye).
4. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. Keep out of the reach and sight of children.

pivalone Interactions

The data available to date do not suggest the existence of clinically significant interactions.

pivalone Warnings and Precautions

Special warnings

Systemic effects may occur during long-term treatment with high doses of nasal corticosteroids.

The risk of systemic repercussions is nevertheless lower than with oral corticosteroids and may vary according to the individual susceptibility and the composition of the corticosteroid medicinal product used. Possible systemic effects are Cushing’s syndrome or cushingoid symptoms, skin thinning, subcutaneous hematomas, adrenal insufficiency, growth retardation in children and adolescents, decreased bone density, cataract and glaucoma, and more rarely, psychological and behavioral disorders including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (especially in children).

Precautions for use

1. To be used after blowing or careful cleaning of the nose.
2. In the event of a general manifestation of bacterial involvement, antibiotic therapy should be considered.

Drive and use machines

Not applicable.

pivalone and PREGNANCY / BREAST FEEDING / FERTILITY

Given the available data, use in pregnant or breastfeeding women is possible.

What happens if I overdose from pivalone ?

Immediately consult your doctor or pharmacist.

In any case, comply with your doctor’s prescription. Do not increase or decrease the dose without the advice of your doctor or pharmacist.

What is  Forms and Composition pivalone?