AF TIPA

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

OXYMETAZOLINE HYDROCHLORIDE

Available from:

PADAGIS ISRAEL AGENCIES LTD, ISRAEL

ATC code:

R01AA05

Pharmaceutical form:

NASAL SPRAY, SOLUTION

Composition:

OXYMETAZOLINE HYDROCHLORIDE 0.05 %W/V

Administration route:

NASAL

Prescription type:

Not required

Manufactured by:

PERRIGO COMPANY, USA

Therapeutic group:

OXYMETAZOLINE

Therapeutic area:

OXYMETAZOLINE

Therapeutic indications:

Relief of nasal congestion, which is a result of common colds, sinusitis, hay fever or allergies of the upper respiratory system.

Authorization date:

2023-01-31

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
AF TIPA
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
0.05%W/V Nasal Spray
1 ml of solution contains 0.5 mg of oxymetazoline hydrochloride.
1 dose (110 microliters) contains 55 micrograms of oxymetazoline
hydrochloride.
INN: _Oxymethazolinum_
Excipient(s) with known effect:
Benzalkonium chloride 0.54 mg/ml;
Benzyl alcohol 2.47 mg/ml.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Nasal spray, solution
A viscous, white to off-white liquid with a pH of 4.0 to 6.5
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Relief of nasal congestion, which is a result of common colds,
sinusitis, hay fever or allergies of the upper
respiratory system.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
2 to 3 sprays in each nostril twice a day, at the morning and evening.
Do not exceed the stated dose.
Oxymetazoline should not be used for longer than 3 days unless
prescribed otherwise by the doctor.
Method of administration
Shake well before use.
Before first use, prime the unit by depressing the pump twice. Blow
your nose gently. While holding upright,
the spray nozzle should be inserted into each nostril in turn and the
pump squeezed according to dosage while
breathing in. Wait for 3-5 minutes. Blow your nose gently again. If
necessary repeat the actions.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1, or known sensitivity to
sympathomimetic substances.
Af Tipa should not be used in:
−
−
−
−
−
patients taking monoamine oxidase inhibitors (MAOIs) or patients who
have taken MAOIs in the
previous two weeks;
patients with narrow-angle glaucoma;
patients after transsphenoidal hypophysectomy;
patients with known hypersensitivity or idiosyncrasy to any
ingredients;
patients with inflammation of the skin and mucosa of the nasal
vestibule and encrustation
(rhinitis sicca);
−
patients with acute cardiovascular disease or cardiac asthma.
Af Tipa should not be used in