RYALTRIS Nasal spray, suspension (2021)
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Περιεχόμενα
1. Name of the medicinal product
Ryaltris 25 micrograms/actuation+600 micrograms/actuation nasal spray, suspension.
2. Qualitative and quantitative composition
One delivered dose (the dose that leaves the actuator) contains mometasone furoate monohydrate equivalent to 25 microgram mometasone furoate and olopatadine hydrochloride equivalent to 600 micrograms olopatadine. ...
3. Pharmaceutical form
Nasal Spray, Suspension. White, homogeneous suspension.
4.1. Therapeutic indications
Ryaltris is indicated in adults and adolescents 12 years of age and older for the treatment of moderate to severe nasal symptoms associated with allergic rhinitis.
4.2. Posology and method of administration
Posology Adults and adolescents (12 years and older) The usual recommended dose is two actuations in each nostril twice daily (morning and evening). Children below 12 years Ryaltris is not recommended ...
4.3. Contraindications
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. Ryaltris should not be used in the presence of untreated localised infection involving the nasal mucosa, such ...
4.4. Special warnings and precautions for use
Local Nasal Effects Instances of nasal ulceration and nasal septal perforation have been reported in patients following the intranasal application of antihistamines. Instances of nasal septal perforation ...
4.5. Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed with Ryaltris. Any drug drug interactions from the combination of olopatadine and mometasone furoate are expected to reflect those of the components taken individually, ...
4.6. Fertility, pregnancy and lactation
Pregnancy Mometasone Furoate There are no or limited amount of data from the use of mometasone furoate in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). Olopatadine ...
4.7. Effects on ability to drive and use machines
In isolated cases dizziness, lethargy, fatigue and somnolence may occur when using Ryaltris. In these cases, the ability to drive and use machines may be impaired. Alcohol may enhance this effect.
4.8. Undesirable effects
Summary of the safety profile The most commonly reported adverse reaction during treatment with Ryaltris was dysgeusia (a substance-specific unpleasant taste), epistaxis and nasal discomfort. Tabulated ...
4.9. Overdose
With the nasal route of administration overdose reactions are not anticipated. No data are available in humans regarding overdose by accidental or deliberate ingestion. Inhalation or oral administration ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Decongestants and other nasal preparations for topical use, corticosteroids/mometasone, combinations <b>ATC code:</b> R01AD59 Mechanism of action and pharmacodynamic effects ...
5.2. Pharmacokinetic properties
Absorption After repeated intranasal administration of 2 sprays per nostril of Ryaltris (2400 microgram of olopatadine and 100 microgram of mometasone furoate) twice daily in patients with seasonal allergic ...
5.3. Preclinical safety data
Olopatadine Non-clinical data reveal no special hazard for humans based on conventional studies of safety, pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential and toxicity to reproduction. ...
6.1. List of excipients
Microcrystalline cellulose (E460) Dibasic sodium phosphate heptahydrate (E 339) Carmellose sodium (E 466) Sodium chloride Benzalkonium chloride Disodium edetate Polysorbate 80 (E 433) Hydrochloric acid ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
3 years. In-use shelf life (after first use): 2 months.
6.4. Special precautions for storage
Do not freeze.
6.5. Nature and contents of container
The nasal spray is contained in a white, high density polyethylene bottle supplied with a metered-dose, manual polypropylene spray pump actuator. The actuator is fitted with a HDPE purple cap. <u>Pack ...
6.6. Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. Marketing authorization holder
Glenmark Pharmaceuticals s.r.o, Hvezdova 1716/2b, Prague 4, 140 78, Czech Republic
8. Marketing authorization number(s)
PA1543/002/001
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 16th July 2021
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