RHINOLAST Nasal spray Ref.[49937] Active ingredients: Azelastine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2022  Publisher: Mylan Products Ltd, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

4.3. Contraindications

Proven allergy against azelastine hydrochloride.

4.4. Special warnings and precautions for use

None.

4.5. Interaction with other medicinal products and other forms of interaction

No specific interactions have been studied.

4.6. Pregnancy and lactation

At high oral doses in animals, 500 times the proposed oral human daily dose, foetal death, growth retardation and an increased incidence of skeletal abnormalities occurred during reproduction toxicity testing. Due to the nasal route of administration and the low dose administered, minimal systemic exposure can be expected. However as with all medicines caution should be exercised with use during pregnancy and lactation.

4.7. Effects on ability to drive and use machines

None.

4.8. Undesirable effects

The following frequencies of undesirable effects were reported:

Commonly (1-10%), a substance-specific bitter taste may be experienced after administration (often due to incorrect method of application, namely tilting the head too far backwards during administration) which, in rare cases, may lead to nausea.

Uncommonly (0.1-1%), a mild, transient irritation of the inflamed nasal mucosa may occur with symptoms such as stinging, itching, sneezing and epistaxis.

In very rare cases (<0.01%), hypersensitivity reactions (such as rash, pruritus, urticaria) were reported.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

6.2. Incompatibilities

None.

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