Otrivine Sinusitis Relief 0.1% w/v Nasal Spray, Solution

Addition of detailed warnings about the interactions of tri- and tetra-cyclic antidepressants, monoamine oxidase inhibitors, anti-hypertensives and Xylometazoline

Addition of "Other Medicines and Otrivine" detailing warnings about the interactions of tri- and tetra-cyclic antidepressants, monoamine oxidase inhibitors, high blood pressure medications and Xylometazoline

Update of HPRA reporting information, update to in-use shelf life from once opened use within 28 days to once opened, can be used until the end of the shelf-life. Update of information regarding container used.

Change of priming information under How to use.

Removal of 'Do not use this bottle for more than 28 days after opening it'.

Update trade mark statement.

SPC Changes – Otrivine Adult Measured Dose Sinusitis 0.1% w/v Nasal Spray, Solution – 20 June 2014

Section 7

Address changed to Camberley.

Section 10

Change of date from 24 March 2014 to 20 June 2014.

SPC Changes – Otrivine Adult Measured Dose Sinusitis 0.1% w/v Nasal Spray, Solution 24 March 2014

Section 2

Qualitative and Quantitative Composition slightly reworded.

Removed: “For full list of excipients, see section 6.1”.

Section 3

Added “nasal spray” in brackets.

Section 4.2

Posology and Method of Administration section reworded.

Added: “Do not exceed 3 applications daily into each nostril.”

Paediatric population section added & several points added with information on Application.

Section 4.3

Contraindications section reworded.

Inserted: “Use in patients who are receiving monoamine oxidase inhibitors, or within 14 days of stopping such treatments.”

“Use in acute coronary disease, hyperthyroidism or narrow angle glaucoma.”

Section 4.4

After “consecutive days” added: “Prolonged or excessive use may cause rebound congestion.”

Special Warnings and Precautions for Use section reworded;

After “insomnia, dizziness” added: “tremor, cardiac arrhythmias or elevated blood pressure.”

Added further warnings for patients with hypertension, cardiovascular disease, diabetic and prostatic enlargement.

Addition of paragraph:

“Otrivine Adult Measured Dose Sinusitis Nasal Spray contains benzalkonium chloride which may cause nasal irritation and bronchospasm.

Do not exceed the recommended dose, especially in children and in the elderly.

For prevention of cross infection, it is recommended that each product package is used by one person only.”

Section 4.5

Added information to heading “Interactions with other Medicaments and other forms of Interaction”

Section 4.6

Under subheading “Pregnancy:” removed: “Label warning: If you are pregnant or taking any other medicines, or are under a doctor’s care, consult him before using Otrivine.”

Added subheadings with information on: “Fertility” & “Breastfeeding”

Section 4.7

“None” replaced with: “Otrivine Adult Measured Dose Sinusitis Nasal Spray has no or negligible influence on the ability to drive or use machines.”

Section 4.8

Removed: “The following side effects have occasionally been encountered: A burning sensation in the nose and throat, local irritation, nausea, headache, and dryness of the nasal mucosa.”

Adverse frequency descriptions added. Adverse events reactions listed and information on reporting suspected adverse reactions added.

Section 4.9

Overdose section reworded.

Removed: “No cases of overdosage in adults have yet been reported.” 

Section 5.1

Added Pharmacotherapeutic group and ATC code; section slightly reworded.

Added: “In a double-blind, saline solution controlled study in 61 patients with common cold, the decongestant effect of Otrivine 0.1% solution was significantly superior (p<0.0001) to saline solution based on rhinomanometry measurement.”

Section 5.2

Added: “Plasma concentrations of xylometazoline in man after local nasal application of the product are very low and close to the limit of detection.”

Section 6.1

“Liquid” added before “Sorbitol” and “(non-crystallising)” added after

Section 6.6

The Heading changed from: “Instructions for Use/Handling” to “Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product”

Section 10

Change of date from 20 April 2011 to 24 March 2014.

Section 1

Change of product name from Otrivine Adult Measured Dose Sinusitis Spray to Otrivine Adult Measured Dose Sinusitis 0.1% w/v Nasal Spray, Solution.

Section 7

Addition of new heading ‘Administrative Data’ just above this section.

Section 10

Change of date from 25 August 2006 to April 2011

Section 2: Addition of: “Excipients: Benzalkonium chloride”

Section 3: Text revised to: “a clear, colourless, virtually odourless solution”

Section 6.1: E number added

Section 6.2: Text revised from “None” to “Not applicable”

Section 6.4: text revised from “no special precautions” to “this medicinal product does not require any special storage conditions”

Section 6.6: Text revised from “medicines should be kept out of the reach of children” to “no special requirements”

Section 9: Updated renewal of authorisation

Section 10: Revision date changed