I-Rinse Spray

Saline Nasal Solution IP

Sodium Chloride IP…………………………. 0.9 % w/v

in Purified Water IP q.s.

Nasal Spray

Sodium Chloride (0.9%w/v)

4.1 Therapeutic Indication 

• Gently cleans the nasal cavities when nose is blocked during colds or in allergic conditions.
• Moisturises the nasal mucosa when dry or irritated.
• Thins and loosens nasal secretions and helps their removal.

4.2 Posology and method of administration

Method of administration: Nasal use

Infants and toddlers up to 2 years: 1 spray/ nostril or 1-2 drops/nostril.

Adults and children > 2 years: 1-2 spray/ nostril or 2-3 drops/ nostril as needed. The usual frequency of use is 2 to 4 times a day per nostril. I Rinse is suitable for infants, children and adults. Seek medical advice before using I Rinse in an infant less than 2 weeks old. For children below 11 years, I Rinse should be used under adult supervision. For hygienic reasons and to avoid contamination, the nasal spray should be used by one person.

Method of Administration

I-Rinse can be used in any position. Remove the protective cap. Delicately insert the nozzle into the nostril. Press the nozzle, spray as long as necessary and allow the excess solution to trickle down. Clear your nose after 30 secs to 1 min. Repeat the procedure if required. Wash the nozzle with soapy water, wipe dry and replace protective cap. For infants & children administer under supervision.

4.3 Contraindications

Hypersensitivity to the active substance.

4.4 Special warnings and precautions for use 

• Consult a doctor before use if you are using the product after nasal surgery or injury.
• Due to its cleansing properties, it should be used first when using another local nasal product (e.g. for cold or allergic rhinitis).
• Keep out of reach and sight of Children.
• Do not use a broken, expired or damaged product.

4.5 Drugs interactions

No known drug-drug interaction.

4.6 Use in special populations

I Rinse nasal spray may be used during pregnancy and breast-feeding.

4.7 Effects on ability to drive and use machines

None known.

4.8 Undesirable effects

Stinging, sneezing increased nasal discharge or salty taste may occur. If any of these effects persists or worsen, notify your doctor. Tell your doctor immediately if frequent nosebleeds occur. If you notice any other effects not listed above, contact your doctor. 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 email to: medico@zuventus.com

Website: https://www.zuventus.com/drug-safety-reporting

By reporting side effects, you can help provide more information on the safety of this medicine.

4.9 Overdose

Treatment should be supportive and systematic.

5.1 Mechanism of Action/Pharmacodynamic properties

The exact mechanism of action of saline nasal irrigation is unknown. One possibility is that the breakdown of the protective function of the nasal mucosa plays a role in upper respiratory conditions. Saline nasal irrigation may improve nasal mucosa function through several physiologic effects, including direct cleansing, removal of inflammatory mediators and improved mucociliary function, as suggested by increasing ciliary beat frequency.

5.2 Pharmacokinetic properties

Absorption

Sodium chloride distributes primarily to extracellular compartments, including plasma and interstitial fluid; sodium is maintained outside the cell via the Na+/K+-ATPase pump, which exchanges intracellular sodium for extracellular potassium. Penetration across the blood-brain barrier is low. Sodium chloride is excreted primarily in the urine, but it is also excreted in sweat and stool. In healthy patients at steady state with minimal sweat losses, sodium excreted in urine is roughly the same as dietary intake. Sweat sodium concentration is increased in children with cystic fibrosis, aldosterone deficiency, or pseudohypoaldosteronism.

6.1 Animal Toxicology or Pharmacology

Not available.

Sodium chloride, also known as salt, common salt, table salt or halite, is an ionic compound with the chemical formula NaCl, representing a 1:1 ratio of sodium and chloride ions. Molecular Weight : 58.44 g/mol.

8.1 Incompatibilities

None known.

8.2 Shelf-life

Refer on the pack.

8.3 Packaging information

8.4 Storage and handing instructions

• Pressurised container. Keep away from heat and sunlight.
• Do not puncture, break or burn even when apparently empty.
• For external use only.
• Shake well before each use.
• Keep away from eyes.

• Shake the bottle before using the medicine.
• Clean your nose thoroughly before using the medicine.
• Insert the bottle tip into one nostril and close the other nostril.
• Direct the spray towards the sides of your nostril, away from the cartilage dividing the two sides of your nose.
• Breathe out gently through your mouth and repeat the same process for the other nostril.
• Avoid deep breathing as it will cause medication to go back to the throat and make it less effective.
• Avoid deep breathing as it will cause the medication to go back to the throat and make it less effective.
• Do not share the bottle with anyone else so that you do not spread germs.

06.01.2025