NAZAL-S
COMPOSITION
Each ml contains:
Sodium Chloride IP 0.65% w/v
Benzalkonium Chloride BP 0.03% w/v (as preservative)
Water for Injections BP q.s.
DESCRIPTION
A clear, colorless to almost colorless solution.
PHARMACODYNAMIC
Pharmacotherapeutic group: Decongestants and other nasal preparations, sodium chloride nasal drops.
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.
ATC code: R01AX10
PHARMACOKINETICS
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.
THERAPEUTIC INDICATION
For relieving nasal congestion by dissolving and softening thick and crusty mucus in the nose.
DOSAGE AND ADMINISTRATION
Saline solution is recommended for children and adults.
Apply 1-2 sprays into each nostril or instill 1-2 drops of the solution into each nostril as needed or as directed by the physician.
Overdose
No experience of overdose, but supportive measures would be the appropriate treatment.
INSTRUCTION FOR USE
For nasal use only. Shake well before use. Before use, ensure that the container is undamaged.
- As a Spray
- Clean your nose by gently blowing over a handkerchief of tissue.
- Remove the cap and insert the nozzle into the affected nostril by tilting the head forwards in erect posture.
- Use the spray by squeezing the bottle in the center once or twice and continue normal breathing inwards (inhalation)
- Release the pressure from the bottle and comfortably remove the nozzle from the nostril.
- Repeat the same steps while applying in the other nostril.
- Replace the cap of the container after use.
- As Drops
- Clean your nose by gently blowing over a handkerchief of tissue.
- In sitting posture, tilt your head back as far as comfortable, or inlying down posture, the head can be tilted backwards or comfortably arched over the edge of the bed.
- With the bottle inverted over the affected nostril, allow sufficient time for 1-2 drops to fall and spread inside the nose.
- Repeat the same steps while applying in the other nostril.
- Wipe the tip of the container with a clean, wet tissue and replace the cap immediately after the application.
- To avoid possible spread of infection, the spray should only be used by one person.
- Do not take a double dose to make up for a forgotten one.
CONTRAINDICATION
There are no absolute contraindications to use Sodium Chloride spray/drops.
WARNING AND PRECAUTIONS
Before use, tell the doctor or pharmacist if you are allergic to any of the ingredients.
Signs of an allergic reaction may include: rash, hives, itching, red-swollen-blistered or peeling skin with or without fever, wheezing, tightness in the chest or throat, trouble breathing, swallowing, unusual hoarseness or swelling of the mouth, face, lips, tongue or throat.
The product contains benzalkonium chloride solution which may cause irritation or swelling inside the nose, especially if used for a long time.
Long term use may cause oedema of the nasal mucosa.
PREGNANCY AND LACTATION
Safe to use during pregnancy and lactation.
SIDE EFFECTS
Usually do not occur, however rarely occurring side effects may include:
- if the inside of the nose is very dry and irritated, stinging may occur
- allergic reactions
- sneezing
- cough
- nose irritation
- abnormal taste
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorization 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.
PRESENTATION
NAZAL-S nasal solution/drops are supplied in Low density polyethylene (LDPE) white bottles with a white screw cap in pack size 10 ml.
STORAGE AND OTHER INFORMATION
Store at temperature below 30 °C.
Protect from light.
Keep this medicine out of the sight and reach of children.
Do not touch the container tip to any surface since this may contaminate the solution.