Consumer medicine information

FLO Saline Plus

Sodium chloride; Sodium bicarbonate; Potassium chloride; Calcium chloride dihydrate; Magnesium chloride hexahydrate

BRAND INFORMATION

Brand name

FLO Saline Plus

Active ingredient

Sodium chloride; Sodium bicarbonate; Potassium chloride; Calcium chloride dihydrate; Magnesium chloride hexahydrate

Schedule

Unscheduled

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using FLO Saline Plus.

What is FLO Saline Plus?

FLO Saline Plus is a sterile, preservative free, non-medicated and isotonic (no-sting formula) saline solution containing the added minerals magnesium chloride hexahydrate, calcium chloride and potassium chloride. The solution also contains sodium chloride (8.10mg/mL) and sodium bicarbonate. There are no chemical buffers and no alcohol.

How does FLO Saline Plus work ?

FLO Saline Plus thins and loosens mucus and moisturises dry nasal tissues. The gentle mist spray helps to move mucus to the back of the nose from where it is naturally swallowed. This action assists in keeping nasal passages clear.

The removal of excess mucus helps to clear the nose during colds and flu and to relieve the nasal congestion experienced with sinusitis.

Washing the nasal tissues with saline helps to reduce the pollen and nasal irritant load in the nose. This can decrease the severity of nasal symptoms experienced in hay fever and allergies.

How to use FLO Saline Plus

Before first use: Remove the protective cap on the nozzle and with your thumb underneath the bottle position your index and middle fingers on either side of the nozzle on the circular depression flange. Depress the pump several times until the spray is seen.

Administering a dose: With the head upright insert the tip of the nozzle into one nostril and angle it slightly backwards. One squirt is delivered each time the pump is depressed. Spray as many times as required to deliver the recommended dose. After the dose has been inserted into both nostrils remove the nozzle and pinch nostrils together. Then tilt your head to each side for 5-10 seconds. Release both nostrils and gently blow your nose if required.

When finished, wipe the nozzle with a clean tissue and replace the protective cap.

Use in young children

Do not insert the nozzle into the child's nostril. Place the nozzle underneath the nostril and insert the dose of FLO Saline Plus as directed. This is done to avoid nasal injury which may be caused by sudden head movement.

What dose do I use and how often should FLO Saline Plus be used?

FLO Saline Plus does not contain any preservatives and is non-medicated so it is not habit forming. It may be used as often as required and for as long as needed to help relieve nasal congestion. However, if symptoms persist you should see your healthcare professional.

Adults and children over 12 years of age: Insert up to 8 sprays per nostril.

Children 2 years to 12 years of age: Insert up to 5 sprays per nostril.

Children up to 2 years of age: Insert 1 to 2 sprays per nostril.

Caution: This dispenser must only be used by one person as sharing may spread infection.

Can FLO Saline Plus be used in pregnancy and while breast feeding?

FLO Saline Plus can be used during both pregnancy and while breast feeding.

Some women experience nasal congestion during pregnancy. The cause of this is not fully understood. It is important to try and relieve this congestion in order to minimise mouth breathing.

Does FLO Saline Plus interact with other medications?

Since FLO Saline Plus is non-medicated and preservative free you can use it with any other medication.

If you are using another nasal product then it is advisable to allow 20-30 minutes between the application of each product.

What side effects can be expected when using FLO Saline Plus?

FLO Saline Plus is a non medicated, preservative free solution and as such you should not experience any side effects while using it as directed. However, if you do experience any nasal discomfort or increased nasal congestion you should stop using it and see your healthcare practitioner.

How is FLO Saline Plus packed ?

FLO Saline Plus is presented in a 30mL spray pump pack. The outer carton is sealed with tabs on the top and bottom flaps. You should not use this product if any of these tabs have been removed or damaged in any way.

What you need to know about expiry dates on FLO Saline Plus

There is an expiry date stamped on the outer carton and on the bottle label. Do not use the product if the expiry date has passed.

Since there is an advanced pump system and a solution which is sterile and free of preservatives, FLO Saline Plus should be discarded 12 months after it has been used for the first time. For your convenience, space has been provided on the bottle label for you to record the discard date. Do not use the product after that date.

This information does not represent all the information on FLO Saline Plus. If you have any questions about the product then please consult your healthcare practitioner. Alternatively, contact ENT Technologies on (local call cost) 1300 857 912.

Remember to use this product only as directed and see your healthcare practitioner if symptoms persist.

ENT Technologies Pty Ltd
Suite 304, 12 Cato Street,
Hawthorn East. VIC 3123. Australia
Phone (03) 9832 3700
Local call 1300 857 912
Web: www.enttech.com.au

Manufactured in Germany by:
URSAPHARM Arzneimittel GmbH

This information leaflet was updated on 12th August 2015.

Published by MIMS May 2020

BRAND INFORMATION

Brand name

FLO Saline Plus

Active ingredient

Sodium chloride; Sodium bicarbonate; Potassium chloride; Calcium chloride dihydrate; Magnesium chloride hexahydrate

Schedule

Unscheduled

 

Name of the medicine

Sodium chloride, anhydrous sodium bicarbonate, potassium chloride, calcium chloride, magnesium chloride hexahydrate and water.

Description

FLO Saline + PLUS is an isotonic nasal spray, pH 7 to 8.5. There are no preservatives and no other chemical additives.

Pharmacology

Traditional nasal saline sprays contain only sodium chloride, sodium bicarbonate, a buffering system and a preservative system which is invariably benzalkonium chloride. There has been extensive exposure, in the medical literature, of the adverse effects of benzalkonium chloride on the functioning of mucosal cilia and also on the function of neutrophils which form part of the healing and defence mechanisms in nasal mucous membranes. The possibility that isotonic saline actually slows cilial beat frequency has been reviewed by Boek WM. It would certainly appear that in comparison to Locke-Ringer solution, saline solutions have been shown to be inferior. (Reference: Physiologic and hypertonic saline solutions impair ciliary activity in vitro. Boek WM et al. The Laryngoscope Vol 109(3) March 1999 pp 396-399, and Ringer-Lactate solution versus isotonic saline solution on mucociliary function after nasal septal surgery. Unal M et al. The Journal of Laryngology and Otology Vol 115 Oct 2001 pp 796-797).
In most of the indications in which FLO Saline + PLUS would be used the normal nasal mucous membrane anatomy is distorted. There is denuding of cilia, disruption of the tight junctions holding the epithelial cells together, distortion of the brush border and smooth contour of the epithelium and disruption to mucus production and consistency. All of these factors expose the epithelium to adverse effects of preservatives and to the adverse effects of hypertonicity in irrigating solutions. For effective healing of the mucous membrane, cellular metabolism must be enhanced. Cellular metabolism involves several trace elements such as sodium, potassium, calcium and magnesium. These are supplied in FLO Saline + PLUS but not in traditional nasal saline sprays and solutions.

Indications

Reduce the thickness of nasal mucus and cleanse the nose of pollens and other irritant particles. Thinning mucus will enable cilia to work more efficiently and effectively.
The preparation can be used effectively in the following situations.

Upper respiratory tract infections (URTIs).

In URTIs to provide temporary relief from congestion. By thinning thick mucus it will assist the cilia to naturally clear excess mucus. The flushing nature of the application will further help in moving mucus plugs.

Sinusitis.

In sinusitis it will help to temporarily relieve nasal congestion due to tenacious mucus.

Hayfever.

In patients suffering from hayfever, flushing of the nasal cavity will help to reduce the pollen load. This will result in an improvement in symptoms.
Clearing the nose of pollens and also of mucus which contains products (cells and chemicals) of the allergic reaction, will help to prepare the nasal epithelium for an application of nasal steroid. This may well result in improved results from the steroid spray.

Congestion in infants.

In infants suffering with nasal congestion.
Infants always breathe through the nose and will persist in trying to do so even if it is congested. This results in an unsettled child who will definitely experience difficulties when feeding. Use of FLO Saline + PLUS about five to ten minutes prior to a feed will help to relieve the nasal congestion and will permit easy and successful feeding. This means a relaxed mother and child.

Pregnancy.

In pregnant patients suffering from nasal congestion.
Nasal congestion during pregnancy, termed rhinitis of pregnancy, is common, affecting about 10% of all women. The aetiology is uncertain, but congestion can result in patients abusing decongestant sprays and ultimately suffering from rhinitis medicamentosa.
Use of FLO Saline + PLUS as and when required will relieve congestion. Patients should also take regular exercise, elevate the head of the bed and try using nasal splints at night. This combination of activities will relieve the symptoms and make patients a lot more comfortable without exposing them to the use of nasal decongestant sprays.

Postoperative.

The postoperative use of FLO Saline + PLUS will assist in cleansing the mucus and blood clots that may impede healing in the nose.

Occupational health.

FLO Saline + PLUS can be used as often as required to clear the nose of irritants, e.g. dust from mining and also flour dust in bakeries.

Contraindications

There should be no contraindication to using this product.

Precautions

Use in pregnancy.

FLO Saline + PLUS may be used during pregnancy.

Use in lactation.

FLO Saline + PLUS may be used while breastfeeding.

Interactions

FLO Saline + PLUS may be used while taking any other medication. There should be no interactions with any other medication.

Adverse Effects

There should be no stinging or pain when using this product.

Dosage and Administration

Dosage.

The frequency with which patients will require nasal treatment will vary as to the severity of symptoms and to the condition for which it is indicated.
FLO Saline + PLUS can be used as often as needed in all age groups, or directed by health care practitioners.

Adults and children over 12 years.

Insert up to 8 squirts/nostril.

Children 2 years to 12 years.

Insert up to 5 squirts/nostril.

Babies and children up to 2 years.

Insert 1 to 2 squirts/nostril.
Do not share the container between patients as this may result in spread of infection.

Method of use.

First time use.

Remove the protective cap and then depress pump firmly several times until the first spray is seen.
With the head in an upright position insert the nozzle into one nostril and angle it slightly backwards. Depress the pump firmly to deliver the recommended dose to each nostril, then pinch nostrils together and tilt head to each side for five to ten seconds. Release the nostrils and gently blow the nose if required.

After use.

Wipe the nozzle with a clean tissue and replace the protective cap.

Expiry and discard rules.

Since this product contains no preservatives it can only be used for a period of three months after first use.
There is a discard date on both the carton and label and this should be filled in at time of first use to ensure that the product is not used after that date.

Packaging.

Do not use the product if any of the outer packaging has been in any way damaged.

Presentation

Spray bottle, 30 mL.

Storage

Shelf life.

FLO Saline + PLUS has been marked with an ‘Expiry date’, indicated on the label and on the outer carton. It should not be used after the date shown.

Poison Schedule

Unscheduled.