Consumer medicine information

Flo CRS

Potassium chloride + Sodium chloride + Xylitol

BRAND INFORMATION

Brand name

FLO CRS

Active ingredient

Potassium chloride + Sodium chloride + Xylitol

Schedule

Unscheduled

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Flo CRS.

What is FLO CRS?

FLO CRS is a non medicated preservative free nasal and sinus irrigation kit.

It has been formulated with a low sodium and potassium content to minimise any adverse affect on the natural immune factors present in nasal and sinus tissue.

FLO CRS can be used to relieve congestion from sinusitis and as a cleansing solution after nasal and sinus surgery.

The kit consists of a wash bottle and pre-mixed sachets of FLO CRS powder. Refill sachets are available separately.

Why use FLO CRS?

FLO CRS is designed to irrigate the nasal and sinus cavities using a large volume of solution delivered at low positive pressure. This method improves the penetration of irrigation fluid into the sinus cavities compared with traditional metered nasal pump sprays1. Symptoms resulting from sinus inflammation may be relieved by washing the sinuses, as this helps remove the excess mucus being produced in those cavities.

How to use and clean the FLO CRS Kit

  1. First time use. Thoroughly wash the bottle, tube and cap with warm soapy water. Rinse all components with tap water and dry using a clean paper towel.
  2. Fill the bottle to the FILL LINE using lukewarm pre-boiled water. NOTE: Water must be boiled for at least 1 minute before cooling until lukewarm. If more convenient, boiled water may be stored in a clean container in the refrigerator for up to 48 hours. You can re-heat the water in the FLO wash bottle using a microwave oven in 5 second bursts until it is lukewarm.
  3. Cut or tear open one sachet of FLO CRS powder. Using the guidelines, fold out the sachet into a funnel shape and pour the entire contents into the FLO bottle.
  4. Screw the cap and tube firmly onto the bottle and gently shake until all the powder has dissolved.

Your mixture is now ready for use

  1. Standing over a basin, bend forward and tilt your head down so that your chin almost touches your chest. Insert the tip of the cap gently into one nostril. Whilst breathing through your mouth, steadily and gently squeeze the bottle until the solution drains from the opposite nostril or from the mouth. Try not to swallow the solution. No harmful effects will occur if you do this. Whenever the bottle needs to refill with air, remove it from your nose before releasing your hand pressure. This helps to prevent “suck back” and contamination of the remaining solution. Repeat these steps until half the solution has been used, then repeat the procedure on the opposite nostril.

  1. Gently blow your nose to clear any remaining fluid and mucus. Note: If you have recently had nasal or sinus surgery, do not blow your nose before checking with your surgeon.
  2. Discard any solution remaining in the bottle. Always make a fresh solution for each treatment.
  3. Cleaning after use: Wash all components with warm soapy water and rinse well. Dry with a clean paper towel. Firmly wipe all components using either a large alcohol swab or a clean papertowel which has been well moistened with isopropyl alcohol(available from pharmacies)

Be sure to wipe down the thread on the bottle neck and inside of the cap. Allow about 5 minutes for the alcohol to dry. This helps to disinfect all components and remove any moisture. Reassemble the FLO bottle and store in the refrigerator until next needed. BEFORE NEXT USE rinse the bottle with previously boiled water to remove any residue from the isopropyl alcohol.

What side effects can be expected?

Blocked ears – this may occur if solution enters the Eustachian tube – this is the tube which connects the back of the nose with the middle ear cavity. Should this occur, clear your ears by pinching your nostrils closed and gently blowing through the nose. Your ears will start to clear when you hear a popping sound. Release the pressure on your nostrils, breathe normally and swallow several times. Repeat as necessary

Earache – this occurs when the solution is forced too vigorously into the nose by squeezing too hard on the bottle. Try to use less pressure on the bottle when using FLO CRS.

If earache persists despite using less force on the bottle, stop using the product and consult your ENT surgeon or doctor.

How often do I need to use FLO CRS?

Use FLO CRS up to three times daily or as directed by your healthcare professional. There are no adverse effects from using FLO CRS more often. Note: Use any time of the day except the last hour before bed. Lying down soon after use can result in fluid draining from the sinuses unexpectedly. This may cause coughing.

Can FLO CRS be used while pregnant or breast feeding?

FLO CRS is non-medicated and free of preservatives and may be used during pregnancy and whilst breast feeding.

Does FLO CRS interact with other medications?

FLO CRS can be used while taking any other medication. If you are using a medicated nasal spray, then it is best to use FLO CRS at least 15 minutes before using the nasal spray.

How FLO CRS is packaged

FLO CRS is available as a Starter Kit (containing a wash bottle, and 4 sachets) and as a Refill Sachet pack containing 50 sachets.

Do not use after the expiry date marked on the sachets or if the sachets appear damaged in any way.

Use only as directed and if symptoms persist consult your doctor or attending ENT surgeon.

Please refer to "Monitoring your sinusitis” on the reverse side

References

  1. A comparative study of 3 methods of nasal irrigation. Wormald PJ et al Laryngoscope Vol 114 pp 2224-2227

For more information or if you have any questions, contact:

ENT Technologies Pty Ltd
Suite 304, 12 Cato Street, Hawthorn East, VICTORIA 3123. Australia
Phone: +613 9832 3700 Fax: +613 9832 3799
Local call 1300 857 912 (Australia only)
Email: info@enttech.com.au
Web: www.flo.com.au

This information was last updated on 16th of October 2017.

Monitoring your sinusitis

The SNOT 20 scoring system (Sino Nasal Outcome Test) scoring system provides a useful guide to the severity of sinusitis.

Directions for monitoring your sinusitis

Simply score each symptom with 0 for no symptom or 1, 2 or 3 depending on the severity of the symptom with 3 being the most severe of symptoms.

The lower the score the less severe the sinusitis.

If your score does not improve with recommended treatment, see your healthcare professional.

Published by MIMS October 2018

BRAND INFORMATION

Brand name

FLO CRS

Active ingredient

Potassium chloride + Sodium chloride + Xylitol

Schedule

Unscheduled

 

Name of the medicine

Sodium chloride.

Excipients.

Potassium chloride, xylitol. There are no preservatives.

Description

FLO CRS contains sodium chloride as the nominated ingredient, it also contains potassium chloride. Xylitol is present as it is used to equilibrate the osmotic pressure to be isotonic with body fluids (approx. 300 mOsm) When reconstituted with 200 mL of cooled boiled water it makes an isotonic solution with a pH of between 5.6 - 7.5. There are no preservatives. The solution is intended to have a low sodium and potassium content to provide a low ionic strength (26 mM) sinus wash. A low ionic strength solution has been formulated in order not to compromise the actions of natural lysozymes, lactoferrin and other defensins in the mucosa of the nose and paranasal sinuses. Isotonic saline and Ringers solutions have ionic strengths of approximately 150 mM and 138 mM respectively. It has been shown in vitro that lysozyme is deactivated by solutions with an ionic strength of more than 31 mM.

Indications

FLO CRS can be used:
a) as a postoperative wash after sinus surgery in patients suffering from chronic rhinosinusitis.
b) as an adjunct to antibiotic and other treatments for chronic rhinosinusitis.
c) to cleanse sinus cavities in patients with chronic rhinosinusitis who also suffer from lower respiratory tract diseases such as COPD, asthma, cystic fibrosis and chronic bronchitis.

Contraindications

There should be no contraindication to using this product.

Precautions

Use in pregnancy.

FLO CRS may be used during pregnancy.

Use in lactation.

FLO CRS may be used whilst breastfeeding.

Interactions

FLO CRS may be used whilst 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.
Should earache be experienced whilst using the product then try to reduce the pressure with which fluid is inserted into the nose by squeezing the bottle less vigorously. If this does not help it may be prudent to stop using this mode of treatment and check with the ENT surgeon as to other options that might be available for sinus cleansing.

Dosage and Administration

Dosage.

The frequency with which patients will require nasal and sinus douching will vary as to the severity of symptoms and to the condition for which it is indicated.
FLO CRS can be used as often as needed for relief of sinus congestion or as directed by healthcare practitioners.

Method of use and cleaning.

FLO CRS must only be used together with the bottle, tube and cap enclosed in the kit and in the way in which it is directed.

First time use.

Thoroughly wash the bottle, tube and cap with warm soapy water to clean all surfaces. Rinse all components with tap water. Thoroughly dry all components with a clean paper towel.
Fill the bottle to the 200 mL fill line using lukewarm preboiled water. Always boil water for 1-2 minutes before cooling until lukewarm.

Note.

If more convenient, boiled water may be stored in a clean container in the refrigerator for up to 48 hours. You may reheat the water in the FLO bottle using a microwave oven in 5 second bursts.
Cut or tear open one sachet of FLO CRS powder. Using the guidelines, fold out sachet into a funnel shape and pour the entire contents into the FLO bottle.
Screw the cap and tube firmly onto the bottle and shake until all powder has dissolved.
The mixture is now ready to use.
Standing next to a basin, bend as far forward as is comfortable and tilt the head down so that the chin is as close to the chest as is comfortable.
While breathing through the mouth, apply the cap firmly up against one nasal passage and squeeze the bottle steadily and gently until solution drains from the opposite nasal passage or from the mouth. Do not swallow the solution. (If solution is accidentally swallowed no harm will result.) This should be done until about half of the solution has been inserted into the one nasal passage. It is important to remove the bottle from the nostril prior to hand pressure being released. This allows the bottle to ‘breathe’ clean air and avoids aspiration of contaminants from the nose into the bottle. In this way, the washing solution remains clean.
Repeat the procedure on the other nostril.
Once the solution has been used, stop and then gently blow the nose.

Important.

If the solution is being used postoperatively, then consideration should be given as to whether nose blowing is permitted, or whether this would interfere with healing and postoperative results. Advice from the attending ENT surgeon should be obtained before nose blowing is undertaken after an operation.
If there is any solution remaining after both nasal passages have been treated, discard it. Fresh solution must be made for each treatment.

Cleaning after use.

It is recommended that the wash bottle, cap and diptube be cleaned after every use.
1. Unscrew the cap and diptube and add 2.5 mL of FLO Cleaning Solution (sold separately) to the wash bottle. Add warm tap water up to the fill line marked on the wash bottle. Replace the cap and diptube and screw on firmly.
2. With your finger over the opening in the cap shake the bottle vigorously for 1-2 minutes.
3. Over a basin squirt out about half of the bottle contents.
4. Then open the cap and pour out all the remaining contents.
5. Rinse the bottle and all components thoroughly under running tap water and dry thoroughly using a clean paper towel. Ensure that you wipe and dry the inside and outside threads on the bottle and cap.
6. Reassemble the bottle diptube and cap and store in the refrigerator until it is next needed.
Alternatively, the bottle and components can be washed in warm soapy water using a bottle brush to clean the bottle. All components must be thoroughly rinsed and dried using a clean paper towel afterwards. The reassembled bottle should be stored in the refrigerator until next needed.

Note.

This method of cleaning may not get rid of all bacteria and biofilms that may form in the bottle over the period of use.

Presentation

FLO CRS comes in a kit containing the dispensing soft squeeze plastic bottle with uniquely designed cap and diptube and 4 sachets.
There are refill sachets available in packs containing 50 sachets.
Do not use the product if any of the outer packaging has been in any way damaged.

Storage

Shelf life.

FLO CRS has been marked with an ‘expiry date’ indicated on each sachet and on the outer carton. It should not be used after the date shown.

Poison Schedule

Unscheduled.