Consumer medicine information

What is Flo Sinus Care?

Flo Sinus Care is a preservative-free, non-medicated isotonic irrigation kit for washing the nose and sinus cavities. It has been formulated to closely mimic the body’s own extracellular fluid, so it is gentle on nasal and sinus tissues. The starter kit contains a sinus wash bottle and 12 premixed sachets of Flo Sinus Care powder. Refill packs of 20, 50 or 100 sachets are also available.

What is Flo Sinus Care used for?

• Colds and sinusitis: to help clear excess mucus, bacteria and inflammatory materials from the nose and sinus cavities which helps minimise congestion and relieves facial pressure often felt with sinusitis.
• Hayfever and allergies: to help wash away excess mucus, pollens, dust, pet dander and other irritants to relieve nasal and sinus congestion.
• CPAP users: to help thin mucus and relieve nasal and sinus congestion caused by use of CPAP devices.
• Post-operative care: to help wash away mucus, dried blood and debris from the nose and sinuses after surgery.
• Postnasal drip: to help wash away excess mucus to reduce the frequency and severity of a dry cough.

How does Flo Sinus Care work?

Flo Sinus Care is designed to irrigate the nose and sinus cavities using a large volume of solution delivered at low positive pressure.

Who can use Flo Sinus Care?

Flo Sinus Care is suitable for use by adults and children 4 years of age and older. Children should use Flo Sinus Care whilst under the supervision of an adult.

How to use Flo Sinus Care

Flo Sinus Care is designed to be easy to use for self-administration:

1. Before use: Thoroughly wash the bottle, tube and cap in warm soapy water. Dry with a clean paper towel to make sure the bottle is clean and ready to use.
2. Fill the bottle to the “Fill” line with lukewarm pre-boiled water (water should be boiled for at least 1 minute and then allowed to cool before use. Alternatively, pre-boiled water can be stored in a clean container in the refrigerator for up to 48 hours and reheated to lukewarm using 10 second bursts in a microwave oven).
3. Add the contents of one Flo sachet into the bottle. Ensure the tube and cap are assembled and then screw the cap firmly onto the bottle. Place your finger over the top of the cap and shake for 30 seconds or until all the powder has dissolved. Once dissolved, use the mixture immediately.
4. Standing over a basin or in the shower, lean forward and tilt your head so that your chin is as close as possible to your chest.
5. Insert the tip of the cap gently into one nostril. Whilst breathing through your mouth, gently squeeze the bottle until the solution drains from the opposite nostril or your mouth. Repeat until approximately half of the solution has been used. Then repeat in the other nostril with the remaining half of the solution.
6. Gently blow your nose to clear excess fluid and mucus. DO NOT blow your nose if you have recently had nasal or sinus surgery unless your surgeon recommends it.

After using Flo Sinus Care

Discard any remaining fluid, and wash the bottle, tube and cap in soapy water. Rinse well and then dry with a clean paper towel. Wipe the bottle and its components using a clean paper towel wetted with isopropyl alcohol (available from your local pharmacy). This helps to remove any remaining moisture and unwanted bacteria. Reassemble the bottle and store in the refrigerator until next use.

Are there any side effects from this product?

Some minor effects have been experienced, however these are not common and you may not experience any of them:

• Blocked ears: this may occur if solution enters the Eustachian Tube. If it happens, try clearing your ears by pinching your nostrils closed and gently blowing through the nose. Your ears should start to clear when you hear a popping sound. Release the pressure on your nostrils, open your jaw and then swallow a few times. Repeat as often as necessary.
• Earache: this may occur if applying too much pressure when squeezing the bottle. Try to use less pressure to avoid this problem. Follow the above procedure to help unblock your ears. If earache persists, stop using this product and consult your health professional.
• Coughing: this may occur if you use Flo Sinus Care within an hour prior to lying down.

Do not use Flo Sinus Care if:

• You have a bleeding disorder or are using anticoagulants, unless advised by your health professional.
• You have nasal tumours.
• You have undergone recent middle ear surgery.
• You have a condition which affects swallowing.

How often do I need to use Flo Sinus Care?

Use Flo Sinus Care twice daily or as directed by your health professional. Flo Sinus Care is gentle enough to be used daily and is non-medicated and preservative-free.

When can I use Flo Sinus Care?

Use Flo Sinus Care any time of the day except the last hour before bed. Lying down too soon after treatment can result in fluid draining from the sinuses into the back of the throat or out a nostril.

Can I use Flo Sinus Care while pregnant or breastfeeding?

Flo Sinus Care may be used during pregnancy or breastfeeding.

Does Flo Sinus Care interact with other medications?

Flo Sinus Care may be used with any other medication whether administered orally or as a nasal spray. If used with nasal sprays, Flo Sinus Care should be used 15 minutes before the nasal spray to help clear excess mucus. This optimises the effectiveness of the nasal spray.

Precautions:

Do not use if any sachets have been damaged or tampered with. Do not use after the expiry date marked on the sachet. Replace the Flo bottle after 3 months of use. Always read the label. Follow the instructions for use. If symptoms persist talk to your health professional.

Storage:

Store below 30°C away from heat and direct sunlight.

ENT Technologies Pty Ltd, 304/12 Cato Street,
Hawthorn East, Victoria 3123 Australia
Ph: 1300 857 912 (Australia only)
Ph: +61 3 9832 3700 (International)
www.flo.com.au

To view how to use Flo Sinus Care: YouTube ‘Flo Nasal Health’

This leaflet was updated March 2019.

Published by MIMS May 2020

Name of the medicine

Sodium chloride 0.772% w/v, potassium chloride 0.042%, calcium lactate pentahydrate 0.032%, sodium bicarbonate 0.015% and anhydrous glucose 0.085%.

Description

FLO Sinus Care when reconstituted with 200 mL of water very closely resembles the composition of Lactated-Ringer's solution. It consists of Sodium chloride 0.772% w/v, Potassium Chloride 0.042%, Calcium Lactate Pentahydrate 0.032%, Sodium Bicarbonate 0.015% and glucose anhydrous 0.085%. It is an isotonic solution with a pH of between 7.2-8.0.
There are no preservatives and no other chemical additives.

Pharmacology

Lactated-Ringers solution has been shown to provide the best medium in which to bathe nasal cilia. There is no deleterious effect on the functioning of the cilia after exposure to this solution. In vitro studies have shown that even when using Normal or Physiological saline there is retardation of cilial motility. (Ref: Physiologic and Hypertonic Saline Solutions Impair Ciliary Activity in Vitro. Boek WM et al The Laryngoscope Vol 109(3) March 1999 pp 396 - 399). In the post operative setting, Ringers Solution has been shown to be superior to isotonic saline solution in terms of mucociliary transport (ref: Ringer-Lactate solution versus isotonic saline solution on mucociliary function after nasal septal surgery. Unal M et al. The Journal of Laryngology and Otology Oct 2001 Vol 115 pp 796-797).
Post operative symptom scores are lower in the first 6 weeks after surgery in patients using Lactated Ringers solution. (A double blind randomized controlled trial of normal saline, lactated Ringer's and hypertonic saline nasal irrigation solution after endoscopic sinus surgery. Low T(Hubert) et al. American Journal of Rhinology and Allergy Vol 28(2014) pp 225-231).
Since the normal functioning of nasal cilia is the cornerstone to normal sinus and nasal physiology, it is important to ensure that the natural motility of these structures is not impaired in any way.

Indications

FLO Sinus Care is used:
a) as post operative irrigation after endoscopic sinus surgery.
b) as an adjunct to antibiotic treatment for acute sinusitis.
c) as a prophylactic for the prevention of sinusitis in predisposed patients who suffer from an upper respiratory tract infection.
d) to cleanse the paranasal sinuses in patients with long term sinus disease such as chronic rhinosinusitis.
e) to reduce pollen load in the upper respiratory tract in patients suffering from hayfever.
f) to cleanse the upper airways of dust or inhaled particles from occupational activities (e.g. flour dust in bakers, or mine dust in miners etc.).
g) to cleanse sinus cavities of purulent material in patients suffering from lower respiratory tract disease such as COPD, Asthma, Cystic Fibrosis and Chronic bronchitis.
h) as symptomatic relief in patients suffering from Rhinitis of Pregnancy.

Contraindications

There should be no contraindication to using this product.

Precautions

Use in pregnancy.

Use in lactation.

Use in children.

Interactions

FLO Sinus Care 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. If this does not improve the earache being experienced with treatment, it may be prudent to cease further use of this mode of therapy.
Occasionally there may be headaches, sneezing, nasal crusting or even episodes of mild epistaxis.

Dosage and Administration

Dosage.

Method of use and cleaning.

First time use.

Note.

Cleaning after use.

Presentation

Packaging.

Storage

Shelf life.

Poison Schedule

Unscheduled.