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Active substance(s): SODIUM FLUORIDE

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Package leaflet: Information for the user
Sodium Fluoride 0.003mg/0.8ml
Read all of this leaflet carefully before you start taking this medicine because it contains important
information for you.


Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even
if their sign of illness are the same as yours.


If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. See section 4.

What is in this leaflet:
1. What Luborant is and what it is used for
2. What you need to know before you take Luborant
3. How to take Luborant
4. Possible side effects
5. How to store Luborant
6. Contents of the pack and other information
1. What Luborant is and what it is used for
Luborant contains sodium fluoride and is used to treat saliva deficiency. It is a saliva substitute for use
in the management of conditions involving dryness of the mouth following radiotherapy or during
treatment with drugs for relieving depression and anxiety, as well as other conditions where
insufficient saliva is produced, such as Sjogren’s disease.
2. What you need to know before you take Luborant
Do not take Luborant:
 if you are allergic to sodium fluoride or any of the other ingredients of this medicine (listed in
section 6).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Luborant

Other medicines and Luborant:
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines,

including medicines obtained without a prescription.
Pregnancy, breast feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your
doctor or pharmacist for advice before taking this medicine..

Excipients warnings:
Luborant contains sorbitol (E420). If you have been told by your doctor that you are intolerant to some
sugars, contact your doctor before taking this medicine.
The Carmoisine Red (E122) in Luborant can sometimes cause allergic type reactions, including
asthma, especially in persons who are allergic to aspirin.
Nipasept sodium (comprising of Sodium p-hydroxybenzoate, E219, E215, E217), a preservative in
Luborant contains hydroxybenzoates which may sometimes cause allergic reactions (possibly
Orange flavor in Luborant contains small amounts of polypropylene glycol which may rarely cause
local irritation.
3. How to use Luborant
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.

The recommended dose is:
Adults and elderly:
Take two or three single applications into the side of the mouth from the pump applicator, up to four
times daily. Each squirt contains 0.8 ml of Luborant.
Route of administration:
Luborant is to be taken by mouth. Take exactly as written on the side of the label.
If you take more Luborant than you should:
It is unlikely you will have any serious symptoms if you accidentally take too much Luborant.
Staining of teeth has occurred following the use of larger amounts of the active ingredient, sodium
fluoride than those recommended for Luborant. However, if you do have any symptoms after taking
too much, you should tell your doctor at once.
If you forget to take Luborant:
If you miss a dose, take it as soon as you remember, if it is within a few hours of the normal time. Do
not take a double dose to make up for a forgotten dose.
If you stop taking Luborant

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicines can cause side effects, although not everybody gets them. Usually,
Luborant does not cause any problems when taking at the recommended dose.
Side effects are classified in the following categories:
Not known: frequency cannot be estimated from the available data
Allergic reaction (inflammation of skin and inflammation of mouth/lips)
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme
5. How to store Luborant
Keep this medicine out of sight and reach of children.Do not use this medicine after the expiry date
which is stated on the bottle and box. If your liquid is out of date, take it to your pharmacist who will
get rid of them safely.
Do not store above 25°C. Keep the bottle in the outer box and protect from light.
Ask your pharmacist how to throw away medicines you no longer use. These measures will help
protect the environment.
6. Contents of the pack and other information
Each 0.8 ml pump spray of Luborant solution contains 3 micrograms of the active sodium fluoride.
Luborant also contains potassium chloride, Magnesium Chloride hexahydrate, Calcium Chloride
dihydrate, potassium phosphate dibasic, potassium phosphate monobasic, sodium
carboxymethylcellulose, sorbitol (E420), nipasept sodium [contains Sodium phydroxybenzoate,
Sodium Methyl 4-Hydroxybenzoate (E219), Sodium Ethyl 4- hydroxybenzoate (E215), Sodium
Propyl 4-hydroxybenzoate (E217)], orange flavour [contains propylene glycol], carmoisine red
(E122), hydrochloric acid and purified water.

What Luborant looks like and contents of the pack
Luborant is a pink, viscous, oromucosal solution with a smell and flavour of orange and is supplied in
cartons of either one or six 60 ml polyethylene bottles fitted with a pump-action applicator.
Marketing Authorisation Holder
Mercury Pharmaceuticals Ltd., Capital House, 85 King William Street, London EC4N 7BL, UK
Dales Pharmaceuticals Ltd., Snaygill Industrial Estate, Keighley Road, Skipton, North
Yorkshire, BD23 2RW, UK
This leaflet was last revised in October 2017

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