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LUBORANT

Active substance(s): SODIUM FLUORIDE / SODIUM FLUORIDE / SODIUM FLUORIDE

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PATIENT INFORMATION LEAFLET
LUBORANT
Sodium Fluoride 3 micrograms/0.8ml
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE.

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
symptoms are the same as yours.
If any of the side effects become serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1. What Luborant is and what it is used for
2. Before you take Luborant
3. How to take Luborant
4. Possible side effects
5. How to store Luborant
6. Further 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. BEFORE YOU TAKE LUBORANT
DO NOT take Luborant if you know that you are allergic to sodium fluoride or any of the other
ingredients of Luborant (see section 6 of this leaflet). Taking other medicines Please tell your doctor
or pharmacist if you are taking or have recently taken any other medicines, including medicines
obtained without a prescription.
Pregnancy and breast feeding
Ask your doctor or pharmacist for advice before taking any medicine.
You should let your doctor know if you are or think you may be pregnant or are planning to become
pregnant, or are breast-feeding Important information about some of the ingredients of Luborant This
medicine also 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
delayed).
3. HOW TO USE LUBORANT
Luborant is to be taken by mouth. Take exactly as written on the side of the label.
Usual dose for 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.
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. Otherwise, leave out that dose completely and take your next dose at the normal time it
is due.
If you have more Luborant than you should:
It is unlikely you will have any serious symptoms if you accidentally take too much Luborant.
However, if you do have any symptoms after taking too much, you should tell your doctor at once.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Luborant can sometimes cause side effects, although not everybody gets them.
Usually, Luborant does not cause any problems when taking at the recommended dose.
• Rarely, a skin rash or signs of allergic reaction have occurred with the use of fluorides.
• Orange flavour in Luborant contains small amounts of polypropylene glycol which may rarely
cause local irritation.
• Staining of teeth has occurred following the use of larger amounts of the active ingredient, sodium
fluoride than those recommended for Luborant. If any of the side effects become serious, or if you
notice any side effects not listed in this leaflet, please tell your doctor.
5. HOW TO STORE LUBORANT
Keep out of the reach and sight of children.
Do not use Luborant 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.
Throw away any liquid that is not used within one month after the date of opening.
6. FURTHER 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
Manufacturer
Dales Pharmaceuticals Ltd., Snaygill Industrial Estate, Keighley Road, Skipton, North
Yorkshire, BD23 2RW, UK
This leaflet was last revised in December 2013

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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