Luborant
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 sorbitoN(S420). 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