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Active substance(s): SODIUM FLUORIDE

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Fluoride 2800 ppm Toothpaste

Read all of this leaflet carefully before you start
using 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,
dentist or pharmacist.
• This medicine has been prescribed for you only. Do
not pass it on to others. It may harm them, even if their
signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, dentist
or pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.
This medicine is available as Fluoride 2800 ppm
Toothpaste but will be called Fluoride Toothpaste
throughout the rest of this leaflet.
What is in this leaflet
1. What Fluoride Toothpaste is and what it is used for
2. What you need to know before you use Fluoride
3. How to use Fluoride Toothpaste
4. Possible side effects
5. How to store Fluoride Toothpaste
6. Contents of the pack and other information
Fluoride Toothpaste is used for the treatment of tooth
decay (dental caries) of the tooth crown and root, in
children and adolescents aged 10 years and older. The
toothpaste contains fluoride as sodium salt, which
belongs to a group of medicines called caries
preventing agents.
Do not use Fluoride Toothpaste:
• if you are allergic to sodium fluoride or any of the other
ingredients of this medicine, listed in section 6.
• if you are a child aged under 10 years.
Warnings and precautions
Talk to your doctor or dentist, or pharmacist before
using Fluoride Toothpaste:

• Fluoride Toothpaste has a high fluoride content.
Fluoride tablets, drops, chewing gum, gels or varnishes,
as well as fluoridated water or salt, should be avoided
during the use of Fluoride Toothpaste. In order to
prevent build up of fluoride, your total intake must be
assessed before using this fluoride toothpaste. Ask your
doctor, dentist, or pharmacist about this.
Children and adolescents
Fluoride Toothpaste is not intended for use by children
aged under 10.
Other medicines and Fluoride Toothpaste
No interactions with other medicines are known.
Tell your doctor, dentist or pharmacist if you are taking
or using, or have recently taken or used, or might take
or use any other medicines, including medicines
obtained without a prescription.
Fluoride Toothpaste with food and drink
Fluoridated water and salt should be avoided while
using this toothpaste. Food and drink, if taken
immediately after brushing your teeth, may reduce the
amount of tooth remineralisation that occurs. You
should therefore brush your teeth with Fluoride
Toothpaste after meals.
Pregnancy, breast-feeding, and fertility
There is no experience with the use of Fluoride
Toothpaste in pregnant women. If you are pregnant or
breast-feeding, think you may be pregnant or are
planning to have a baby, ask your doctor, dentist, or
pharmacist for advice before taking this medicine.
Driving and using machines
Using Fluoride Toothpaste will not affect your ability to
drive or use machinery.
Fluoride Toothpaste contains sorbitol solution and
propylene glycol:
• if you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before
using this medicinal product.
• propylene glycol may cause skin irritation.
Fluoride Toothpaste is only for use by persons aged ten
years and older.

Always use this medicine exactly as described in this
leaflet or as your doctor, dentist, or pharmacist has told
you. Check with your doctor, dentist or pharmacist if you
are not sure.

directly via the national reporting system, the Yellow
card scheme; website By
reporting side effects you can help provide more
information on the safety of this medicine.

Use Fluoride Toothpaste daily instead of your normal
toothpaste. Brush carefully and thoroughly, for one
minute, morning and evening:
• apply a 1 cm ribbon of toothpaste onto your toothbrush
for each brushing.
• brush your teeth vertically, from the gum to the tip of
the teeth.
• spit out excess foam and do not swallow.
Careful brushing of your teeth takes about one minute.


For best results, you should not drink or rinse for 30

Replace the tube cap after use. This product requires
no special storage conditions.

Use in children and adolescents
This toothpaste is not for use by children aged less than
10 years.

Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures
will help protect the environment.

If you use more Fluoride Toothpaste than you
should, or if you have swallowed the toothpaste
If you swallowed a large amount of toothpaste by
mistake, and if you experience digestive problems such
as being sick, diarrhoea, and pain in the stomach or
abdomen, you must tell a doctor immediately as
treatment may be required. Please take this leaflet with
If you constantly swallow too much of the toothpaste
over several months, or years, you may get stained or
speckled appearance of tooth enamel, and enamel
fragility (dental fluorosis), or increased bone density,
osteosclerosis (bone fluorosis).
If you forget to use Fluoride Toothpaste
Use as soon as you remember, but do not use a double
dose to make up for a missed dose. Continue treatment
as usual after the next meal.
If you have any further questions on the use of this
medicine, ask your doctor, dentist, or pharmacist.
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
In some rare cases (less than 1 in 1,000 users) allergic
(hypersensitivity) reactions can occur, such as rash,
itching, swelling, and redness.
Burning oral sensation has also been reported.
Reporting of side effects
If you get any side effects, talk to your doctor, dentist, or
pharmacist. This includes any possible side effects not
listed in this leaflet. You can also report side effects

Keep this medicine out of the sight and reach of
Do not use this medicine after the expiry date which is
stated on the tube and carton after Exp. The expiry date
refers to the last day of that month. Discard 6 months
after opening.

What Fluoride Toothpaste contains
• The active substance is fluoride, as sodium fluoride.
Each 1 g of toothpaste contains 2.8 mg fluoride (as
sodium fluoride), which is 2800 ppm fluoride.
The other ingredients (excipients) are: Sorbitol solution
(non-crystallising) (E420), glycerol (E422), macrogol
600 (E1521), saccharin sodium (E954), carmellose
sodium (E466), sodium laurilsulfate, silica dental type
precipitated (E551), titanium dioxide (E171), mint
flavouring (containing menthol, propylene glycol,
spearmint oil, carvone, anethol, ethyl maltol, vanillin)
and purified water.
What Fluoride Toothpaste looks like and contents of
the pack
Fluoride Toothpaste is a smooth, white coloured paste
with the odour and taste of spearmint.
It is supplied in a 75 ml collapsible tube enclosed in an
outer carton.
Marketing Authorisation Holder:
Morningside Healthcare Ltd, 115 Narborough Road,
Leicester, LE3 0PA, UK
Morningside Pharmaceuticals Ltd, 5 Pavilion Way,
Loughborough, LE11 5GW, UK
This leaflet was last revised in 05 / 2015.

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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.