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DICLOFENAC 0.74 MG/ML MOUTHWASH

Active substance(s): DICLOFENAC FREE ACID

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Diclodent

0.74 mg/ml Mouthwash

Diclofenac acid

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.
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.
In this leaflet:
1. What Diclodent is and what it is used for
2. What you need to know before you use Diclodent
3. How to use Diclodent
4. Possible side effects
5. How to store Diclodent
6. Contents of the pack and other information
1. What Diclodent is and what it is used for
The name of your medicine is Diclodent 0.74 mg / ml
Oromucosal Solution, which will be called
Diclodent in this leaflet. Diclodent contains
0.74 mg / ml diclofenac base. Diclofenac base is
one of a group of medicines called non – steroidal
anti – inflammatory drugs (NSAIDs). It is used
to reduce pain, redness, heat and swelling in the
mouth and throat that may be associated with gum
disease, or inflammation of the mouth, lips, tongue,
or throat, sore throat, or following dental treatment.
An oromucosal solution is also known as a
mouthwash.
2. What you need to know before you used
Dicoldent
Do not use Diclodent
- if you are allergic (hypersensitive) to diclofenac
acid, or closely related substances, such as
diclofenac sodium, aspirin or other NSAIDs,
or any of the other ingredients of Diclodent.
See Section 6.
- if you are pregnant, or think you might be
pregnant, or are breast – feeding, talk to your
doctor, dentist, or pharmacist before using
Diclodent.
Warnings and precautions
When using Diclodent avoid swallowing the medicine;
following rinsing or gargling, it should be spat out.
Other medicines and Diclodent
Tell your doctor, dentist, or pharmacist if you
are taking or have recently taken any other
medicines, including medicines obtained without
a prescription.

Item Code

M0112-LA-M-UK-NA-001

Proof By

neil.everitt

Proof No.

1

Date

27/07/2015

MPS No.

585479

Keyline Ref

MLEAF008

Dimensions

160 x 220mm

Using Diclodent with food and drink
Diclodent mouthwash can be used between meals.
Pregnancy and breast-feeding
There is no information available on use of
Diclodent in pregnancy or while breast – feeding.
Therefore, if you are pregnant, might be pregnant,
or are planning to become pregnant, or you are
breast feeding, you should talk to your doctor,
dentist or pharmacist before using Diclodent.
Ask your doctor or pharmacist for advice before
taking any medicine.
Driving and using machines
Diclodent should not affect your ability to drive or
use machines.
Diclodent contains Sorbitol, Sodium Benzoate
and Ponceau 4R
Diclodent contains the following ingredients:
- Sorbitol – if you have been told by your doctor
that you have an intolerance to some sugars,
contact your doctor before using this medicine
- Sodium benzoate – this is mildly irritant to the
skin, eyes and mucous membranes
- Ponceau 4R (E 124) – may cause allergic
reactions.
3. How to use Diclodent
Always use Diclodent exactly as your doctor or
dentist has told you. You should check with your
doctor, dentist or pharmacist if you are not sure.
The usual dose is 15 ml, as a single rinse or
gargle, either two, or three times a day.
To help you, each bottle of Diclodent is supplied
with a measuring cup, as shown in the picture
below. A single rinse or gargle of 15 ml is
measured into the measuring cup, and then taken
into the mouth. Do not swallow the dose. Rinse
your mouth, or gargle, for about one minute,
and then spit the dose out.
The diagram shows the measuring cup,
and indicates where the dose mark is.
Dose mark
Fill the dosing cup to the 15 ml
mark as shown by arrow
above.
If needed, you can add drinking water to the
measuring cup to just below the rim, before use.
If this is done, take care not to overfil or spill any of
the dose.
The dose should be used as soon as you have
measured it out.

After each use of the dose cup, wash immediately
with warm soapy water, rinse and dry. The dose
cup can be re-used until you have finished the
bottle, after which it should be thrown away.
Close the bottle securely after each use, by replacing
and fully screwing the plastic cap closed.
If you use more Diclodent than you should
If you rinse, or gargle, but do not swallow, more
Diclodent than you should, it is unlikely that there
will be any effect. If you swallow Diclodent, or you
use and swallow more Diclodent than you should,
there is also unlikely to be any effect. However,
in both cases, if you feel in any way different,
or you are worried, talk to your doctor, dentist,
or pharmacist immediately.
If you forget to use Diclodent
If you forget to use Diclodent when you should, use
it as soon as you remember, unless it is nearly time
for you to use it again, and carry on as before. If it is
nearly time for you to use it again, miss the forgotten
dose, and use the next dose when required.
Do not use a double dose to make up for a
forgotten dose.
If you stop using Diclodent
You should not stop using Diclodent without talking
to your doctor, dentist, or pharmacist.
If you have any further questions on the use of this
product, ask your doctor, dentist or pharmacist.
4. Possible side effects
Like all medicines, Diclodent can cause side
effects, although not everybody gets them.
If you get an allergic reaction, such as swelling of
the the lips, throat, difficulty breathing, red, itchy
skin, sometimes with lumps, or rash, you should stop
using Diclodent and contact your doctor or dentist,
or pharmacist, immediately. This type of reaction is
very rare, it may affect up to 1 in 10,000 users.
Use of Diclodent may give rise to sensitisation,
especially if usage is prolonged. Symptoms could
include rash, itch skin, possibly with raised lumps.
If this happens, you should contact your doctor,
dentist, or pharmacist as soon as possible, and
stop using Diclodent.
Use of Diclodent may cause irritation and soreness
in the mouth, generally mild. This may be more
likely to happen if use of Diclodent is prolonged.
Use of Diclodent may give rise to a cough.
If any of these side effects occur, and are severe,
or you are worried, you should talk to your doctor,
dentist, or pharmacist. It is not known how often
such side effects occur.
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 directly, via the national Yellow
Card scheme, available online at
www.mhra.gov.uk/yellowcard. By reporting side
effects you can help provide more information on
the safety of this medicine.

Keyline Ref

MLEAF008

Dimensions

160 x 220mm

5. How to store Diclodent
Keep out of the sight and reach of children.
This medicine does not require any special
temperature storage conditions. Do not refrigerate
or freeze.
Keep the bottle tightly closed when not in use,
to protect it from mositure and prevent evaporation.
Do not use Diclodent after the expiry date which is
stated on the bottle label and carton after Exp.
The expiry date refers to the last day of that month.
Do not use Diclodent if you notice visible
cloudiness, or solid particles. Return the bottle to
your pharmacist and talk to them.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer
required. These measures will help to protect the
environment.
6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Diclodent contains
- The active substance is diclofenac acid
- The other ingredients are:
- Sorbitol solution, E 420
- Choline
- Sodium benzoate, E 211
- Sodium edetate
- Acesulfame potassium, E 950
- Ponceau 4 R, E 124
- Peach flavour
- Peppermint oil
- Purified water
What Diclodent looks like and contents of the
pack
Diclodent mouthwash is a clear to slightly
opalescent, red – orange solution, with a
characteristic peppermint and peach smell. Each ml
contains 0.74m of diclofenac acid.
It is presented in amber (type III) glass bottles,
with a white polyethylene screw cap, in a carton,
with a leaflet and an opalescent polypopylene
measuring cup.
Marketing Authorisation Holder:
Morningside Healthcare Ltd
115, Narborough Road,
Leicester,
LE3 0PA,
United Kingdom.
Manufacturer:
Doppel Farmaceutici S.R.L.,
Via Martiri delle Foibe, 1,
29016 Cortenaggiore (PC),
Italy.
This leaflet was last revised in June 2014.

M0112-LA-M-UK-NA-001

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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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