Diclofenac 0.74 Mg/Ml Mouthwash
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.
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
- Fbnceau 4R (E 124) - may cause allergic reactions.
3. How to use Diclodent
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.
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 -5*.
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.
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.
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.
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.
Laboratorios Atral, S.A.
Rua da Esta^ao, 42
Vala do Carregado
2600-726 Castanheira do Ribatejo
Portugal
This leaflet was last revised in March 2016.
M0112-LA-M-UK-NA-001
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Keyline Ref |
MLEAF008 |
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Dimensions |
160 x 220mm |