DICLODENT 0.74 MG / ML MOUTHWASH, DICLOFENAC 0.74 MG / ML MOUTHWASH - patient leaflet, side effects, dosage

Diclofenac

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 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.

What is in this leaflet:

• 1. What Diclofenac Mouthwash is and what it is used for

• 2. What you need to know before you use Diclofenac Mouthwash

• 3. How to use Diclofenac Mouthwash

• 4. Possible side effects

• 5. How to store Diclofenac Mouthwash

• 6. Contents of the pack and other information

1. what diclofenac mouthwash is and what it is used for

The name of your medicine is Diclofenac 0.74 mg/ml Oromucosal Solution, which will be called diclofenac mouthwash in this leaflet. Diclofenac mouthwash 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 use diclofenac mouthwash

Do not use diclofenac mouthwash

• if you are allergic to diclofenac acid, or closely related substances, such as diclofenac sodium, aspirin or other NSAIDs, or any of the other ingredients of diclofenac mouthwash. 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 diclofenac mouthwash.

Warnings and precautions

Talk to your doctor, dentist or pharmacist before using Diclofenac.

When using diclofenac mouthwash avoid swallowing the medicine; following rinsing or gargling, it should be spat out.

Other medicines and Diclofenac Mouthwash Tell your doctor, dentist, or pharmacist if you are taking, have recently taken or might take any other medicines.

Using Diclofenac Mouthwash with food and drink

Diclofenac mouthwash can be used between meals.

Pregnancy and breast-feeding

Diclofenac mouthwash should not be used in pregnancy or while breast – feeding unless considered essential by the doctor.

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 using this medicine.

Driving and using machines

Diclofenac mouthwash should not affect your ability to drive or use machines.

Diclofenac Mouthwash contains Sorbitol, Sodium Benzoate and Ponceau 4R

Diclofenac mouthwash 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 (E124) – may cause allergic reactions.

3. how to use diclofenac mouthwash

Always use diclofenac mouthwash 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 diclofenac mouthwash 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

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 Diclofenac Mouthwash than you should

If you rinse, or gargle, but do not swallow more diclofenac mouthwash than you should, it is unlikely that there will be any effect. If you swallow diclofenac mouthwash, or you use and swallow more diclofenac mouthwash 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 Diclofenac Mouthwash If you forget to use diclofenac mouthwash 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 Diclofenac Mouthwash

You should not stop using diclofenac mouthwash 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, diclofenac mouthwash can cause side effects, although not everybody gets them.

If you get an allergic reaction, such as swelling of the lips, throat, difficulty breathing, red and/or itchy skin, sometimes with lumps, or rash, you should stop using diclofenac mouthwash 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 diclofenac mouthwash may give rise to sensitisation, especially if usage is prolonged. Symptoms could include rash, itchy skin, possibly with raised lumps. If this happens, you should contact your doctor, dentist, or pharmacist as soon as possible, and stop using diclofenac mouthwash.

Use of diclofenac mouthwash may cause irritation and soreness in the mouth, generally mild. This may be more likely to happen if use of diclofenac mouthwash is prolonged.

Not known:

Burning sensation in the mouth

Use of diclofenac mouthwash 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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store diclofenac mouthwash

Keep this medicine 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 moisture and prevent evaporation.

Do not use diclofenac mouthwash 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 diclofenac mouthwash if you notice visible cloudiness, or solid particles. Return the bottle to your pharmacy and talk to them.

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.

6. contents of the pack and other information

What Diclofenac Mouthwash contains

• The active substance is diclofenac acid.
• The other ingredients are: Sorbitol solution (E420), Choline, Sodium benzoate (E211), Sodium edetate, Acesulfame potassium (E950), Ponceau 4R (E124), Peach flavour, Peppermint oil, Purified water

What Diclofenac Mouthwash looks like and contents of the pack

Diclofenac mouthwash is a clear to slightly opalescent, red – orange solution, with a characteristic peppermint and peach smell. Each ml contains 0.74mg 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 polypropylene measuring cup.

Marketing Authorisation Holder: Morningside Healthcare Ltd

• 115, Narborough Road, Leicester, LE3 0PA, United Kingdom.