Diclostim

Leaflet attached to the packaging: patient information

Diclostim, 0.74 mg/mL (0.074%), mouthwash/throat rinse solution
Diclofenac

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If after 7 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Diclostim and what is it used for
• 2. Important information before using Diclostim
• 3. How to use Diclostim
• 4. Possible side effects
• 5. How to store Diclostim
• 6. Package contents and other information

1. What is Diclostim and what is it used for

Diclostim contains the active substance diclofenac, which is a non-steroidal anti-inflammatory drug (NSAID).
When used topically in inflammatory conditions of the oral mucosa and throat, diclofenac has analgesic and anti-inflammatory effects.
Diclostim is used for the symptomatic treatment of inflammatory conditions of the oral mucosa and throat (e.g. symptoms of gingivitis, oral thrush, pharyngitis, post-dental procedures, symptoms of mechanical irritation).
If after 7 days there is no improvement or the patient feels worse, they should consult their doctor.

2. Important information before using Diclostim

When not to use Diclostim:

• if the patient is allergic to diclofenac or any of the other ingredients of this medicine (listed in section 6).
• if the patient has a hypersensitivity (allergy) to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (e.g. after administration of ibuprofen, ketoprofen, acetylsalicylic acid, an asthma attack, hives, or allergic rhinitis occurred).
• in children under 14 years of age.
• during the last three months of pregnancy.

Warnings and precautions

Before starting to use Diclostim, the patient should discuss it with their doctor or pharmacist.

• During topical use of the medicine, especially long-term, hypersensitivity (allergy) may develop. In such a case, the use of the medicine should be discontinued and the patient should contact their doctor, who will prescribe appropriate treatment if necessary.
• The patient should avoid contact between Diclostim and their eyes.

The patient should consult their doctor or pharmacist, even if the above warnings concern situations that occurred in the past.

Special precautions for certain patient groups using Diclostim

Using Diclostim in patients with kidney and liver function disorders

There are no special dosage recommendations for patients with kidney and liver function disorders. Theoretically, there is a possibility of accumulation of the medicine and its metabolites in the case of severe kidney failure, but its clinical significance is unknown.

Using Diclostim in patients with hereditary fructose intolerance

Due to the risk of swallowing, patients with hereditary fructose intolerance should not take this medicine.

Using Diclostim in elderly patients

No dosage adjustment is necessary.

Children and adolescents

Diclostim should not be used in children under 14 years of age.

Diclostim and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
There are no known interactions between this medicine and other medicines for topical use in the mouth.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
Diclostim should not be used during the last three months of pregnancy. During the first six months of pregnancy, Diclostim should not be used unless it is necessary and recommended by a doctor.
If use is necessary, the smallest possible dose should be given for the shortest possible time.
After oral administration of diclofenac-containing medicines (e.g. tablets), side effects may occur in the unborn child. It is not known whether the same risk applies to Diclostim when used in the mouth.
Diclostim should not be used in breastfeeding women.

Driving and using machines

Diclostim has no effect on the ability to drive vehicles or operate machines.
Diclostim contains sodium, potassium, ethanol, sodium benzoate (E 211), cochineal red (E 124),
propylene glycol (E 1520), and sorbitol (E 420)

Sodium

The medicine contains 58 mg of sodium per single dose (15 mL), which corresponds to 2.9% of the WHO-recommended maximum daily sodium intake of 2 g for adults.

Potassium

The medicine contains less than 3 mg of potassium per dose, which means it is considered "potassium-free".

Etanol

Diclostim contains 0.56 mg of alcohol (ethanol) per milliliter, which is equivalent to 0.58 mg/mL. The amount of alcohol in 15 mL of this medicine is equivalent to less than 1 mL of beer or 1 mL of wine. The small amount of alcohol in this medicine will not have noticeable effects.

Sodium benzoate (E 211)

Diclostim contains 312 mg of sodium benzoate in each single dose (15 mL), which may cause local irritation.

Cochineal red (E 124)

Diclostim contains cochineal red, which may cause allergic reactions.

Propylene glycol (E 1520)

Diclostim contains 75 mg of propylene glycol (E 1520) in each single dose (15 mL).

Sorbitol (E 420)

Diclostim contains 375 mg of sorbitol in each single dose (15 mL). Sorbitol is a source of fructose. If the patient has previously been diagnosed with intolerance to some sugars or has a rare genetic disorder, hereditary fructose intolerance, they should consult their doctor before taking the medicine or giving it to their child.

3. How to use Diclostim

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.
Recommended dose

Children under 14 years of age

Diclostim should not be used in children under 14 years of age.

Adults and children over 14 years of age

It is recommended to use the mouthwash/throat rinse solution 2 to 3 times a day. Each time, 15 mL of the solution (1 measuring cup) should be used undiluted or diluted with a small amount of water and the mouth should be rinsed for about 30-60 seconds.
After use, the solution should be spat out.
If symptoms worsen or do not improve after 7 days of using Diclostim, the patient should contact their doctor.
If the patient feels that the effect of the medicine is too strong or too weak, they should consult their doctor.

Using a higher dose of Diclostim than recommended

Accidental, unintentional swallowing of a single dose of the mouthwash/throat rinse solution does not pose a risk to the patient, as the potential swallowed dose of the medicine would be one-fifth to one-sixth of the recommended dose for general use.
There have been no reports of Diclostim overdose.
In patients with hereditary fructose intolerance, the body does not break down the fructose contained in this medicine, which, in the event of unintentional swallowing, may cause side effects.
In case of taking a higher dose of the medicine than recommended, the patient should immediately consult their doctor or pharmacist.

Missing a dose of Diclostim

In case of missing a dose, the patient should not take a double dose to make up for the missed dose, but should take it at the time resulting from the recommended dosing schedule.
In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Diclostim can cause side effects, although not everybody gets them.
During the use of the medicine (especially long-term), symptoms of irritation of the oral mucosa (e.g. burning) and cough may occur. Allergic reactions may also develop.
In such a case, the use of the medicine should be discontinued and the patient should contact their doctor, who will prescribe appropriate treatment.
It cannot be excluded that systemic side effects may occur in case of swallowing or long-term use of Diclostim.
Reporting side effects
If any side effects occur, including any possible side effects not listed in this leaflet, the patient should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw,
phone: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be collected on the safety of the use of the medicine.

5. How to store Diclostim

The medicine should be stored out of sight and reach of children.
There are no special recommendations for the storage temperature of the medicine. Store in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the packaging after "Expiry date". The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Diclostim contains

• The active substance of the medicine is diclofenac. Each milliliter of the mouthwash/throat rinse solution contains 0.74 mg of diclofenac (Diclofenacum) (in the form of diclofenac sodium).
• The other ingredients (excipients) are: sorbitol (E 420), acesulfame potassium (E 950), disodium edetate, sodium benzoate (E 211), choline chloride, sodium bicarbonate, disodium phosphate dihydrate, propylene glycol (E 1520), levomenthol, glycerol, blackcurrant flavor (propylene glycol E 1520, flavor enhancers, natural flavor enhancers, natural flavorings), peppermint flavor (propylene glycol E 1520, glycerol triacetate E 1518, natural flavor enhancers), lemon flavor (ethanol, water, flavor enhancers, natural flavor enhancers), cochineal red (E 124), sodium dihydrogen phosphate dihydrate, purified water.

What Diclostim looks like and what the package contains

Diclostim is a clear, bright red, homogeneous solution without mechanical impurities.
The packaging of Diclostim consists of a PET bottle with an HDPE screw cap, containing 150 mL, 200 mL, or 250 mL of the mouthwash/throat rinse solution, with a 15 mL measuring cup made of polypropylene, placed in a cardboard box. Not all pack sizes may be marketed.

Marketing authorization holder

Solinea Sp. z o.o.
Elizówka, Szafranowa 6
21-003 Ciecierzyn
Phone: 81 463-48-82

Manufacturer

Mako Pharma Sp. z o.o.
Kolejowa 231A
05-092 Dziekanów Polski
Medicofarma S.A.
ul. Tarnobrzeska 13
26-613 Radom

Date of last revision of the leaflet: