CHLORCHINALDIN 2 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Chlorchinaldin VP, 2 mg, lozenges
   1. Read the package leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet
3. What is Chlorchinaldin VP and what is it used for
4. Important information before using Chlorchinaldin VP
   1. When not to use Chlorchinaldin VP
   2. Warnings and precautions
   3. Chlorchinaldin VP and other medicines
   4. Chlorchinaldin VP with food and drink
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and using machines
   7. Chlorchinaldin VP contains sucrose
   8. Chlorchinaldin VP contains sodium
5. How to use Chlorchinaldin VP
   1. Using more than the recommended dose of Chlorchinaldin VP
   2. In case of using more than the recommended dose of the medicine, the patient should contact their doctor.
   3. Treatment in case of overdose includes inducing vomiting and rinsing the stomach, as well as symptomatic treatment.
   4. Missing a dose of Chlorchinaldin VP
6. Possible side effects
   1. Reporting side effects
7. How to store Chlorchinaldin VP
8. Contents of the pack and other information
   1. What Chlorchinaldin VP contains
   2. What Chlorchinaldin VP looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. Date of last revision of the leaflet:

Package Leaflet: Information for the User

Chlorchinaldin VP, 2 mg, lozenges

Chlorquinaldine

Read the package 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 package leaflet for the patient 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 those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If after a few days there is no improvement or the patient feels worse, they should contact their doctor.

Table of Contents of the Leaflet

• 1. What is Chlorchinaldin VP and what is it used for
• 2. Important information before using Chlorchinaldin VP
• 3. How to use Chlorchinaldin VP
• 4. Possible side effects
• 5. How to store Chlorchinaldin VP
• 6. Contents of the pack and other information

1. What is Chlorchinaldin VP and what is it used for

Chlorchinaldin VP is a medicine with antibacterial, antifungal, and antiprotozoal properties.
It is indicated for local use:

• in bacterial infections of the mouth and gums,
• in thrush,
• in fungal infections of the mouth and throat after antibiotic treatment.

2. Important information before using Chlorchinaldin VP

When not to use Chlorchinaldin VP

• if the patient is allergic to chlorquinaldine or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting to use Chlorchinaldin VP, the patient should discuss it with their doctor or pharmacist.
If the symptoms persist or worsen despite using the medicine for several days, the patient should consult their doctor, who will recommend appropriate treatment. In bacterial infections, it is often necessary to use an appropriate systemic antibiotic, and Chlorchinaldin VP is used only as an adjunct.

Chlorchinaldin VP and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Metal and iodine compounds weaken the effect of the medicine.

Chlorchinaldin VP with food and drink

The medicine should not be used during meals.

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.
The medicine should not be used during pregnancy, unless the doctor considers it absolutely necessary.
The medicine should not be used during breastfeeding.

Driving and using machines

Chlorchinaldin VP does not affect the ability to drive vehicles or operate machines.

Chlorchinaldin VP contains sucrose

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine. The medicine may have a harmful effect on teeth.

Chlorchinaldin VP contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per lozenge, which means the medicine is considered "sodium-free".

3. How to use Chlorchinaldin VP

This medicine should always be used exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.
Recommended dose
Suck 1 lozenge every 1-2 hours. Do not use more than 10 lozenges per day.
Do not chew the lozenges.
Do not use the medicine during meals.
If the symptoms worsen or do not improve after a few days of using the medicine, the patient should contact their doctor.
The medicine should not be used for a long time and in higher doses than recommended.

Using more than the recommended dose of Chlorchinaldin VP

No cases of overdose have been reported so far.
Due to the dose of the medicine and its negligible absorption, the occurrence of severe side effects as a result of an overdose is unlikely. However, study results indicate that chloroquinoline derivatives (chlorquinaldine belongs to this group), especially when used in high doses and for a long time, may cause subacute optic neuropathy (a type of nervous system disorder), characterized by sensory disturbances, muscle weakness, pain, and vision disturbances. Symptoms are often preceded by persistent diarrhea and abdominal pain, and a characteristic symptom is the green discoloration of urine and tongue.

In case of using more than the recommended dose of the medicine, the patient should contact their doctor.

Treatment in case of overdose includes inducing vomiting and rinsing the stomach, as well as symptomatic treatment.

Missing a dose of Chlorchinaldin VP

If the patient misses a dose, they should take it as soon as possible. However, if it is almost time for the next dose, the patient should skip the missed dose. The patient should not take a double dose to make up for the missed dose.
In case of any further doubts about using this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The frequency of the following side effects is unknown (cannot be determined from available data).
General disorders and administration site conditions: irritation of the mucous membrane, itching, allergic reactions.
Immune system disorders: allergic reactions (rash or urticaria) in hypersensitive individuals.
If any of the side effects get worse or if the patient experiences any side effects not listed in the leaflet, they should inform their doctor or pharmacist.

Reporting side effects

If the patient experiences any side effects, including those not listed in the leaflet, they should inform their doctor or pharmacist. 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:
Jerozolimskie Avenue 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Chlorchinaldin VP

Store in a temperature below 25°C. Store in the original packaging to protect from light and moisture.
The medicine should be kept out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. 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 no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Chlorchinaldin VP contains

• The active substance is chlorquinaldine. One lozenge contains 2 mg of chlorquinaldine.
• The other ingredients are: citric acid monohydrate, sucrose, sodium carmellose, talc, magnesium stearate.

What Chlorchinaldin VP looks like and contents of the pack

Chlorchinaldin VP lozenges are round, flat on both sides, with a marbled surface.
The medicine is available in a pack containing 20 or 40 lozenges (1 or 2 blisters of aluminum/PVC foil containing 20 lozenges, in a cardboard box).

Marketing authorization holder

Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland

Manufacturer

ICN Polfa Rzeszów S.A.
Przemysłowa Street 2
35-959 Rzeszów

Date of last revision of the leaflet: