Chlorchinaldin with black currant flavor

Package leaflet: Information for the user

Chlorchinaldin blackcurrant flavour, 2 mg, lozenges
Chlorquinaldolum
Please read all of this leaflet carefully before you start taking this medicine, because it contains
important information for you.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please contact your pharmacist.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If there is no improvement after a few days, or if you feel worse, you should contact your doctor.

Contents of the leaflet

1. What Chlorchinaldin blackcurrant flavour is and what it is used for
2. Important information before taking Chlorchinaldin blackcurrant flavour
3. How to take Chlorchinaldin blackcurrant flavour
4. Possible side effects
5. How to store Chlorchinaldin blackcurrant flavour
6. Contents of the pack and other information

1. What Chlorchinaldin blackcurrant flavour is and what it is used for

Chlorchinaldin blackcurrant flavour is an antibacterial, antifungal and antiprotozoal medicinal product.
It is indicated for local use:

• in bacterial infections of the oral cavity and gums,
• in candidiasis,
• in fungal infections of the oral cavity and throat following antibiotic treatment.

2. Information before using Chlorchinaldin blackcurrant-flavoured

When not to use Chlorchinaldin blackcurrant-flavoured

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

Warnings and precautions
Before starting to take Chlorchinaldin blackcurrant-flavoured, discuss it with your doctor or pharmacist.
If symptoms persist or worsen despite using the medicine for several days, consult a doctor who will recommend appropriate treatment. In bacterial infections, an appropriate systemic-acting antibiotic is often required, and Chlorchinaldin blackcurrant-flavoured should be used only as an adjunct.

Chlorchinaldin blackcurrant-flavoured with other medicines
Tell your doctor about all medicines currently taken or recently taken, as well as any medicines the patient plans to take.
Metal compounds and iodine-containing substances reduce the effectiveness of this medicine.

Chlorchinaldin blackcurrant-flavoured with food and drink
This medicine should not be taken during meals.

Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Chlorchinaldin blackcurrant-flavoured should not be used during pregnancy unless the doctor considers it absolutely necessary.
Do not use during breastfeeding.

Driving and operating machinery
Chlorchinaldin blackcurrant-flavoured has no effect on the ability to drive or operate machinery.

Chlorchinaldin blackcurrant-flavoured contains sucrose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine. This medicine may have harmful effects on teeth.

Chlorchinaldin blackcurrant-flavoured contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is considered "sodium-free".

Chlorchinaldin blackcurrant-flavoured contains d-limonene and linalool
This medicine contains a flavouring substance containing d-limonene and linalool (components of the blackcurrant flavour) which may cause allergic reactions.

3. How to use Chlorchinaldin with blackcurrant flavour

This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Recommended dose
Suck 1 tablet every 1–2 hours. Do not exceed 10 tablets per day.
Do not chew the tablets.
Do not use the medicine during meals.
If symptoms worsen or do not improve within a few days of treatment, consult your doctor.
Do not use the medicine for prolonged periods or in doses higher than recommended.
Use of a higher than recommended dose of Chlorchinaldin with blackcurrant flavour
No cases of overdose have been reported so far.
Due to the dosage and low systemic absorption, severe adverse effects following overdose are unlikely. However, study results indicate that chlorinated derivatives of quinoline (chlorquinaldol belongs to this group), especially when used in high doses and for prolonged periods, may cause subacute myelo-optic neuropathy (a type of nervous system disorder), characterized by sensory disturbances, muscle weakness, pain, and visual disturbances. Symptoms are often preceded by persistent diarrhoea and abdominal pain, and a characteristic sign is greenish discoloration of urine and tongue.
In case of ingestion of a higher than recommended dose, contact your doctor immediately.
Management of overdose includes induction of vomiting and gastric lavage, as well as symptomatic treatment.
Missed dose of Chlorchinaldin with blackcurrant flavour
If you miss a dose at the scheduled time, take it as soon as possible. However, if it is almost time for the next dose, skip the missed dose. Do not take a double dose to make up for a missed one.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The frequency of the adverse reactions listed below is unknown (cannot be estimated from the available data).
General disorders and administration site conditions: mucous membrane irritation, itching, allergic symptoms.
Immune system disorders: allergic symptoms (rash or urticaria) in hypersensitive individuals.
If any of the adverse reactions worsen or if any adverse reactions not listed in this leaflet occur, inform a doctor or pharmacist.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions enables continuous monitoring of the benefit-risk balance of the medicine and helps provide safer use.

5. How to store Chlorchinaldin blackcurrant-flavoured

Store below 25°C. Keep in the original packaging to protect from light and moisture.
Keep the medicine 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 indicated.
Medicines must not be disposed of via sewage or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the packaging and other information

What Chlorchinaldin blackcurrant-flavoured contains

• The active substance is chlorquinaldol. Each pastille contains 2 mg of chlorquinaldol.
• Other ingredients are: citric acid monohydrate, sucrose, sodium carmellose, talc, blackcurrant flavour [containing, among others, propylene glycol (E1520), d-limonene, linalool], magnesium stearate.

What Chlorchinaldin blackcurrant-flavoured looks like and contents of the pack
Chlorchinaldin blackcurrant-flavoured pastilles are round, flat on both sides, with a marbled surface.
The medicine is available in packaging containing 20 or 40 pastilles (1 or 2 aluminium/PVC blisters containing 20 pastilles each, in a cardboard box).

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

Manufacturer
ICN Polfa Rzeszów S.A.
Przemysłowa 2 Street
35-105 Rzeszów
Poland