Plak Out
Italy
Table of Contents
Package leaflet: Information for the user
PLAK OUT 0.12% Solution
Chlorhexidine digluconate
Read this leaflet carefully before using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you to do.
- Keep this leaflet. You may need to read it again.
- If you need more information or advice, consult your pharmacist.
- If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
- Consult your doctor if you do not notice improvement or if you experience worsening of symptoms after a short period of treatment. Contents of this leaflet:
- What Plak Out is and what it is used for
- What you need to know before using Plak Out
- How to use Plak Out
- Possible side effects
- How to store Plak Out
- Contents of the pack and other information
1. What Plak Out is and what it is used for
Plak Out contains chlorhexidine digluconate, a disinfectant for local oral use that acts on the oral mucosa.
Plak Out is indicated for disinfecting the mouth, gums, and throat in adults when oral hygiene is difficult.
Consult your doctor if you do not feel better or if you feel worse after a short period of treatment.
2. What you need to know before using Plak Out
Do not use Plak Out
- if you are allergic to chlorhexidine digluconate or to any of the other ingredients of this medicinal product (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before using Plak Out.
The use, especially if prolonged, of topical products may lead to allergic reactions (see section "Possible side effects"). In such case, discontinue treatment and consult your doctor, who will initiate appropriate therapy.
Use Plak Out for topical use only, without swallowing.
If you have accidentally swallowed or inhaled this medicinal product, consult your doctor or go to the nearest hospital, as accidental ingestion or inhalation of certain disinfectants may have serious, sometimes fatal, consequences (see section 3 "If you use more Plak Out than you should").
Avoid contact with the eyes.
This medicinal product is not contraindicated in patients affected by celiac disease.
For those engaged in sports activities
Plak Out contains ethyl alcohol, which may result in a positive anti-doping test depending on the blood alcohol concentration limits set by certain sports federations.
Children and adolescents
This medicinal product should be used only when strictly necessary and only after consulting a doctor.
Other medicines and Plak Out
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Avoid simultaneous use of other disinfectants and oral, gingival, or throat cleansers.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicinal product.
Use this medicinal product only when strictly necessary and only after consulting your doctor.
Driving and using machines
Plak Out does not affect the ability to drive or operate machinery.
3. How to use Plak Out
Take this medicine exactly as stated in this leaflet or as instructed by your
doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 10 ml of Plak Out 2–3 times a day.
The maximum dose is 3 rinses per day (corresponding to 36 mg of active substance).
Warning: Do not exceed the recommended doses.
Use Plak Out starting with short rinses (10–15 seconds).
It is advisable to perform the rinses after meals, and only for the necessary duration.
The antiseptic effect will increase with prolonged rinsing time, up to 3–4 minutes.
Consult your doctor if the condition recurs or if you have noticed any recent changes
in its characteristics.
Take Plak Out undiluted (without mixing with water):
- Unscrew the cap from the bottle and use it as a measuring dispenser (the cap holds 10 ml).
- Fill the cap with the solution and rinse your mouth.
Use in children and adolescents
This medicine should be used only when strictly necessary and only after consulting a doctor.
If you use more Plak Out than you should
It is unlikely that you could use an excessive dose of this medicine. However, if you
accidentally use too much Plak Out, consult your doctor immediately or go to the nearest
hospital.
Accidental ingestion or inhalation of some antiseptics may have serious, sometimes fatal, consequences. In
case of accidental ingestion of the product, consult your doctor immediately or go to the nearest
hospital.
If you forget to use Plak Out
Do not use a double dose to make up for the forgotten dose.
If you stop treatment with Plak Out
If you have any doubts about using this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The following side effects have been reported:
- mild alteration of taste (after rinsing)
- slight yellowish discoloration of the tongue and teeth, following prolonged use at high doses. Discoloration of the tongue resolves by reducing the frequency and duration of rinsing, while using a good toothpaste is sufficient to remove enamel pigmentation.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor or pharmacist.
You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Plak Out
Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the packaging after "Exp.". The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
6. Package contents and other information
What Plak Out contains
- The active substance is chlorhexidine digluconate. 100 ml of solution contain 0.120 g of chlorhexidine digluconate.
- The other components are: lycasine, ethanol 96°, polidocanol, peppermint essential oil, colour E124, purified water.
Description of the appearance of Plak Out and package contents
Plak Out 0.12% solution for oral mucosa is a clear, light red solution contained in a 150 ml plastic bottle.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Polifarma Benessere S.r.l., Via Laurentina, 289 - 00142 Rome, Italy
Manufacturer
Takeda Pharma Sp. z.o.o., Ksiestwa Lowickiego Str. 12, 99-420 Lyszkowice – Poland