PACKAGE LEAFLET

LENIDENT ZETA

Dental analgesic drops 3.5 g 6 ml
BEFORE USE, READ CAREFULLY ALL THE INFORMATION CONTAINED IN THIS LEAFLET
This is a self-medication product intended for the treatment of mild and transient symptoms that are easily recognizable and resolvable without medical intervention.
It may therefore be purchased without a prescription, but must be used correctly to ensure effectiveness and minimize potential adverse effects.

For further information and advice, consult your pharmacist
Consult a doctor if symptoms persist or worsen after a short period of treatment.

LENIDENT ZETA
Procaine hydrochloride

Composition:
Each 1 ml of solution contains:
Active substance:
Procaine hydrochloride: 20 mg
Excipients: Ethanol, Propylene glycol, Clove essential oil, Phenol,
Deionized water.

Presentation:
LENIDENT ZETA is supplied as a dental solution. The package contains one 6 ml bottle with dropper, holding 3.5 g of product.

What it is: LENIDENT ZETA is a solution for local oral treatment (ATC: A01AD11).

Marketing Authorization Holder:
ZETA FARMACEUTICI S.p.A. - Via Mentana No. 38 - 36100 Vicenza
Manufacturer and Final Control:
ZETA FARMACEUTICI S.p.A., Via Galvani No. 10, 36066 Sandrigo (VI)

Why it is used:
LENIDENT ZETA is a local anesthetic and analgesic used for toothache caused by dental caries, pulpitis, and periodontitis.
Module 1.3.1
ZETA FARMACEUTICI S.p.A. PACKAGE LEAFLET

LENIDENT ZETA

Dental drops 3.5 g 6 ml
When it must not be used:
Hypersensitivity to the components or to other substances closely related from a chemical standpoint.
When it can only be used after consulting a doctor:
In children under six years of age, LENIDENT ZETA should be used only after consulting a doctor and evaluating with him the risk/benefit ratio in the individual case.
What to do during pregnancy and breastfeeding:
LENIDENT ZETA may be used during pregnancy and breastfeeding.
Precautions for use
If no appreciable results are obtained after a short period of treatment, consult your physician.
Which medicines or foods can alter the effect of the medicine
No interactions with other medicines or other types have been reported.
If you are taking other medicines, consult your doctor or pharmacist.
It is important to know that
In children under six years of age, LENIDENT ZETA should be used only after consulting a doctor and evaluating with him the risk/benefit ratio in the individual case.
The use, especially if prolonged, of topical products may lead to sensitization phenomena. If these occur, discontinue application of the product and consult your doctor.
Health education notes:
To prevent toothache caused by caries, pulpitis, and periodontitis, appropriate dental and gingival hygiene and regular check-ups with a specialist are recommended.
LENIDENT ZETA may be used for occasional, symptomatic, emergency relief of acute dental pain caused by caries, pulpitis, and periodontitis.
How to use this medicine
How much, when, and for how long
1 or 2 drops as needed or as prescribed by a physician.
Caution: Do not exceed the indicated doses without medical advice.
Module 1.3.1
ZETA FARMACEUTICI S.p.A. PACKAGE LEAFLET

LENIDENT ZETA

Dental drops 3.5 g 6 ml
Warning: use only for short-term treatment.
Consult your doctor if the condition recurs or if you have noticed any recent change in its characteristics.
How to use:
Spray the drops directly into the decayed cavity.
What to do if you have taken an excessive dose of the medicine:
No cases of overdose are known.
In case of accidental ingestion of an excessive dose of LENIDENT ZETA, contact your doctor immediately or go to the nearest hospital.
Undesired effects
No adverse effects have been reported. Following the instructions in the package leaflet reduces the risk of adverse effects.
These adverse effects are generally temporary. However, if they occur, it is advisable to consult your doctor or pharmacist.
It is important to inform your doctor or pharmacist about any adverse effects not described in the package leaflet.
Request and complete the adverse reaction reporting form available at pharmacies (Form B).
Expiry and storage
Warning: do not use the medicine after the expiry date stated on the packaging.
Do not use the product if the packaging shows visible signs of deterioration.
Keep the medicine out of the reach of children.
It is important to always keep the medicine information available; therefore, retain both the box and the package leaflet.
Revision of the package leaflet by the Ministry of Health:
September 2005
Module 1.3.1