Tirocular, collyrium, solution

Name of the medical product
Tirocular®

Qualitative and quantitative composition:
Each 10 ml vial contains:
Active substance: Acetylcisteine: 400 mg

Pharmaceutical form and content:
10 ml vial of collyrium, solution at 4%

Pharmacotherapeutic class
Pharmacotherapeutic group: 15.6.1. – Adstringents, lubricants and artificial tears
ATC code: S01XA08 – Other medicines used in ophthalmology

Market authorisation holder
L. Lepori Ldª
Rua João Chagas, nº 53-3º Piso
1495-072 Algés

Therapeutic indications
Tirocular is indicated in the treatment of ophthalmic disorders produced by a lacrimal deficit with or without changes in the mucus behaviour, such as:

• Dry keratoconjunctivitis
• Cornea disorders caused by changes in the lacrimal secretion
• Keratopathies of diverse ethyology
• Corneal ulcer

Contraindications and side effects
Tirocular is not indicated in patients with known hypersensitivity to the active ingredient.

No local or systemic reactions directly related with the nature of the medicine are known.

Drug interactions and other forms of interaction
There are no clinical assays on the potential interactions with other drugs.
However, it is advisable to avoid the concomitant use of other preparations for ocular instillation, particularly, certain antibiotics that may present a risk of chemical interaction. It is also not advisable to administer this medication at the same time, it is better to have an interval of several hours between the applications.

Warnings and special precautions for use
From the preclinical and clinical assays there is no evidence that support the need for special precautions with the use of this drug. However, it is advisable to avoid instillation when the patient has to drive or use machines. Also, the patient should not wear contact lens during therapy, since the preservative contained in the preparation may accumulate.

Effects on pregnant women, breast-feeding women, children, elderly patients and patients with special pathologies
There is no data demonstrating any contraindication to the use of Tirocular during pregnancy and lactation.

Effects on the ability to drive and use machines
There is no data showing that the drug affects the ability/responsibility to drive. However, it is advisable to avoid the instillation of the preparation while driving or using machines.

List of excipients
Polivinilic alcohol, Benzalcomium chloride, sodium edetate, sodium chloride, potassium chloride, sodium hydroxide, purified water q.s.

Usual posology, with reference to maximum dose
One or two drops in the conjunctival sac, 3-4 times a day, or follow the doctor’s indications.

To administer the preparation:
a) Remove the seal
b) Remove the rubber lid.
c) Extract the dripper tip and introduce it inside the vial’s orifice.
d) Remove the lid and apply the collyrium.

Indication of the most favourable moment for the administration of the medicine
According to the doctor’s indication.

Duration of the average treatment when it should be limited
The duration of the treatment depends on the clinical situation and its evolution.

Instructions about what to do if you forget to administer one or more doses
If you forget to administer one or more doses, treatment must be continued.

Indication of how to discontinue the treatment when its discontinuation causes withdrawal effects
No special precaution is necessary to suspend the treatment.

Measures to adopt in case of overdosage and/or intoxication, emergency measures and antidotes
Overdosage is not to be considered.

Advice to the patient
If you notice any side effect not mentioned in this leaflet, please inform your doctor or pharmacist.

Check if the product is within the expiry date mentioned in the package.

The vial should be closed immediately after each application.
Keep out of reach and sight of children.

Special precautions of storage and indication of visible signs of deterioration, if they exist
Store at a temperature below 25ºC
After the 1st opening it is valid for 3 weeks

Date of the revision of the leaflet
April 2005

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