Visustrin
Italy
BEFORE USE
READ CAREFULLY ALL THE INFORMATION CONTAINED
IN THIS LEAFLET
This is a self-medication product that you can use to treat mild and transient disorders
easily recognizable and resolvable without medical assistance.
It can therefore be purchased without a prescription, but must be used correctly to ensure effectiveness and reduce
the risk of adverse effects.
- for further information and advice, consult your pharmacist
- consult your doctor if symptoms do not resolve after a short period of treatment.
NAME OF THE MEDICINAL PRODUCT
VISUSTRIN 0.1% eye drops, solution
COMPOSITION
10 ml of eye drops contain:
Active substance: tetrizoline hydrochloride 10 mg.
Excipients: Boric acid; sodium chloride; borax; benzalkonium chloride; edetate disodium; purified water.
PRESENTATION
VISUSTRIN is available as eye drops, solution.
The pack contains one 10 ml bottle.
WHAT IT IS
VISUSTRIN is a sympathomimetic drug used as a decongestant for ocular use.
MARKETING AUTHORISATION HOLDER
Marketing Authorisation Holder:
Pietrasanta Pharma S.p.A.
Via San Francesco, 67 - Viareggio (LU)
MANUFACTURER AND FINAL CONTROLLER
Farmigea S.p.A. – Via G.B. Oliva 8- 56121 Pisa
WHY IT IS USED
Visustrin is used in cases of: redness, itching, burning, swelling of the conjunctiva.
WHEN IT MUST NOT BE USED
Hypersensitivity to the active substance or to any of the excipients.
It must not be used in patients with glaucoma or other serious eye diseases, or in children under three years of age.
What to do during pregnancy and breastfeeding
In pregnant women or during breastfeeding, the product should be used only after consulting a doctor and evaluating the risk/benefit ratio in your individual case. Consult your doctor if you suspect you are pregnant or are planning a pregnancy.
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PRECAUTIONS FOR USE
Safety and efficacy in children have not been established. Use in children over three years of age requires medical approval (see WHEN IT MUST NOT BE USED).
If no relief is obtained within 48 hours of starting treatment, discontinue use and consult your doctor.
The product may cause toxic effects if accidentally ingested or used for prolonged periods at excessive doses.
Caution for athletes: the product contains substances prohibited in doping. Any use differing from the recommended dosage regimen or route of administration is prohibited.
If symptoms persist or worsen after a short period of treatment, consult your doctor; in any case, the product must not be used for more than four consecutive days, as adverse effects may otherwise occur.
Consult your doctor in case of eye infections, presence of pus, foreign bodies in the eye, or mechanical, chemical, or thermal injuries. Although systemic absorption is minimal, the product should be used with caution in patients with high blood pressure, thyroid disorders, heart conditions, hyperglycemia (diabetes), or those undergoing treatment with antidepressant medications.
May cause eye irritation.
Avoid contact with soft contact lenses. Remove contact lenses before application and wait at least 15 minutes before reinserting them. The product is known to cause discoloration of soft contact lenses.
Strictly adhere to the recommended dosage.
Keep out of reach of children, as accidental ingestion may cause marked sedation.
WHICH MEDICINES OR FOODS CAN AFFECT THE MEDICINE'S EFFECT
No pharmacological interactions are known. However, if you are using other medicines, consult your pharmacist or doctor.
IT IS IMPORTANT TO KNOW THAT
Effects on ability to drive and use machines: the product does not interfere with the ability to drive vehicles or operate machinery.
HOW TO USE THIS MEDICINE
Dosage
Caution: do not exceed the recommended dose without medical advice.
FOR ADULTS ONLY. USE IN CHILDREN OVER THREE YEARS OF AGE REQUIRES MEDICAL APPROVAL.
The recommended dose is 1-2 drops in each eye two or three times daily.
(see PRECAUTIONS FOR USE).
When and for how long
Do not use for more than four days.
Consult your doctor if symptoms recur frequently or if you have noticed any recent changes in their characteristics.
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WHAT TO DO IF YOU HAVE TAKEN AN EXCESSIVE DOSE
In case of overdose, stop treatment immediately and contact your doctor or go to the nearest hospital.
ADVERSE EFFECTS
The following have been reported with use of the product: pupillary dilation, systemic absorption effects (high blood pressure, cardiac disorders, hyperglycemia), increased intraocular pressure, nausea, headache.
Following the instructions in this leaflet reduces the risk of adverse effects.
These adverse effects are generally transient. However, if they occur, consult your doctor or pharmacist.
It is important to inform your doctor or pharmacist of any adverse effects not described in this leaflet.
Request and complete the adverse reaction reporting form available at pharmacies (Model B).
EXPIRY DATE AND STORAGE
Store below 25 °C.
Expiry date: see the date printed on the packaging.
Warning: do not use the medicine after the expiry date stated on the packaging.
Do not use the bottle more than 30 days after first opening.
Keep the medicine out of reach of children.
It is important to always keep the medicine information available; therefore, retain both the packaging and the leaflet.
The shelf life stated refers to the product in intact packaging and stored correctly.
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