Lacrilube

PACKAGE LEAFLET

This is a SELF-MEDICATION medicine that you can use to treat mild and
transient disorders which are easily recognizable and resolvable without medical intervention.
It can therefore be purchased without a prescription, but must be used correctly to ensure its effectiveness and
minimize side effects.
For further information and advice, consult your pharmacist.
Consult a doctor if the condition does not resolve after a short period of treatment.

LACRILUBE 42.5% liquid paraffin + 57.3% white soft paraffin ophthalmic ointment

COMPOSITION
100 g contains:
Active ingredients: Liquid paraffin, White soft paraffin
Excipients: Lanolin alcohol

PRESENTATION
Lacrilube is a homogeneous, smooth ointment of white color.
Each tube contains 3.5 g of ophthalmic ointment.

WHAT IT IS
Ocular lubricant.

MARKETING AUTHORIZATION HOLDER AND MANUFACTURER
AbbVie S.r.l.
S.R. 148 Pontina km 52 snc
04011 Campoverde di Aprilia (LT)
Italy

MANUFACTURER AND FINAL CONTROLLER
TUBILUX PHARMA S.p.A
Via Costarica, 20/22
Pomezia (Rome)

WHY IT IS USED
Lacrilube is used to lubricate and protect the eyes in cases of ocular dryness.

WHEN IT MUST NOT BE USED
Hypersensitivity to lanolin alcohols or to any of the excipients.

When it can be used after consulting a doctor
This product is for external use only; prolonged use of topical products may lead to sensitization reactions. In such cases, discontinue treatment and consult a doctor.
It is advisable to consult a doctor also if such reactions have occurred in the past.

Pregnancy and breastfeeding
Lacrilube contains ingredients that have been used for years in other medicines without concerning effects during pregnancy or breastfeeding. Therefore, no special precautions are necessary when using Lacrilube under these conditions.

Driving and use of machinery
This medicine may cause blurred vision and temporary visual disturbances in some patients.
Do not drive or operate machinery until symptoms have resolved.

PRECAUTIONS FOR USE
Since Lacrilube is a sterile preparation, avoid contact between the tip of the tube and any surface.

WHICH MEDICINES OR FOODS CAN AFFECT THE MEDICINE'S EFFECT
No interactions with other medicinal products have been observed.
If you are using other medicines (including non-prescription ones), consult your doctor or pharmacist. If you are using (or plan to use) other ophthalmic treatments, apply the other medication first and wait at least 5 minutes before applying Lacrilube.

IMPORTANT INFORMATION TO KNOW
Keep the medicine out of the reach and sight of children.
If you wear contact lenses, remove them before using this product. Lenses may be reinserted 30 minutes after ointment application.

Important information about some excipients in Lacrilube
Lacrilube contains lanolin alcohol, which may cause local reactions (e.g., contact dermatitis).

HOW TO USE THIS MEDICINE
Use Lacrilube exactly as directed in this leaflet. In case of doubt, contact your doctor or pharmacist.

Dosage
Apply a small amount of Lacrilube to the eye one or more times daily.

Caution: Do not exceed the recommended doses without medical advice.
Accidental overdose (in the eyes) is not dangerous, apart from temporary blurred vision. If Lacrilube is accidentally swallowed, contact your doctor or pharmacist.
Do not apply a double dose if you miss a dose. Apply the next dose at the scheduled time as advised by your doctor or pharmacist.

When and for how long
Caution: Use only for short-term treatment.
This product must not be used for longer than 72 hours.
Consult your doctor if symptoms recur or if you notice any recent changes in their characteristics.
If irritation, pain, redness, or changes in vision occur or worsen, discontinue treatment with Lacrilube and consult your doctor or pharmacist.

How to apply

• Wash your hands.
• Gently pull down the lower eyelid to form a small pocket for the ointment.
• Tilt your head slightly backward.
• Hold the tube between thumb and index finger and apply a small amount into the pocket formed.
• Close your eyes and roll them from side to side to help distribute the ointment.

UNDESIRABLE EFFECTS
Like all medicines, Lacrilube can cause side effects, although not everyone experiences them.
After application of Lacrilube, the following side effects may occur, although their frequency is unknown:

• Ocular irritation
• Eye redness
• Eye pain
• Blurred vision
• Ocular allergy
• Swelling and itching of the eye and/or eyelid
• Ocular discharge
• Foreign body sensation in the eye
• Excessive tearing

Following the instructions in this leaflet reduces the risk of side effects.
These side effects are generally transient. However, if they occur, it is advisable to consult your doctor or pharmacist.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You may also report side effects directly via the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

EXPIRY DATE AND STORAGE
No special storage precautions required.
Caution: Do not use the medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
After first opening, the product remains valid for 28 days.
Keep the medicine out of the reach and sight of children.
It is important to always have medicine information available. Therefore, keep both the packaging and the package leaflet.