TONLIT 50 micrograms/ml EYE DROPS SOLUTION

Introduction

Package Leaflet: Information for the User

Tonlit 50 micrograms/ml eye drops, solution

Latanoprost

Read the package leaflet carefully before you start usingthe medicine.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or the doctor treating your child or your pharmacist.
• This medicine has been prescribed for you or your child, do not give it to others, even if their symptoms are the same, as it may harm them.
• If you consider that any of the adverse effects that you are suffering from is serious, or if you notice any adverse effect not mentioned in this package leaflet, inform your doctor or the doctor treating your child or your pharmacist.

Contents of the package leaflet

1. What is Tonlit and what is it used for
2. Before using Tonlit
3. How to use Tonlit
4. Possible side effects
5. Storage of Tonlit
6. Further information

1. What is Tonlit and what is it used for

Tonlit contains latanoprost, which belongs to a group of medicines known as prostaglandin analogues.

Tonlit is used to treat conditions known as open-angle glaucoma and ocular hypertension in adults. Both conditions are related to an increase in pressure inside the eye, which can affect vision.

Tonlit is also used to treat increased pressure inside the eye and glaucoma in children and babies of all ages.

2. Before using Tonlit

Tonlit can be used in adult men and women (including the elderly) and in children from birth to 18 years of age. Tonlit has not been investigated in premature children (less than 36 weeks of gestation).

Do not use Tonlit

• If you are allergic (hypersensitive) to latanoprost or to any of the other ingredients of Tonlit.

Be careful with Tonlit

If you consider that any of the following situations apply to you or your child, consult your doctor, the doctor treating your child, or your pharmacist before administering Tonlit or before giving it to your child:

Tonlit may cause a gradual change in eye color by increasing the amount of brown pigment in the iris.

Treating only one eye may cause a permanent change in color, mainly observed in patients with non-homogeneous iris pigmentation. In most cases, the color change is mild and has no clinical consequences. You can continue using Tonlit even if eye darkening occurs. Some cases of skin discoloration around the eyes have been observed. To date, this discoloration is not permanent and, in some cases, is reversible even during treatment.

Tonlit may gradually change the eyelashes of the treated eye; these changes include increased length, thickness, darkening of the eyelashes, and abnormal growth of eyelashes. These changes are reversible once treatment is discontinued.

Stop treatment with Tonlit and contact your doctor immediately if you suspect that Tonlit is causing an allergic reaction. The symptoms of an allergic reaction include: skin rash, severe itching, swelling, dizziness, and difficulty breathing.

Using other medicines

Tell your doctor, the doctor treating your child, or your pharmacist if you or your child are using or have recently used other medicines, including those obtained without a prescription and herbal products.

If you use an eye drop that contains thimerosal as a preservative, you should wait at least 5 minutes between the application of this and Tonlit.

No specific data on interactions with other medicines are available.

Concomitant use of two similar eye drops or prostaglandin derivatives is not recommended.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Tonlit should not be used during pregnancy or breastfeeding.

Driving and using machines

Like any other eye drop, if your vision becomes blurred when you apply the drops, wait a moment until the effect disappears before driving or using machines.

Important information about some of the ingredients of Tonlit

This medicine may cause eye irritation because it contains benzalkonium chloride.

Avoid contact with soft contact lenses. Remove contact lenses before use and wait at least 15 minutes before putting them back. It alters the color of soft contact lenses. Follow the instructions included in section 3 for contact lens users.

3. How to use Tonlit

Follow the instructions for administering Tonlit exactly as indicated by your doctor or the doctor treating your child. Consult your doctor, the doctor treating your child, or your pharmacist if you have any doubts.

The usual dose for adults (including the elderly) and children is one drop once a day in the affected eye(s), preferably at night.

If you are using another eye drop, you should wait at least 5 minutes before applying it.

Use Tonlit as your doctor or the doctor treating your child has indicated until they tell you to stop.

Instructions for the correct administration of Tonlit:

1. Wash your hands and sit comfortably.
2. Remove the cap.
3. Using your finger, gently separate the lower eyelid of the eye to be treated.
4. Place the tip of the bottle close to the eye, without touching it.
5. Squeeze the bottle carefully so that only one drop is introduced into the eye. Remove your finger from the lower eyelid.
6. Press the corner of the affected eye, near the nose, with your finger.

Apply pressure for 1 minute, keeping your eye closed.

1. Repeat the operation in the other eye, if your doctor has indicated it.

After use, immediately replace the cap by screwing it until it is firmly in place. The dropper is designed to provide a single drop as the correct dose; therefore, do not increase the dropper hole.

Contact lens users

If you or your child use contact lenses, you should remove them before using Tonlit.

After applying Tonlit, you should wait 15 minutes before putting the contact lenses back.

If you use more Tonlit than you should

If you have applied more Tonlit than you should, you may feel a slight irritation and redness of the eye.

In case of accidental ingestion by you or your child of Tonlit, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91.562.04.20. The following information may be useful: each bottle contains 125 micrograms of latanoprost.

If you forget to use Tonlit

If you forget to apply a dose of Tonlit, you should wait until the next scheduled dose.

Do not apply a double dose to make up for the missed doses.

If you stop using Tonlit

If you need to stop treatment, contact your doctor or the doctor treating your child, or your pharmacist immediately.

If you have any further questions about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Tonlit can cause side effects, although not everyone gets them.

The possible side effects of Tonlit are:

Very common (may affect more than 1 in 10 people):

Increased pigmentation of the iris, eye irritation (foreign body sensation), changes in eyelashes (darkening, thickening, and lengthening).

Common (may affect up to 1 in 10 people):

Mild or moderate eye redness, dry eyes, blurred vision, transient punctate epithelial erosions (generally asymptomatic), eyelid inflammation, eye pain.

Uncommon (may affect up to 1 in 100 people):

Swelling of the eyelids.

Skin rash.

Nausea.

Vomiting.

Rare (may affect up to 1 in 1,000 people):

Swelling of some parts of the eye or surrounding areas (iris, macula, cornea, and orbital area), abnormal growth of eyelashes that may cause eye irritation, appearance of an additional row of eyelashes, darkening of the eyelid skin, reactions of the eyelid skin.

Asthma (or worsening of asthma) and difficulty breathing.

Very rare (may affect up to 1 in 10,000 people):

Worsening of angina pectoris if you already have it, palpitations.

Headache, dizziness, and joint pain.

Tell your doctor or pharmacist immediately if you experience any of these side effects or any other unusual symptoms, especially if you experience any changes or visual disturbances when using Tonlit after eye surgery.

The side effects observed in children at a higher frequency than in adults are runny nose and itchy nose and fever.

If you consider that any of the side effects that you are suffering from is serious, or if you notice any side effect not mentioned in this package leaflet, inform your doctor or pharmacist.

5. Storage of Tonlit

Keep out of the reach and sight of children.

Unopened bottle: store in the refrigerator (between 2°C and 8°C).

After opening the bottle: do not store above 25°C.

The Tonlit bottle should be discarded 4 weeks after it was first opened.

Do not use Tonlit after the expiration date stated on the packaging after EXP. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Further information

Composition of Tonlit

• The active substance is latanoprost. One ml of eye drops solution contains 50 micrograms of latanoprost.

The other ingredients are: benzalkonium chloride, sodium chloride, sodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate, sodium hydroxide, phosphoric acid, and purified water.

Appearance and packaging of the product

Tonlit is presented as a clear and colorless eye drop solution in a dropper bottle with a screw cap.

Each bottle contains 2.5 ml of ophthalmic solution and is presented in packs of 1, 3, and 6 bottles. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing Authorization Holder

LABORATORIOS S.A.L.V.A.T., S.A.

Gall, 30-36

08950 Esplugues de Llobregat (Barcelona)

Manufacturer

BRUSCHENTTINI, S.R.L.

Via Isonzo, 6

Genova I-16147 Italy

This package leaflet was approved in March 2022