Tanolux 50 micrograms/ml eye drops solution in single-dose container

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Tanolux 50 micrograms/ml eye drops solution in single-dose container

latanoprost

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, consult your doctor, or the doctor treating your child, or your pharmacist.
• This medicine has been prescribed for you or your child only and must not be given to other people, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor, or the doctor treating your child, or your pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Package leaflet contents:

1. What Tanolux is and what it is used for
2. What you need to know before using Tanolux
3. How to use Tanolux
4. Possible side effects
5. How to store Tanolux
6. Contents of the pack and other information

1. What Tanolux is and what it is used for

Latanoprost belongs to a group of medicines known as prostaglandin analogues. It works by increasing the natural outflow of fluid from inside the eye into the bloodstream.

Latanoprost is used to treat conditions known as open-angle glaucoma and ocular hypertension in adults. Both conditions are associated with increased pressure inside the eye, which can eventually affect vision.

Latanoprost is also used to treat elevated intraocular pressure and glauoma in children and infants of all ages.

2. What you need to know before starting to use Tanolux

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

Do not use Tanolux

• If you are allergic (hypersensitive) to latanoprost or to any of the other components of this medicine (listed in section 6).

Warnings and precautions

If you think that any of the following situations apply to you or your child, consult your doctor, or the doctor treating your child, or the pharmacist before using Tanolux or before administering it to your child:

• If you or your child have had or are going to have eye surgery (including cataract surgery).
• If you or your child have eye problems (such as eye pain, irritation or inflammation, blurred vision).
• If you or your child have dry eyes.
• If you or your child have severe asthma or asthma that is not well controlled.
• If you or your child wear contact lenses. You may continue using Tanolux, but you must follow the instructions provided in section 3 for contact lens wearers.
• If you have had or are currently experiencing a viral eye infection caused by the herpes simplex virus (HSV).

Use of Tanolux with other medicines

Tanolux may interact with other medicines. Inform your doctor, the doctor treating your child, or pharmacist if you or your child are using or have recently used any other medicines (or eye drops), including those obtained without a prescription. In particular, consult your doctor or pharmacist if you know you are taking prostaglandins, prostaglandin analogues, or prostaglandin derivatives.

Pregnancy and breastfeeding

You should not use Tanolux if you are pregnant or breastfeeding unless considered necessary by your doctor. If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.

Driving and using machines

Blurred vision may occur for a short period of time when using Tanolux. If this happens to you, do not drive or operate tools or machinery until your vision returns to normal.

Tanolux contains benzalkonium chloride and phosphate buffers

This medicine contains 0.2 mg/ml of benzalkonium chloride.

Benzalkonium chloride may be absorbed by soft contact lenses and may change the color of contact lenses. You should remove your contact lenses before using this medicine and wait 15 minutes before putting them back in.

Benzalkonium chloride may also cause eye irritation, particularly if you have dry eyes or corneal disorders (the transparent front part of the eye). If you experience a foreign body sensation, stinging, or eye pain after using this medicine, consult your doctor.

This medicine contains 6.3 mg/ml of phosphates, equivalent to 0.2 mg per drop.

If you have a severe injury to the transparent front part of the eye (cornea), phosphates may, in very rare cases, cause cloudy areas in the cornea due to calcium deposits occurring during treatment.

3. How to use Tanolux

Follow exactly the administration instructions for Tanolux given by your doctor, or by the doctor treating your child. Consult your doctor, the doctor treating your child, or the pharmacist if you have any doubts.

The recommended dose for adults (including elderly patients) and children is one drop in the affected eye or eyes once daily. It is preferable to administer it at night.

Do not use Tanolux more than once a day; treatment efficacy may decrease if administered more frequently.

Use Tanolux exactly as directed by your doctor or the doctor treating your child, until instructed to stop.

Contact lens users

If you or your child wears contact lenses, they must be removed before using Tanolux. After applying Tanolux, you must wait 15 minutes before reinserting the contact lenses.

Instructions for Use

Wash your hands before use. Ensure the single-dose container is intact before using this medicine. The solution should be used immediately after opening the container. To avoid contamination, do not let the tip of the single-dose container touch the eye or any other surface.

1, 2, 3. Take a single-dose container from the pouch and hold it upright (with the cap facing upwards), then twist the cap until it comes off.

1. Gently pull down the lower eyelid to form a pouch. Invert the single-dose container and squeeze until one drop falls into the affected eye or eyes.

2. Discard the single-dose container after use, even if there is some solution left inside.

If you use Tanolux with other eye drops

Wait at least 5 minutes between the application of Tanolux and the administration of other eye drops.

If you use more Tanolux than you should

If more drops than recommended have been applied to the eye, you may experience mild eye irritation, redness, and tearing. This condition should resolve on its own, but if you are concerned, contact your doctor or your child's physician.

In case of accidental ingestion of Tanolux by you or your child, consult your doctor or pharmacist as soon as possible, or call the Toxicology Information Service at telephone number: 91 562 04 20.

If you forget to use Tanolux

Continue with the next dose as usual. Do not apply an additional drop to the eye to make up for the missed dose. If you have any doubts, consult your doctor or pharmacist.

If treatment with Tanolux is interrupted

If you wish to stop using Tanolux, consult your doctor or the doctor treating your child.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

The following are known adverse effects when using Tanolux:

Very common adverse effects (may affect more than 1 in 10 patients):

• Gradual change in eye color due to an increase in brown pigment in the colored part of the eye known as the iris. If you have mixed-colored eyes (blue-brown, gray-brown, yellow-brown or green-brown), you are more likely to experience this change than if your eyes are of a single color (blue, gray, green or brown). The change in eye color develops over years, although it is usually noticeable after about 8 months of treatment. The change in eye color may be permanent and may be more pronounced if Tanolux is used in only one eye. The change in eye color does not appear to be associated with any problems. The change in eye color does not progress once treatment with Tanolux is stopped.
• Redness of the eye.
• Eye irritation (burning sensation, gritty feeling in the eye, itching, pain, and foreign body sensation in the eye). If you experience severe eye irritation causing excessive tearing or making you consider stopping treatment, consult your doctor, pharmacist, or nurse as soon as possible (within one week). You may need your treatment reviewed to ensure you are receiving the appropriate treatment for your condition.
• Gradual change in the eyelashes of the treated eye and in the fine hair around the treated eye, observed in most Japanese-origin patients. These changes include increased pigmentation (darkening), lengthening, thickening, and increased number of eyelashes.

Common adverse effects (may affect up to 1 in 10 patients):

• Irritation or erosion on the eye surface, eyelid inflammation (blepharitis), eye pain, and light sensitivity (photophobia), conjunctivitis.

Uncommon adverse effects (may affect up to 1 in 100 patients):

• Swelling of the eyelids, dry eye, inflammation or irritation of the eye surface (keratitis), blurred vision, inflammation of the colored part of the eye (uveitis), swelling of the retina (macular edema).
• Skin rash.
• Chest pain (angina), awareness of heartbeat (palpitations).
• Asthma, difficulty breathing (dyspnea).
• Chest pain.
• Headache, dizziness.
• Muscle pain, joint pain.
• Nausea, vomiting.

Rare adverse effects (may affect up to 1 in 1,000 patients):

• Inflammation of the iris (iritis), symptoms of swelling or injury/damage to the eye surface, swelling around the eye (periorbital edema), misdirected eyelashes or an extra row of eyelashes, scarring of the eye surface, fluid accumulation in the colored part of the eye (iris cyst), light sensitivity (photophobia).
• Skin reactions on the eyelids, darkening of the eyelid skin.
• Worsening of asthma.
• Intense skin itching.
• Development of a viral eye infection caused by the herpes simplex virus (HSV).

Very rare adverse effects (may affect up to 1 in 10,000 patients):

• Worsening of angina in patients who also have heart problems, appearance of sunken eyes (increased depth of the eyelid crease).

Adverse effects observed in children at a higher frequency than in adults are runny nose, nasal itching, and fever.

In very rare cases, some patients with severe damage to the clear front part of the eye (cornea) have developed cloudy areas in the cornea due to calcium deposits during treatment.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse reactions:

If you experience any type of adverse reaction, consult your doctor, including possible adverse reactions not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es.

By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Tanolux

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage temperature conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point in your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the container and other information

The active substance is latanoprost 50 micrograms/ml.

The other components are: benzalkonium chloride, sodium chloride, monohydrate sodium dihydrogen phosphate (E339i), anhydrous disodium hydrogen phosphate (E339ii), and water for injections.

Appearance of the product and contents of the pack

Tanolux eye drops are a clear, colourless liquid supplied in single-dose plastic containers, each containing 0.4 ml of solution.

The carton contains 3, 6, or 9 aluminium pouches, each with 10 single-dose containers, providing a total of 30, 60, or 90 single-dose containers in the carton, respectively.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Laboratorios Salvat, S.A.

Gall, 30-36 - 08950

Esplugues de Llobregat (Barcelona)

Spain

Manufacturer Responsible

Pharmaloop S.L.

C/Bolivia, 15 – Polig Industrial Azque

28806 Alcalá de Henares,

Madrid – Spain

Laboratorios Salvat, S.A.

Gall, 30-36 - 08950

Esplugues de Llobregat (Barcelona)

Spain

Date of the most recent review of this leaflet: January 2023

This medicinal product is authorized in the European Economic Area member states under the following names:

Spain: Tanolux 50 micrograms/ml eye drops solution in single-dose container

Portugal: Tanolux 0.02 mg/0.4 ml eye drops, solution in single-dose container

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/