TANOLUX 50 micrograms/ml eye drops in solution, single-dose containers

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 the inside of the eye into the bloodstream.

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

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

2. What you need to know before you start using Tanolux

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

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

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If you think any of the following apply to you or your child, consult your doctor, or the doctor treating your child, or your pharmacist before using Tanolux or before giving 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 uncontrolled asthma.
• If you or your child wear contact lenses. You can continue to use Tanolux, but you must follow the instructions in section 3 for contact lens wearers.
• If you have had or are having a viral infection of the eye caused by the herpes simplex virus (HSV).

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Tanolux may interact with other medicines. Tell your doctor, or the doctor treating your child, or your pharmacist if you or your child are using or have recently used 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.

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You should not use Tanoluxif you are pregnant or breastfeeding unless your doctor considers it necessary. If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.

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When using Tanolux, blurred vision may occur for a short period of time. If this happens, do not driveor use tools or machines until your vision is clear again.

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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 the contact lenses. You should remove your contact lenses before using this medicine and put them back 15 minutes afterwards.

Benzalkonium chloride can also cause eye irritation, especially if you have dry eyes or corneal disorders (the transparent front part of the eye). If you experience any unusual sensation in the eyes, stinging or eye pain after using this medicine, consult your doctor.

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

If you have severe damage 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 produced during treatment.

3. How to use Tanolux

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

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

Do not use Tanolux more than once a day; the effectiveness of the treatment may decrease if it is administered more frequently.

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

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If you or your child wear contact lenses, you must remove them before using Tanolux. After applying Tanolux, you must wait 15 minutes before putting your contact lenses back in.

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Wash your hands before using it. Make sure 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 bag and hold it in a vertical position (with the cap upwards) and twist the cap until it comes off.

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

1. Discard the single-dose container after use, even if there is still solution inside.

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

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If you have applied more drops in the eye than you should, you may feel a slight irritation in the eye and your eyes may also become red and tear; this situation should disappear, but if it worries you, contact your doctor or the doctor treating your child.

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

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

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following are known side effects of using Tanolux:

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

• Gradual change in eye color due to an increase in the amount of brown pigment in the colored part of the eye known as the iris. If you have mixed-color eyes (blue-brown, gray-brown, yellow-brown or green-brown) you are more likely to experience this change than if your eyes are a single color (blue, gray, green or brown). The change in eye color takes years to develop, although it can usually be seen after 8 months of treatment. The change in eye color may be permanent and may be more noticeable if Tanolux is used in only one eye. The change in eye color does not seem to be associated with the development of any problems. The change in eye color does not progress once treatment with Tanolux has been stopped.
• Redness of the eye.
• Eye irritation (feeling of stinging, feeling of grit in the eye, itching, pain and feeling of a foreign body in the eye). If you experience severe eye irritation that makes your eyes water excessively or makes you consider stopping treatment, consult your doctor, pharmacist or nurse as soon as possible (within a week). You may need to have your treatment reviewed to ensure you are receiving the right treatment for your condition.
• Gradual change in the eyelashes of the treated eye and the fine hair around the treated eye, observed in most patients of Japanese origin. These changes include an increase in color (darkening), length, thickness and number of eyelashes.

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

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

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

• 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), feeling your heartbeat (palpitations).
• Asthma, difficulty breathing (dyspnea).
• Chest pain.
• Headache, dizziness.
• Muscle pain, joint pain.
• Nausea, vomiting.

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

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

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

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

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

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

If you think you have experienced any of the side effects mentioned, or any other side effects not mentioned in this leaflet, tell your doctor or pharmacist.

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If you experience any side effects, talk to your doctor, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es.

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

5. Storing Tanolux

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

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

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of the containers and medicines you no longer need in the pharmacy's SIGRE collection point. Ask your pharmacist how to dispose of the containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

The active substance is latanoprost 50 micrograms/ml.

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

Appearance of the product and contents of the pack

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

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

Not all pack sizes may be marketed.

Marketing authorization holder

Laboratorios Salvat, S.A.

Gall, 30-36 - 08950

Esplugues de Llobregat (Barcelona)

Spain

Manufacturer

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 last revision of this leaflet: January 2023

This medicine is authorized in the Member States of the European Economic Area 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 medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/