Latatim

Patient Information Leaflet: Information for the User

LATATIM 50 micrograms/ml + 5 mg/ml eye drops, solution

Latanoprost / Timolol
Equivalent medicine
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What LATATIM is and what it is used for

LATATIM contains two active substances: latanoprost and timolol. Latanoprost belongs to a group of
medicines known as prostaglandin analogues. It works by increasing the natural outflow of fluid from
the eye into the bloodstream.
Timolol belongs to a group of medicines known as beta-blockers. It works by slowing down the
production of fluid in the eye.
LATATIM is used to reduce pressure inside the eye when it is affected by conditions known as
open-angle glaucoma or ocular hypertension. Both of these conditions are associated with an
increase in pressure inside the eye, which may damage vision.
Your doctor usually prescribes LATATIM when other medicines have not worked adequately.

2. What you need to know before using LATATIM

LATATIM can be used in adult women and men (including elderly patients), but is not recommended for individuals under 18 years of age.
Do not use LATATIM

• If you are allergic (hypersensitive) to any of the active substances (timolol or latanoprost), to beta-blockers, or to any of the other components of Latatim (listed in section 6).
• If you have or have previously had respiratory problems such as asthma, severe chronic obstructive pulmonary disease (severe lung disease that may cause shortness of breath, breathing difficulties, and/or long-lasting cough).
• If you have severe heart problems or cardiac rhythm disorders.

Warnings and precautions
Consult your doctor or pharmacist before using Latatim if you have or have previously had:

• any type of eye surgery (including cataract surgery);
• eye problems such as: eye pain, eye irritation, eye inflammation, or blurred vision;
• dry eye;
• contact lenses. You may use LATATIM, but you must follow the instructions for contact lens wearers in section 3;
• respiratory problems, asthma, or chronic obstructive pulmonary disease;
• coronary heart disease (symptoms may include chest pain or tightness, shortness of breath, or a feeling of suffocation), heart failure, low blood pressure;
• heart rhythm disorders such as slow heartbeat;
• poor blood circulation disorders (such as Raynaud's disease or Raynaud's syndrome);
• diabetes, as timolol may mask signs and symptoms of low blood sugar;
• overactive thyroid gland, as timolol may mask its signs and symptoms;
• angina (particularly a type known as Prinzmetal's angina);
• severe allergic reactions that may have required hospital treatment;
• viral eye infections caused by the herpes simplex virus (HSV).

Before undergoing surgery, inform your doctor that you are using LATATIM, as timolol may alter the effects of certain drugs used during anesthesia.
Other medicines and LATATIM
Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those without a prescription.
LATATIM may affect or be affected by other medicines, including other eye drops used to treat glaucoma. Inform your doctor if you are using or plan to use medicines to lower blood pressure, heart medications, or drugs used to treat diabetes.
In particular, inform your doctor or pharmacist if you are taking any of the following types of medicines:

• prostaglandins, prostaglandin analogues, or prostaglandin derivatives (e.g., other medications for glaucoma treatment);
• beta-blockers (e.g., for high blood pressure);
• epinephrine (adrenaline);
• medicines used to treat high blood pressure (e.g., oral calcium antagonists, guanethidine, antiarrhythmics, digitalis glycosides, or parasympathomimetics);
• quinidine (used to treat heart conditions and certain types of malaria);
• known antidepressants such as fluoxetine and paroxetine.

LATATIM with food and drink
Eating or drinking has no effect on how or when to use LATATIM.
Pregnancy, breastfeeding, and fertility
Pregnancy
Do not use LATATIM during pregnancy unless your doctor considers it necessary. Inform your doctor immediately if you are pregnant, think you may be pregnant, or are planning a pregnancy.
Breastfeeding
Do not use LATATIM while breastfeeding. Timolol may be excreted in breast milk.
Ask your doctor for advice before taking any medicine during breastfeeding.
Fertility
Animal studies have shown that latanoprost and timolol do not affect male or female fertility.
Driving and using machines
When using LATATIM, your vision may become blurred for a short time after administration. If this occurs, do not drive or operate tools or machinery until your vision clears.
LATATIM contains benzalkonium chloride and phosphate buffer
This medicine contains 0.2 mg of benzalkonium chloride per millilitre.
Benzalkonium chloride may be absorbed by soft contact lenses and may cause a change in their colour. Remove your contact lenses before using this medicine and wait 15 minutes before reinserting them.
Benzalkonium chloride may also cause eye irritation, especially if you have dry eye or corneal disorders (the transparent outer layer of the eye). If you experience unusual sensations, burning, or pain in the eye after using this medicine, speak with your doctor.
This medicine contains 6.3 mg of phosphate buffer per millilitre, equivalent to 0.2 mg per drop.
If you have severe damage to the outermost transparent layer of the eye (the cornea), phosphates may very rarely cause cloudy corneal deposits due to calcium accumulation during treatment.
For athletes: using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.

3. How to use LATATIM

Use LATATIM exactly as directed by your doctor. If you have any doubts, consult your doctor or
pharmacist.
The recommended dose for adults (including the elderly) is one drop once daily in the eye(s) to be treated.
Do not use LATATIM more than once a day, as the effectiveness of treatment may be reduced if the product is used more frequently than recommended.
Use LATATIM as directed by your doctor, until your doctor tells you to stop treatment.
If you are using LATATIM, your doctor may decide to request additional monitoring of your heart and circulation.
Contact lens wearers
If you wear contact lenses, remove them before using LATATIM. After using LATATIM, wait 15 minutes before reinserting your contact lenses.
Use in children: LATATIM is not recommended in children and adolescents.
Instructions for use
Wash your hands and sit or stand comfortably.
Unscrew the outer cap (which can be discarded).

Unscrew the inner cap, keeping the protective cap.

Gently pull down the lower eyelid of the eye to be treated with your fingers.
Hold the tip of the bottle close to the eye, but without touching it.
Gently squeeze the bottle to instill only one drop into the eye, then release the lower eyelid.

Press a finger against the corner of the eye near the nose for 2 minutes. This helps prevent the absorption of latanoprost and timolol into the rest of the body.
Repeat in the other eye, if prescribed by your doctor.
Replace the protective cap on the bottle.
If you use LATATIM with other eye drops
After using LATATIM, wait at least 5 minutes before using any other eye drop.
If you use more LATATIM than you should
If you put in too many drops, you may experience mild irritation, tearing, and eye redness. These effects are temporary, but if you are concerned, consult your doctor.
If you swallow LATATIM
If you accidentally swallow LATATIM, you must consult your doctor. If you swallow a large amount of LATATIM, you may experience stomach pain, tiredness, dizziness, flushing, and sweating.
If you forget to use LATATIM
Continue with your usual dose at the usual time. Do not take a double dose to make up for a missed dose.
If you have further questions about the use of this product, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
You can usually continue taking the product unless the side effects are severe. If you are concerned, speak to your doctor or pharmacist. Do not stop using LATATIM without talking to your doctor first.
The most important side effect is the possibility of a gradual and permanent change in eye colour. LATATIM may also cause serious effects on heart function. If you notice changes in your heart rate or heart function, you should speak to your doctor and mention that you have used LATATIM.

The following side effects have been observed:

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

• Gradual change in eye colour due to an increasing amount of brown pigment in the coloured part of the eye (iris). This change is more likely if you have eyes with mixed colours (blue-brown, grey-brown, yellow-brown or green-brown) rather than a single uniform colour (blue, grey, green or brown). Any change in eye colour may take years to occur. The colour change may be permanent and may be more noticeable if LATATIM is used in only one eye. No problems associated with the change in eye colour have been detected. The change in eye colour does not continue after stopping treatment with LATATIM.

Common side effects (less than 1 in 10 people):

• Eye irritation (a burning sensation, feeling of sand, itching, stinging or sensation of a foreign body in the eye).
• Eye pain.

Uncommon side effects (less than 1 in 100 people):

• Headache.
• Redness of the eyes.
• Eye infection (conjunctivitis).
• Blurred vision.
• Watery eyes.
• Inflammation of the eyelids.
• Irritation or abrasion of the eye surface.
• Skin rashes or itching.

Other side effects:
Like other medicines applied to the eyes, timolol is absorbed into the bloodstream. This may cause side effects similar to those seen with beta-blockers administered intravenously or orally. The incidence of side effects after topical ophthalmic administration is lower than when these medicines are taken by mouth or by injection. The side effects listed below include common reactions to the class of beta-blockers when used to treat eye conditions:

Infections:
Development of a viral eye infection caused by the herpes simplex virus (HSV).

Immune system disorders:
Generalised allergic reactions including swelling under the skin that may occur in areas such as the face and limbs, may block airways and may cause difficulty swallowing or breathing, urticaria or itchy skin rash, localised and generalised rash, itching, sudden severe allergic reaction (anaphylaxis) that may be life-threatening.

Metabolism and nutrition disorders:
Low blood sugar levels.

Psychiatric disorders:
Depression, memory loss, sleep disturbances (insomnia), nightmares, hallucinations.*
*Adverse effect with unknown frequency.

Nervous system effects:
Dizziness, tingling or numbness of the skin, reduced blood supply to the brain, worsening of symptoms of myasthenia gravis (a muscle disorder) – (if you already suffer from this condition), sudden fainting or feeling faint (syncope), stroke, unusual sensations such as tingling and headache.

Eye effects:
Signs and symptoms of eye irritation (e.g. burning, stinging, itching, tearing, redness), changes in eyelashes and surrounding fine hair (increased number, length, thickness and darkening), change in the direction of eyelash growth, swelling around the eye, swelling of the coloured part of the eye (iritis/uveitis), swelling at the back of the eye (macular edema), inflammation/irritation of the eye surface (keratitis), dry eyes, double vision, eyelid inflammation, drooping of the upper eyelid (causing the eye to appear half-closed), and lesions to the lining at the back of the eye (a condition known as retinal detachment, but observed only when the product is used following certain types of eye surgery), fluid-filled cysts within the coloured part of the eye (iris cysts), light sensitivity (photophobia), sunken eyes (deepening of the eyelid groove).

Ear effects:
Ringing or buzzing in the ears (tinnitus).

Heart effects:
Worsening of angina, slow heart rate, chest pain, oedema (fluid accumulation), awareness of heartbeat (palpitations), changes in heart rhythm or heart rate, heart failure (cardiac arrest), congestive heart failure (heart disease with shortness of breath and swelling of feet and legs due to fluid), heart rhythm disorders, heart attack.

Effects on blood circulation:
Low blood pressure, change in colour/cooling of hands and feet (Raynaud's phenomenon), cold hands and feet.

Respiratory effects:
Asthma, worsening of asthma, narrowing of the airways in the lungs (mainly in patients with pre-existing disease), shortness of breath, difficulty breathing (bronchospasm), cough.

Digestive effects:
Feeling unwell (nausea), diarrhoea, dyspepsia, dry mouth, taste disturbances, indigestion, abdominal pain, vomiting (nausea).

Skin effects:
Darkening of the skin around the eyes, hair loss/baldness (alopecia), itching or worsening of itching conditions, white-silver coloured skin rashes (psoriasiform eruption) or worsening of psoriasis, skin rash.

Reproductive system and breast effects:
Sexual dysfunction, decreased libido (reduced sexual desire).

Muscle and joint effects:
Joint pain, muscle pain not caused by physical exercise, muscle weakness/fatigue.

General effect:
Tiredness.

In very rare cases, some patients with severe damage to the clear layer at the front of the eye (cornea) have developed opaque spots on the cornea due to calcium accumulation during treatment.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can 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.

5. How to store LATATIM

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the label of the
bottle after Exp. The expiry date refers to the last day of that month.
Before opening, store the LATATIM 50 mcg/ml + 5 mg/ml eye drops solution bottle in
the refrigerator (between 2°C and 8°C). After first opening, do not store above 25°C and
do not use the bottle for more than 28 days. Keep the bottle in the outer carton to protect it
from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What LATATIM contains

• The active substances are: latanoprost 50 micrograms/ml and timolol (as timolol maleate) 5 mg/ml.
• The excipients are: benzalkonium chloride, sodium chloride, sodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate, water for injections.

Description of the appearance of LATATIM and package contents
Eye drops, solution.
Clear, colourless solution.
Pack sizes: 2.5 ml bottle of eye drops, pack of 3 x 2.5 ml bottles of eye drops, pack of 6 x 2.5 ml bottles of eye drops.
It is possible that not all pack sizes are marketed.

Marketing Authorisation Holder and Manufacturer
SIFI SpA, Via Ercole Patti 36, 95025 Aci S. Antonio (CT), Italy.