Latanoprost and timolol Zentiva: detailed information

PACKAGE LEAFLET: INFORMATION FOR THE USER

Latanoprost and Timolol Zentiva

50 micrograms/ml + 5 mg/ml eye drops, solution
Equivalent medicine
Please read this leaflet carefully before 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 other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Latanoprost and Timolol Zentiva is and what it is used for
What you need to know before using Latanoprost and Timolol Zentiva
How to use Latanoprost and Timolol Zentiva
Possible side effects
How to store Latanoprost and Timolol Zentiva
Contents of the pack and other information

1. What Latanoprost and Timolol Zentiva is and what it is used for

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

2. What you need to know before using Latanoprost and Timolol Zentiva

Latanoprost and Timolol Zentiva can be used in adult women and men (including elderly people), but is not recommended for use in individuals under 18 years of age.
Do not use Latanoprost and Timolol Zentiva if

you are allergic to the active substances latanoprost and timolol, to beta-blockers, or to any of the other ingredients of Latanoprost and Timolol Zentiva (listed in section 6);
you have or have previously had serious breathing problems such as asthma, or severe chronic obstructive pulmonary disease (a serious lung disease that may cause shortness of breath, difficulty breathing, and/or persistent cough);
you have serious heart problems or heart rhythm disorders. Warnings and precautions Before using this medicine, inform your doctor or pharmacist if you have or have previously had:
heart problems such as 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 bradycardia (slowing of the heart rate), or Prinzmetal's angina (chest pain at rest). If you use Latanoprost and Timolol Zentiva, you should be monitored for signs of worsening of these conditions;
breathing problems, asthma, or chronic obstructive pulmonary disease;
poor blood circulation such as Raynaud's disease or Raynaud's syndrome (discoloration of the fingertips in response to cold, accompanied by pain);
diabetes or low blood sugar levels (hypoglycaemia), as timolol may mask the signs and symptoms of low blood sugar;
overactive thyroid gland, as timolol may mask its signs and symptoms;
are about to undergo any eye surgery (including cataract surgery) or have previously undergone eye surgery;
eye problems (such as eye pain, eye irritation, eye inflammation, blurred vision, dry eyes, or problems with the cornea or choroid);
are taking beta-blocking medicines (used to treat high blood pressure, rapid heartbeat, etc.);
severe allergic reactions that usually require hospital treatment;
a viral eye infection caused by the herpes simplex virus (HSV);
wear contact lenses. You can still use Latanoprost and Timolol Zentiva, but follow the instructions for contact lens wearers in section 3.

Before undergoing any surgery, inform your doctor that you are using Latanoprost and Timolol Zentiva, as timolol may affect the effects of certain medicines used during anaesthesia.
Your doctor may carry out additional checks on your heart and circulation if you are using Latanoprost and Timolol Zentiva.
For athletes: the use of this medicine constitutes doping and may result in a positive anti-doping test.
Other medicines and Latanoprost and Timolol Zentiva
Inform your doctor or pharmacist if you are taking, have recently taken, or plan to take any other medicines, including eye drops and over-the-counter medicines.
Latanoprost and Timolol Zentiva may affect or be affected by other medicines you are taking, including other eye drops for glaucoma. Inform your doctor if you are taking or plan to take medicines to lower blood pressure, heart medicines, or medicines to treat diabetes.
In particular, inform your doctor or pharmacist if you know you are taking any of the following types of medicines:

prostaglandins, prostaglandin analogues, or prostaglandin derivatives;
beta-blockers;
adrenaline;
medicines used to treat high blood pressure, such as oral calcium channel blockers, guanethidine, antiarrhythmics (including amiodarone, quinidine – used to treat heart problems or certain types of malaria), digitalis glycosides, or parasympathomimetics;
antidepressants such as fluoxetine and paroxetine.

Use of Latanoprost and Timolol Zentiva with food, drink and alcohol
Normal meals, food or drinks do not affect when or how you should use Latanoprost and Timolol Zentiva.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Do not use Latanoprost and Timolol Zentiva if you are pregnant unless your doctor considers it necessary.
Breastfeeding
Do not use Latanoprost and Timolol Zentiva if you are breastfeeding. Latanoprost and Timolol Zentiva may pass into breast milk.
Fertility
In animal studies, latanoprost and timololo did not show any effect on male or female fertility.
Driving and using machines
When using Latanoprost and Timolol Zentiva, your vision may become blurred for a short time. If this happens, do not drive or use tools or machines until your vision is clear again.
Latanoprost and Timolol Zentiva contains benzalkonium chloride and phosphate buffers
This medicine contains 0.412 mg of benzalkonium chloride at 50% per ml. Benzalkonium chloride may be absorbed by soft contact lenses and is known to cause a change in lens colour. You must remove contact lenses before applying this medicine and may reinsert them after 15 minutes (see section 3).
Benzalkonium chloride may also cause eye irritation, particularly if you have dry eyes or corneal problems (the transparent layer at the front of the eye). If you experience an unusual, stinging, or painful sensation in the eye after using this medicine, inform your doctor.
This medicine contains 9.28 mg/ml of phosphates. If you have severe damage to the transparent layer at the front of the eye (the cornea), phosphates may, very rarely, cause cloudy spots on the cornea due to calcium accumulation during treatment.

3. How to use Latanoprost and Timololo Zentiva

Use this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The recommended dose for adults (including elderly patients) is one drop once daily in the affected eye(s).
Do not use Latanoprost and Timololo Zentiva more than once a day, as the effectiveness of treatment may be reduced if administered more frequently.
Continue using Latanoprost and Timololo Zentiva as directed by your doctor until your doctor tells you to stop.
If you are using Latanoprost and Timololo Zentiva, your doctor may require additional monitoring of your heart and circulation.
Contact lens wearers
If you wear contact lenses, you must remove them before using Latanoprost and Timololo Zentiva. After using Latanoprost and Timololo Zentiva, wait 15 minutes before reinserting your contact lenses.
Instructions for use
Follow the instructions below to help ensure correct use of Latanoprost and Timololo Zentiva:

Wash your hands and position yourself comfortably, either sitting or standing.
Unscrew the outer protective cap.
Use your fingers to gently pull down the lower eyelid of the affected eye to form a "pocket" between the eyelid and the eye. The drop should be instilled here.
Position the dropper tip close to the eye. Do not touch the eye, eyelid, surrounding areas, or any other surface with the dropper tip, as this may contaminate the eye drops.

Black and white drawing showing a hand holding a container to apply a product near the

Gently press the bottle so that only one drop enters the eye, then release the lower eyelid.
After using Latanoprost and Timololo Zentiva, press with one finger at the inner corner of the affected eye, near the nose. Hold for 2 minutes while keeping the eye closed. This helps prevent Latanoprost and Timololo Zentiva from reaching the rest of the body.

If you are using the eye drops in both eyes, repeat the instructions for the other eye.
If a drop does not enter the eye, try again.
Replace the cap on the bottle.

If you use Latanoprost and Timololo Zentiva with other eye drops
Wait at least 5 minutes between using Latanoprost and Timololo Zentiva and other eye drops.
If you use more Latanoprost and Timololo Zentiva than you should
If you have instilled too many drops into the eye, you may experience mild eye irritation, tearing, and redness. This condition is temporary, but if you are concerned, contact your doctor for advice.
If you swallow Latanoprost and Timololo Zentiva
If you accidentally swallow Latanoprost and Timololo Zentiva, contact your doctor for advice. If you swallow a large amount of Latanoprost and Timololo Zentiva, you may feel unwell, have stomach pain, feel tired, warm, dizzy, and begin to sweat.
If you forget to use Latanoprost and Timololo Zentiva
Continue with your usual dose at the regular time. Do not apply a double dose to make up for a missed dose.
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
You can usually continue using the drops unless the side effects are severe. If you are concerned, consult your doctor or pharmacist. Do not stop using Latanoprost and Timololo Zentiva without first talking to your doctor.
Listed below are the side effects known to be associated with the use of the combination latanoprost and timololo.
The most important side effect is the possibility of a gradual, permanent change in eye colour.
Latanoprost and Timololo Zentiva may also cause serious changes in the way the heart works.
Contact your doctor immediately if you notice changes in your heart rate or heart function while using Latanoprost and Timololo Zentiva.

The side effects known to date are listed below according to frequency:

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

A gradual change in eye colour due to an increase in brown pigment in the coloured part of the eye known as the iris. If you have eyes with mixed-coloured patterns (blue-brown, grey-brown, yellow-brown or green-brown), you are more likely to experience this change than people with uniformly coloured eyes (blue, grey, green or brown). Any change in eye colour may take years to develop. The colour change may be permanent and may be more noticeable if Latanoprost and Timololo Zentiva is used in only one eye. There appear to be no associated problems with the change in eye colour. The change in eye colour does not continue after treatment with Latanoprost and Timololo Zentiva has been stopped.

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

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

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

Headache.
Eye redness, eye infection (conjunctivitis), blurred vision, watery eyes, inflammation of the eyelids, irritation or injury to the surface of the eye.
Skin rash or itching.

Other side effects
Although not observed with Latanoprost and Timololo Zentiva, the following side effects have been observed with the active substances contained in Latanoprost and Timololo Zentiva (latanoprost and timololo) and therefore may occur when using Latanoprost and Timololo Zentiva:
Like other eye drops, Latanoprost and Timololo Zentiva is absorbed into the bloodstream. The timololo component of this combination may cause side effects similar to those seen with intravenous and/or oral beta-blockers. The incidence of side effects after using eye drops is lower than when medicines are taken orally or by injection.

Development of a viral eye infection caused by the herpes simplex virus (HSV).
Generalised allergic reactions including swelling under the skin which may occur in areas such as the face and limbs and may block the airways causing difficulty in swallowing and breathing, urticaria or itchy rash, localised and generalised rash, itching, sudden severe life-threatening allergic reaction.
Low blood sugar levels.
Dizziness.
Difficulty sleeping (insomnia), depression, nightmares, memory loss, hallucination.
Fainting, heart attack, reduced blood supply to the brain, worsening of signs and symptoms of myasthenia gravis (a muscle disorder), unusual sensations such as tingling, and headache.
Swelling at the back of the eye (macular edema), fluid-filled cysts within the coloured part of the eye (iris cysts), light sensitivity (photophobia), sunken eyes (deepening of the eyelid groove).
Signs and symptoms of eye irritation (such as burning, stabbing pain, itching, tearing, redness), eyelid inflammation, corneal inflammation, blurred vision, and detachment of the layer beneath the retina containing blood vessels following filtering surgery, which may cause visual disturbances, reduced corneal sensitivity, dry eyes, corneal erosion (damage to the front layer of the eyeball), drooping of the upper eyelid (causing the eye to be half closed), double vision.
Darkening of the skin around the eyes, changes in eyelids and eyelash hair around the eye (increased number, length, thickness and pigmentation), changes in the direction of eyelash growth, swelling around the eye, swelling of the coloured part of the eye (iritis/uveitis), scarring of the eye surface.
Ringing or buzzing in the ears (tinnitus).
Angina, worsening of angina in patients already affected by heart disease, slow heartbeat, chest pain, palpitations (awareness of heartbeat), oedema (fluid accumulation), changes in heart rhythm or heart rate, congestive heart failure (heart disease associated with shortness of breath and swelling of feet and legs due to fluid accumulation), a type of heart rhythm disorder, heart attack, heart failure.
Low blood pressure, poor blood circulation causing pale and numb fingers of hands and feet, cold hands and feet.
Shortness of breath, narrowing of the airways in the lungs (mainly in patients with pre-existing lung disease), difficulty breathing, cough, asthma, worsening of asthma.
Taste disturbances, nausea, indigestion, diarrhoea, dry mouth, abdominal pain, vomiting.
Hair loss, skin rash with a silvery-white appearance (psoriasiform rash) or worsening of psoriasis, skin rash.
Joint pain, muscle pain not caused by physical exercise, muscle weakness, fatigue.
Sexual dysfunction, decreased libido.

In very rare cases, some patients with severe damage to the transparent layer at the front of the eye (the cornea) have developed an opaque area on the cornea due to calcium deposits 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.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Latanoprost and Timolol Zentiva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle and carton after "Exp". The expiry date refers to the last day of that month.
Before first opening, store in a refrigerator (2°C – 8°C). After first opening, do not store above 25°C. After opening, do not use this bottle for more than 4 weeks. Record the date of opening.
Keep the bottle in the outer packaging to protect the medicine from light.
Do not use this medicine if you notice that the bottle is damaged or if the eye drops appear different for any other reason.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Latanoprost and Timololo Zentiva contains

The active substances are latanoprost and timolol maleate. 1 ml of Latanoprost and Timololo Zentiva contains 50 micrograms of latanoprost and 6.83 mg of timolol maleate, equivalent to 5 mg of timolol.
The other components are: sodium chloride, sodium dihydrogen phosphate monohydrate, disodium phosphate anhydrous, benzalkonium chloride, hydrochloric acid, sodium hydroxide, water for injections.

Description of the appearance of Latanoprost and Timololo Zentiva and package contents
The solution is a colourless, odourless, clear liquid. Each bottle contains 2.5 ml of eye drop solution.
Pack sizes:
1 x 2.5 ml
3 x 2.5 ml
4 x 2.5 ml
6 x 2.5 ml
8 x 2.5 ml
12 x 2.5 ml
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Zentiva Italia S.r.l.
Viale L. Bodio 37/B
20158 Milano
Italy

Manufacturer:
Tubilux Pharma S.p.A
Via Costarica 20/22
00071 Pomezia (Roma)
Italy

This medicinal product is authorised in the European Economic Area countries under the following names:
Ireland Latanoprost/Timolol Zentiva 50 microgram/ml + 5 mg/ml eye drops solution
France Latanoprost/Timolol Zentiva 0.05 mg/5mg/ml, eye drops solution
Italy Latanoprost e Timololo Zentiva