LATANOPROST 50 MICROGRAMS/ML + 5 MG/ML Eye drops, solution

Зміст інструкції

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

Latanoprost e Timololo Zentiva

50 micrograms/ml + 5 ml/ml eye drops, solution
Generic medicine

Read this leaflet carefully before you start using this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Latanoprost and Timolol Zentiva contains two active ingredients: latanoprost and timolol.
Latanoprost belongs to a group of medicines known as prostaglandin analogues.
Timolol 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. Timolol works by slowing down the
formation of fluid in the eye.
Latanoprost and Timolol Zentiva is used to reduce eye pressure if you suffer from
conditions known as open-angle glaucoma or ocular hypertension. Both of these conditions are related to an
increase in pressure inside your eye, which can affect your vision. Your doctor will usually prescribe
Latanoprost and Timolol 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 the elderly), but it is not
recommended for use if you are under 18 years of age.

Do not use Latanoprost and Timolol Zentiva if

• you are allergic to the active ingredients 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 had in the past, severe breathing problems such as asthma, severe chronic obstructive bronchitis (a serious lung disease that can cause shortness of breath, difficulty breathing and/or persistent cough);
• you suffer from severe heart problems or heart rhythm disorders. Warnings and precautionsBefore using this medicine, tell your doctor or pharmacist if you have or have had in the past:
• heart problems such as coronary heart disease (symptoms may include chest pain or a feeling of 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), Prinzmetal's angina (chest pain at rest). If you use Latanoprost and Timolol Zentiva you must be monitored for signs of worsening of these diseases; Page. 1to 7
• breathing problems, asthma or chronic obstructive pulmonary disease;
• poor blood circulation such as Raynaud's disease or Raynaud's syndrome (discolorationof the fingertips in response to cold accompanied by pain);
• diabetes or low blood sugar levels (hypoglycemia) as timolol can mask thesigns and symptoms of low blood sugar;
• hyperactivity of the thyroid gland as timolol can mask its signs and symptoms;
• you are about to undergo any eye surgery (including cataract surgery) or if you have had any eye surgeryin the past;
• problems with the eye (such as eye pain, eye irritation, eye inflammation or blurred vision, dry eyes orproblems with the cornea);
• taken beta-blockers (used to treat high blood pressure, fast heartbeat etc.);
• severe allergic reactions that usually require hospital treatment;
• a viral infection of the eye caused by the herpes simplex virus (HSV);
• wear contact lenses. You can still use Latanoprost and Timolol Zentiva but follow the instructions forcontact lens wearers in section 3.

Before undergoing surgery, tell your doctor that you are using Latanoprost and
Timolol Zentiva as timolol can affect the effects of some medicines used during
anaesthesia.
Your doctor may perform further checks related to your heart and circulation if you are using
Latanoprost and Timolol Zentiva.
For those who play sports: the use of the drug constitutes doping and may still result in a positive
doping test.

Other medicines and Latanoprost and Timolol Zentiva
Tell your doctor or pharmacist if you are taking, have recently taken or intend to take any other
medicines, including eye drops and over-the-counter medicines.
Latanoprost and Timolol Zentiva can affect or be affected by other medicines you are taking,
including other eye drops for the treatment of glaucoma. Tell your doctor if you are taking or intend to take
medicines to lower blood pressure, heart medicines or medicines to treat diabetes.
In particular, tell 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 - to treat heart problems or some types of malaria), digitalis glycosides or parasympathomimetics;
• antidepressants such as fluoxetine and paroxetine.

Use of Latanoprost and Timolol Zentiva with food, beverages and alcohol
Normal meals, food or drinks have no effect on when or how you should use Latanoprost and Timolol
Zentiva.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect 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.
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Breastfeeding
Do not use Latanoprost and Timolol Zentiva if you are breastfeeding. Latanoprost and Timolol Zentiva can
pass into breast milk.
Fertility
In animal studies, latanoprost and timolol have not been shown to have any effect on the fertility of
males or females.

Driving and operating machinery
When using Latanoprost and Timolol Zentiva, vision may become blurred for a short period. If
this happens, do not drive or use tools or machinery until your vision returns to normal.

Latanoprost and Timolol Zentiva contains benzalkonium chloride and phosphate buffers
This medicine contains 0.412 mg of benzalkonium chloride 50% in each ml. Benzalkonium chloride can
be absorbed by soft contact lenses and is known to cause a change in the colour of contact
lenses. You should remove your contact lenses before applying this medicine and wear them again after 15 minutes (see section 3).
Benzalkonium chloride can also cause eye irritation, especially if you have dry eyes or corneal problems
(the transparent layer at the front of the eye). If you experience an abnormal, stinging or painful sensation
in the eye after using this medicine, tell your doctor.
This medicine contains 9.28 mg/ml of phosphates. If you suffer from severe damage to the transparent layer at the front
of the eye (the cornea), phosphates can very rarely cause opaque spots on the cornea
due to calcium deposits during treatment.

3. How to use Latanoprost and Timolol Zentiva

Use this medicine following exactly the instructions of your doctor. If you have any doubts, ask your doctor or pharmacist.

The recommended dosefor adults (including the elderly) is one drop once a day in the affected eye(s).
Do not use Latanoprost and Timolol Zentiva more than once a day, as the effectiveness of the treatment may be reduced if administered more frequently.
Use Latanoprost and Timolol Zentiva as directed by your doctor until your doctor tells you to stop.
If you are using Latanoprost and Timolol Zentiva, your doctor may request further monitoring of your heart and circulation.

Contact lens wearers
If you wear contact lenses, you must remove them before using Latanoprost and Timolol Zentiva. After using Latanoprost and Timolol Zentiva, you must wait 15 minutes before putting your contact lenses back in.

Instructions for use
Follow the instructions below to facilitate the correct use of Latanoprost and Timolol Zentiva:

• 1. Wash your hands and sit or stand comfortably.
• 2. Unscrew the outer protective cap.
• 3. 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.
• 4. Position the bottle nozzle close to the eye. Do not touch the eye or eyelid, surrounding areas, or other surfaces with the dropper. You could infect the eye drops.

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• 5. Gently press the bottle so that only one drop reaches the eye and then release the lower eyelid.
• 6. After using Latanoprost and Timolol Zentiva, press with a finger on the corner of the affected eye, near the nose. Hold for 2 minutes while keeping your eye closed. This helps prevent Latanoprost and Timolol Zentiva from reaching the rest of your body.

• 7. If you are using the eye drops for both eyes, repeat the instructions for the other eye.
• 8. If a drop does not enter the eye, try again.
• 9. Reposition the cap on the bottle.

If you are usingLatanoprost and Timolol Zentiva with other eye drops
Wait at least 5 minutes between using Latanoprost and Timolol Zentiva and using other eye drops.

If you use more Latanoprost and Timolol Zentiva than you should
If you have instilled too many drops in your eye, you may experience mild eye irritation, and your eyes may water and become red. This condition is temporary but if you are concerned, contact your doctor for advice.

If you swallowLatanoprost and Timolol Zentiva
If you accidentally swallow Latanoprost and Timolol Zentiva, contact your doctor for advice. If you swallow a large amount of Latanoprost and Timolol Zentiva, you may feel unwell, have stomach pain, feel tired, feel hot, and experience dizziness and sweating.

If you forget to use Latanoprost and Timolol Zentiva
Continue with your usual dose at the usual time. Do not apply a double dose to make up for the missed dose.
If you have any questions about using 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.
Usually, you can continue to use the drops unless the side effects are serious. If you are
worried, ask your doctor or pharmacist. Do not stop using Latanoprost and Timolol Zentiva without
talking to your doctor.
Below are listed the side effects known to be related to the use of the latanoprost and
timolol association.
The most important side effect is the possibility of a gradual, permanent change in the color
of the eye.
It is also possible that Latanoprost and Timolol Zentiva cause serious changes in the way the heart works.

Immediately inform yourdoctorthat you are using Latanoprost and Timolol Zentiva if you notice
changes in heart rate or heart function.
Below are reported the known side effects up to date in terms of frequency:

Very common(may affect more than 1 in 10 people):
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• A gradual change in the color of the eye as the amount of brown pigment in the colored part of the eye, known as the iris, increases. If you have eyes with mixed color combinations (blue-brown, gray-brown, yellow-brown, or green-brown), you are more likely to see this change than those with eyes of a single color (blue, gray, green, or brown eyes). Any change in eye color may take years to develop. The color change may be permanent and may be more noticeable if you use Latanoprost and Timolol Zentiva in only one eye. There do not appear to be problems associated with the change in eye color. The change in eye color does not continue after treatment with Latanoprost and Timolol Zentiva has been stopped.

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

• Eye irritation (a burning sensation, presence of foreign bodies, itching, stinging, or a feeling of something in the eye) and eye pain.

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

• Headache.
• Eye redness, eye infection (conjunctivitis), blurred vision, tearing of the eyes, inflammation of the eyelids, irritation or damage to the surface of the eye.
• Skin rashes or itching.

Other side effects
Although not observed with Latanoprost and Timolol Zentiva, the following side effects have been observed
with the active ingredients present in Latanoprost and Timolol Zentiva (latanoprost and timolol) and therefore may
occur when using Latanoprost and Timolol Zentiva:
Like other medicines instilled into the eyes, Latanoprost and Timolol Zentiva is absorbed into the blood. The
share of timolol in this association can cause side effects similar to those observed with intravenous agents and/or “oral” beta-blockers. The incidence of side effects after the use of an eye drop is
lower than when the medicines are, for example, taken orally or by injection.

• Development of a viral eye infection caused by the herpes simplex virus (HSV).
• Generalized allergic reactions including swelling under the skin that can occur in areas such as the face and limbs and can obstruct the airways causing difficulty swallowing and breathing, hives or itchy rash, localized and generalized rash, itching, severe life-threatening allergic reaction.
• Low blood glucose levels.
• Dizziness.
• Difficulty sleeping (insomnia), depression, nightmares, memory loss, hallucination.
• Fainting, heart attack, reduced blood supply to the brain, increased signs and symptoms of myasthenia gravis (muscle disease), unusual sensations such as tingling, and headache.
• Swelling of the back of the eye (macular edema), fluid-filled cyst inside the colored part of the eye (iridic cyst), sensitivity to light (photophobia), sunken eyes (deepening of the palpebral groove).
• Signs and symptoms of eye irritation (such as burning, stinging pain, itching, tearing, redness), inflammation of the eyelids, inflammation of the cornea, blurred vision, and detachment of the layer beneath the retina containing blood vessels following filtering surgery which can cause visual disturbances, decreased corneal sensitivity, dry eye, corneal erosion (damage to the front layer of the eyeball), drooping of the upper eyelid (making the eye half-closed), double vision.
• Darkening of the skin around the eyes, changes to eyelids and eyelashes around the eye (increased number, length, thickness, and pigmentation), changes in the direction of eyelash growth, swelling around the eye, swelling of the colored part of the eye (iritis/uveitis), scarring of the surface of the eye.
• Whistling/ringing in the ears (tinnitus).
• Angina, worsening of angina in patients already affected by heart disease. Slowed heartbeat, chest pain, palpitations (perception of the heartbeat), edema (fluid accumulation), changes in the rhythm or rate of the heartbeat, congestive heart failure (heart disease Page. 5to 7

associated with shortness of breath and swelling of the feet and legs due to fluid accumulation), a
type of heart rhythm disturbance, heart attack, heart failure.

• Low blood pressure, poor blood circulation that makes fingers and toes pale and numb, cold hands and feet.
• Shortness of breath, narrowing of the airways in the lungs (predominantly in patients with pre-existing disease), difficulty breathing, cough, asthma, worsening of asthma.
• Changes in taste, nausea, indigestion, diarrhea, dry mouth, abdominal pain, vomiting.
• Hair loss, skin rash with a silvery-white color (psoriasiform rash) or worsening of psoriasis, rash.
• Joint pain, muscle pain not caused by exercise, muscle weakness, fatigue.
• Sexual dysfunction, decreased libido.

In very rare cases, some patients with severe damage to the transparent layer in the front part of the eye (the
cornea) have developed an opaque area on the cornea due to calcium formation during treatment

Reporting of side effects
If you get any side effects, even if not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through 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 Latanoprost and Timololo Zentiva

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 bottle and the carton after Expiry. The
expiry date refers to the last day of that month.
Before first opening, store in a refrigerator (2° C – 8° C). Once the bottle has been opened,
do not store above 25° C. After opening, do not use this bottle for more than 4 weeks. Note 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 the eye drops appear different for any other
reason.
Do not dispose of any medicine in the drain or household waste. Ask your pharmacist how to dispose of the
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Latanoprost and Timolol Zentiva contains

• The active ingredients are latanoprost and timolol maleate. 1 ml of Latanoprost and Timolol Zentiva contains50 micrograms of latanoprost and 6.83 mg of timolol maleate equivalent to 5 mg of timolol.
• The other ingredients are: sodium chloride, sodium phosphate monobasic monohydrate, disodium phosphate anhydrous, benzalkonium chloride, hydrochloric acid, sodium hydroxide, water for injections.

Description of the appearance of Latanoprost and Timolol Zentiva and contents of the pack
The solution is a colorless, clear, odorless liquid. Each bottle contains 2.5 ml of eye drops 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
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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

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

This medicinal product is authorised in the Member States of the European Economic Area under the following
denominations:
Ireland Latanoprost/Timolol Zentiva 50 micrograms/ml + 5 mg/ml eye drops solution
France Latanoprost/Timolol Zentiva 0.05 mg/5mg/ml, collyre en solution
Italy Latanoprost e Timololo Zentiva
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