Latanoprost and timolol Aurobindo Italia: detailed information

Package leaflet: Information for the patient

Latanoprost and Timolol Aurobindo Italia

50 micrograms/ml and 5 mg/ml eye drops
latanoprost/timolol
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 adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Latanoprost and Timolol Aurobindo Italia is and what it is used for

Latanoprost and Timololo Aurobindo Italia is a medicine used to treat elevated intraocular pressure (pressure within the eye).
Latanoprost and Timololo Aurobindo Italia is a fixed combination medicine containing two active substances:
latanoprost (a prostaglandin analogue) and timolol maleate (a beta-blocker).

A fluid known as aqueous humour is produced inside the eye. This fluid is then drained into the bloodstream, thereby maintaining the proper pressure within the eye. If this drainage is blocked, the pressure inside the eye increases.

In addition to other effects, beta-blockers reduce intraocular pressure by decreasing the production of aqueous humour. Prostaglandin analogues enhance the outflow of aqueous humour.

Latanoprost and Timololo Aurobindo Italia is used to:

reduce intraocular pressure in patients with open-angle glaucoma (optic nerve damage caused by excessive pressure within the eye),
reduce intraocular pressure in patients for whom treatment with either a beta-blocker alone or a prostaglandin analogue alone is insufficient.

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

Do not use Latanoprost and Timolol Aurobindo Italia:

if you are allergic (hypersensitive) to latanoprost or timolol, to beta-blockers, or to any of the excipients of this medicine (listed in section 6).
if you currently have or have previously had respiratory problems, such as asthma, severe chronic obstructive bronchitis (a serious lung disease that may cause wheezing, difficulty breathing and/or long-lasting cough).
if you have a slow heartbeat, heart failure, or heart rhythm disorders (irregular heartbeats).

Warnings and precautions
Before using this medicine, inform your doctor if you suffer or have previously suffered from:

coronary heart disease (symptoms may include chest pain or tightness, shortness of breath, or suffocation sensation), heart failure, low blood pressure
heart rate disorders, such as slow heartbeat
respiratory problems, asthma, or chronic obstructive pulmonary disease
circulatory disorders (such as Raynaud's disease or Raynaud's syndrome)
diabetes, because timolol may mask the signs and symptoms of low blood sugar levels
overactive thyroid, because timolol may mask the signs and symptoms
any type of eye surgery (including cataract surgery)
eye problems (such as eye pain, eye irritation, eye inflammation, or blurred vision)
dry eyes
if you wear contact lenses. You may still use Latanoprost and Timolol Aurobindo Italia, but you must follow the instructions for contact lens wearers contained in “Important information about some excipients of Latanoprost and Timolol Aurobindo Italia”.
angina (particularly a type known as Prinzmetal's angina)
severe allergic reactions that usually require hospital treatment
if you suffer or have previously suffered from a viral eye infection caused by the herpes simplex virus (HSV).

Inform your doctor that you are using Latanoprost and Timolol Aurobindo Italia before undergoing any surgical procedure, because timolol may alter the effects of certain medicines used during anesthesia.

Other medicines and Latanoprost and Timolol Aurobindo Italia
Latanoprost and Timolol Aurobindo Italia may affect or be affected by other medicines you are using, including other eye drops for glaucoma treatment. Inform your doctor if you are using or intend to use medicines to lower blood pressure, medicines for the heart, or medicines to treat diabetes.
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine (including eye drops). This also includes medicines obtained without a prescription.
Medicines can interact with each other and interactions may occur. You should be aware of this if you are taking any of the following types of medicines:

Calcium channel blockers (e.g. for coronary heart disease or hypertension)
Guanethidine (for hypertension)
Beta-blockers (for hypertension)
Antiarrhythmics (medicines that normalize heart rhythm)
Digitalis glycosides (for heart failure)
Parasympathomimetic agents (e.g. for glaucoma treatment)
Taking/using Latanoprost and Timolol Aurobindo Italia together with these medicines may cause low blood pressure and/or slow heartbeat.
Medicines with similar action to Latanoprost and Timolol Aurobindo Italia
When used together with Latanoprost and Timolol Aurobindo Italia, the effect of other medicines with actions similar to latanoprost/timolol may increase. Therefore, the ophthalmic (i.e. in the eye) use of two beta-blockers or of two prostaglandins, prostaglandin analogues, or prostaglandin derivatives is not recommended.
Clonidine: if you are using the active substance clonidine together with Latanoprost and Timolol Aurobindo Italia to reduce intraocular pressure and you suddenly stop using clonidine, your pressure may increase. If you are simultaneously using a beta-blocker to lower blood pressure, the pressure may increase even more due to this reversible effect.
Quinidine (used to treat certain heart conditions and some types of malaria)
Antidepressants known as fluoxetine and paroxetine
Epinephrine (adrenaline)

Children and adolescents
Latanoprost and Timolol Aurobindo Italia is not recommended for use in children and adolescents.

Elderly patients
Latanoprost and Timolol Aurobindo Italia is suitable for use in elderly patients.

Pregnancy and breastfeeding
Pregnancy
Do not use Latanoprost and Timolol Aurobindo Italia during pregnancy unless your doctor considers it necessary.

Breastfeeding
Do not use Latanoprost and Timolol Aurobindo Italia while breastfeeding. Latanoprost and Timolol Aurobindo Italia may pass into breast milk.

If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.

Driving and using machines
After instilling Latanoprost and Timolol Aurobindo Italia eye drops, your vision may become temporarily blurred.
If you experience blurred vision, particularly immediately after instilling Latanoprost and Timolol Aurobindo Italia eye drops, you must not:

drive any vehicle
use any tools or machinery.

Latanoprost and Timolol Aurobindo Italia contains phosphate buffer and benzalkonium chloride
This medicine contains 6.3 mg of phosphate buffer and 0.2 mg of benzalkonium chloride per milliliter.
If you have severe damage to the outermost transparent layer of the eye (the cornea), phosphates may, very rarely, cause corneal opacities due to calcium deposits during treatment.
Benzalkonium chloride may be absorbed by soft contact lenses and may cause a change in their color. 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 most superficial transparent layer of the eye). If you experience an unusual sensation in the eye, burning, or pain after using this medicine, speak with your doctor.

For athletes: using this medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.

3. How to use Latanoprost and Timolol Aurobindo Italia

Always use Latanoprost and Timolol Aurobindo Italia exactly as directed by your doctor. If you have
any doubts, consult your doctor or pharmacist.
Unless otherwise prescribed by your doctor, the usual dose is:
Adults, including elderly patients: instil one drop once daily into each affected eye.
Do not use Latanoprost and Timolol Aurobindo Italia more than once a day, as the effectiveness of
treatment may be reduced if used more frequently.
Your doctor may wish you to have additional checks on your heart and circulation while using Latanoprost and
Timolol Aurobindo Italia.
If you are using other eye drops in addition to Latanoprost and Timolol Aurobindo Italia, these should be
administered at least 5 minutes apart.

Instructions for use

Wash your hands and sit or position yourself comfortably
Remove the protective cap from the bottle
Gently pull down the lower eyelid of the affected eye using the tip of your finger
Hold the tip of the bottle close to, but not touching, the eye. Carefully squeeze the bottle until one drop falls into the eye. Be careful not to squeeze too hard, so that only one drop enters the affected eye
Release the eyelid
After using Latanoprost and Timolol Aurobindo Italia, press a finger against the corner of the eye near the nose for two minutes. This helps prevent Latanoprost and Timolol Aurobindo Italia from spreading into the rest of the body

Line drawing of a face showing a finger gently touching the eyelid

If prescribed by your doctor, repeat the procedure in the other eye. If the drop did not enter the eye, instil another one.

Close the bottle.

If you use more Latanoprost and Timolol Aurobindo Italia than you should
If too many drops have entered the eye, irritation and redness may occur. These symptoms should
subside, but if you are concerned, contact your doctor for advice.
Inform a doctor immediately if you or someone else has accidentally ingested the eye drops, or if you have used
the drops more often than prescribed. If a large amount of Latanoprost and Timolol Aurobindo Italia is swallowed,
you may feel nauseous, have stomach pain, feel tired or flushed, experience dizziness, and begin to sweat.
Keep the medicine packaging available so the doctor can obtain information about the medicine and decide on the appropriate action.

If you forget to use Latanoprost and Timolol Aurobindo Italia
If you have forgotten to use your eye drops, continue treatment as usual at the next scheduled dose.
The daily dose of one drop in the affected eye must not be exceeded.
Do not take a double dose to make up for a missed dose.

If you stop using Latanoprost and Timolol Aurobindo Italia
Do not stop or discontinue treatment with Latanoprost and Timolol Aurobindo Italia without first discussing it
with your doctor.
If you do not use Latanoprost and Timolol Aurobindo Italia regularly or frequently forget to use it, the
success of treatment may be at risk.
Increased intraocular pressure (pressure inside the eye) can damage the optic nerve and worsen vision. Blindness may occur. You may not notice an increase in intraocular pressure yourself. This condition can only be diagnosed through an examination by an ophthalmologist. If you suffer from increased intraocular pressure, regular eye examinations, together with measurement of intraocular pressure, are required. Intraocular pressure should be measured at least every 3 months. Visual field testing and examination of the optic nerve should be performed at least once a year.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Below are the known side effects of eye drops containing the active substances latanoprost and timolol. The most important side effect is the possibility of a gradual and permanent change in eye colour. Eye drops containing the active substances latanoprost and timololo may also cause serious changes in the way the heart functions. If you notice changes in your heart rate or heart function, you must speak to a doctor and inform them that you are taking Latanoprost and Timololo Aurobindo Italia.
You can usually continue using the drops unless the side effects are serious. If you are concerned, speak to your doctor or pharmacist. Do not stop using Latanoprost and Timololo Aurobindo Italia without talking to your doctor.

The following are known side effects of Latanoprost and Timololo Aurobindo Italia.
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. People who have mixed-colour eyes (blue-brown, grey-brown, yellow-brown or green-brown) are more likely to experience this change than those with eyes of a single colour (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 Aurobindo Italia is used in only one eye. There appear to be no problems associated with the change in eye colour. The change in eye colour does not continue after stopping treatment with Latanoprost and Timololo Aurobindo Italia.

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

Eye irritation (burning sensation, feeling of sand in the eye, 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, eyelid inflammation, irritation or damage to the surface of the eye
Skin rash or itching

Other side effects
Although not observed with Latanoprost and Timololo Aurobindo Italia, the following additional side effects may occur with latanoprost/timolol and therefore could occur with latanoprost/timololo.
The following side effects have been observed with latanoprost:
Infections and infestations:

Development of a viral infection in the eye caused by the herpes simplex virus (HSV)

Nervous system disorders:

Dizziness

Eye disorders:

Changes in eyelashes and hair around the eye (increased number, length, thickness and darkening), changes in the direction of eyelash growth, swelling around the eyes, 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, damage or erosion of the surface of the eye or cornea, swelling (edema) of the cornea, fluid-filled cysts in the coloured part of the eye (iris cysts), sensitivity to light (photophobia), sunken appearance of the eye (deepening of the eye socket)

Cardiac disorders:

Worsening of angina, awareness of heartbeat (palpitations)

Respiratory disorders:

Asthma, worsening of asthma, shortness of breath

Skin disorders:

Darkening of the skin around the eyes

Musculoskeletal disorders:

Joint pain, muscle pain

General disorders:

Chest pain

Like other eye medicines, Latanoprost and Timololo Aurobindo Italia is absorbed into the bloodstream. Timolol, one component of this combination, may cause side effects similar to those observed after intravenous or oral administration of beta-blockers. The incidence of side effects after local ocular administration is lower than when medicines are taken orally or by injection. The listed side effects include reactions observed with the class of beta-blocking medicines when used to treat eye diseases.

Generalised allergic reactions, including swelling beneath the skin, which may occur in areas such as the face and limbs and may block the airways, causing difficulty in swallowing or breathing. Hives or itchy rash, localized or generalised rash, itching, severe and sudden life-threatening allergic reaction.
Low blood sugar levels.
Difficulty sleeping (insomnia), depression, nightmares, seeing, hearing or sensing things that are not real (hallucinations), memory loss.
Fainting, stroke, reduced blood flow to the brain, worsening of signs and symptoms of myasthenia gravis (a muscle disorder), dizziness, unusual sensation of pins and needles, headache.
Signs and symptoms of eye irritation (e.g. burning, stinging pain, itching, tearing, redness), eyelid inflammation, corneal inflammation, inflammation/irritation of the eye surface (keratitis), visual disturbances, blurred vision, 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 appear half-closed), double vision.
Ringing or buzzing in the ears (tinnitus)
Slow heartbeat, chest pain, palpitations, oedema (fluid retention), changes in heart rhythm or rate, congestive heart failure (heart disease causing shortness of breath and swelling of the feet and legs due to fluid retention), a type of heart rhythm disorder, heart attack, heart failure.
Low blood pressure, change in colour/coldness in fingers and toes (Raynaud's phenomenon), cold hands and feet.
Constriction of the airways in the lungs (mainly in patients with pre-existing conditions), breathing difficulties, cough.
Altered taste, nausea, indigestion, diarrhoea, dry mouth, abdominal pain, vomiting.
Hair loss, skin rash appearing silvery-white (psoriasiform rash) or worsening of psoriasis, skin rash.
Muscle pain not caused by exercise.
Sexual dysfunction, decreased sexual desire.
Muscle weakness/tiredness.

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

Reporting of side effects
If you experience any side effect, 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 Latanoprost and Timololo Aurobindo Italia

Keep this medicine out of the sight and reach of children.
Do not use Latanoprost and Timololo Aurobindo Italia after the expiry date stated on the label
of the bottle and on the packaging following the word “Exp”. The expiry date refers to the last day
of the month.
Please observe the following storage instructions:
Unopened bottles: store in a refrigerator at 2–8 °C.
After first opening of the bottle: do not store above 25 °C.
Once opened, the bottle must be discarded, together with any remaining content, after 4 weeks, otherwise
there is a risk of ocular infections.
Medicines must not be disposed of 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 Aurobindo Italia contains
The active substances are latanoprost and timolol maleate.
1 ml of eye drops solution contains 50 micrograms of latanoprost and 6.8 mg of timolol maleate,
equivalent to 5 mg of timolol.
The other components are:
Sodium chloride, benzalkonium chloride, sodium dihydrogen phosphate dihydrate, disodium hydrogen phosphate dodecahydrate (see section 2, “Latanoprost and Timololo Aurobindo Italia contains a phosphate buffer and benzalkonium chloride”), purified water, sodium hydroxide to adjust pH, hydrochloric acid to adjust pH.
Description of the appearance of Latanoprost and Timololo Aurobindo Italia and package contents
Latanoprost and Timololo Aurobindo Italia is a clear, colourless liquid , packaged in transparent bottles with dropper and screw cap.
Latanoprost and Timololo Aurobindo Italia is available in the following pack sizes:
1 bottle with dropper containing 2.5 ml of eye drops,
3 bottles with dropper each containing 2.5 ml of eye drops,
6 bottles with dropper each containing 2.5 ml of eye drops.
It is possible that not all pack sizes are marketed.
Marketing Authorization Holder:
Aurobindo Pharma (Italia) S.r.l.
Via San Giuseppe, 102
21047 – Saronno (VA)
Italy
Manufacturer
S.C. ROMPHARM COMPANY S.R.L.
Eroilor Street, no. 1A
Otopeni 075100, Ilfov district
Romania