LATAFIX 50 MICROGRAMMI/ML + 5 MG/ML Eye drops, solution

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1. LATAFIX 50 micrograms/ml + 5 mg/ml eye drops, solution
   1. WHAT LATAFIX IS AND WHAT IT IS USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LATAFIX
   3. HOW TO TAKE LATAFIX
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE LATAFIX
   6. PACKAGE CONTENTS AND OTHER INFORMATION

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

Latanoprost and timolol
Generic medicine

Read this leaflet carefully before you start to use this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could 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 LATAFIX is and what it is used for
• 2. What you need to know before you use LATAFIX
• 3. How to use LATAFIX
• 4. Possible side effects
• 5. How to store LATAFIX
• 6. Contents of the pack and other information

1. WHAT LATAFIX IS AND WHAT IT IS USED FOR

LATAFIX is a medicine for the treatment of elevated intraocular pressure(pressure
inside the eye).
LATAFIX is a pharmaceutical association of two active ingredients: latanoprost (a prostaglandin derivative) and timolol maleate (a beta blocker).
The fluid known as aqueous humor is produced inside the eye. This fluid is then
drained into the bloodstream, thus maintaining adequate pressure inside the eye. If
this outflow is obstructed, the pressure inside the eye increases.
Among other things, beta blockers reduce the pressure inside the eye by reducing the
production of aqueous humor. Prostaglandins promote the outflow of aqueous humor.

LATAFIX is used for:

• reducing internal eye pressure in patients with open-angle glaucoma (damage to the optic nerve caused by excessive pressure inside the eye)
• reducing internal eye pressure in patients for whom the effect of beta-blockers or prostaglandin derivatives alone is not sufficient

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LATAFIX

Do not take LATAFIX:

• if you are allergic(hypersensitive) to latanoprost or timolol, or to beta-blockers or to any of the other ingredients of LATAFIX (listed in section 6).
• if you have, or have had in the past, breathing problems such as asthma, severe chronic obstructive bronchitis (a severe lung disease that can cause wheezing, difficulty breathing and/or persistent cough)
• if you have serious heart problems or heart rhythm disorders

Warnings and precautions
Talk to your doctor or pharmacist before taking LATAFIX if you have or have had in the past

• coronary artery disease (symptoms may include chest pain or tightness, shortness of breath or suffocation), heart failure, low blood pressure
• heartbeat disorders such as slowing
• breathing problems, asthma or chronic obstructive pulmonary disease
• reduced blood circulation (such as Raynaud’s disease or Raynaud’s syndrome)
• diabetes because timolol can mask the signs and symptoms of low blood sugar levels
• hyperactivity of the thyroid gland because timolol can mask its signs and symptoms
• any type of eye surgery (including cataract surgery)
• eye problems (such as pain, irritation, inflammation of the eye or blurred vision)
• dry eyes
• angina (especially a type of angina known as Prinzmetal’s angina)
• severe allergic reactions that may require hospital treatment

Talk to your doctor or pharmacist before taking LATAFIX if:

• you suffer or have suffered from a viral eye infection caused by the herpes simplex virus (HSV)
• you wear contact lenses. You can continue to take LATAFIX, but you must follow the instructions provided for contact lens wearers in the section “Important information about some excipients of LATAFIX”

Before undergoing surgery, tell your doctor that you are using LATAFIX as it may alter the effects of some medicines used during anesthesia.

If you participate in competitive sports: the use of the medicine without a therapeutic need constitutes doping and

may still result in a positive doping test.

Other medicines and LATAFIX
LATAFIX can influence or be influenced 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 reduce blood pressure, heart medicines or to treat diabetes.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Medicines can affect each other and interactions can occur. If you are taking any of the following medicines:

Calcium antagonists(for example for coronary artery disease or high blood pressure)

Guanethidine(for high blood pressure)

Beta-blockers(for high blood pressure)

Antiarrhythmics(medicines used to normalize the heartbeat)

Digitalis glycosides(for heart failure)

Parasympathomimetic drugs(for example for the treatment of glaucoma)
you should be aware that taking LATAFIX with these medicines can cause a drop in blood pressure and/or slow down the heart rate.

Medicines that act in a similar way to LATAFIX
If taken together with LATAFIX, the effect of other medicines with an action similar to LATAFIX may increase. For this reason, ophthalmic use (i.e. in the eye) of two beta-blockers or two prostaglandins is not recommended.

Clonidine
If you are taking clonidine to reduce the internal pressure of the eye together with LATAFIX and suddenly stop using clonidine, the eye pressure may rise.
If you are also taking beta-blockers at the same time to reduce high blood pressure, blood pressure may, due to the opposite effect, increase further.

Quinidine(used to treat heart conditions and some types of malaria)

Antidepressantsknown as fluoxetine and paroxetine
Children and adolescents
The use of LATAFIX is not recommended in children and adolescents.
Elderly
LATAFIX is suitable for the treatment of elderly patients.

Pregnancy, breastfeeding and fertility
Pregnancy
Do not use LATAFIX if you are pregnant unless your doctor considers it necessary.
Breastfeeding
Do not use LATAFIX if you are breastfeeding. Timolol and latanoprost can pass into your milk.
If you are pregnant, suspect you are pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
After instilling LATAFIX eye drops, your vision may be temporarily impaired.
If your visionbecomes blurred, especially after instilling LATAFIX drops, you should not drive vehicles or use tools or machinery.

LATAFIX contains benzalkonium chloride.
This medicine contains benzalkonium chloride, which can cause irritation of the eye. Avoid contact with soft contact lenses. Remove contact lenses before application and wait at least 15 minutes before replacing them. Benzalconium chloride is known to alter the color of soft contact lenses.

3. HOW TO TAKE LATAFIX

Take this medicine following exactly the instructions of your doctor. If you have any doubts
consult your doctor or pharmacist.
Unless otherwise prescribed by your doctor, the recommended doseis:
Adults, including elderly patients: insert one drop once a day into the affected eye.
If you are using LATAFIX in association with another eye drop, wait at least 5 minutes between one and
the other.
Instructions for use

• 1. Wash your hands and sit or get into a comfortable position
• 2. Remove the protective cap from the bottle
• 3. Use the tip of your finger to gently pull down the lower eyelid of the affected eye
• 4. Place the tip of the dropper close to the eye without touching it. Carefully press the bottle until a single drop falls into the eye. Be careful not to press the bottle too hard to avoid more than one drop falling into the eye to be treated
• 5. Release the eyelid
• 6. After using LATAFIX, press your finger on the corner of the eye next to the nose for two minutes. This helps to stop LATAFIX from passing into the rest of the body. If prescribed by your doctor, repeat the procedure in the other eye. If the drop should miss the eye, apply another drop.
• 7. Close the bottle.

If you take more LATAFIXthan you should
If too many drops go into the eye, irritation and rednessmay occur.
Tell your doctor immediatelyif you or someone else has ingesteddrops by mistake or if you have
applied the drops more often than prescribed.
Keep the medicine package ready to allow the doctor to obtain further
information. The doctor will then decide what to do.

If you forget to take LATAFIX
If you have forgotten to use the drops, continue treatment as usual at the next dose. The
daily dose of one drop in the affected eye must not be exceeded.

Do notuse a double doseto make up for a missed dose.

If you stop taking LATAFIX
Do not stop treatment with LATAFIX without first talking to your doctor.
If you do not use LATAFIX regularly or if you frequently forget to use it, the effectiveness of
treatment may be at risk.
Increased intraocular pressure (pressure inside the eye) can damage the optic nerve
and worsen vision. Blindness may occur. Normally, you may simply feel the
increased intraocular pressure. The disorder can only be diagnosed by an eye examination.
If you suffer from high intraocular pressure, regular eye tests are necessary along with
measurements of the internal pressure of the eye. The pressure inside the eye must
be measured at least every 3 months. Visual field measurements and examination of the optic nerve
should be performed at least once a year.
If you have any doubts 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 everyone gets them.
The known side effects related to the use of eye drops containing the active ingredients latanoprost and
timolol are listed below. The most important side effect is the possibility of a gradual, permanent change in the color of the eye. It is also possible that eye drops containing the
active ingredients latanoprost and timolol may cause serious changes in the way the heart
works. If you notice changes in your heartbeat or heart function, you should talk to your doctor
and tell them that you are using LATAFIX.
You can continue to take the drops unless the effects are serious. If you are worried, tell your
doctor or pharmacist. Do not stop using LATAFIX without talking to your doctor.
The frequency of possible side effects listed below is defined according to the convention
following.
Very common: may affect more than 1 in 10 patients
Common: may affect up to 1 in 10 patients
Uncommon: may affect up to 1 in 100 patients
Rare: may affect up to 1 in 1,000 patients
Very rare: may affect up to 1 in 10,000 patients
Not known: frequency cannot be estimated based on available data
Very common

• gradual change in eye color due to increased brown pigment in the colored part of the eye, known as the iris. If you have eyes of different colors (blue-brown, gray-brown, yellow-brown, or green-brown), you are more likely to experience this change than those with eyes of a single color (blue, gray, green, or brown). Any change in eye color may take years to develop. The color change may be permanent and may be more noticeable if you use LATAFIX in only one eye. There do not appear to be any problems associated with the change in eye color. After treatment with LATAFIX is stopped, the change in eye color does not continue.

Common

• eye irritation (burning sensation, feeling of grit in the eye, itching, irritation, or a foreign body in the eye) and eye pain

Uncommon

• headache
• redness of the eye, eye infection (conjunctivitis), blurred vision, watery eye, inflammation of the eyelids, irritation or damage to the surface of the eye
• skin rashes or itching

Other side effects

Infections and infestations:

• development of a viral eye infection caused by the herpes simplex virus (HSV)

Immune system disorders:

• symptoms of an allergic reaction (skin swelling and redness and rash)

Psychiatric disorders:

• depression, memory loss, reduced sexual drive, problems falling asleep, nightmares

Nervous system disorders:

• dizziness, tingling or numbness of the skin, changes in blood flow to the brain, worsening of symptoms of myasthenia gravis (if you already suffer from this condition), fainting or feeling faint (syncope)

Eye disorders:

• changes in eyelashes and fluff around the eye (increased number, length, thickness, and darkening), changes in the direction of eyelash growth, swelling around the eye, swelling of the colored part of the eye (iritis/uveitis), swelling behind the eye (macular edema), inflammation/irritation of the surface of the eye (keratitis), dry eye, visual disturbances/changes, double vision, drooping of the upper eyelid, and damage to the lining of the back of the eye (a condition known as retinal detachment, but which only occurs following certain types of eye surgery), fluid-filled cysts inside the colored part of the eye (iridic cysts), sensitivity to light (photophobia), periorbital and eyelid changes resulting in hollowing of the palpebral sulcus

Ear disorders:

• ringing/buzzing in the ears (tinnitus)

Heart (cardiac) disorders:

• worsening of angina, sensitivity of heart rate (palpitations), changes in heart rate, slowed heart rate, heart failure (cardiac arrest, heart block, or congestive heart failure)

Blood vessel (vascular) disorders:

• low blood pressure, discoloration/cooling of the fingers and toes (Raynaud’s phenomenon), and cooling of the hands and feet

Respiratory (pulmonary) disorders:

• asthma, worsening of asthma, shortness of breath, sudden difficulty breathing (bronchospasm), cough

Gastrointestinal disorders:

• feeling unwell (nausea), diarrhea, dyspepsia, dry mouth

Skin disorders:

• darkening of the skin around the eyes, hair loss/baldness (alopecia), itchy rash or worsening of existing rash

Musculoskeletal disorders:

• joint pain, muscle pain

General disorders:

• chest pain, fatigue, swelling (edema)

As with other medicines applied to the eye, timolol is absorbed into the blood. This can
cause side effects similar to those observed with beta-blockers given intravenously
and/or orally. The incidence of these side effects after topical ophthalmic administration is
lower than when the medicines are, for example, taken by mouth or injected. The side effects
listed include reactions observed within the class of beta-blockers when used for
treating eye conditions:

• Generalized allergic reactions including swelling under the skin that can occur in areas such as the face and limbs and can obstruct the airways, which can cause difficulty swallowing or breathing. Hives or itchy rash, localized and generalized rash, itching, severe, life-threatening allergic reaction.
• Low blood glucose levels.
• Difficulty sleeping (insomnia), depression, nightmares, memory loss.
• Fainting, stroke, reduced blood flow to the brain, increased signs and symptoms of myasthenia gravis (muscle disease), dizziness, unusual sensation like pins and needles, headache.
• Signs and symptoms of eye irritation (e.g., burning, irritation, itching, tearing, redness), eyelid inflammation, inflammation of the cornea, blurred vision, and detachment of the layer under the retina containing blood vessels following filtration surgery which can cause visual disturbances, decreased corneal sensitivity, dry eyes, erosion of the cornea (damage to the outermost layer of the cornea), drooping of the upper eyelid (leaving the eye half-closed), double vision.
• Slowed heartbeat, chest pain, palpitations, edema (fluid retention), changes in the rhythm or rate of the heartbeat, congestive heart failure (heart condition with shortness of breath and swelling of legs and feet due to fluid accumulation), a type of heart rhythm disorder, heart attack, heart failure.
• Low blood pressure, Raynaud’s phenomenon, cold hands and feet.
• Constriction of the airways in the lungs (usually in patients with pre-existing disease), difficulty breathing, cough.
• Changes in taste, nausea, indigestion, diarrhea, dry mouth, abdominal pain, vomiting.
• Hair loss, skin rash with a silvery-white appearance (psoriasiform rash) or worsening of psoriasis, rash.
• Muscle pain not caused by exercise.
• Sexual dysfunction, decreased libido.
• Muscle weakness/fatigue.

In very rare cases, some patients with severe damage to the outermost transparent layer of the eye (the
cornea) have developed opaque patches on the cornea due to calcium accumulation during
treatment.
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or
pharmacist. You can also report side effects directly through the national reporting system at
www.agenziafarmaco.gov.it/it/responsabili .
By reporting side effects you can help provide more information on the
safety of this medicine.

5. HOW TO STORE LATAFIX

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry datethat is stated on the bottle and the packaging
after “EXP”. The expiry date refers to the last day of that month.

Take note of the following storage instructions:
Intact bottle: store in a refrigerator at 2°C-8°C.
After first opening of the bottle: do not store at a temperature above 25°C.
Once opened, you must discard the bottle – with the remaining contents – after 4 weeks.
Otherwise there is a risk of eye infection.
Do not dispose of any medicine in 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 LATAFIX contains
The active ingredientsare latanoprost and timolol maleate.
1 ml contains 50 micrograms of latanoprost and 6.8 mg of timolol maleate equivalent to 5 mg of
timolol.
The other ingredientsare: sodium chloride, benzalkonium chloride, sodium phosphate monobasic
dihydrate, disodium phosphate dodecahydrate, purified water, sodium hydroxide for pH adjustment,
hydrochloric acid for pH adjustment.

Description of LATAFIX and package contents
LATAFIX is a clear, colorless liquidsolution contained in a transparent dropper bottle
with a screw cap.
LATAFIX is available in the following pack sizes:
1 dropper bottle containing 2.5 ml of eye drops
3 dropper bottles, each containing 2.5 ml of eye drops
6 dropper bottles, each containing 2.5 ml of eye drops
Not all pack sizes may be marketed.

Marketing Authorisation Holder
DOC Generici S.r.l
Via Turati 40
20121 Milano
Italy

Manufacturer
S.C. Rompharm Company S.r.l
Eroilor Street, no. 1A
Otopeni 075100, Ilfov District
Romania

This medicinal product is authorised in the Member States of the European Economic Area with the
following names:
Denmark: Latanoprost/Timolol Apotex 50 micrograms and 5 mg/ml Øjendråber, opløsning
Belgium: Latanoprost-Timolol Apotex 0.005%-0.5% oogdruppels/collyre/Augentropfen
Italy: LATAFIX 50 mcg/ml + 5 mg/ml eye drops, solution
Poland: ApoLatimol
Portugal: Latimocom
Czech Republic: LATANOPROST/TIMOLOL APOTEX 50 ug/ml a 5 mg/ml oční kapky, roztok
Spain: Latanoprost/Timolol Apotex colirio en solucion

This leaflet was last updated in