Latfix

PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER

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

Latanoprost and timolol
Equivalent medicine
Please read all of 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, 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, talk to 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 using 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 used to treat elevated intraocular pressure (pressure inside the eye).
LATAFIX is a fixed combination of two active substances: latanoprost (a prostaglandin derivative) 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 appropriate pressure inside the eye. If this drainage is impaired, the pressure inside the eye increases.
Among other effects, beta blockers reduce the pressure inside the eye by decreasing the production of aqueous humour. Prostaglandins enhance the outflow of aqueous humour.
LATAFIX is used to:

• reduce internal eye pressure in patients with open-angle glaucoma (damage to the optic nerve caused by excessive pressure inside the eye)
• reduce internal eye pressure in patients for whom treatment with either beta blockers or prostaglandin analogues alone is insufficient

2. WHAT YOU SHOULD KNOW BEFORE TAKING LATAFIX

Do not take LATAFIX:

• if you are allergic (hypersensitive) to latanoprost or timolol, or to beta-blockers, or to any of the other excipients of LATAFIX (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 wheezing, difficulty breathing and/or persistent cough)
• if you have serious heart problems or heart rhythm disorders

Warnings and precautions
Consult your doctor or pharmacist before taking LATAFIX if you have or have previously had:

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

Consult 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 may continue using LATAFIX, but you must follow the instructions provided for contact lens wearers in the section “Important information on some excipients of LATAFIX”

Before undergoing surgery, inform your doctor that you are using LATAFIX, as it may alter the effects of certain medicines used during anaesthesia.
If you are involved in sports: using this medicine without therapeutic need constitutes doping and
may result in a positive anti-doping test.

Other medicines and LATAFIX
LATAFIX may affect or be affected by other medicines you are using, including other eye drops for glaucoma treatment. Inform your doctor if you are taking or intend to take medicines to lower blood pressure, heart medications or treatments for diabetes.
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Medicines can interact with each other, leading to interactions. If you are taking any of the following medicines:
Calcium channel blockers (e.g. for coronary heart disease or high blood pressure)
Guanethidine (for high blood pressure)
Beta-blockers (for high blood pressure)
Antiarrhythmics (medicines used to normalize heart rhythm)
Digitalis glycosides (for heart failure)
Parasympathomimetic drugs (e.g. for glaucoma treatment)
you should be aware that taking LATAFIX together with these medicines may cause a decrease in blood pressure and/or slow down the heart rate.

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

Clonidine
If you are taking clonidine together with LATAFIX to reduce intraocular pressure and suddenly stop taking clonidine, your eye pressure may rise again.
If you are also taking beta-blockers at the same time to reduce high blood pressure, your blood pressure may further increase due to opposing effects.

Quinidine (used to treat heart conditions and certain types of malaria)
Antidepressants known as fluoxetine and paroxetine

Children and adolescents
The use of LATAFIX is not recommended in children and adolescents.

Elderly
LATAFIX is suitable for treatment in elderly patients.

Pregnancy, breastfeeding and fertility
Pregnancy
Do not use LATAFIX during pregnancy unless your doctor considers it necessary.

Breastfeeding
Do not use LATAFIX while breastfeeding. Timolol and latanoprost may pass into your breast milk.
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Driving and using machines
After instilling LATAFIX eye drops, your vision may be temporarily impaired.
If your vision becomes blurred, especially after instilling LATAFIX drops, you must not drive or operate tools or machinery.

LATAFIX contains benzalkonium chloride.
This medicine contains benzalkonium chloride, which may cause eye irritation. Avoid contact with soft contact lenses. Remove contact lenses before application and wait at least 15 minutes before reinserting them. Benzalkonium chloride is known to change the colour of soft contact lenses.

3. HOW TO TAKE LATAFIX

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Unless otherwise prescribed by your doctor, the recommended dose is:
Adults, including elderly patients: instill one drop once daily into the affected eye.
If you are using LATAFIX in combination with another eye drop, wait at least 5 minutes between each application.

Instructions for use

1. Wash your hands and sit or position yourself comfortably.
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 dropper tip close to the eye without touching it. Squeeze the bottle carefully until a single drop falls into the eye. Be careful not to squeeze the bottle too hard to avoid more than one drop falling into the eye being treated.
5. Release the eyelid.
6. After using LATAFIX, press your finger against the corner of the eye next to the nose for two minutes. This helps prevent LATAFIX from passing into the rest of the body. If prescribed by your doctor, repeat the procedure in the other eye. If the drop misses the eye, apply another drop.
7. Close the bottle.

If you use more LATAFIX than you should
If too many drops go into the eye, irritation and redness may occur.
Tell your doctor immediately if you or someone else has accidentally swallowed the drops or if you have applied the drops more often than prescribed.
Keep the medicine package available so that the doctor can obtain further information. The doctor will then decide what to do.

If you forget to use LATAFIX
If you forget 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 not use a double dose to make up for a forgotten dose.

If you stop using LATAFIX
Do not stop treatment with LATAFIX without first speaking to your doctor.
If you do not use LATAFIX regularly or 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. Usually, you cannot simply feel increased intraocular pressure. The condition can only be diagnosed through an eye examination by an ophthalmologist. If you suffer from elevated intraocular pressure, regular eye tests together with measurements of the internal eye pressure are necessary. 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 questions about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The known adverse reactions associated with eye drops containing the active substances latanoprost and timolol are listed below. The most important adverse reaction is the possibility of a gradual, 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 heartbeat or heart function, speak to your doctor and inform them that you are using LATAFIX.
You may continue using the drops unless the effects are serious. If you are concerned, tell your doctor or pharmacist. Do not stop using LATAFIX without speaking to your doctor.
The frequency of the possible adverse reactions listed below is defined according to the following convention:
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1,000 people
Very rare: may affect up to 1 in 10,000 people
Not known: frequency cannot be estimated from the available data

Very common

• Gradual change in eye colour due to increased brown pigment in the coloured part of the eye known as the iris. If you have eyes of mixed colour (blue-brown, grey-brown, yellow-brown or green-brown), you are more likely to experience this change than those 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 you use LATAFIX in only one eye. There appear to be no problems associated with the change in eye colour. After stopping treatment with LATAFIX, the change in eye colour does not progress.

Common

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

Uncommon

• Headache

• Eye redness, eye infection (conjunctivitis), blurred vision, watery eyes, eyelid inflammation, eye surface irritation or damage

• Skin rash or itching

Other adverse reactions
Infections and infestations:

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

Immune system disorders:

• Symptoms of allergic reaction (skin swelling and redness, skin rash)

Psychiatric disorders:

• Depression, memory loss, reduced sex drive, difficulty sleeping, 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 periorbital hair (increased number, length, thickness and darkening), changes in the direction of eyelash growth, swelling around the eye, swelling of the coloured part of the eye (iritis/uveitis), swelling behind the eye (macular edema), inflammation/irritation of the eye surface (keratitis), dry eye, visual disturbances/changes, double vision, drooping of the upper eyelid, and lesions to the lining at the back of the eye (a condition known as retinal detachment, occurring only following certain types of eye surgery), fluid-filled cysts within the coloured part of the eye (iris cysts), light sensitivity (photophobia), periorbital and eyelid changes causing hollowing of the eyelid crease

Ear disorders:

• Ringing or buzzing in the ears (tinnitus)

Cardiac disorders:

• Worsening of angina, awareness of heartbeat (palpitations), changes in heart rhythm, slow heart rate, heart failure (cardiac arrest, heart block or congestive heart failure)

Vascular disorders:

• Low blood pressure, discolouration/cooling of fingers and toes (Raynaud’s phenomenon), and cold hands and feet

Respiratory disorders:

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

Gastrointestinal disorders:

• Feeling unwell (nausea), diarrhoea, dyspepsia, dry mouth

Skin disorders:

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

Musculoskeletal and connective tissue disorders:

• Joint pain, muscle pain

General disorders:

• Chest pain, fatigue, swelling (oedema)

Like other medicines applied to the eye, timolol is absorbed into the bloodstream. This may cause adverse reactions similar to those observed with intravenous and/or oral beta-blockers. The incidence of these adverse reactions after topical ophthalmic administration is lower than when medicines are taken orally or injected. The adverse reactions listed include those observed within the class of beta-blockers when used to treat eye conditions:

• Generalised allergic reactions including swelling under the skin which may occur in areas such as the face and limbs and may block the airways, potentially causing difficulty in swallowing or breathing. Urticaria or itchy rash, localised and generalised skin rash, itching, severe sudden allergic reaction which may be life-threatening.
• Low blood sugar levels.
• Sleep difficulties (insomnia), depression, nightmares, memory loss.
• Fainting, stroke, reduced blood flow to the brain, increased signs and symptoms of myasthenia gravis (a muscle disorder), dizziness, unusual sensations such as pins and needles, headache.
• Signs and symptoms of eye irritation (e.g., burning, irritation, itching, tearing, redness), eyelid inflammation, corneal inflammation, blurred vision, and detachment of the layer beneath the retina containing blood vessels following filtration surgery, which may cause visual disturbances, reduced corneal sensitivity, dry eyes, corneal erosion (damage to the outermost layer of the cornea), drooping of the upper eyelid (leaving the eye half-closed), double vision.
• Slow heartbeat, chest pain, palpitations, oedema (fluid accumulation), changes in heart rhythm or rate, 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.
• Airway constriction in the lungs (usually in patients with pre-existing lung disease), difficulty breathing, cough.
• Taste disturbances, nausea, indigestion, diarrhoea, dry mouth, abdominal pain, vomiting.
• Hair loss, skin rash with silvery appearance (psoriasiform rash) or worsening of psoriasis, skin 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 spots on the cornea due to calcium deposits during treatment.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report adverse reactions directly via the national reporting system at
www.agenziafarmaco.gov.it/it/responsabili .
By reporting adverse reactions, 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 date stated on the bottle and the carton
after “EXP”. The expiry date refers to the last day of that month.
Please follow these storage instructions:
Unopened bottle: store in the refrigerator at 2°C–8°C.
After first opening the bottle: do not store above 25°C.
Once opened, discard the bottle – together with any remaining contents – after 4 weeks.
Otherwise, there is a risk of eye infection.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer in use. This will help protect the environment.

6. PACK CONTENTS AND OTHER INFORMATION

What LATAFIX contains
The active substances are 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 components are: sodium chloride, benzalkonium chloride, monobasic sodium phosphate dihydrate, dibasic sodium phosphate dodecahydrate, purified water, sodium hydroxide to adjust pH, hydrochloric acid to adjust pH.

Description of the appearance of LATAFIX and pack contents
LATAFIX is a clear, colourless liquid solution stored in a transparent dropper bottle.
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 Authorization Holder
DOC Generici S.r.l
Via Turati 40
20121 Milan
Italy

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

This medicinal product has been authorised in the European Economic Area Member States under the following names:
Denmark: Latanoprost/Timolol Apotex 50 micrograms and 5 mg/ml eye drops, solution
Belgium: Latanoprost-Timolol Apotex 0.005%-0.5% eye drops/collyrium/Augentropfen
Italy: LATAFIX 50 mcg/ml + 5 mg/ml eye drops, solution
Poland: ApoLatimol
Portugal: Latimocom
Czech Republic: LATANOPROST/TIMOLOL APOTEX 50 ug/ml and 5 mg/ml oční kapky, roztok
Spain: Latanoprost/Timolol Apotex eye drops in solution

This leaflet was last updated in