Lifoduo

Patient Information Leaflet

Lifoduo 50 micrograms/mL + 5 mg/mL eye drops, solution

latanoprost / timolol
Equivalent medicinal product
Please read all of 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 give it to other people, even if they have the same symptoms as you, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Lifoduo is and what it is used for

Lifoduo contains two active substances: 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 inside the eye into the bloodstream. Timolol works by slowing down the production of fluid inside the eye.
Lifoduo is used to reduce the pressure inside the eye when affected by conditions known as open-angle glaucoma or ocular hypertension. Both of these conditions are associated with increased eye pressure, which may eventually impair vision.
Your doctor usually prescribes Lifoduo when other medicines have not worked adequately.
Lifoduo can be used in adults, both men and women (including elderly patients), but is not recommended for individuals under 18 years of age.

2. What you need to know before using Lifoduo

Do not use Lifoduo

• if you are allergic to latanoprost or timolol, beta-blockers, or any of the other ingredients of this medicine (listed in section 6)
• if you have or have previously had breathing problems, such as asthma, or severe chronic obstructive pulmonary disease (COPD) (a serious lung disease that may cause wheezing, difficulty breathing, and/or persistent cough)
• if you have heart problems, such as heart failure or irregular heartbeat.

Warnings and precautions
Talk to your doctor or pharmacist before using Lifoduo if you have or have previously had:

• coronary heart disease (symptoms may include chest pain or tightness, shortness of breath, or a feeling of suffocation), heart failure, or low blood pressure
• irregular heartbeat, such as a slow heartbeat
• breathing problems, asthma, or chronic obstructive pulmonary disease (COPD)
• circulation problems (such as Raynaud's disease or Raynaud's syndrome)
• diabetes, as timolol may mask the signs and symptoms of low blood sugar
• overactive thyroid gland (hyperthyroidism), 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, or blurred vision)
• are aware of suffering from dry eye syndrome
• wear contact lenses. You may continue using Lifoduo, but follow the instructions for contact lens wearers provided in section 3
• are aware of suffering from angina (particularly a type known as Prinzmetal's angina)
• are known to experience severe allergic reactions usually requiring hospital treatment
• have suffered or currently suffer from a viral eye infection caused by the herpes simplex virus (HSV).

Before undergoing surgery, inform your doctor that you are using Lifoduo, as timolol may alter the effects of certain medicines used during anaesthesia.
For individuals engaged in sports: using this medicine without a therapeutic need constitutes doping and may result in a positive anti-doping test.
Other medicines and Lifoduo
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including eye drops and over-the-counter medicines.
Lifoduo 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, medicines for the heart, or medicines for diabetes treatment.
In particular, inform your doctor or pharmacist if you are taking a medicine belonging to the following classes:

• Prostaglandins, prostaglandin analogues, or prostaglandin derivatives
• Beta-blockers
• Epinephrine
• Medicines used to treat high blood pressure, such as oral calcium antagonists, guanethidine, antiarrhythmics, digitalis glycosides, or parasympathomimetics
• Quinidine (used to treat heart conditions and certain types of malaria)
• Certain antidepressants such as fluoxetine and paroxetine.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not use Lifoduo if you are pregnant, unless your doctor considers it necessary. Inform your doctor immediately if you are pregnant, think you might be pregnant, or are planning a pregnancy.
Breastfeeding
Do not use Lifoduo while breastfeeding. Lifoduo may pass into your breast milk. Ask your doctor for advice before taking any medicine during breastfeeding.
Fertility
In animal studies, latanoprost and timolol did not show effects on male or female fertility.
Driving and using machines
Lifoduo may cause blurred vision for a short time after instillation. If this occurs, do not drive or operate machinery until your vision clears.
Lifoduo contains phosphates
This medicine contains 6 mg of phosphate buffer per millilitre.
If you have severe damage to the transparent layer at the front of the eye (the cornea), phosphates may, in very rare cases, cause cloudy deposits on the cornea due to calcium accumulation during treatment.

3. How to use Lifoduo

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Dosage
The recommended dose for adults (including elderly patients) is one drop once daily
in the eye(s) to be treated.
Do not use Lifoduo more than once a day, as treatment efficacy may decrease if the
medicine is administered more frequently.
Use Lifoduo as directed by your doctor, until your doctor tells you to stop treatment.
Your doctor may require additional checks of your heart and circulation while you are using Lifoduo.
Contact lens wearers
If you wear contact lenses, you must remove them before applying Lifoduo. After applying
Lifoduo, you must wait 15 minutes before reinserting your contact lenses.
Instructions for correct use
Follow the steps below to correctly use Lifoduo eye drops, solution:

1. Wash your hands and sit or stand in a comfortable position.
2. Remove the protective cap (Figure 1). To avoid contaminating the solution, the tip of the bottle must not touch any surface.
3. Hold the bottle upside down, placing your thumb on the shoulder of the bottle and the other fingers on the base of the bottle (Figure 2). Before first use, press the bottle repeatedly approximately 12 times until the first drop appears.
4. Tilt your head backwards and gently pull down the lower eyelid with one finger to form a pouch between the eye and the eyelid.
5. Bring the tip of the bottle close to the eye, taking care not to touch it.
6. Press the finger grip area and the lower part of the bottle so that one single drop enters the eye, then release the lower eyelid (Figure 3).
7. Place a finger on the corner of the treated eye near the nose (Figure 4). Maintain pressure for 2 minutes with the eye closed.
8. Repeat steps 4, 5, 6 and 7 in the other eye, if your doctor has instructed you to do so.
9. After each use, shake the bottle downwards once, without touching the dropper tip, to remove any residual liquid from the tip. This is necessary to ensure proper delivery of subsequent drops and to prevent contamination.
10. Replace the cap on the bottle.

Figure 1 Figure 2 Figure 3 Figure 4
Use only one bottle of medicine at a time. Do not open the cap until you are ready to use the eye drops.
The 2.5 mL bottle must be discarded 30 days after first opening, and the 7.5 mL bottle must be discarded 90 days after first opening, to prevent the risk of infection.
Record the date of opening the bottle in the space provided on the carton.
If you use Lifoduo together with other eye drops
If you need to use other eye drops, wait at least 5 minutes after applying Lifoduo. Ocular ointments should be applied last.
If you use more Lifoduo than you should
If you put too many drops in your eyes, you may experience mild eye irritation, tearing, and eye redness. These effects are temporary, but if you are concerned, contact your doctor for advice.
If you swallow Lifoduo
Consult your doctor if you have accidentally swallowed Lifoduo. If you swallow a large amount of Lifoduo, you may feel unwell, have stomach pain, feel tired, warm, dizzy, and begin to sweat.
If you forget to use Lifoduo
Continue with your usual dose at your usual time. Do not use a double dose to make up for a forgotten dose.
If you stop using Lifoduo
Talk to your doctor if you wish to stop treatment with Lifoduo.
If you have any doubts 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 everybody gets them.
You can usually continue using the drops unless the side effects are severe. If you are concerned, speak to your doctor or pharmacist. Do not stop using Lifoduo without first consulting your doctor.

Listed below are the known side effects associated with the use of Lifoduo. The most important side effect is the possible gradual and permanent change in eye colour due to increased brown pigment in the coloured part of the eye (iris). Lifoduo may also cause serious changes in heart function. If you notice any changes in your heartbeat or heart function, you must contact your doctor and inform him/her that you are using Lifoduo.

The known side effects associated with the use of Lifoduo are:

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

• Gradual change in eye colour due to increased amount of brown pigment in the coloured part of the eye (iris). This change is more likely if your eyes are of mixed colour (blue-brown, grey-brown, yellow-brown or green-brown) rather than uniform colour (blue, grey, green or brown). Any change in eye colour may occur after several years. The change in colour may be permanent and more noticeable if you use Lifoduo in only one eye. No problems have been observed that are associated with the change in eye colour. After discontinuation of Lifoduo treatment, no further change in eye colour has been observed.

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

• Eye irritation (burning sensation, sensation of sand in the eyes, itching, stinging pain or foreign body sensation in the eyes) and eye pain.

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

• Headache.
• Red eyes, eye infection (conjunctivitis), blurred vision, watery eyes, inflammation of the eyelids, irritation or changes on the eye surface.
• Skin rash or pruritus (itching sensation).

Other side effects
Like other eye medicines, Lifoduo (latanoprost and timolol) is absorbed into the bloodstream. The incidence of adverse reactions after using eye drops is lower than when medicines are taken orally or by injection, for example.
Although not specifically associated with the use of Lifoduo, the following side effects have been observed with medicines contained in Lifoduo (latanoprost and timololo). These effects may therefore occur when using Lifoduo. The listed side effects include reactions observed within the class of beta-blockers (e.g., timololo) when used to treat eye disorders:

• Nausea, vomiting (uncommon).
• Development of a viral eye infection caused by the herpes simplex virus (HSV).
• Generalised allergic reactions, including swelling under the skin that may occur in areas such as the face and limbs and may block the airways causing difficulty in swallowing and breathing, urticaria or itchy skin rash, localised or generalised skin rash, pruritus, sudden severe life-threatening allergic reaction (anaphylaxis).
• Low blood sugar levels.
• Dizziness.
• Difficulty sleeping (insomnia), depression, nightmares, memory loss, hallucinations.
• 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 cyst in the coloured part of the eye (iris cyst), light sensitivity (photophobia), sunken eyes (deepening of the eyelid groove).
• Signs and symptoms of eye irritation (such as burning, stinging 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 eyelashes and surrounding vellus hair (increased number, length, thickness, 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 with pre-existing heart disease.
• Slow heart rate, chest pain, palpitations (awareness of heartbeat), oedema (fluid accumulation), changes in heart rhythm or 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 disturbance, heart attack, heart failure.
• Low blood pressure, poor blood circulation causing numbness and paleness of fingers and toes, cold hands and feet.
• Shortness of breath, narrowing of the lung airways (mainly in patients with pre-existing conditions), difficulty breathing, cough, asthma, worsening of asthma.
• Taste disturbances, indigestion, diarrhoea, dry mouth, abdominal pain.
• Hair loss, skin rash with whitish-silver appearance (psoriasiform rash) or worsening of psoriasis, skin rash.
• Joint pain, muscle pain not caused by physical exercise, muscle weakness, fatigue.
• Sexual dysfunction, reduced libido.

In very rare cases, some patients with severe damage to the transparent front layer of the eye (cornea) have developed opaque spots 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 Italian Medicines Agency website: 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 Lifoduo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton and on the bottle after "Exp". The expiry date refers to the last day of that month.
Do not store above 25 °C.
Keep the bottle in the outer carton to protect it from light.
Do not freeze.
After first opening: do not store above 25 °C, keep the bottle in the outer carton to protect it from light. Do not freeze.
After opening, use the 2.5 mL bottle within 30 days.
After opening, use the 7.5 mL bottle within 90 days.
Record the date of opening of the bottle in the space provided on the carton.
Do not dispose of any medicine via 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 Lifoduo contains

• The active substances are latanoprost and timolol.

Each millilitre of solution contains 50 micrograms of latanoprost and 5 mg of timolol (as maleate).

• The other components are: sodium chloride, disodium phosphate, monosodium dihydrogen phosphate monohydrate, polysorbate 80, disodium edetate, sodium hydroxide (for pH adjustment), diluted hydrochloric acid (for pH adjustment), water for injections.

Description of the appearance of Lifoduo and contents of the pack
Lifoduo is a colourless, clear liquid.
The pack consists of an HDPE bottle closed with a multidose dropper dispenser (PP, HDPE, LDPE) equipped with a pump, an HDPE cap, and a finger grip made of PP.
Lifoduo eye drops, solution are available in the following pack sizes:
1 bottle of 2.5 mL
1 bottle of 7.5 mL
2 bottles of 7.5 mL
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Alfa Intes Industria Terapeutica Splendore S.r.l.
Via Fratelli Bandiera 26 - 80026 Casoria (NA)
Italy

Manufacturer
Lomapharm GmbH
Langes Feld 5, Emmerthal, Niedersachsen, 31860
Germany

This medicinal product is authorised in the European Economic Area countries under the following names:
CZ: Latanoprost/Timolol Polpharma
DE: Lifoduo 50 Mikrogramm/ml + 5 mg/ml Augentropfen, Lösung
ES: Lifog Duo 50 microgramos/ml + 5 mg/ml colirio en solución
FR: Vortia 50 microgrammes/5 mg par mL, collyre en solution
IE: Loracom 0.05 mg/ml + 5 mg/ml eye drops, solution
IT: Lifoduo 50 microgrammi/mL + 5 mg/mL collirio, soluzione
PT: Lifog Duo 50 microgramas/ml + 5 mg/ml colírio, solução