Droplacomb

PACKAGE LEAFLET: INFORMATION FOR THE USER

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

Latanoprost/Timolol
Equivalent medicine
Read this leaflet carefully before using this medicine. Even if you have previously used
Droplacomb or a similar medicine, it is advisable to read this leaflet carefully. The
information may have been updated.

• 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 others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist.

Contents of this leaflet:

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

1. WHAT DROPLACOMB IS AND WHAT IT IS USED FOR

Droplacomb contains two active substances: latanoprost and timolol. Latanoprost belongs to a
category of medicines known as prostaglandin analogues. Timololo belongs to a category of
medicines known as beta-blockers. Latanoprost works by increasing the natural outflow of fluid
from inside the eye into the bloodstream. Timololo works by reducing the production of fluid
within the eye.
Droplacomb 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 intraocular pressure, which may eventually impair vision. Your doctor usually
prescribes Droplacomb when other medicines have not worked adequately.

2. WHAT YOU NEED TO KNOW BEFORE USING DROPLACOMB

Do not use Droplacomb eye drops, solution:

• If you are allergic (hypersensitive) to the active substances latanoprost or timolol, to beta-blockers, or to any of the excipients of Droplacomb (listed in Section 6)
• If you have severe respiratory problems, suffer from asthma, or have a personal or family history of asthma
• If you have severe heart problems (congestive heart failure, overt heart failure) or heart rhythm disorders
• If you are pregnant or trying to become pregnant
• If you are breastfeeding
• If you currently suffer or have previously suffered from respiratory disorders such as asthma, severe chronic obstructive pulmonary disease (COPD) (a serious lung disease that may cause wheezing, difficulty breathing, and/or prolonged coughing).

Take special care with Droplacomb
Before using this medicine, inform your doctor if any of the following conditions currently affect you or have affected you in the past:

• Any eye surgery (including cataract surgery)
• Eye problems (such as eye pain, eye irritation or inflammation, blurred vision)
• Dry eye
• Contact lenses. You may still use Droplacomb, following the instructions for contact lens wearers provided in Section 3
• Breathing problems, asthma, or chronic obstructive pulmonary disease
• Coronary artery disease (symptoms may include chest pain or tightness, shortness of breath, or suffocation sensation), heart failure, low blood pressure
• Heart rhythm disorders such as slow heartbeat
• Circulatory disorders (such as Raynaud’s disease or Raynaud’s syndrome)
• Diabetes or low blood sugar levels (hypoglycemia)
• Diabetes, because timolol may mask the signs and symptoms of low blood sugar
• Overactive thyroid gland, because timolol may mask its signs and symptoms
• Angina, particularly a type of angina known as Prinzmetal’s angina (chest pain occurring at rest)
• Severe allergic reactions that usually require hospital treatment.

Before undergoing surgery, inform your doctor that you are using Droplacomb, as timolol may alter the effects of certain anesthetic drugs. Your doctor may require additional monitoring of your heart and circulation if you are using Droplacomb. Cardiac reactions, including, rarely, death associated with heart failure, have been reported following administration of timolol maleate.
For athletes: Using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.
Use with other medicines
Droplacomb may alter the effects of other medicines you are taking, or its effects may be altered by other medicines, including other eye drops used to treat glaucoma. Inform your doctor if you are taking or intend to take medicines to lower blood pressure, medicines for heart conditions, or medicines to treat diabetes.
Inform your doctor or pharmacist if you are taking or have recently taken any other medicines (or eye drops), including those not requiring a prescription.
In particular, inform your doctor or pharmacist if you are taking a medicine belonging to any of the following classes:

• Prostaglandins, prostaglandin analogues, or prostaglandin derivatives
• Beta-blockers
• Epinephrine
• Medicines used to raise blood pressure such as orally administered calcium channel blockers, guanethidine, antiarrhythmics, digitalis glycosides, or parasympathomimetics
• Quinidine (used to treat heart conditions and certain types of malaria)
• Antidepressants known as fluoxetine and paroxetine.

Use of Droplacomb with food and drinks
Normal meals, food, or drinks do not affect how or when to use Droplacomb.
Fertility, pregnancy, and breastfeeding
Do not use Droplacomb if you are pregnant, unless your doctor considers it necessary. Inform your doctor immediately if you are pregnant, think you may be pregnant, or are planning a pregnancy.
Do not use Droplacomb if you are breastfeeding. Timolol may pass into breast milk. Due to the potential for serious adverse reactions in breastfed infants caused by timolol, a decision must be made whether to discontinue the medicine or breastfeeding, taking into account the importance of the medicine to the mother. Consult your doctor before using any medicine during breastfeeding.
Driving and using machines
No studies have been conducted on the effects of Droplacomb on the ability to drive or operate machinery. However, when driving or operating machinery, you should be aware that occasional visual disturbances may occur, including changes in refraction, diplopia (double vision), ptosis (drooping eyelid), frequent episodes of mild and transient blurred vision, and occasional episodes of dizziness and fatigue, which may interfere with the ability of some patients to drive and/or operate machinery. If this occurs, do not drive or operate equipment or machinery until your vision has normalized.
Important information about some excipients in Droplacomb
Droplacomb contains benzalkonium chloride, monosodium dihydrogen phosphate monohydrate, disodium phosphate anhydrous (phosphate buffer).

• Benzalkonium chloride: this medicine contains 0.01 mg of benzalkonium chloride per dose, equivalent to 0.01 mg/drop volume (equal to 0.0265 ml). Benzalkonium chloride may be absorbed by soft contact lenses and may cause discoloration. Remove 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 outermost transparent layer of the eye). If you experience an unusual sensation, burning, or pain in the eye after using this medicine, speak with your doctor.
• Monosodium dihydrogen phosphate monohydrate, disodium phosphate anhydrous (phosphate buffer). Droplacomb 50 micrograms/ml + 5 mg/ml eye drops, solution contains 0.24 mg of phosphate buffer per dose, equivalent to 0.24 mg/drop volume (equal to 0.0265 ml). If you have severe damage to the outermost transparent layer of the eye (the cornea), phosphates may, in very rare cases, cause calcium deposits leading to cloudy spots on the cornea during treatment.

3. HOW TO USE DROPLACOMB

Always use Droplacomb eye drops, solution exactly as your doctor has instructed. If you have any
doubts, consult your doctor or pharmacist.
After using Droplacomb, press with a finger on the inner corner of the eye, near the nose, for 2 minutes. This helps prevent latanoprost and timolol from being absorbed into the rest of the body.
The usual dose in adults (including elderly patients) is one drop once daily in the affected eye(s).
Do not use Droplacomb more than once a day, as treatment effectiveness may be reduced if the medicine is administered more frequently.
Use Droplacomb as directed by your doctor, until your doctor tells you to stop treatment.
Use in children and adolescents
The use of Droplacomb in children and adolescents (under 18 years of age) is not recommended.
Contact lens wearers
If you wear contact lenses, you must remove them before applying Droplacomb. After applying Droplacomb, wait 15 minutes before reinserting your contact lenses.
Instructions for using Droplacomb
Follow the steps below to ensure correct use of Droplacomb:

1. Wash your hands and sit or stand comfortably.
2. Unscrew the outer protective cap.
3. Gently pull down with one finger the lower eyelid of the eye to be treated until a "pocket" forms between the eyelid and the eye. The drop should be placed here.
4. Position the dropper tip near the eye. Do not touch the eye, eyelid, surrounding areas, or any other surfaces with the dropper tip. This could contaminate the eye drops.

5. Gently squeeze the bottle so that one single drop enters the eye, then release the lower eyelid.
6. Press with a finger on the inner corner of the treated eye, near the nose. Keep your eyes closed for one minute.

7. Repeat the procedure in the other eye, if your doctor has instructed you to do so.
8. If a drop missed the eye, try again.
9. Replace the cap on the bottle.

If you use Droplacomb with another eye drop
Wait at least 5 minutes between administering Droplacomb and another eye drop.
If you use more Droplacomb than you should
If you put too many drops in your eyes, you may experience mild irritation, tearing, and redness of the eyes. These effects are temporary, but if you are concerned, contact your doctor for advice.
If you swallow Droplacomb
If you have accidentally swallowed Droplacomb, consult your doctor for advice. If you have swallowed a large amount of Droplacomb, you may experience nausea, stomach pain, fatigue, feeling hot, dizziness, and sweating.
If you forget to use Droplacomb
Continue using your usual dose at the regular time. Do not take a double dose to make up for the missed dose.
If you have any doubts about using Droplacomb, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, Droplacomb may cause adverse reactions, although not everyone experiences
them.
You can generally continue using the drops unless the side effects are serious. If you are concerned,
consult your doctor or pharmacist. Do not stop using Droplacomb without consulting your doctor.
Contact your doctor immediately if you experience any changes in heart rate or cardiac function
while taking Droplacomb. Droplacomb may also cause serious disturbances in cardiac function.
The frequencies of the adverse reactions listed below are defined according to the following
convention:
Very common (affects more than 1 in 10 people)
Common (affects 1 to 10 in 100 people)
Uncommon (affects 1 to 10 in 1,000 people)
Frequency not known (frequency cannot be estimated from available data)
Very common (may affect more than 1 in 10 patients): gradual change in eye colour due to an
increase in brown pigment in the coloured part of the eye called the 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). Changes in eye colour may occur even after several
years. The colour change may be permanent and may be more noticeable if you use Droplacomb in
only one eye. There appear to be no associated problems with this change in eye colour. After
discontinuation of Droplacomb treatment, no further change in eye colour has been observed.
Common (may affect 1 to 10 in 100 patients): eye irritation (burning sensation, sensation of sand,
itching, stinging pain or foreign body sensation in the eyes) and eye pain.
Uncommon (may affect 1 to 10 in 1,000 patients):

• Headache
• Red eyes, eye infection (conjunctivitis), blurred vision, watery eyes, eyelid inflammation, eye surface irritation or abrasion
• Skin rashes or itching.

Like other ophthalmic medicines, Droplacomb (latanoprost and timolol) is absorbed into the
bloodstream.
The incidence of adverse reactions following topical ophthalmic administration is lower than that
observed when medicines are taken orally or injected.
Although not specifically associated with the use of Droplacomb, the following adverse reactions
have been observed with the use of medicines contained in Droplacomb (latanoprost and timololo).
Therefore, these effects may occur when using Droplacomb. The listed adverse reactions include
those observed with the class of beta-blockers (e.g., timolol) when used to treat eye diseases:

• Generalized allergic reactions including subcutaneous swelling that may occur in areas such as the face and limbs and may obstruct airways causing difficulty in swallowing or breathing (angioedema), urticaria or itchy skin rash, a chronic autoimmune disease that may affect various organs and tissues of the body (systemic lupus erythematosus), localized and generalized skin rash, sudden severe allergic reaction potentially life-threatening (anaphylaxis).
• Low or high blood glucose levels, masking of signs and symptoms of low blood glucose in insulin-dependent diabetics.
• Difficulty sleeping (insomnia), depression, nightmares, memory loss, hallucinations.
• Fainting, stroke, reduced blood supply to the brain, worsening of signs and symptoms of myasthenia gravis (a muscle disorder), arthralgia, dizziness, unusual sensations such as tingling and numbness, and headache.
• Signs and symptoms of eye irritation (e.g., burning, pain, itching, tearing, redness), conjunctival inflammation, eyelid inflammation, corneal inflammation, blurred vision, corneal erosion (damage to the outer layer of the eyeball), iris cysts, ocular conjunctival pseudopemphigoid, detachment of the inner layer of the retina containing blood vessels after filtration surgery, which may cause visual disturbances, decreased corneal sensitivity, dry eyes, foreign body sensation, visual disturbances, drooping of the upper eyelid (with the eye half-closed), double vision. Cases of corneal calcification have been very rarely reported in association with the use of eye drops containing phosphate in some patients with significantly damaged corneas.
• Slow heart rate, chest pain (angina, unstable angina), palpitations, edema (fluid accumulation), changes in heart rhythm or rate, congestive heart failure (heart disease causing breathing difficulties and swelling of feet and legs due to fluid accumulation), a type of heart rhythm disorder, heart attack, and heart failure.
• Low blood pressure, Raynaud's phenomenon, cold hands and feet, difficulty walking (claudication).
• Constriction of airways in the lungs (mainly in patients with pre-existing lung disease), breathing difficulties, cough, respiratory failure.
• Altered taste, nausea, indigestion, diarrhea, dry mouth, abdominal pain, vomiting.
• Hair loss, white-silvery coloured skin rash (psoriasiform eruption) or worsening of psoriasis, skin rash. Muscle pain not caused by physical exercise.
• Sexual dysfunction (e.g., impotence), reduced libido, changes in penile structure (Peyronie's disease).
• Muscle weakness/fatigue.
• Ear disorders: ringing or buzzing in the ears (tinnitus).

Adverse reactions without known causal relationship
The following adverse reactions have been reported, but a causal relationship to timolol maleate therapy
has not been established: macular edema in an aphakic eye (cystoid macular edema), nasal
congestion, effects on the central nervous system (e.g., behavioral changes including confusion,
hallucinations, anxiety, disorientation, nervousness, drowsiness and other psychiatric disorders),
high blood pressure, retroperitoneal fibrosis, and pseudopemphigoid.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or
pharmacist. You may also report adverse reactions directly via the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting adverse reactions, you can help provide more information on the safety of this
medicine.
If any of the adverse reactions worsen, or if you notice any adverse reaction not listed in this
leaflet, inform your doctor or pharmacist.

5. HOW TO STORE DROPLACOMB

Keep this medicine out of the sight and reach of children.
Do not use Droplacomb after the expiry date stated on the vial and carton, following "Exp". The expiry date refers to the last day of the month.
Before opening Droplacomb, store it at a temperature of 2°C-8°C (in the refrigerator).
After the vial has been opened, Droplacomb may be stored at room temperature (below 25°C).
Discard the vial 4 weeks after first opening to prevent infections, and use a new vial.
Record the date of opening.
Keep the vial in the outer carton to protect the medicine from light.
Do not use Droplacomb if you notice that the vial is damaged or if the eye drops appear unsuitable for any other reason.
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. Pack contents and OTHER INFORMATION

What Droplacomb contains

• The active substances are latanoprost and timolol maleate. 1 ml of Droplacomb contains 50 micrograms of latanoprost and 6.83 mg of timolol maleate, equivalent to 5 mg of timolol.
• The other components are: sodium chloride, monohydrate sodium dihydrogen phosphate, anhydrous disodium phosphate, benzalkonium chloride, hydrochloric acid, sodium hydroxide, water for injections.

Description of the appearance of Droplacomb and pack contents
The solution is a clear, colourless and odourless liquid. Each bottle contains 2.5 ml of
eye drops, solution.
Pack sizes:
1 x 2.5 ml
3 x 2.5 ml
6 x 2.5 ml
Not all pack sizes may be marketed.

Marketing Authorisation Holder
OmniVision Italia S.r.l.
Via Montefeltro, 6
20156 Milan
Italy

Manufacturers
Tubilux Pharma S.p.A.
Via Costarica 20/22, 00071 Pomezia (Rome)
Italy

Italy: DROPLACOMB 50 microgrammes/ml + 5 mg/ml eye drops, solution

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