Package leaflet: Information for the user

Timololo OmniVision 0.25% eye drops, solution, 0.50% eye drops, solution

timolol
Generic medicine
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 side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Timololo OmniVision is and what it is used for

Timololo OmniVision contains the active substance timolol, which belongs to a group of medicines called beta-blockers that help reduce the pressure inside the eye.
This medicine is indicated for the treatment of certain conditions in which increased pressure inside the eye occurs, such as:

ocular hypertension;
chronic open-angle glaucoma;
glaucoma in aphakic patients (lacking the crystalline lens, the internal lens of the eye);
narrow-angle glaucoma and with previous episodes of spontaneous or medically induced (iatrogenic) angle closure in the fellow eye;
glaucoma in children and adolescents (pediatric), in combination with other medicines for the treatment of this disorder (other anti-glaucoma therapies).

2. What you need to know before using Timololo OmniVision

Do not use Timololo OmniVision

if you are allergic to timolol or to any of the other ingredients of this medicine (listed in section 6);
if you have or have had breathing problems (reactive airway disease including bronchial asthma or history of asthma, or severe chronic obstructive bronchopulmonary disease, i.e. a severe lung disease that may cause wheezing, difficulty breathing and/or long-lasting cough);
if you have heart rhythm disorders (sinus bradycardia, sick sinus syndrome, sino-atrial block, second- or third-degree atrioventricular block not controlled by a pacemaker);
if you have severe heart disease (congestive heart failure, overt heart failure, cardiogenic shock);
if you are pregnant or breastfeeding (See section “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before using Timololo OmniVision.
Refer to the section “Timololo OmniVision contains benzalkonium chloride” if you wear soft contact lenses.
Use this medicine with caution and inform your doctor in the following cases:

if you are taking another beta-blocking medicine by mouth (orally), as this may increase the effects of timolol both on eye pressure (intraocular pressure) and on the whole body (systemic effects of beta-blockade) (See section “Other medicines and Timololo OmniVision”);
if you have heart problems (coronary heart disease, Prinzmetal's angina, heart failure, first-degree heart block) or low blood pressure (hypotension), as these conditions may worsen and undesirable effects may occur. Therefore, your doctor will carefully consider whether an alternative and safer therapy is possible. Moreover, if you have heart failure, your doctor must correct this condition before starting treatment with Timololo OmniVision;
if you have circulation problems in your hands and feet causing finger pain and tingling (peripheral vascular disorders such as severe forms of Raynaud's disease or Raynaud's syndrome);
if you have lung problems (chronic obstructive pulmonary disease, COPD, mild/moderate);
if you have low blood sugar levels (spontaneous hypoglycemia) or suffer from diabetes (diabetes mellitus, especially unstable diabetes) and are being treated with insulin or other medicines (oral hypoglycemics), as timolol may mask the signs and symptoms of low blood sugar (acute hypoglycemia);
if your thyroid gland is overactive (hyperthyroidism), as timolol may mask symptoms of this condition;
if you have been diagnosed with a condition characterized by muscle weakness (myasthenia gravis);
if you have corneal diseases (corneal disorders), as timolol may cause dry eyes;
if you have any eye irritation or eye disorders, such as eye redness and eyelid swelling;
if you suffer from any type of allergy;
if you are scheduled for surgery, as timolol may alter the effects of certain medicines used during anesthesia (beta-agonists, adrenaline).

For the treatment of closed-angle glaucoma, your doctor will always prescribe Timololo OmniVision together with a medicine to constrict the pupil (a miotic).
During treatment with this medicine, the following conditions may occur (See section “Possible side effects”):

heart disorders (cardiac reactions, heart failure) and, rarely, death;
breathing problems (bronchospasm) which may be fatal in people suffering from asthma;
in predisposed individuals (history of atopy) or those who have previously experienced a severe allergic reaction (anaphylactic reaction): increased sensitivity to substances causing allergies (allergens) and lack of response to adrenaline, used to treat these allergic reactions;
eye problems (choroidal detachment). As with other ophthalmic medicines applied locally to the eyes, Timololo OmniVision may be absorbed systemically. Consequently, the same undesirable effects on the heart, circulation, and lungs observed with systemic administration of beta-blocking medicines may occur, although the risk is lower. To reduce systemic absorption, see section 3 “How to use Timololo OmniVision”.

If you use this medicine for a long time, the effect of timolol 0.25% may decrease (reduced hypotensive response). In this case, your doctor may prescribe the solution with a higher concentration of timolol (0.50%) or an alternative therapy (an anti-glaucoma medicine not belonging to the beta-blocker class).
For those engaged in sports: using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.
Children and adolescents
The use of this medicine is not recommended in children born prematurely (preterm infants).
In newborns, infants, and young children (early childhood), the use of this medicine is not recommended; however, if necessary, timolol maleate must be administered with extreme caution and under the supervision of a specialist doctor, as it may cause severe breathing problems (apnea, Cheyne-Stokes respiration). Additionally, in newborns, it may be helpful to use a device capable of detecting breathing abnormalities or interruptions (portable apnea detector).
In children and adolescents, Timololo OmniVision must be administered with caution. If symptoms such as cough and wheezing (wheezing sound) occur, treatment must be stopped immediately and the doctor informed.
Other medicines and Timololo OmniVision
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Use this medicine with caution and inform your doctor if you are taking the following medicines:

oral calcium antagonists, agents causing catecholamine depletion, adrenergic beta-blockers, guanethidine and clonidine, medicines used to treat high blood pressure;
antiarrhythmics (including amiodarone and quinidine), medicines used to treat heart rhythm disorders;
digitalis glycosides, medicines used to treat certain heart disorders;
parasympathomimetics, medicines used to treat glaucoma, intestinal or respiratory disorders;
fluoxetine, paroxetine and monoamine oxidase inhibitors (MAOIs), medicines used to treat depression;
adrenaline (epinephrine), a medicine used to increase blood pressure;
narcotics, medicines used to relieve pain and induce anesthesia;
antidiabetics, medicines used to treat diabetes.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before using this medicine. Do not use Timololo OmniVision if you are pregnant, except in cases of absolute necessity and under strict medical supervision. If you use this medicine until delivery, the newborn will be closely monitored during the first days of life, as serious adverse effects may occur. To reduce absorption of the medicine, follow the instructions in the section “How to use Timololo OmniVision”. Do not use Timololo OmniVision if you are breastfeeding, as timolol passes into breast milk. If Timololo OmniVision must be used, your doctor will have to decide whether you should discontinue treatment or breastfeeding, as this medicine may cause serious adverse effects in the infant.

Driving and using machines
This medicine may cause dizziness, visual disturbances (occasional visual disturbances, blurred vision), and fatigue. If you experience these symptoms, avoid driving or operating machinery.
Timololo OmniVision 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 cause discoloration of soft contact lenses.

3. How to use Timololo OmniVision

Use this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.

Use in adults
The appropriate dose and duration of treatment must be determined by your doctor.
The recommended initial dose is 1 drop of Timololo OmniVision 0.25% in each affected eye, twice daily.
If intraocular pressure remains at satisfactory levels, therapy may continue with once-daily administration.
If the response to the medicine is not sufficient, the dose may be increased to 1 drop of Timololo OmniVision 0.50% in each affected eye, twice daily.

Method of administration
Apply one single drop of eye drops into the eye for each administration. Immediately after applying the eye drops, press with a finger on the corner of the eye near the nose (nasolacrimal occlusion) and keep the eyes closed for 2 minutes. This will help prevent the medicine from being absorbed into the rest of the body (systemic absorption).

Treatment of glaucoma in combination with other medicines
If you are using this medicine in combination with other medicines (cholinergic miotics, alpha-blocking miotics, adrenergics, prostaglandins, systemic or topical carbonic anhydrase inhibitors), the recommended dose is 1 drop of Timololo OmniVision 0.25% in each affected eye every 12 hours, or Timololo OmniVision 0.50% if the clinical response is not sufficient.

Switching from another therapy
If you are currently being treated with a beta-blocking medicine (topically administered ophthalmic beta-blocking anti-glaucoma agent), you must discontinue the previous treatment for one full day before starting therapy with Timololo OmniVision. The recommended dose is 1 drop of Timololo OmniVision 0.25% in each affected eye, twice daily.
If the response to the medicine is not sufficient, the dose may be increased to 1 drop of Timololo OmniVision 0.50% in each affected eye, twice daily.

If you are currently using a non-beta-blocking medicine (topically administered ophthalmic non-beta-blocking anti-glaucoma agent) and are starting treatment with timolol maleate, on the first day continue your previous therapy, adding 1 drop of Timololo OmniVision 0.25% in each affected eye, twice daily. On the following day, completely discontinue the previous medicine and continue treatment with Timololo OmniVision 0.25% only.
If the response to the medicine is not sufficient, the dose may be increased to 1 drop of Timololo OmniVision 0.50% in each affected eye, twice daily.

Use in children and adolescents
The use of this medicine in children and adolescents is indicated only for certain forms of glaucoma (primary congenital glaucoma, juvenile primary glaucoma) and for short periods of time, while awaiting a decision on whether to perform surgery or initiate alternative therapy. Your doctor will decide whether to use this medicine only after careful evaluation of the child's health status, and will determine the dose and duration of treatment on an individual basis.
It is recommended to use the lowest available concentration of timolol maleate, i.e. 0.1% active substance, in each affected eye, once daily. If intraocular pressure cannot be controlled, administration twice daily at 12-hour intervals may be necessary.
These patients, particularly newborns, must be closely monitored in the outpatient setting for at least 1 or 2 hours after the first application, and monitored for the occurrence of adverse effects (ocular or systemic), until they undergo surgical intervention.

Method of administration
Apply one single drop of eye drops into the eye for each administration. Immediately after applying the eye drops, press with a finger on the corner of the eye near the nose (nasolacrimal occlusion) and keep the eyes closed as long as possible (e.g., for 3–5 minutes). This will help prevent the medicine from being absorbed into the rest of the body (systemic absorption).

If you use more Timololo OmniVision than you should
Following accidental overdose of ophthalmic solutions containing timolol maleate, the following effects may occur:

dizziness, lightheadedness;
headache;
slowing of the heartbeat (bradycardia);
low blood pressure (hypotension);
breathing difficulties (shortness of breath, bronchospasm);
inadequate heart function (acute heart failure, first- or second-degree heart block).

Your doctor will determine the most appropriate treatment based on the severity of your symptoms. In case of accidental ingestion/overdose of Timololo OmniVision, contact your doctor immediately or go to the nearest hospital, taking the medicine package with you.

If you forget to use Timololo OmniVision
If you forget to apply a dose of Timololo OmniVision, do so as soon as possible. However, if it is almost time for the next dose, skip the missed dose and resume your usual dosing schedule.
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 everyone gets them.
Timololo OmniVision, even when applied locally to the eyes, may be absorbed systemically (systemic absorption). Therefore, it may cause, albeit with lower incidence, side effects similar to those caused by other systemic beta-blocking agents. To minimize the occurrence of systemic side effects, see "Instructions for use".

The following side effects may occur:
Frequency not known (frequency cannot be estimated from the available data)

systemic allergic reactions such as swelling of the face, lips, mouth, tongue or throat due to fluid accumulation (angioedema), skin irritation (urticaria, localized or generalized rash), itching, severe allergic reaction (anaphylactic reaction), skin irritation with red spots and bleeding (non-thrombocytopenic purpura), severe immune system disease systemic lupus erythematosus;
changes in blood sugar levels (hyperglycaemia, hypoglycaemia), masking of signs and symptoms of low blood sugar (hypoglycaemia) in people with diabetes (insulin-dependent diabetes);
depression, inability to fall asleep (insomnia), nightmares, memory loss, increased dreaming (increased dream activity), reduced concentration ability;
fainting accompanied by temporary loss of consciousness (syncope), stroke (cerebrovascular accident), cerebral circulation problems (cerebral ischaemia), worsening of signs and symptoms of a disease characterized by muscle weakness and fatigue (myasthenia gravis), dizziness, tingling in the extremities (paraesthesia), headache (cephalalgia);
signs and symptoms of eye irritation such as burning, eye pain (stabbing pain), itching, tearing, redness, eye inflammation (conjunctivitis), of the eyelids (blepharitis), of the cornea (keratitis), blurred vision, corneal lesions (corneal erosion), eye problems (decreased corneal sensitivity), dry eyes (ocular dryness), other vision disturbances (refractive changes due in some cases to discontinuation of miotic therapy, diplopia, ptosis, choroidal detachment following filtering surgery);
perception of ringing in the ear (tinnitus);
decreased heart rate (bradycardia), chest pain (thoracic pain), heart problems (arrhythmia, heart block, sinoatrial block, atrioventricular block, congestive heart failure, heart failure), increased awareness of heartbeats (palpitations), cardiac arrest, swelling due to fluid accumulation (oedema), especially in the feet, ankles, legs or around the lungs (pulmonary oedema), worsening of chest pain caused by heart circulation problems (angina pectoris);
low blood pressure (hypotension), tingling and pain in the fingers followed by sensation of heat and pain (Raynaud's phenomenon), circulation problems in arms and legs causing cold hands and feet, difficulty walking (claudication), increased blood flow (vasodilation);
reduced airway space (bronchospasm), especially if you suffer from lung problems (pre-existing bronchospastic disease), difficulty breathing (respiratory failure, dyspnoea), cough, noisy breathing (rattles);
altered taste (dysgeusia), nausea, digestive problems (dyspepsia), diarrhoea, dry mouth, abdominal pain, vomiting;
enlargement of the liver (hepatomegaly);
hair loss (alopecia), inflammatory skin disease called psoriasis (psoriasiform rash or exacerbation of psoriasis), skin irritation (rash, skin irritation), sweating, increased skin pigmentation, peeling of the skin (exfoliative dermatitis);
muscle pain (myalgia) and joint pain (arthralgia), weakness;
sexual disorders (sexual dysfunction, decreased libido, impotence), Peyronie's disease (which may cause curvature of the penis);
difficulty urinating (urination difficulty);
feeling of fatigue (asthenia), pain in hands and feet (extremity pain), reduced exercise tolerance, weight loss;
changes in certain blood test values (increased blood urea nitrogen, serum potassium and uric acid, triglycerides, and minimal decreases in haemoglobin, haematocrit and HDL cholesterol);
eye problems (aphakic cystoid macular oedema);
stuffy nose (nasal congestion);
decreased appetite (anorexia);
effects on the brain (central nervous system, CNS), such as behavioural changes including mental confusion, hallucinations, anxiety, disorientation, nervousness, drowsiness and other mental (psychiatric) disturbances;
increased blood pressure (hypertension);
chronic inflammatory abdominal disease called retroperitoneal fibrosis.
Timololo OmniVision contains phosphates. In very rare cases, some patients with severe damage to the transparent layer at the front of the eye (the cornea) have developed opaque areas on the cornea due to calcium accumulation 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. Side effects can also be reported directly via the national reporting system at http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Timololo OmniVision

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp.".
The expiry date refers to the last day of that month and to the product in its original packaging, stored correctly.
The shelf life after first opening the bottle is 28 days.
This medicine does not require any special storage conditions.
Do not dispose of medicines 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 Timololo OmniVision contains
Timololo OmniVision 0.25% eye drops, solution

The active substance is timolol. 1 ml of solution contains 2.5 mg of timolol (equivalent to 3.4 mg of timolol maleate).
The other components are: polyvinyl alcohol, monobasic sodium phosphate monohydrate, dibasic sodium phosphate heptahydrate, benzalkonium chloride, purified water.

Timololo OmniVision 0.50% eye drops, solution

The active substance is timolol. 1 ml of solution contains 5 mg of timolol (equivalent to 6.8 mg of timolol maleate).
The other components are: polyvinyl alcohol, monobasic sodium phosphate monohydrate, dibasic sodium phosphate heptahydrate, benzalkonium chloride, purified water. Description of the appearance of Timololo OmniVision and contents of the pack Eye drops, solution. 5 ml bottle.

Marketing Authorization Holder
OmniVision Italia S.r.l.
Via Montefeltro, 6
20156 Milano
Manufacturer
Tubilux Pharma S.p.A. – Via Costarica 20/22 – 00071 Pomezia (Rome) – Italy