TIMOLOLO 0.25% Eye drops, solution

Зміст інструкції

1. Timololo OmniVision 0.25% eye drops, solution, 0.50% eye drops, solution
   1. What is Timololo OmniVision and what it is used for
   2. What you need to know before using Timololo OmniVision
   3. How to use Timololo OmniVision
   4. Possible side effects
   5. How to store Timololo OmniVision
   6. Contents of the pack and other information

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

timololo

Equivalent medicinal product

Read 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 pass it on to others, even if they have the same symptoms as you, 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 Timololo OmniVision is and what it is used for
• 2. What you need to know before you use Timololo OmniVision
• 3. How to use Timololo OmniVision
• 4. Possible side effects
• 5. How to store Timololo OmniVision
• 6. Contents of the pack and other information

1. What is Timololo OmniVision 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 to reduce the pressure inside the eye.
This medicine is indicated for the treatment of certain conditions in which there is an increase in
pressure inside the eye such as:

• ocular hypertension;
• chronic open-angle glaucoma;
• glaucoma in aphakic patients (without a crystalline lens, the internal lens of the eye);
• angle-closure glaucoma and with previous episodes of angle closure, spontaneous or caused by medical therapy (iatrogenic), in the contralateral eye;
• glaucoma in children and adolescents (pediatric), in association with other medicines for the treatment of this disorder (other antiglaucoma therapies).

2. What you need to know before using Timololo OmniVision

Do not use Timololo OmniVision

• if you are allergic to timolol or any of the other ingredients of this medicine (listed in section 6);
• if you suffer from or have suffered from breathing problems (reactive airway disease including bronchial asthma or a history of asthma or severe chronic obstructive pulmonary disease, i.e. a serious lung disease that can cause wheezing, difficulty breathing and/or long-lasting cough);
• if you suffer from heart rhythm disorders (sinus bradycardia, sick sinus syndrome, sino-atrial block, second or third degree atrioventricular block not controlled by a pacemaker);
• if you suffer from severe heart disease (congestive heart failure, decompensated 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.
See 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-blocker medicine orally (by mouth), as it may increase the effects of timolol on both eye pressure (intraocular pressure) and the whole body (systemic beta-blocker effects) (See section “Other medicines and Timololo OmniVision”);
• if you suffer from heart problems (coronary heart disease, Prinzmetal's angina, heart failure, first-degree heart block) or have low blood pressure (hypotension) as these conditions may worsen and side effects may occur. Therefore, your doctor will carefully assess the possibility of alternative and safer therapy. Also, if your heart is not functioning properly (heart failure), your doctor will need to correct this condition before starting treatment with Timololo OmniVision;
• if you suffer from blood circulation disorders in the hands and feet that manifest with pain in the fingers and tingling (peripheral circulatory diseases such as severe forms of Raynaud's disease or Raynaud's syndrome);
• if you suffer from lung problems (chronic obstructive bronchopneumopathy, COPD, mild/moderate);
• if you have low blood sugar levels (spontaneous hypoglycemia) or if you suffer from diabetes (diabetes mellitus, especially unstable diabetes) and are being treated with insulin or other medicines (oral hypoglycemic agents), 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 the symptoms of this disorder;
• if you have been diagnosed with a condition characterized by muscle weakness (myasthenia gravis);
• if you suffer from corneal diseases (corneal pathologies), as timolol may cause dry eyes;
• if you suffer from any irritation or discomfort of the eyes, such as redness of the eye and swelling of the eyelid;
• if you suffer from any type of allergy;
• if you are going to have surgery, as timolol may alter the effects of some medicines used during anesthesia (beta-agonists, adrenaline).

For the treatment of angle-closure glaucoma, your doctor will always prescribe Timololo OmniVision
together with a medicine to constrict the pupil (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 can be fatal in people who suffer from asthma;
• in predisposed people (history of atopy) or who have had a severe allergic reaction (anaphylactic reaction) in the past: increased sensitivity to substances that cause allergies (allergens) and failure to respond to adrenaline, used to treat these allergic reactions;
• eye problems (choroidal detachment). As with other ophthalmic medicines applied locally to the eyes, Timololo OmniVision can also be absorbed systemically. Consequently, the same side effects on the heart, circulation and lungs may occur as with systemic administration of beta-blocker medicines, 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, a reduction in the effect of timolol 0.25% may occur
(decrease in the hypotensive response). In this case, your doctor may prescribe you the solution with a higher
amount of timolol (0.50%) or an alternative therapy (glaucoma medicine not belonging to the
category of beta-blockers).
For those who play sports: the use of the medicine without therapeutic need constitutes doping and may
still result in positive doping tests.

Children and adolescents
The use of this medicine is not recommended in children born before the end of pregnancy (premature infants).
In newborns, infants and young children (early childhood) the use of this medicine is not recommended but, if
necessary, timolol maleate must be administered always with extreme caution and under the supervision of
a specialist doctor, as it may cause serious breathing problems (apnea, Cheyne-Stokes respiration). In addition, in newborns, it may be useful to have a device capable of detecting anomalies or
interruptions of breathing (portable apnea detector).
In children and adolescents, Timololo OmniVision must be administered with caution. As soon as
symptoms such as cough and wheezing appear, treatment should be discontinued and
the doctor should be informed.

Other medicines and Timololo OmniVision
Tell 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 that cause depletion of catecholamines, 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 some heart disorders;
• parasympathomimetics, medicines used to treat glaucoma, bowel disorders or breathing problems;
• fluoxetine, paroxetine and monoamine oxidase inhibitors (MAOIs), medicines used to treat depression;
• adrenaline (epinephrine), medicine used to raise blood pressure;
• narcotics, medicines used to reduce pain and induce anesthesia;
• antidiabetics, medicines used to treat diabetes. Pregnancy and breastfeedingIf you are pregnant, suspect you are pregnant, are 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, unless absolutely necessary and under strict medical supervision. If you use this medicine until delivery, the newborn will be monitored during the first few days of life because serious side effects may occur. To reduce the absorption of the medicine, follow the instructions in the “How to use Timololo OmniVision” section. Do not use Timololo OmniVision if you are breastfeeding as timolol passes into breast milk. If it is necessary to use Timololo OmniVision, your doctor will decide whether to stop treatment or breastfeeding because this medicine can cause serious side effects in the baby.

Driving and using machines
This medicine can cause dizziness, visual disturbances (occasional visual disturbances, blurred vision) and
fatigue. If you experience these symptoms, avoid driving vehicles or using machines.

Timololo OmniVision contains benzalkonium chloride
This medicine contains benzalkonium chloride, which can cause eye irritation.
Avoid contact with soft contact lenses.
Remove contact lenses before application and wait at least 15 minutes before re-applying them.
It is known to cause discoloration of soft contact lenses.

3. How to use Timololo OmniVision

Use this medicine following the doctor's instructions exactly at all times. If you have any doubts, consult your doctor
or pharmacist.

Use in adults
The appropriate dose and duration of treatment must be established by the doctor.
The recommended initial dose is 1 drop of Timololo OmniVision 0.25% in each affected eye, 2 times a
day.
If the pressure in the eye (intraocular) remains at satisfactory values, you can continue therapy with 1
administration only per day.
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, 2 times a day.

Method of administration
Apply 1 drop of eye drops to 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 close your
eyes for 2 minutes. This will prevent the medicine from penetrating throughout the body (systemic absorption).

Treatment of glaucoma in association with other medicines
If you use this medicine in association with other medicines (cholinergic miotics, alpha-blocking miotics,
adrenergic agents, 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% in case of insufficient clinical response.

Transfer from another therapy
If you are being treated with a beta-blocker medicine (topical ophthalmic beta-blocking antiglaucoma agent
), before starting therapy with Timololo OmniVision, you must discontinue the previous therapy for
an entire day. The recommended dose is 1 drop of Timololo OmniVision 0.25% in each affected eye,
2 times a day.
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, 2 times a day.
If you are using a non-beta-blocker medicine (non-beta-blocking antiglaucoma agent for topical ophthalmic use) and need to start treatment with timolol maleate, on the first day continue the previous therapy,
adding 1 drop of Timololo OmniVision 0.25% in each affected eye, 2 times a day. The next
day, completely discontinue the medicine you were using and continue therapy only
with Timololo OmniVision 0.25%.
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, 2 times a day.

Use in children and adolescents
The use of this medicine in children and adolescents is indicated only for some forms of glaucoma
(primary congenital glaucoma, primary juvenile glaucoma) and for short periods of time, while waiting to
decide whether to undergo surgery or start alternative therapy. The doctor will decide whether to use
this medicine only after a careful examination of the child's health status and will establish the dose and duration
of treatment based on the individual case.
It is recommended to use the lowest available concentration of timolol maleate, equal to 0.1% of
active ingredient, in each affected eye, 1 time a day. If it is not possible to keep the pressure
under control, it may be necessary to administer the medicine 2 times a day, 12 hours apart.
These patients, especially infants, after the first application, must be kept under close
observation in the outpatient clinic for at least 1 or 2 hours and monitored to assess the appearance of adverse effects
(at the ocular or systemic level), until they undergo surgery.

Method of administration
Apply 1 drop of eye drops to 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
your eyes closed for as long as possible (for example, for 3-5 minutes). This will prevent the medicine from penetrating
throughout the body (systemic absorption).

If you use more Timololo OmniVision than you should
Following the unintentional use of an excessive dose of timolol maleate solutions for ocular use,
the following effects may occur:

• dizziness, lightheadedness;
• headache;
• slowing of the heartbeat (bradycardia);
• lowering of blood pressure (hypotension);
• difficulty breathing (shortness of breath, bronchospasm);
• insufficient heart function (acute heart failure, first or second degree cardiac block). The doctor will establish the most appropriate therapy for you based on the severity of your symptoms. In case of accidental ingestion/intake of an excessive dose of Timololo OmniVision, immediately notify your doctor or go to the nearest hospital, bringing the package of the medicine 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 application, skip the forgotten dose and resume the usual dosage schedule.
If you have any doubts about the use of 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.
Timololo OmniVision, even if applied locally to the eyes, can be absorbed throughout the body
(systemic absorption). Therefore, it can cause, albeit with a lower incidence, side effects similar to those caused by other medicines (systemic beta-adrenergic blockers). To
minimize the occurrence of systemic side effects, see “How to administer the medicine”.
The following side effects may occur:

Frequency not known(the frequency of which cannot be estimated on the basis of available data)

• allergic reactions affecting the whole body (systemic) 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 autoimmune disease systemic lupus erythematosus);
• alteration of blood sugar levels (hyperglycemia, hypoglycemia), masking of signs and symptoms of low blood sugar (hypoglycemia) in people with diabetes (insulin-dependent diabetes);
• depression, inability to fall asleep (insomnia), nightmares, memory loss, increased dreaming ability (dream activity), reduced ability to concentrate;
• fainting accompanied by temporary loss of consciousness (syncope), stroke (cerebrovascular accident), problems with blood circulation in the brain (cerebral ischemia), increased signs and symptoms of a disease characterized by muscle weakness and fatigue (myasthenia gravis), dizziness, tingling of the extremities (paresthesia), headache (cephalalgia);
• signs and symptoms of eye irritation such as burning, eye pain (stinging pain), itching, tearing, redness, inflammation of the eyes (conjunctivitis), eyelids (blepharitis), cornea (keratitis), blurred vision, corneal lesions (corneal erosion), eye problems (decreased corneal sensitivity), dry eyes (ocular dryness), other visual disturbances (changes in refraction due to suspension of miotic therapy in some cases, diplopia, ptosis, choroidal detachment following filtering surgery);
• perception of ringing inside the ear (tinnitus);
• decreased heart rate (bradycardia), chest pain (thoracic pain), heart problems (arrhythmia, heart block, sinoatrial block, atrioventricular block, congestive heart failure, cardiac failure), increased awareness of heartbeats (palpitations), cardiac arrest, swelling due to fluid accumulation (edema) especially at the level of the feet, ankles, legs or around the lungs (pulmonary edema), worsening of chest pain caused by heart circulation problems (angina pectoris);
• lowering of blood pressure (hypotension), tingling and pain in the fingers followed by a sensation of warmth and pain (Raynaud's phenomenon), circulatory problems in the arms and legs causing a feeling of coldness in the hands and feet, difficulty walking (claudication), increased blood flow (vasodilation);
• reduction of the space inside the bronchi (bronchospasm) especially if you suffer from lung problems (pre-existing bronchospastic disease), difficulty breathing (respiratory failure, dyspnea), cough, labored breathing (rales);
• altered taste (dysgeusia), nausea, digestive problems (dyspepsia), diarrhea, 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, skin scaling (exfoliative dermatitis);
• muscle pain (myalgia) and joint pain (arthralgia), weakness;
• sexual disorders (sexual dysfunction, decreased libido, impotence), Peyronie's disease (which can cause a curvature of the penis);
• difficulty urinating (difficulty with micturition);
• feeling of fatigue (asthenia), pain in the hands and feet (pain in the extremities), reduced exercise tolerance, weight loss;
• alteration of some blood test values (increases in azotemia, serum potassium and uric acid, triglycerides and slight decreases in hemoglobin, hematocrit and HDL cholesterol);
• eye problems (cystoid macular edema aphakic);
• nasal congestion (nasal congestion);
• decreased appetite (anorexia);
• effects on the brain (central nervous system, CNS) such as changes in behavior, for example, mental confusion, hallucinations, anxiety, disorientation, nervousness, drowsiness and other mental disorders (psychic);
• increased blood pressure (hypertension);
• chronic inflammatory disease of the abdomen, called retroperitoneal fibrosis. Timololo OmniVision contains phosphates. In very rare cases, some patients with severe damage to the transparent layer of 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 effects, including those not listed in this leaflet, tell your
doctor or pharmacist. Side effects can also be reported directly through the
national reporting system at http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects helps to provide more information on the safety of
this medicine.

5. How to store Timololo OmniVision

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after “Scad.”.
The expiry date refers to the last day of that month and the product in intact packaging,
correctly stored.
The period of validity after first opening of the bottle is 28 days.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Timololo OmniVision contains
Timololo OmniVision 0.25% eye drops, solution

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

Timololo OmniVision 0.50% eye drops, solution

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

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