OMKIPO 5 mg /Ml Eye Drops, Solution

Зміст інструкції

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

OMKIPO 5 mg/ml eye drops, solution

timolol

Generic medicine
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 may 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 OMKIPO is and what it is used for
• 2. What you need to know before you use OMKIPO
• 3. How to use OMKIPO
• 4. Possible side effects
• 5. How to store OMKIPO
• 6. Contents of the pack and other information

1. What is OMKIPO and what it is used for

OMKIPO 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 OMKIPO

Do not use OMKIPO

• if you are allergic to timolol, to other beta-blockers or to 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 prolonged cough);
• if you suffer from heart rhythm disturbances (sinus bradycardia, sick sinus syndrome, sinoatrial 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 if you are breastfeeding (see section “Pregnancy and breastfeeding”).

Warnings and precautions
Consult your doctor or pharmacist before using OMKIPO.
See section “OMKIPO 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 eye pressure (intraocular pressure) and on the whole body (systemic beta-blocker effects) (see section “Other medicines and OMKIPO”);
• if you suffer from heart problems (coronary artery 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 OMKIPO;
• 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 eye redness and eyelid swelling;
• 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 OMKIPO
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, OMKIPO can also
be absorbed systemically. Consequently, the same side effects on the heart, circulation and lungs, found with systemic administration of
beta-blockers, may occur, although the risk is lower. To reduce systemic absorption,
see section 3 “How to use OMKIPO”.
For those who play sports: the use of the medicine without a therapeutic need constitutes doping
and may still result in a positive doping test.

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 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 control 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 in breathing (portable apnea detector).
In children and adolescents, OMKIPO should be administered with caution. As soon
as symptoms such as cough and wheezing appear, treatment should be discontinued
and the doctor informed.

Other medicines and OMKIPO
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, medicines 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, intestinal disorders or breathing problems;
• fluoxetine and 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 for the treatment of diabetes.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before using this medicine.
Do not use OMKIPO if you are pregnant, unless absolutely necessary and under strict
medical supervision. If you use this medicine until the time of delivery, the newborn will be
monitored during the first few days of life because serious side effects may occur.
To reduce absorption of the medicine, follow the instructions in section “How to use
OMKIPO”.
Do not use OMKIPO if you are breastfeeding as timolol passes into breast milk. If
it is necessary to use OMKIPO, your doctor will decide whether to stop treatment or
breastfeeding because this medicine can cause serious side effects in the
child.

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

OMKIPO 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 reinserting them.
It is known to cause discoloration of soft contact lenses.

3. How to use OMKIPO

Use this medicine following the doctor's instructions exactly. 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 eye drops containing timolol at a concentration of 2.5 mg/ml in each affected eye, 2 times a day.
If the response to the medicine is not sufficient, your doctor may prescribe OMKIPO 5 mg/ml at a dose of 1 drop in each affected eye, 2 times a day.
If the pressure in the eye (intraocular) remains at satisfactory values, you can continue therapy with only 1 administration per 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).
The tip of the dropper must not come into contact with the eye or the surrounding areas. This may cause bacterial contamination and can cause eye infections responsible for serious damage, including loss of vision. To avoid possible bacterial contamination, do not place the tip of the dropper on any surface.

Transfer from another therapy
If you are being treated with a beta-blocker medicine (topical ophthalmic beta-blocker antiglaucoma agent), before starting therapy with timolol maleate, you must stop the previous therapy for an entire day. The recommended dose is 1 drop of eye drops at an active ingredient concentration of 2.5 mg/ml 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 OMKIPO 5 mg/ml in each affected eye, 2 times a day.
If you are using a medicine that is not a beta-blocker (non-beta-blocker topical ophthalmic antiglaucoma agent) and need to start treatment with timolol maleate, continue the previous therapy on the first day, adding 1 drop of eye drops at an active ingredient concentration of 2.5 mg/ml in each affected eye, 2 times a day. The next day, completely stop the treatment with the medicine you were using and continue therapy only with the 2.5 mg/ml concentration eye drops. If the response to the medicine is not sufficient, the dose may be increased to 1 drop of OMKIPO 5 mg/ml 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 awaiting a decision on 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 1 mg/ml 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, must be kept under close observation in the outpatient clinic for at least 1 or 2 hours after the first application and checked 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 OMKIPO than you should
Following the involuntary use of an excessive dose of timolol maleate-based solutions for ocular use, the following effects may occur:

• dizziness, lightheadedness
• headache
• difficulty breathing (shortness of breath, bronchospasm)
• slowing of the heartbeat (bradycardia);
• lowering of blood pressure (hypotension);
• insufficient heart function (acute heart failure, first or second degree cardiac block).

The doctor will establish the most suitable therapy for you based on the severity of your symptoms.
In case of ingestion/accidental intake of an excessive dose of OMKIPO, immediately inform your doctor or go to the nearest hospital, bringing the package of the medicine with you.

If you forget to use OMKIPO
If you forget to apply a dose of OMKIPO, 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 everyone will experience them.
OMKIPO, 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 blocking agents
). To minimize the occurrence of systemic side effects, see “How to administer”.
The following side effects may occur:

Frequency not known(frequency cannot be estimated based on 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), serious disease of the immune system (systemic lupus erythematosus);
• alteration of blood sugar levels (hyperglycemia, hypoglycemia), masking of the signs and symptoms of low blood sugar (hypoglycemia) in people with diabetes (insulin-dependent diabetes);
• depression, inability to fall asleep (insomnia), nightmares, memory loss, nervousness;
• fainting accompanied by temporary loss of consciousness (syncope), stroke (cerebrovascular accident), problems with brain circulation (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 discontinuation 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, atrioventricular block, congestive heart failure), reduced blood supply to the brain (cerebral ischemia), increased awareness of heartbeats (palpitations), cardiac arrest, swelling due to fluid accumulation (edema) especially at the level of the feet, ankles, legs;
• lowering of blood pressure (hypotension), tingling and pain in the fingers followed by a sensation of warmth and pain (Raynaud's phenomenon), circulation problems in the arms and legs causing a feeling of cold in the hands and feet, difficulty walking (claudication);
• 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);
• muscle pain (myalgia) and joint pain (arthralgia);
• sexual disorders (sexual dysfunction, decreased libido, impotence), Peyronie's disease (which can cause a curvature of the penis);
• feeling of fatigue (asthenia), reduced exercise tolerance, thirst;
• 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 after aphakia);
• nasal congestion (nasal congestion);
• 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;
• disease characterized by the appearance of blistering lesions on the skin and/or mucous membranes that tend to thicken, called pseudopemphigoid fibrosis.

OMKIPO contains phosphates. In very rare cases, some patients with severe damage to the transparent layer
of the front part 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, please
tell your doctor or pharmacist. You can also report side effects directly
through the national reporting system at
www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help
provide more information on the safety of this medicine.

5. How to store OMKIPO

Do not store at a temperature above 25°C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after “Exp.”.
The expiry date refers to the last day of that month and the product in intact packaging
correctly stored.
The shelf life after first opening the bottle is 28 days.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What OMKIPO contains

• The active ingredient is timolol. 1 ml of solution contains 6.83 mg of timolol maleate (equivalent to 5.00 mg of timolol).
• The other ingredients are: polyvinyl alcohol, sodium citicoline, sodium phosphate monobasic monohydrate, sodium phosphate dibasic heptahydrate, benzalkonium chloride, sodium hydroxide or hydrochloric acid (pH adjusters), purified water.

Description of the appearance of OMKIPO and contents of the pack
Eye drops, solution. Bottle of 5 ml.

Marketing Authorisation Holder
Omikron Italia S.r.l. - Viale Bruno Buozzi, 5 - 00197 Rome (Italy)
Tel: +39 – 06-80693572
Fax: +39 – 06-80665266
e-mail: [email protected]

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