TIMOD <2.5 mg/ml Krople do oczu, roztwór

Treść ulotki

1. TIMOD 2.5 mg/ml Eye drops, solution, 5 mg/ml Eye drops, solution
   1. What TIMOD is and what it is used for
   2. What you need to know before using TIMOD
   3. How to use Timod
   4. Possible side effects
   5. How to store Timod
   6. Contents of the pack and other information

TIMOD 2.5 mg/ml Eye drops, solution, 5 mg/ml Eye drops, solution

Timolol maleate

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 their symptoms are the same as yours, 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 TIMODis and what it is used for
• 2. What you need to know before you use TIMOD
• 3. How to use TIMOD
• 4. Possible side effects
• 5. How to store TIMOD
• 6. Contents of the pack and other information

1. What TIMOD is and what it is used for

TIMODis an eye drop that contains the active substance timolol maleate and belongs to the group
of medicines called beta-blockers which work by reducing the pressure inside
the eye.

TIMOD is used in the treatment of:

• High eye pressure (ocular hypertension);
• Chronic open-angle glaucoma: increased eye pressure is caused by increased resistance in the outflow pathways;
• Aphakia (absence of the lens, i.e. the internal lens of the eye), eye with glaucoma;
• Narrow iridocorneal angle (iris/the colored part surrounding the pupil, cornea/the front part of the eye) and episodes in the other eye of closure of the iridocorneal angle which can be spontaneous or due to medications;
• pediatric glaucoma, when inadequately controlled with other therapies.

Contact your doctor if you do not feel better or if you feel worse after the prescribed days of therapy
.

2. What you need to know before using TIMOD

Do not use TIMOD

• if you are allergic to timolol maleate, to other chemically related substances or to any of the other ingredients of this medicine (listed in section 6).
• if you suffer from respiratory diseases (asthma, previous episodes of asthma, chronic obstructive bronchopneumopathy, severe bronchial hyperreactivity, allergic rhinitis)
• if you have uncontrolled heart failure
• if you have cardiogenic shock
• if you have defects in the heart's conduction system (second and third degree atrioventricular block) without a pacemaker
• if you experience Prinzmetal's angina (an unusual form of angina caused by spasms of the coronary arteries)
• if you suffer from alterations to the structure where the heartbeat originates, the sinoatrial node (sinus node disease, including sinoatrial block)
• if you have a slowed heartbeat (bradycardia: less than 45 - 50 beats per minute)
• if you experience circulation disorders (Raynaud's disease and peripheral circulation)
• if you have untreated pheochromocytoma (a tumor that causes sudden increases in blood pressure)
• if you have low blood pressure (hypotension)
• if you have corneal alterations (corneal dystrophies)
• in association with floctafenine (non-steroidal anti-inflammatory drug)
• in association with sultopride (antipsychotic drug) Consider the contraindications of beta-blockers in general, i.e., those that reach all areas of the body, although these effects are rare following ocular instillation.

Warnings and precautions
Talk to your doctor or pharmacist before using TIMOD.

Ocular
As with any treatment for glaucoma,

• have your eye pressure and corneal thickness measured regularly.

In closed-angle glaucoma, Timod is not sufficient on its own to reopen the space between the iris
and cornea (iridocorneal angle), in this case your doctor will tell you to also use an eye drop
that constricts the pupil (miotic).
Contact lenses
If you wear contact lenses, there is a risk of developing contact lens intolerance due to
reduced tear secretion caused by the beta-blocker.
Avoid using contact lenses during treatment with TIMOD.

Cardiovascular diseases
Your doctor will reduce the dosage of the medicine if your heart rate drops below
50-55 beats per minute at rest, and if you experience symptoms related to a slowed heart rate
(bradycardia): shortness of breath, dizziness for example.
Due to the effect of reducing the speed of conduction (negative dromotropic) of beta-
blockers, these drugs must be administered to you with caution if you are a patient with defects
in the heart's conduction (first-degree atrioventricular block, sick sinus syndrome) or low blood pressure.
Before starting treatment, your doctor must rule out the presence of impaired
cardiac function (heart failure). If you are a patient with a history of severe
heart disease, you should be monitored by your doctor to detect
any signs of possible heart failure.

Metabolic diseases
Use with caution if you have an imbalance of water and electrolytes in the blood (metabolic acidosis).

Adrenal tumor (Pheochromocytoma) in treatment
To control the symptoms caused by the tumor, in addition to beta-blockers, your doctor will prescribe
alpha-blockers.

Diabetic patients
During the early stages of treatment, your doctor will tell you to perform self-monitoring
of blood sugar levels (glycemic profile). Signs of an initial low
sugar concentration (incipient hypoglycemia), in particular increased heart rate (tachycardia), awareness of the heartbeat (palpitations) and sweating, may be
masked.

Psoriasis (skin disease characterized by redness and silvery-white scales)
Beta-blockers have been shown to worsen psoriasis, so if you suffer from this
condition, your doctor will tell you not to use Timod.

Allergic reactions
If you are at risk of developing severe allergic reactions (anaphylactic) of any origin,
particularly with substances that absorb X-rays (iodinated contrast media), anesthesia or
non-steroidal anti-inflammatory drugs (floctafenine) or during allergy desensitization therapy, you should know that beta-blockers can worsen the reaction and make you unresponsive (resistant) to treatment with normal doses of adrenaline.

General anesthesia
If you are to undergo anesthesia, inform your doctor or anesthesiologist that you are being treated with
beta-blocking drugs.
Your doctor may consider it necessary to interrupt treatment for a period of 48 hours.
Your doctor will tell you not to interrupt treatment with beta-blockers for systemic use
(systemic):

• if you have coronary insufficiency. Your doctor will tell you to continue treatment until the surgery, given the risks associated with abrupt discontinuation of beta-blocker treatment;
• in emergency situations or when discontinuation of treatment is impossible, your doctor will administer an adequate dose of atropine to avoid excessive stimulation of the vagus nerve through. The doctor will perform the anesthesia with medications that cause the least possible cardiac depression, and will compensate for any blood loss.

For those who play sports:
The use of the drug without a therapeutic need constitutes doping and may still result in
positive doping tests
Other medicines and TIMOD
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
Although the amount of beta-blockers that passes into the blood (systemic) after ocular instillation
is low, the risk of drug interactions remains present.
Therefore, consider the interactions observed for beta-blockers taken systemically.

Do not use Timod in conjunction with the following medicines because it is contraindicated:

• Floctafenine (non-steroidal anti-inflammatory drug)
• Sultopride (antipsychotic drug)
• Be careful if you use Timod with the following medicines because this association is not recommended: Calcium channel blockers (Bepridil, Diltiazem, Verapamil).Timolol potentiates the effects of Bepridil on the structure where the heartbeat originates: excessively slowed heartbeats (bradycardia), conduction system disorders (sinoatrial and atrioventricular, sinus block), increased risk of ventricular rhythm disturbances (torsade de pointes), heart failure. This association should only be carried out under strict medical supervision, which will monitor you via ECG, especially if you are an elderly patient or at the beginning of treatment.

Be careful if you use Timod with the following medicines

• Eye drops.If you are undergoing treatment with eye drops containing adrenaline, you should have your eyes checked for the risk of pupillary dilation (mydriasis). Do not use two eye drops with beta-blocking action.
• Amiodarone, a drug used in case of heart rhythm abnormalities (myocardial contractility, automatism, conduction disorders/suppression of sympathetic compensatory mechanisms). If you are taking Amiodarone and timolol at the same time, your doctor will monitor you carefully via ECG.
• Inhalation anestheticsIf you are being treated with beta-blockers, inform the anesthesiologist, as the anti-adrenergic effect of the beta-blocker may be counterbalanced during surgery by drugs with adrenergic-like action.
• Baclofen,as it may increase the risk of reduced blood pressure (hypotension), particularly a sudden drop in pressure when moving from a lying to an upright position (orthostatic hypotension). The doctor

will check your blood pressure values and, if necessary, adjust the dosage of
the drug that lowers blood pressure (antihypertensive).

• Central antihypertensives,as they can produce a significant increase in blood pressure if therapy with drugs that lower blood pressure and act on the central nervous system (central antihypertensives) is abruptly discontinued. The doctor will forbid you to abruptly discontinue therapy with central antihypertensives and will monitor you constantly.
• Insulin, drugs that reduce blood sugar - oral hypoglycemic agentsoral.All beta-blockers can mask some symptoms of low blood sugar (hypoglycemia) including, awareness of the heartbeat (palpitations) and increased heart rate (tachycardia). Especially at the beginning of treatment, perform self-monitoring of blood sugar levels (glycemia) more frequently.
• Lidocaine.The doctor will perform careful clinical monitoring via ECG and, when possible, the dosage of lidocaine concentrations in the blood (plasma) during combination therapy, even after the beta-blocker treatment has been discontinued. The doctor will adjust the dosage of lidocaine, if necessary.
• Drugs that can cause torsade de pointes (except forsultopride),as they may increase the risk of ventricular arrhythmia, particularly torsade de pointes. The doctor will perform careful clinical monitoring via ECG. Propafenone,as it can cause heart rhythm abnormalities (myocardial contractility, automatism) and conduction disorders (suppression of sympathetic compensatory mechanisms). The doctor will perform careful clinical monitoring via ECG.
• Urogenital alpha-blockers and antihypertensive alpha-blockers;
• Amifostine
• Imipramine antidepressants and neuroleptics,may cause an increased risk of low blood pressure, particularly a sudden drop in pressure when moving from a lying to an upright position (orthostatic hypotension).
• Non-steroidal anti-inflammatory drugs,as they can cause a reduction in the blood pressure lowering effect
• Other bradycardic drugsas they can cause an excessive slowing of the heartbeat (bradycardia).
• Dihydropyridinesas it can cause low blood pressure (Hypotension), heart failure in patients with latent or uncontrolled heart failure (decrease in excitability due to additive negative inotropic effects).
• Dipiridamol,as it can cause an increase in the blood pressure lowering effect (antihypertensive).
• Pilocarpine,as it may increase the risk of excessive bradycardia (additive bradycardic effects).

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, or are planning to become pregnant, or if you are
breastfeeding, ask your doctor or pharmacist for advice before using
this medicine.

Use the medicine as needed and under the direct supervision of a doctor.
Pregnancy
Although studies have not been conducted in this regard, if you are pregnant, use timolol in
ophthalmic solution only after careful evaluation by your doctor.
Breastfeeding
Timolol is excreted in breast milk. If you are breastfeeding, your doctor will decide whether
to discontinue the drug or to discontinue breastfeeding, due to possible
negative effects on the child.
Since cases of low blood sugar (hypoglycemia) and slowed heartbeats (bradycardia, due to beta-blockers poorly bound to plasma proteins) have been described, as a precaution, it is preferable to avoid breastfeeding when
treatment is necessary.

Driving and using machines
TIMOD slightly impairs the ability to drive vehicles or use machines. When
driving vehicles or using machines, you should consider that you may
experience visual disturbances (focusing, double vision, drooping eyelids, frequent
episodes of mild and transient blurred vision) and occasional episodes of
dizziness or fatigue.

3. How to use Timod

Use this medicine following the instructions of your doctor exactly. If you have any doubts
consult your doctor or pharmacist.
Therapy may be started with the instillation of one drop of TIMOD eye drops 2.5mg/ml every
12 hours. If the therapeutic response is insufficient, your doctor may increase the dosage
by telling you to administer one drop of TIMOD eye drops 5mg/ml every 12 hours. If the pressure
inside the eye remains at satisfactory levels, your doctor will tell you to continue the
therapy with a single daily administration.

Use in children and adolescents
Your doctor will advise you to start therapy with TIMOD eye drops 2.5mg/ml by instilling one
drop into the affected eye every 12 hours, in addition to other antiglaucoma therapy. If a
satisfactory therapeutic effect is not obtained, your doctor may increase the dosage
by telling you to administer one drop of TIMOD 5mg/ml into the affected eye every 12 hours.

If you use more TIMOD than you should
In case of ingestion/accidental intake of an excessive dose of TIMOD, immediately inform
your doctor or go to the nearest hospital.
The symptoms you may experience in case of overdose are similar to those adopted for
beta-blockers administered systemically.

If you forget to use TIMOD
Do not use a double dose to make up for a missed dose.

If you stop using TIMOD
Do not abruptly stop therapy with beta-blockers in general, especially if
you suffer from reduced blood flow to the heart (angina). A sudden interruption could
cause a serious alteration of the heart rhythm (arrhythmia), reduction of blood flow
(myocardial infarction) and sudden death.
Your doctor will tell you to reduce the dosage gradually over a period of one or two
weeks.
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.
If you experience any of the following side effects, inform your doctor:

• Systemic lupus erythematosus (chronic inflammatory disease)
• Signs and symptoms of allergic reactions including a severe allergic reaction (anaphylaxis) swelling (angioedema), itchy red spots (urticaria), skin irritation (erythematous rash).
• Low blood sugar (hypoglycemia).
• Headache, dizziness, worsening of signs and symptoms of myasthenia gravis (neuromuscular disease characterized by weakness and fatigue), depression, insomnia, nightmares, decreased sexual desire (libido), impotence.
• Signs and symptoms of eye irritation including a slight burning or stinging sensation at the beginning of treatment, eye inflammation (conjunctival hyperemia), conjunctivitis, inflammation of the eyelid margin (blepharitis), corneal inflammation (keratitis), reduced corneal sensitivity (corneal hypoesthesia), dryness.
• Visual disturbances, including blurred vision, refractive defects (various focusing defects, in some cases due to discontinuation of miotic therapy which stimulates pupillary constriction), drooping eyelids (ptosis), double vision (diplopia), choroidal detachment (inner membrane of the eye) following filtering surgery (incisional surgical procedure). In very rare cases, some patients with severe damage to the transparent layer in the front of the eye (cornea) have developed cloudy areas on the cornea due to calcium accumulation during treatment.
• Fainting (syncope), awareness of heartbeat (palpitations), arrhythmia, slowed heart rate (bradycardia), low blood pressure (hypotension), heart failure, alterations in heart rhythm (atrioventricular block), difficulty walking with calf pain (intermittent claudication), decreased blood flow to the extremities (Raynaud's phenomenon, feeling of cold).
• Difficulty breathing (dyspnea), cough, wheezing (bronchospasm), especially in patients with pre-existing lung disease.
• Digestive disorders (dyspepsia), dry mouth (xerostomia), nausea, vomiting, diarrhea, stomach pain (gastralgia).
• Hair loss (alopecia). Various skin disorders including itchy red spots (urticaria), hypersensitivity reactions, angioedema (angioneurotic edema), skin irritation and redness (erythematous skin rash), redness and silvery-white scales (psoriasiform rash or worsening of psoriasis).
• Fatigue, lack of strength and loss of strength (asthenia), chest pain.

In rare cases, antibodies that the body produces against itself
(antinuclear) have been detected, only exceptionally accompanied by clinical symptoms such as lupus, which
have regressed with discontinuation of treatment.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet,
please inform your doctor or pharmacist. You can also report side effects directly
through the national reporting system at
www.agenziafarmaco.gov.it/it/responsabili. Reporting side effects can
help provide more information on the safety of this medicine.

5. How to store Timod

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. The expiry date refers to the last day of that month.
Do not store at a temperature above 25 °C.
The shelf life after first opening the bottle is 12 weeks.
Do not use this medicine if you notice that the solution is not clear.
The expiry date refers to the product in intact packaging, correctly
stored.
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 Timod contains

TIMOD 2.5 mg/ml Eye drops, solution bottle 5 ml

• The active ingredient is timolol maleate. 1 ml of eye drops contains 3.42 mg of timolol maleate (equivalent to 2.5 mg of timolol)
• The other ingredients are: monobasic sodium phosphate; dibasic sodium phosphate; water for injections.

TIMOD 5 mg/ml Eye drops, solution bottle 5 ml

• The active ingredient is timolol maleate. 1 ml of 5 mg/ml eye drops, solution contains 6.84 mg timolol maleate (equivalent to 5 mg of timolol)
• The other ingredients are: monobasic sodium phosphate; dibasic sodium phosphate; water for injections.

Description of the appearance of TIMOD and contents of the pack
TIMOD Eye drops is presented in the form of a solution, in packs of:
TIMOD 2.5 mg/ml eye drops, solution. 1 bottle of 5 ml
TIMOD 5 mg/ml eye drops, solution. 1 bottle of 5 ml

Marketing Authorisation Holder
VISUFARMA S.p.A.
Via Canino, 21
Rome
Italy

Manufacturer
URSAPHARM, Industriestraße, D-66129 Saarbrücken, Germany