CUSIMOLOL 5 mg /Ml Krople Do Oczu, Roztwór

Treść ulotki

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

CUSIMOLOL 5 mg/ml eye drops, solution

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

1. What is CUSIMOLOL and what is it used for

CUSIMOLOL contains the active ingredient timolol maleate, which belongs to a group of medicines
called beta-blockers, which are used to reduce the pressure inside the eye, in the presence
or absence of an eye disease called glaucoma.
CUSIMOLOL is used in adults to treat:

• high pressure inside the eye (ocular hypertension), a condition that causes damage to the optic nerve due to excessive pressure inside the eye;
• open-angle glaucoma and secondary glaucoma, even in patients without a lens (the lens present inside the eye).

2. What you need to know before using CUSIMOLOL

DO NOT use CUSIMOLOL

• If you are allergic to timolol maleate, beta-blockers or any of the other ingredients of this medicine (listed in section 6).
• If you have or have had respiratory problems such as asthma, severe chronic obstructive bronchitis (a serious lung condition that can cause wheezing, difficulty breathing and/or long-lasting cough).
• If you have a slow heartbeat (sinus bradycardia) or heart rhythm disorders (sino-atrial block, second or third degree atrioventricular block not controlled with a pacemaker).
• If you suffer from manifest heart failure or cardiogenic shock.

Warnings and precautions
Talk to your doctor before using CUSIMOLOL.
Take special care with CUSIMOLOL and, before using this medicine, tell your doctor if
you suffer, or have suffered in the past from:

• coronary heart disease (symptoms may include chest pain or tightness, shortness of breath or suffocation), heart failure, low blood pressure.
• Changes in heart rate such as a slow heartbeat.
• Breathing problems, asthma or chronic obstructive pulmonary disease (lung disease that can cause wheezing, difficulty breathing and/or long-lasting cough).
• Disease of poor blood circulation (such as Raynaud's disease or Raynaud's syndrome).
• Hypoglycemia or diabetes, as timolol maleate may mask the signs and symptoms of low blood sugar.
• Hyperthyroidism (overactive thyroid), as timolol maleate may mask its signs and symptoms.
• Genetic predisposition to allergic reactions or a severe allergic reaction to various substances, as the administration of timolol may increase the likelihood that you have an allergic reaction to repeated contact with these substances. If you have a severe allergic reaction (skin rash, redness and itching of the eyes) while using CUSIMOLOL, whatever the cause, the administration of adrenaline may not be as effective as it should. Tell your doctor if, while using CUSIMOLOL, you are taking any other treatment.
• Muscle weakness (myasthenia gravis).
• First-degree heart block, due to the negative effect of beta-blockers on conduction time.
• Corneal disease, as ophthalmic beta-blockers can cause dry eyes.

Before an operation, tell your doctor that you are using CUSIMOLOL, as timolol maleate may
alter the effects of some medicines used during anesthesia.
It may cause eye irritation. Avoid contact with soft contact lenses (see also the
section “CUSIMOLOL contains benzalkonium chloride”).
Tell your doctor if you have been given therapy to reduce the production of aqueous humor
after filtering surgery.

Children
Specific clinical studies have not been conducted to establish safety and efficacy in children.

Other medicines and CUSIMOLOL
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
CUSIMOLOL can interact with other medicines you are taking, including other eye drops for the
treatment of glaucoma. Tell your doctor if you are taking or intend to take medicines
to lower blood pressure, heart medicines, including quinidine (used to treat
heart problems and some types of malaria), antidepressants known as fluoxetine and paroxetine or
medicines for the treatment of diabetes.
The effect on eye pressure or the known general effects on the body of beta-blockers can
be potentiated when timolol maleate is administered concurrently with another beta-blocker administered orally or by injection. Tell your doctor if you are taking another
beta-blocker medicine.
Although timolol eye drops have little or no effect on pupil diameter, pupillary miosis (increase in pupil size) resulting from concomitant therapy with epinephrine (adrenaline) has been rarely
reported.
If you are using another eye drop or eye ointment at the same time, allow at least 5
minutes between using each medicine. The eye ointment should be administered last.

Pregnancy and breastfeeding
Pregnancy
Do not use CUSIMOLOL during pregnancy unless your doctor considers it necessary.
Breastfeeding
If you are breastfeeding, ask your doctor for advice before taking this medicine, who will assess
whether to let you take the medicine as timolol is excreted in breast milk, and may
potentially cause serious adverse effects in breastfed infants.

Driving and using machines
As with any eye drop, transient blurred vision and other visual disturbances
may impair the ability to drive or operate machinery. If you experience blurred
vision after using CUSIMOLOL, wait until your vision returns to clear before driving or using
machinery.

CUSIMOLOL contains benzalkonium chloride
This medicine contains 0.5 mg of benzalkonium chloride per 5 ml which is equivalent to 0.1 mg/ml.
Benzalkonium chloride can be absorbed by soft contact lenses and can lead to a change
in their color. Remove contact lenses before using this medicine and wait 15 minutes before
reapplying them.
Benzalkonium chloride can also cause eye irritation, especially if you have dry eyes or
corneal disorders (the most superficial transparent layer of the eye). If you experience an abnormal
sensation in the eye, burning or pain after using this medicine, talk to your doctor.

CUSIMOLOL contains phosphate buffer
This medicine contains 59 mg of phosphate buffer per 5 ml which is equivalent to 11.8 mg/ml.
If you have severe damage to the outermost transparent layer of the eye (the cornea), phosphates may
cause, in very rare cases, opaque spots on the cornea due to calcium accumulation during
treatment.

Doping warning
For athletes: the use of the drug without therapeutic necessity constitutes doping and may
still result in a positive doping test.

3. How to use CUSIMOLOL

Use this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor or pharmacist.

The recommended doseis one drop twice a day, according to the instructions provided by your
doctor.
Use CUSIMOLOL only for instillation into the eye(s).

How to apply CUSIMOLOL

1 2 3

• Wash your hands
• Take the CUSIMOLOL bottle and unscrew the cap.
• If you are opening the bottle for the first time, remove the cap detached from the cap before using the

product.

• Hold the bottle upside down between your thumb and middle finger.
• Tilt your head back. Lower your eyelid with a clean finger to form a pouch between the eyelid and the eye. The drop should be instilled in this area (figure 1).
• Bring the tip of the bottle close to the eye.
• Do not touch the eye, eyelid, surrounding areas or other surfaces with the dropper tip to avoid infecting the drops remaining in the bottle.
• Gently press the base of the bottle to release one drop of CUSIMOLOL at a time.
• Do not squeeze the bottle: it is designed so that only a gentle pressure on the bottom is sufficient (figure 2).
• After using CUSIMOLOL, press the corner of your eye, near the nose, with your finger for 2 minutes as shown in figure 3. This helps to prevent CUSIMOLOL from spreading throughout the body.
• If you instill drops into both eyes, repeat the same operation for the other eye.
• Immediately replace the cap after use, screwing it on tightly.

If a drop does not enter the eye,try again.

If you use more CUSIMOLOL than you should
Immediately wash your eye with lukewarm water. Do not use the eye drops again until the time scheduled for the next
administration.
Possible symptoms of overdose include decreased heart rate, decreased
blood pressure, heart failure and difficulty breathing.

If you forget to use CUSIMOLOL
If you forget to use CUSIMOLOL, do not worry and instill it as soon as you remember. However, if it is almost
time to administer the next dose, skip the forgotten dose and return to the regular dosing schedule. Do notuse a double dose to make up for a missed dose.

If you stop using CUSIMOLOL
Do notstop using CUSIMOLOL without talking to your doctor.

If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, CUSIMOLOL can cause side effects, although not everybody gets them.
Generally you can continue to use the eye drops unless the effects experienced are severe. If you are
worried, ask your doctor or pharmacist. Do not stop using CUSIMOLOL without talking to your doctor.
The side effects listed below have been reported with timolol maleate eye drops.
Common side effects (may affect up to 1 in 10 people)

• blurred vision, eye pain, eye irritation, red eyes.

Uncommon side effects (may affect up to 1 in 100 people)

• damage to the front layer of the eyeball (corneal erosion), keratitis and inflammation of the cornea (punctate keratitis and keratitis), inflammation of the iris, inflammation of the conjunctiva (conjunctivitis), inflammation of the eyelid (blepharitis), corneal discoloration, reduced vision, light sensitivity (photophobia), dry eye, eye discomfort, increased tearing, eye secretion, itchy eyes, crusting of the eyelid margin, abnormal eye sensation, foreign body sensation in the eyes, inflammation of the front part of the eye, eyelid swelling, inflammation with redness of the eye (conjunctival hyperemia);
• asthma, bronchitis, difficulty breathing;
• headache;
• altered sense of taste;
• slowed heart rate, decreased blood pressure;
• fatigue.

Rare side effects (may affect up to 1 in 1000 people)

• inflammation of the eye (uveitis), corneal pathology, double vision, eye fatigue, eczema of the eyelid, reddened eyelid (erythema of the eyelid), eyelid pathology, itchy eyelid, eye swelling (conjunctival edema), corneal pigmentation, eyelash growth;
• depression, reduced blood flow to the brain (cerebral ischemia), dizziness, migraine, myocardial infarction, increased blood pressure, fluid retention in the extremities (peripheral edema), cold extremities, lung disease that can cause wheezing, difficulty breathing and/or long-lasting cough (chronic obstructive pulmonary disease), bronchospasm, cough, wheezing, nasal congestion (stuffy nose), upper respiratory tract infection, difficulty digesting, abdominal discomfort, dry mouth, facial swelling, skin erythema, excessive sweating, weakness (asthenia), chest discomfort.

Additional side effects detected during post-marketing experience, for which the frequency is not
known

• detachment of the layer under the retina containing blood vessels following filtering surgery, which can cause visual disturbances, drooping of the upper eyelids, the eye remains half-closed (palpebral ptosis);
• swelling under the skin that can occur in areas such as the face and limbs and which can obstruct the airways causing difficulty swallowing or breathing (angioedema), allergy (hypersensitivity), low blood sugar levels, hallucinations, insomnia, nightmares, memory loss, stroke, fainting, unusual sensations such as pins and needles (paresthesia), cardiac arrest, irregular heartbeat, heart disease with shortness of breath and swelling of the feet and legs due to fluid accumulation (worsening of congestive heart failure), changes in heart rate or rhythm, palpitations, disease of poor blood circulation (Raynaud's phenomenon) cold hands and feet, vomiting, diarrhea, nausea, hives, hair loss, skin rash, psoriasis, joint disease (or joint damage), sexual dysfunction (such as impotence).

As with other medicines applied to the eyes, timolol maleate is absorbed into the blood. This can
cause side effects similar to those that occur with the administration of beta-blockers
by intravenous and/or oral route. The incidence of side effects after administration to the eyes is
lower than when the medicines are, for example, taken by mouth or injected.
Further side effects detected with the use of beta-blockers for the treatment of eye disorders
are listed below:
Reduced corneal sensitivity, a condition that causes swelling and redness of the skin
with fever and joint pain (systemic lupus erythematosus), localized and
widespread skin rash, urticaria, itching, severe, life-threatening allergic reactions, increased
signs and symptoms of myasthenia gravis (muscle disorder), chest pain, fluid accumulation
(edema), heart disease with shortness of breath and swelling of the feet and legs due to an
accumulation of fluid (congestive heart failure), a white-silvery appearance skin rash
(psoriasiform rash) or worsening of psoriasis, muscle pain not caused by exercise,
reduced sexual desire.
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 get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through
the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-
avverse. By reporting side effects you can help provide more information on
the safety of this medicine.

5. How to store CUSIMOLOL

Keep this medicine out of the sight and reach of children.
Do not store at a temperature above 25°C.
Do not use this medicine after the expiry date which is stated on the bottle and the packaging after
“Expiry”. The expiry date refers to the last day of that month.
The expiry date refers to the product in intact packaging, correctly stored.
The period of validity after first opening of the bottle is 30 days.
Medicines should not be disposed of via drains 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 CUSIMOLOL
5 mg/ml eye drops, solution contains

• The active ingredient is timolol maleate. 1 ml of eye drops contains 6.8 mg of timolol maleate (equivalent to 5 mg/ml of timolol base).
• The other ingredients are: disodium hydrogen phosphate dihydrate, disodium phosphate dodecahydrate, benzalkonium chloride, purified water.

Description of the appearance of CUSIMOLOL and contents of the pack
CUSIMOLOL is a transparent, colorless solution. Each pack contains a 5 ml plastic dropper bottle of
CUSIMOLOL 5 mg/ml eye drops, solution.

Marketing Authorisation Holder
Immedica Pharma AB
SE-113 29 Stockholm
Sweden

Manufacturer
S.A. Alcon-Couvreur N.V.
Rijksweg 14 B-2870 Puurs
Belgium
Novartis Pharma GmbH
Roonstraße 25, D-90429 Nuremberg
Germany
Siegfried El Masnou, S.A.
Camil Fabra 58, El Masnou, 08320 Barcelona
Spain
Novartis Farmacéutica, S.A.
Gran Via de les Corts Catalanes 764, 08013 Barcelona
Spain