EQUITON 5 mg /Ml + 10 Mg/Ml Eye Drops, Solution

Зміст інструкції

1. EQUITON 5mg/ml + 10mg/ml eye drops, solution
   1. What is EQUITON and what is it used for
   2. What you need to know before using EQUITON
   3. How to use EQUITON
   4. Possible side effects
   5. How to store EQUITON
   6. Contents of the pack and other information

EQUITON 5mg/ml + 10mg/ml eye drops, solution

Timolol + Pilocarpine

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

1. What is EQUITON and what is it used for

EQUITON is an eye drop that contains the active substances timolol and pilocarpine. Timolol works by lowering the
pressure inside the eye, while pilocarpine works by promoting the natural flow of fluid
from inside the eye to the bloodstream.
This medicine is used for the treatment of diseases that cause an increase in pressure
in the eye, which over time could damage vision (ocular hypertension, narrow irido-corneal angle
or blockage of the irido-corneal angle, spontaneous or iatrogenic, open-angle chronic glaucoma).

2. What you need to know before using EQUITON

Do not use EQUITON

• if you are allergic to timolol or similar substances, to pilocarpine or to any of the other components of this medicine (listed in section 6);
• if you have or have had in the past respiratory problems (asthma) or severe COPD - chronic obstructive pulmonary disease (a condition that can cause shortness of breath, difficulty breathing and persistent cough);
• if you have or have had in the past heart problems that have caused a reduction in heart rate (sinus bradycardia) or irregular heartbeat (sick sinus syndrome, sino-atrial block, second or third degree atrioventricular block not controlled with a pacemaker);
• if you suffer from poor heart function (heart failure and/or cardiogenic shock);
• if you have or have had in the past an inflammation of the eye (iritis or iridocyclitis).
• breastfeeding

Warnings and precautions
Talk to your doctor or pharmacist before using EQUITON.
If you need to use this medicine for long periods, undergo periodic eye examinations.
Use this medicine with cautionand inform your doctor if you have the following conditions:

• if you suffer from or have suffered in the past from serious heart problems, such as coronary heart disease (symptoms may include chest pain or a feeling of tightness, shortness of breath or suffocation), heart failure, first-degree heart block;
• if you suffer from or have suffered from heart rate disorders such as a slow heartbeat;
• if you suffer from or have suffered from low blood pressure;
• if you have or have had problems with circulation to the hands and feet that manifests with pain in the fingers and tingling (Raynaud's syndrome);
• if you suffer from or have suffered from respiratory problems such as asthma or chronic obstructive pulmonary disease;
• if you suffer from diabetes, as timolol maleate may mask signs and symptoms of hypoglycemia;
• if you have thyroid problems (hyperthyroidism), as timolol maleate may mask its signs and symptoms;
• if you have problems with the cornea (corneal diseases), as this medicine can cause dry eye;
• if you are going to undergo surgery, in which case inform the anesthesiologist that you are using this medicine;
• if you wear contact lenses (see section EQUITON contains benzalkonium chloride).

Choroidal detachment has been reported following the administration of aqueous humor suppressive therapy (e.g. timolol, acetazolamide) after filtration procedure.
Timolol, like other beta-blockers, can be absorbed and pass into the blood, this can cause some systemic side effects such as heart and blood circulation problems (cardiovascular problems) and lung problems (respiratory problems). However, these reactions occur very rarely when these drugs are administered through eye drops compared to when they are administered in other formulations such as tablets.
For those who play sports: the use of the drug without therapeutic need constitutes doping and may still result in a positive doping test.

Children and adolescents
The safety regarding the use of the medicine in children and adolescents has not been established.
The use of the product is not intended in pediatric age unless, at the doctor's discretion, in cases of absolute necessity.

Other medicines and EQUITON
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription.
EQUITON can affect or be affected by other medicines you are taking, including other eye drops for the treatment of glaucoma.
Use EQUITON with cautionand inform your doctor if you are using the following medicines:

• medicines used for heart problems (oral beta-blockers, antiarrhythmics including amiodarone, digitalis glycosides, parasympathomimetics, guanethidine);
• medicines used to treat high blood pressure (oral calcium antagonists and carbonic anhydrase inhibitors diuretics);
• other medicines used to control eye pressure such as miotics or epinephrine for topical use;
• reserpine, a medicine used to treat high blood pressure (antihypertensive) and as an antipsychotic;
• medicines used to control mood (fluoxetine, paroxetine);
• quinidine, used to treat heart problems and some types of malaria;
• medicines for the treatment of diabetes.

Ophthalmic beta-blocker medicines can block the effects of systemic beta-agonists, for example adrenaline. Inform your doctor that you are using EQUITON before undergoing surgery as timolol maleate may change the effects of some drugs used during anesthesia.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
Do not use this medicine during pregnancy unless in cases of absolute necessity and always under strict medical supervision. Inform your doctor if you use EQUITON until delivery, as the newborn must be carefully monitored in the first few days of life.
Do not use EQUITON if you are breastfeeding, as timolol maleate may be excreted in breast milk.

Driving and using machines
Using this medicine can cause temporary blurred vision. If this happens, avoid driving vehicles or using machinery until your vision is clear again.

EQUITON 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 have a discoloring action on soft contact lenses.

EQUITON contains phosphate buffer
If you have severe damage to the outermost transparent layer of the eye (the cornea), phosphates may in very rare cases cause opaque spots on the cornea due to calcium accumulation during treatment.

3. How to use EQUITON

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts
consult your doctor or pharmacist.
The doctor will adjust the dosage according to your needs.
The recommended doseis 1-2 eye drops every 12 hours in the eye to be treated. Its action begins
approximately 20 minutes after instillation and is maximal within 1-2 hours, remaining practically unchanged for about 12
hours. If the response to treatment is insufficient, the dosage may be increased at the doctor's discretion.

Duration of treatment: In relation to the severity of the condition. If it is necessary to prolong the
treatment for long periods, it is advisable to consult your treating physician.

Method of use:

• open the bottle by pressing on the cap and unscrewing it simultaneously (Fig. 1);
• gently lower the lower eyelid of the eye to be treated with a finger;
• bring the tip of the bottle close to the eye, without touching it;
• exert slight pressure on the bottle, allowing 1-2 drops to fall into the eye, then release the lower eyelid;
• press with a finger on the corner of the eye, near the nose. Keep pressed for 2 minutes while keeping the eye closed, this prevents systemic absorption of the medicine (Fig. 2);
• repeat the operation also for the other eye if necessary;
• close the bottle by pressing on the cap and screwing it on tightly simultaneously and store (Fig. 3).

Fig. 1 Fig. 2 Fig.3

If you use more EQUITON than you should
In case of ingestion or accidental application of an excessive dose of this medicine, immediately inform
your doctor or go to the nearest hospital.
If you use EQUITON for a long time and at high doses, toxic effects may occur. It is therefore advisable to avoid
excessive doses and press a finger on the corner of the eye, after each application, to reduce any
systemic absorption.
In case of prolonged therapy, it is advisable to monitor the intraocular tone and functional parameters of vision.

If you forget to use EQUITON
If you forgot to use EQUITON eye drops, continue to use the usual dose at the usual time. Do not use a
double dose to make up for a missed dose.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist

4. Possible side effects

Like all medicines, EQUITON eye drops can cause side effects, although not everybody gets them.
Like other medicines applied to the eyes, timolol maleate is absorbed into the bloodstream. This can
cause side effects similar to those observed with intravenous or oral administration of similar
medicines (beta-blockers), although with a lower incidence.
The following side effects may occur:

Eye and vision disorders:

• eye irritation (burning, stinging, itching, tearing, redness, conjunctivitis);
• eyelid inflammation (blepharitis);
• cornea inflammation (keratitis);
• blurred vision and detachment of the layer beneath the retina containing blood vessels following filtering surgery, which can cause visual disturbances, reduced corneal sensitivity, dry eyes, corneal erosion (damage to the front layer of the eyeball), lowering of the upper eyelid (making the eye closed, half-closed), double vision.

Immune system disorders:

• systemic allergic reactions including widespread swelling under the skin (which can occur in areas such as the face and limbs), swelling of the tongue, larynx and throat that can cause problems with breathing and swallowing (angioedema);
• life-threatening sudden allergic reaction (anaphylactic shock);
• skin allergic reactions including localized and widespread skin rashes, urticaria, itching, rash.

Nervous system disorders:

• sleep disturbances (insomnia), depression, nightmares, memory loss;
• fainting; heart attack, reduced blood supply to the brain;
• worsening of signs and symptoms of myasthenia gravis, a muscle disease;
• dizziness, headache;
• altered sensitivity of the limbs (paresthesia).

Heart and circulation disorders:

• slowing of the heartbeat (bradycardia);
• chest pain, palpitations;
• fluid retention (edema);
• irregular heartbeat (arrhythmias);
• congestive heart failure (heart disease with shortness of breath and swelling of the feet and legs due to fluid accumulation), heart rhythm disturbance, heart attack, heart failure.
• excessive lowering of blood pressure (hypotension);
• problems with circulation to the hands and feet (Raynaud's syndrome), cold hands and feet.

Respiratory disorders:

• constriction of the airways in the lungs (predominantly in patients with pre-existing disease), difficulty breathing, cough.

Gastrointestinal disorders:

• reduced sense of taste (dysgeusia);
• nausea, vomiting, abdominal pain and diarrhea;
• digestive difficulties (dyspepsia), dry mouth.

Skin and muscle disorders:

• hair loss (alopecia);
• skin rashes with a silvery-white appearance (psoriasis-like rash) or worsening of psoriasis, skin rash;
• lupus erythematosus, an autoimmune skin disease that causes lesions on the face and pain;
• muscle pain and inflammation (myalgia).

Sexual disorders:

• sexual dysfunction, impotence;
• decreased sexual desire.

Changes in diagnostic tests:

• positive results for some autoantibodies (antinuclear antibodies).

Metabolic and nutritional disorders

• reduction of blood sugar levels (hypoglycemia).

Systemic diseases and conditions related to the site of administration:

• muscle weakness and fatigue.

Psychiatric disorders

• hallucinations

Other side effects reported with eye drops containing phosphates
If you have severe damage to the outermost transparent layer of the eye (the cornea), phosphates may in
very rare cases cause opaque spots on the cornea due to calcium deposits 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 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 EQUITON

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.
Store in the original packaging to protect the medicine from light and at a temperature not
exceeding 25°C.
The eye drops must be used within 30 days of first opening the bottle. Any excess
medicine must be discarded.
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 EQUITON contains

• The active ingredients are timolol maleate and pilocarpine hydrochloride. 100 ml of eye drops contain 0.5 g of timolol maleate and 1 g of pilocarpine hydrochloride.
• The other ingredients are sodium phosphate monobasic dihydrate, sodium phosphate dibasic dihydrate, benzalkonium chloride and purified water.

Description of the appearance of EQUITON and contents of the pack
Pack containing a 5 ml bottle of eye drops

Marketing Authorisation Holder and Manufacturer
BRUSCHETTINI S.r.l.
Via Isonzo 6
16147 Genova
Italy