Package leaflet: Information for the patient

TIMOLABAK 2.5 mg/ml eye drops, solution, 5 mg/ml eye drops, solution

Timolol
Please read this leaflet carefully before using this medicine because 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What TIMOLABAK is and what it is used for
What you need to know before using TIMOLABAK
How to use TIMOLABAK
Possible side effects
How to store TIMOLABAK
Contents of the pack and other information

1. What TIMOLABAK is and what it is used for

TIMOLABAK is a medicine containing timolol, an active substance belonging to a class of medicines called ophthalmic beta-blockers, which help reduce the pressure inside the eye.
TIMOLABAK is indicated for the treatment of ocular diseases in patients with ocular hypertension, chronic open-angle glaucoma, aphakic patients with glaucoma, patients with narrow angle and previous episodes of angle closure, spontaneous or iatrogenic, in the contralateral eye, when reduction of intraocular pressure is required.
TIMOLABAK is also indicated as concomitant therapy in pediatric glaucoma inadequately controlled with other anti-glaucoma therapies.

2. What you should know before using TIMOLABAK

Do not use TIMOLABAK

if you are allergic to timolol or to any of the other ingredients of this medicine (listed in section 6);
if you have or have previously had respiratory problems such as asthma, severe chronic obstructive bronchitis (a serious lung disease that may cause shortness of breath, difficulty breathing and/or persistent cough);
if you have or have previously had sinus bradycardia, sino-atrial block due to sick sinus syndrome, second- or third-degree atrioventricular block not controlled by a pacemaker, cardiac failure, or cardiogenic shock.

Warnings and precautions
Before using TIMOLABAK, inform your doctor:

if you have or have previously had first-degree heart block;
if you have or have previously had coronary heart disease (disease of the coronary arteries whose symptoms may include chest pain or tightness, shortness of breath or suffocation), heart failure, or low blood pressure;
if you suffer from heart rate disorders such as slow or irregular heartbeat;
if you suffer from respiratory problems (asthma or chronic obstructive pulmonary disease);
if you suffer from circulation problems in the fingers of the hands and feet (such as Raynaud's disease or Raynaud's syndrome);
if you have diabetes, as timolol maleate may mask the signs and symptoms of low blood sugar;
if you have thyroid problems. Timolol may hide signs and symptoms of increased thyroid activity;
if you have psoriasis (skin eruptions with a silvery appearance), as TIMOLABAK may worsen it;
if you have corneal disorders or dry eyes, as ophthalmic beta-blockers may worsen them;
if you are already taking another beta-blocking medicine by mouth or by injection, as this may lead to an enhanced effect on intraocular pressure and increased risk of side effects; the use of two beta-blocking eye drops should also be avoided;
if you have experienced allergic reactions to any substances regardless of type or severity, as beta-blockers may promote such reactions and reduce the therapeutic effectiveness of adrenaline, a drug used to treat these reactions;
before undergoing surgery, inform the anaesthetist that you are using Timolabak, as it may alter the effects of certain medicines used during anaesthesia.

For athletes: using this medicine without a therapeutic need constitutes doping and may lead to a positive result in anti-doping tests.

Children
The use of TIMOLABAK is not recommended in premature infants and newborns.
Timolol eye drop solution should generally be used with great caution in pediatric patients. Timolol must be used with extreme caution in newborns and younger children.
If your child develops any of the following symptoms: cough, shortness of breath (dyspnea), abnormal breathing, or abnormal pauses in breathing (apnea), you must stop using the medicine immediately and contact your doctor as soon as possible. A portable device to monitor abnormal breathing pauses (apnea) may be helpful.

Other medicines and TIMOLABAK
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
TIMOLABAK may affect or be affected by other medicines you are using, including other eye drops for glaucoma treatment.
Follow your doctor's instructions carefully if switching from another product used to lower intraocular pressure.
Inform your doctor if you are taking or plan to start taking medicines for:

psychiatric disorders (amisulpride, MAO inhibitors such as fluoxetine, paroxetine);
dilation or reduction of pupil diameter and glaucoma treatment (which reduce intraocular pressure);
heart conditions (e.g. amiodarone, disopyramide, quinidine, propafenone);
high blood pressure (hypertension such as verapamil, diltiazem, clonidine, hydralazine, nifedipine);
medicines used in the treatment of diabetes (e.g. insulin);
local or general anaesthesia;
medicines used to treat malaria (e.g. quinidine and mefloquine).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Do not use Timolabak during pregnancy unless your doctor considers it necessary.
Do not use TIMOLABAK while breastfeeding unless your doctor considers it necessary. Timolol may pass into breast milk.

Driving and using machines
No studies have been conducted on the effect of this medicine on driving. When driving vehicles or operating machinery, bear in mind that visual disturbances may occasionally occur, including: changes in visual ability, double vision (diplopia), drooping eyelids (ptosis), frequent episodes of mild and temporary blurred vision, and sometimes episodes of dizziness or fatigue. If this happens to you, do not drive or operate tools or machines.

3. How to use TIMOLABAK

Use this medicine exactly as your doctor has instructed you. If you have any doubts,
consult your doctor or pharmacist.
The recommended dose is one drop of TIMOLABAK in the affected eye(s) twice daily.
TIMOLABAK is for ocular use only (eye use only). Do not swallow it.
Your doctor may adjust the dosage depending on how your condition progresses.
Follow your doctor’s instructions carefully. Do not exceed the recommended dose.
Apply one drop into the eye (look upwards and gently pull down the lower eyelid); the drop
will come out of the bottle after a longer time compared to a traditional eye drop bottle.
After application, keep your eyes closed for as long as possible (e.g. 3–5 minutes) and apply
pressure to the inner corner of the eye (near the nose) to prevent timolol eye drops from
spreading throughout the body.
Close the bottle tightly after use.
Use in children and adolescents
Your doctor will perform a detailed assessment of your child before starting treatment with
timolol. The doctor will carefully evaluate the risks and benefits of treatment with timolol. If
the benefits outweigh the risks, your doctor will advise using the lowest available dose once
daily.
If you use more TIMOLABAK than you should
In case of accidental ingestion or overdose of TIMOLABAK, contact your doctor immediately or
go to the nearest hospital, taking this leaflet with you.
If you forget to use TIMOLABAK
Do not use a double dose to make up for the missed dose.
If you stop using TIMOLABAK
If you have any questions about using 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.
If you have any doubts, consult your doctor or pharmacist. Do not stop using TIMOLABAK without discussing it with your doctor.
As with other medicines applied to the eyes, timolol is absorbed into the bloodstream. This may cause side effects similar to those observed with beta-blocking agents administered by "intravenous (injected into a vein)" and/or "oral" routes.
The frequency of side effects after ocular administration is lower than when the medicines are taken by mouth or injected.
The side effects listed below include reactions observed with medicines similar to TIMOLABAK used to treat eye diseases:

Effects related to the immune system:
systemic lupus erythematosus (a condition causing skin swelling and redness with fever and joint pain);
generalized allergic reactions including subcutaneous swelling which may affect the face and limbs and may obstruct the airways causing difficulty in breathing and swallowing;
urticaria or itchy rash, localized or widespread skin rash, itching, sudden severe allergic reaction with life-threatening risk.
Effects related to metabolism and nutrition:
low blood glucose levels.
Effects related to psychiatric disorders:
sleep disturbances (insomnia), depression, nightmares, memory loss, hallucinations.
Effects related to the nervous system:
fainting, reduced blood supply to the brain, worsening of signs and symptoms of myasthenia gravis (a muscle disorder), dizziness, tingling, and headache.
Effects related to the eye:
signs and symptoms of ocular irritation (e.g. burning, sharp pain, itching, tearing, redness), inflammation of the eyelids;
corneal inflammation, blurred vision, and detachment of the layer beneath the retina containing blood vessels following filtering surgery, which may cause visual disturbances, reduced corneal sensitivity, dry eye, corneal erosion (damage to the outer layer of the eye), drooping eyelid (partially closed eye), double vision.
Effects related to the heart:
slowed heart rate, chest pain, palpitations, edema (swelling due to fluid accumulation in tissues), changes in heart rate or rhythm;
congestive heart failure (a heart condition with shortness of breath and swelling of feet and legs due to fluid accumulation), irregular heartbeat, heart attack (myocardial infarction), heart failure.
Effects related to blood circulation:
low blood pressure, Raynaud's phenomenon (circulatory problems affecting fingers and toes), cold hands and feet.
Effects related to respiration:
narrowing of the airways (mainly in patients with pre-existing lung disease), breathing difficulties, cough.
Gastrointestinal effects:
taste disturbances, nausea, indigestion, diarrhea, dry mouth, abdominal pain, vomiting.
Effects related to the skin:
hair loss;
skin rashes with silvery appearance (psoriasiform rash) or worsening of psoriasis;
skin rash.
Effects related to muscles, bones, and connective tissue:
muscle pain not caused by physical exercise.
Effects related to the reproductive organs:
sexual dysfunction;
decreased sexual desire;
impotence (inability to achieve and maintain an erection).
Effects related to the general body:
muscle weakness / fatigue.

TIMOLABAK 2.5 mg/ml
This medicine contains 1.195 mg of phosphate buffer per drop, equivalent to 37.35 mg/ml.
TIMOLABAK 5 mg/ml
This medicine contains 1.107 mg of phosphate buffer per drop, equivalent to 34.6 mg/ml.
In patients with severe damage to the outermost transparent layer of the eye (the cornea), phosphates may very rarely cause calcium deposits leading to cloudy spots on the cornea during treatment.
Very rarely, some patients with severe damage to the transparent layer at the front of the eye (cornea) have developed areas of corneal clouding due to calcium accumulation during treatment.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the website 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 TIMOLABAK

Do not store above 25°C.
The shelf life after first opening the bottle is 8 weeks.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.".
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What TIMOLABAK contains

The active substance is timolol 2.5 or 5 mg/ml. The other components are disodium phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate, purified water.

Description of the appearance of TIMOLABAK and contents of the pack
TIMOLABAK is a clear, colourless solution contained in a 5 ml bottle.
It is available in 5 ml packs in the strengths of 2.5 mg/ml and 5 mg/ml.
It is possible that not all pack sizes are marketed.

Marketing Authorisation Holder and Manufacturer
THEA FARMA S.p.A. – Via Tiziano, 32 – 20145 MILAN
Manufacturer
FARMILA-THEA FARMACEUTICI S.p.A.
Via Enrico Fermi, 50
20019 Settimo Milanese (MI)
and
EXCELVISION
Rue de la Lombardière
07100 Annonay
France