TIMOLABAK 2.5 mg/ml Krople do oczu, roztwór

Treść ulotki

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

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

1. What TIMOLABAK is and what it is used for

TIMOLABAK is a medicine that contains timolol, an active ingredient that belongs to a
class of medicines called beta-blockers for ophthalmic use, which help to reduce the
pressure inside the eye.
TIMOLABAK is indicated for the treatment of eye diseases in patients with ocular hypertension,
chronic open-angle glaucoma, aphakic patients with glaucoma, patients with
narrow angles and with previous episodes of angle closure, spontaneous or iatrogenic,
in the contralateral eye, where it is necessary to reduce intraocular pressure.
TIMOLABAK is also indicated as concomitant therapy in pediatric glaucoma, which is
inadequately controlled with other antiglaucoma therapies.

2. What you need to know before using TIMOLABAK

Do not use TIMOLABAK

• if you are allergic to timolol 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 disease that can cause shortness of breath, difficulty breathing and/or persistent cough);
• if you have or have had sinus bradycardia, sino-atrial block from sick sinus syndrome, second and third degree atrioventricular block not controlled with a pacemaker, heart failure, cardiogenic shock.

Warnings and precautions
Before using TIMOLABAK, tell your doctor:

• if you have or have had first-degree heart block
• if you have or have 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 a slow or irregular heartbeat
• if you suffer from respiratory problems (asthma or chronic obstructive bronchopneumopathy)
• if you suffer from problems with blood circulation in the fingers of your hands and feet (such as Raynaud's disease or Raynaud's syndrome)
• if you suffer from diabetes as timolol maleate may mask the signs and symptoms of low blood sugar
• if you suffer from problems with the thyroid gland. Timolol may hide the signs and symptoms of increased thyroid activity
• if you suffer from psoriasis (skin rashes with a silvery-white appearance) because TIMOLABAK may worsen it
• if you suffer from corneal diseases or dry eyes because ophthalmic beta-blockers can worsen them
• if you are already taking another beta-blocker medicine by mouth or injection because it may cause an increase in the effects on eye pressure and unwanted effects; the use of two beta-blocker eye drops should also be avoided
• if you have had allergic reactions to substances of any kind and severity, because beta-blockers may favor them and reduce the effectiveness of adrenaline, a medicine used to treat these reactions
• before an operation, inform the anesthesiologist that you are using Timolabak because it may change the effects of some medicines used during anesthesia

For those who play sports: the use of the drug without a therapeutic need constitutes
doping and may still result in a positive doping test.

Children
The use of TIMOLABAK is not recommended in premature babies and newborns.
Timolol eye solution should generally be used with great caution in childhood.
In newborns and young children, timolol should be used with extreme
caution.
If your child experiences any of the following symptoms: cough, shortness of breath (dyspnea),
abnormal breathing or pauses in breathing (apnea), the use of the medicine should
be stopped immediately, and a doctor should be consulted as soon as possible. A portable device for measuring abnormal pauses in breathing
(apnea) may also be useful.

Other medicines and TIMOLABAK
Tell your doctor or pharmacist if you are taking, have recently taken or may
take any other medicines.
TIMOLABAK may influence or be influenced by other medicines you are taking,
including other eye drops for the treatment of glaucoma.
Follow your doctor's instructions carefully when switching from another product
used to lower eye pressure.
Tell your doctor if you are taking or intend to start taking medicines for:

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

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 Timolabak if you are pregnant unless your doctor considers it necessary.
Do not use TIMOLABAK if you are breastfeeding unless your doctor considers it
necessary. Timolol may pass into breast milk.

Driving and operating machinery
Studies have not been conducted on the effect of this medicine on driving. When driving
vehicles and operating machinery, it should be kept 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 use tools or machinery.

3. How to use TIMOLABAK

Use this medicine following the instructions of your doctor exactly. If you have any doubts
consult your doctor or pharmacist.
The recommended dose is one drop of TIMOLABAK in the affected eye(s) 2 times a
day.
TIMOLABAK is only for use in the eyes (ocular use). Do not ingest it.
The doctor may modify the dosage based on the progress of your condition.
Follow your doctor's instructions carefully. Do not exceed the recommended dose.
Apply one drop into the eye (looking upwards and pulling the lower eyelid down slightly), the drop will exit the bottle after a longer time than with 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 corner of the eye closest to the nose to prevent the timolol
eye drops from spreading throughout the body.
Close the bottle tightly after application.

Use in children and adolescents
Your doctor will perform a detailed check-up on your child before using timolol. The
doctor will carefully evaluate the risks and benefits of treatment with timolol. If the benefits
outweigh the risks, your doctor will advise you to use the lowest available dose once a
day.

If you use more TIMOLABAK than you should
In case of ingestion/accidental intake of an excessive dose of TIMOLABAK, immediately notify
your doctor or go to the nearest hospital, bringing 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 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 have any doubts, please consult your doctor or pharmacist. Do not stop using TIMOLABAK without
talking to your doctor.
As with other medications applied to the eyes, timolol is absorbed into the bloodstream. This
may cause side effects similar to those observed with beta-blockers taken for
“intravenous administration (injected into a vein)” and/or “oral use”.
The frequency of side effects after administration into the eye is lower
than when the medications are taken orally or injected.
The side effects listed include reactions observed with medicines similar to
TIMOLABAK used to treat eye diseases:

• Effects involving the immune system:
• systemic lupus erythematosus (a condition that causes swelling and redness of the skin with fever and joint pain);
• generalized allergic reactions including subcutaneous swelling that can affect the face and limbs and can obstruct the airways causing difficulty breathing and swallowing;
• urticaria or itchy rash, localized or widespread skin rash, itching, a sudden, life-threatening allergic reaction.
• Effects involving metabolism and nutrition:
• low blood glucose levels.
• Effects involving psychiatric disorders:
• sleep disturbances (insomnia), depression, nightmares, memory loss, hallucinations.
• Effects involving the nervous system:
• fainting, reduced blood supply to the brain, worsening of signs and symptoms of myasthenia gravis (muscle disorder), dizziness, tingling and headache.
• Effects involving the eye:
• signs and symptoms of eye irritation (e.g., burning, sharp pain, itching, tearing, redness), inflammation of the eyelids;
• corneal inflammation, blurred vision and detachment of the layer under the retina containing blood vessels following filtering surgery which may cause

visual disturbances, decreased corneal sensitivity, dry eye, corneal erosion (damage to the outer layer of the eye), lowering of the eyelid
(half-closed eye), double vision.

• Effects involving the heart:
• slowed heartbeat, chest pain, palpitations, edema (swelling from fluid accumulation in the tissues), changes in the rhythm or speed of the heartbeat;
• congestive heart failure (heart condition with shortness of breath and swelling of the feet and legs due to fluid accumulation), irregular heartbeat, heart attack, heart failure.
• Effects involving blood circulation:
• low blood pressure, Raynaud's phenomenon (problems with blood circulation in the fingers and toes), cold hands and feet.
• Effects involving breathing:
• constriction of the airways in the lungs (mainly in patients with pre-existing disease), difficulty breathing, cough.
• Gastrointestinal effects:
• taste disturbances, nausea, indigestion, diarrhea, dry mouth, stomach pain, vomiting.
• Effects involving the skin:
• hair loss;
• skin rashes with a silvery-white appearance (psoriasiform rash) or worsening of psoriasis;
• skin rash.
• Effects involving muscles, bones and connective tissue:
• muscle pain not caused by exercise.
• Effects involving the reproductive organs:
• sexual dysfunction;
• decreased sexual desire;
• impotence (inability to achieve and maintain an erection).
• Effects involving the whole organism:
• 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.
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.
In very rare cases, some patients with severe damage to the transparent layer in the front
part of the eye (cornea) have developed areas of corneal opacity due to
calcium accumulation during treatment.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet,
please inform your doctor or pharmacist. You can also report side effects
directly through 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 at a temperature 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 which is stated on the pack after Exp.
The expiry date refers to the last day of that month.
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 TIMOLABAK contains

• The active ingredient is timolol 2.5 or 5 mg/ml. The other components are disodium phosphate dodecahydrate, monosodium phosphate dihydrate, purified water.

Description of the appearance of TIMOLABAK and contents of the pack
TIMOLABAK is presented as a clear and colourless solution, contained in a 5
ml bottle.
It is available in a 5 ml pack in the dosages 2.5 mg/ml and 5 mg/ml.
Not all pack sizes may be marketed

Marketing authorisation holder and manufacturer
THEA FARMA S.p.A. – Via Tiziano, 32 – 20145 MILANO

Manufacturer
FARMILA-THEA FARMACEUTICI S.p.A.
Via Enrico Fermi, 50
20019 Settimo Milanese (MI)
and
EXCELVISION
Rue de la Lombardière
07100 Annonay
France