TIMABAK 0.50% eye drops solution contains: Active ingredient: Timolol 0.500 g in the form of timolol maleate 0.685 g for 100 ml of solution.
It is a beta-blocker used by eye drops route.
Excipients/Inactive Ingredients: Disodium phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate, water for injections.
This medicine is prescribed for the treatment of certain types of eye disease involving intraocular hypertension e.g. glaucoma and intraocular hypertension.
Follow the doctor's instructions very carefully when using TIMABAK 0.50% eye drops solution. If in doubt ask the doctor or pharmacist. As a guideline, the usual dosage is 1 drop in the affected eye, twice daily (morning and evening).
Premature babies, newborns and infants: the use of this eye drops solution is not recommended.
Means of administration: Eye drops route. This medicine is intended to be used in the eye.
Do not inject, do not swallow.
Wash the hands carefully before instilling the drops.
Avoid touching the eye or eyelids with the tip.
Look upwards and pull the lower lid of the eye down slightly and instill 1 drop.
After using TIMABAK 0.50% eye drops solution press the finger on the corner of the eye next to the nose for 2 minutes. This helps to prevent timolol diffusing into the rest of the body.
Put the cap back on the bottle after use.
Frequency of administration: Apply twice daily (morning and evening).
The ophthalmologist will advise on the time of day to apply.
Duration of treatment: Follow the doctor's prescription.
If the patient forgets to take TIMABAK 0.50% eye drops solution: Take TIMABAK 0.50% eye drops solution as prescribed by the doctor. Do not take a double dose to compensate for the dose the patient forgot to take. Instill the forgotten dose as soon as possible. However, if it is nearly time to take the next dose; do not instill the forgotten dose.
Effects that may appear on discontinuing treatment with TIMABAK 0.50% eye drops solution: If the patient interrupts the treatment, the intraocular pressure may increase and impair the vision. Do not discontinue treatment without the doctor's advice.
If the patient has instilled too many drops or accidentally swallowed the contents of the bottle, the patient may, in addition to other side effects, feel empty-headed, have difficulty breathing or feel the pulse rate slow down; in this case contact the doctor immediately.
Never use TIMABAK 0.50% eye drops solution in the following cases: allergy to one of the components of the eye drops solution, cardiac insufficiency not controlled by medication (heart function failure not controlled by the treatment), cardiogenic shock (shock of cardiac origin), Prinzmetal's angina (type of angina attack), sinus dysfunction of the heart (including sino-auricular block), bradycardia (pulse less than 45-50 beats per minute) (slowed heart rhythm), cardiac conduction disorders (second and third degree atrioventricular block), Raynaud's disease and peripheral circulatory disturbances (symmetrical circulatory disturbances in the fingers with numbness and peripheral arterial disturbances), untreated phaeochromocytoma (excessive hormone production causing severe arterial hypertension), hypotension, treatment with floctafenine, treatment with sultopride (medicine used mostly for psychiatric therapy), asthma and chronic pulmonary and bronchial disease with obstruction (except on doctor's advice).
This medicine should generally not be taken in combination with amiodarone, certain calcium antagonists (bepridil, verapamil, diltiazem) and beta-blockers used to treat heart failure.
Take special care when using TIMABAK 0.50% eye drops solution: Do not stop treatment suddenly without the doctor's advice.
Do not inject, do not swallow.
Periodic ophthalmological examination should be performed while undergoing this treatment, in particular, to check for drug resistance (loss of drug efficacy during long-term treatment).
Before using this medicine, tell the doctor of any current or previous occurrence of the following medical conditions: coronary heart disease (symptoms may include pain or tightness in the chest, shortness of breath or choking), heart failure or drop in blood pressure (hypotension); heart rhythm disorders, such as a slow pulse; respiratory problems, asthma or chronic pulmonary or bronchial disease with obstruction; poor blood circulation (such as Raynaud's syndrome or disease); diabetes - as timolol may mask the signs and symptoms of hypoglycaemia; an overactive thyroid - as timolol may mask the signs and symptoms; phaeochromocytoma: this will require careful monitoring of the arterial pressure; psoriasis (skin disorder); disease of the cornea.
Contact lens wearers: Avoid wearing contact lenses during treatment due to reduction in lachrymal secretion, linked to beta-blockers in general.
If the patient has to undergo surgery, tell the doctor that the patient is using TIMABAK as timolol may modify the effects of certain drugs used during anaesthesia.
Athletes: The attention of sports professionals is drawn to the fact that this medicinal product contains an active ingredient, which can induce a positive reaction in anti-doping tests.
Do not use TIMABAK 0.50% eye drops solution if the patient is pregnant, unless the doctor considers it necessary.
Do not use TIMABAK 0.50% eye drops solution if the patient is breastfeeding. Timolol may pass into the breast milk.
Ask the doctor for advice before taking any medicine during breastfeeding.
Like any medicine, TIMABAK 0.50% eye drops solution, is liable to have side effects; however they do not occur systematically in everyone: Provided there are no serious side effects, the patient can usually continue to use the eye drops solution. If the patient has any concerns, talk to a doctor or a pharmacist. Do not discontinue use of TIMABAK 0.50% eye drops solution without seeking the doctor's advice.
As with other eye care medicines, timolol passes into the blood. This can have side effects similar to those observed with beta-blocker agents that are administered intravenously and/or orally.
The frequency of occurrence of side effects after topical eye drops administration is less than that observed when the medicines are taken orally or injected. The listed side effects are those observed in the class of beta-blockers used to treat ocular pathologies: Generalised allergic reactions, particularly swelling under the skin (that can occur in areas such as the face, arms or legs, and which may obstruct the airways, leading to difficulties in breathing or swallowing), hives (or itching), localised or generalised skin eruptions, itching, sudden onset and serious allergic reaction that may cause a life-threatening risk.
Drop in blood sugar level (hypoglycaemia).
Sleep disorders (insomnia), depression, nightmares, loss of memory.
Loss of consciousness, strokes, decreased blood flow to the brain, increase in signs and symptoms of myasthenia gravis (muscular disorder), dizziness, unusual sensations (such as tingling), and headaches.
Signs and symptoms of ocular irritation (such as a burning sensation, stinging, itching, watery eyes, redness), inflammation of the eyelid, conjunctival redness, conjunctivitis, inflammation of the cornea, blurred vision and detachment of the sub-retinal layer containing blood vessels following filtration surgery that may cause visual disorders, decreased corneal sensitivity, dry eyes, corneal erosion (damage to the upper layer of the eyeball), upper eyelid sagging (leaving the eye half-closed), double vision, visual disorders including changes in the refraction index (sometimes due to discontinued treatment with myotic drops).
Slow pulse, chest pain, palpitations, oedema (accumulation of fluids), changes in heart rhythm and rate, congestive heart failure (heart disease characterised by shortness of breath or swelling of the feet and legs due to accumulation of fluids), a certain type of heart rhythm disorder, heart attack, heart failure.
Hypotension, Raynaud's phenomenon, cold hands and feet, claudication (cramps in the feet and/or pain in the legs when walking).
Constriction of the pulmonary airways (mainly in patients already suffering a pathology), breathing difficulties, coughing.
Taste disorders, nausea, indigestion, diarrhoea, dry mouth, abdominal pain, vomiting.
Hair loss, skin eruptions with a silvery white appearance (psoriasis-like outbreaks) or worsening of psoriasis, skin eruptions.
Muscular pain not due to exercise, systemic lupus erythematosus.
Sexual disorders, loss of libido, impotence.
Positive results during tests for anti-nuclear antibodies.
If the patient notices any side effects not listed in this notice, or if certain side effects become serious, please tell the doctor or pharmacist.
If the doctor has prescribed another eye drops solution, the patient must instill this solution 15 minutes before using TIMABAK 0.50% eye drops solution.
TIMABAK 0.50% eye drops solution can affect or be affected by other medicines that the patient is using or taking, particularly other eye drops solutions for the treatment of glaucoma.
Tell the doctor of any medicines that the patient is taking or plan to take for hypotension, heart problems or diabetes, quinidine (used to treat heart rhythm disorders and certain types of malaria), or antidepressants such as fluoxetine and paroxetine.
Tell the doctor or pharmacist if the patient is taking or have recently taken another medicine, including a medicine available without a prescription.
Do not use TIMABAK 0.50% eye drops solution if the patient notices visible signs of damage or deterioration.
Medicines should not be disposed of via wastewater or household waste. Ask the pharmacist how to dispose of any unused medicines. Doing this helps to protect the environment.
Store at a maximum temperature of +25°C.
After first-time opening of the bottle, the eye drops solution can be kept for up to 8 weeks.
S01ED01 - timolol ; Belongs to the class of beta blocking agents. Used in the treatment of glaucoma.
Eye drops (preservative-free) 0.5% x 5 mL.