The active substances are latanoprost 50 micrograms/ml and timolol (as timolol maleate) 5 mg/ml.
LATAMOLOL eye drops, solution is a clear, colourless, aqueous solution, with pH between 5.7 and 6.3 and osmolality 260 to 320 mosmol/kg.
Excipients/Inactive Ingredients: The other ingredients are: benzalkonium chloride, sodium chloride, sodium dihydrogen phosphate monohydrate, disodium phosphate anhydrous, sodium hydroxide or hydrochloric acid (for pH adjustment), water for injection.
LATAMOLOL contains two medicines: latanoprost and timolol. Latanoprost belongs to a group of medicines known as prostaglandin analogues. Timolol belongs to a group of medicines known as beta-blockers. Latanoprost works by increasing the natural outflow of fluid from the eye into the bloodstream. Timolol works by slowing the formation of fluid in the eye.
LATAMOLOL is used to reduce the pressure in the eye if the patient has conditions known as open angle glaucoma or ocular hypertension. Both these conditions are linked to an increase in the pressure within the eye, eventually affecting the eyesight. The doctor will usually prescribe the patient LATAMOLOL when other medicines have not worked adequately.
Always use this medicine exactly as the doctor has told. Check with the doctor or pharmacist if the patient is not sure.
The usual dosage for adults (including the elderly) is one drop once a day in the affected eye(s).
Do not use LATAMOLOL more than once a day, because the effectiveness of the treatment can be reduced if the patient administers it more often.
Use LATAMOLOL as instructed by the doctor until the doctor tells the patient to stop.
The doctor may want the patient to have extra checks on the heart and circulation if they use LATAMOLOL.
Contact lens wearers: If the patient wears contact lenses, they should remove them before using LATAMOLOL. After using LATAMOLOL the patient should wait 15 minutes before putting the contact lenses back in.
Instructions for use: 1. Wash the hands and sit or stand comfortably.
2. Unscrew the cap.
3. Use the finger to gently pull down the lower eyelid of the affected eye.
4. Place the tip of the bottle close to, but not touching the eye.
5. Squeeze the bottle gently so that only one drop goes into the eye and then release the lower eyelid.
6. After using LATAMOLOL, press a finger into the corner of the eye by the nose by 2 minutes. This helps to stop timolol getting into the rest of the body.
7. Repeat in the other eye if the doctor has told the patient to do this.
8. Put the cap back on the bottle.
If the patient uses LATAMOLOL with other eye drops: Wait at least 5 minutes between using LATAMOLOL and using other eye drops.
If the patient uses more LATAMOLOL than they should: If the patient puts too many drops in the eye they may experience some minor irritation in the eye and the eyes may water and turn red. This should pass but if the patient is worried contact the doctor for advice.
If the patient swallows LATAMOLOL: If the patient swallows LATAMOLOL accidentally they should contact the doctor for advice. If the patient swallows a lot of LATAMOLOL they may feel sick, have stomach pains, feel tired, flushed and dizzy and start to sweat.
If the patient forgets to use LATAMOLOL: Carry on with the usual dose at the usual time. Do not take a double dose to make up for a forgotten dose.
If the patient has any further questions on the use of this medicine, ask the doctor or pharmacist.
Do not use LATAMOLOL: if the patient is allergic to either of the medicines in LATAMOLOL (latanoprost or timolol), beta-blockers, or any of the other ingredients of this medicine (listed in Description); if the patient has now or has had in the past respiratory problems such as asthma, severe chronic obstructive bronchitis (severe lung disease which may cause wheeziness, difficulty in breathing and/or long-standing cough); if the patient has serious heart problems or heart rhythm disorders; if the patient is pregnant (or trying to become pregnant); if the patient is breast feeding.
LATAMOLOL
can be used in adult men and women (including the elderly), but is not
recommended for use if the patient is less than 18 years of age.
Before using this medicine, tell the doctor if the patient has now or has had in the past: coronary heart disease (symptoms can include chest pain or tightness, breathlessness or choking), heart failure, low blood pressure; disturbances of heart rate such as slow heartbeat; breathing problems, asthma or chronic obstructive pulmonary disease; poor blood circulation disease (such as Raynaud's disease or Raynaud's syndrome); diabetes as timolol may mask signs and symptoms of low blood sugar; overactivity of the thyroid gland as timolol may mask signs and symptoms; the patient is about to have any kind of eye surgery (including cataract surgery) or has had any kind of eye surgery in the past; the patient suffers from eye problems (such as eye pain, eye irritation, eye inflammation or blurred vision); the patient knows that they suffer from dry eyes; the patient wears contact lenses. The patient can still use LATAMOLOL but follow the instructions for contact lens wearers in Dosage & Administration; the patient knows that they suffer from angina (particularly a type known as Prinzmetal angina); the patient knows that they suffer from severe allergic reactions that would usually require hospital treatment; the patient has suffered or is currently suffering from a viral infection of the eye caused by the herpes simplex virus (HSV).
Tell the doctor before the patient has an operation that they are using LATAMOLOL as timolol may change effects of some medicines used during anaesthesia.
LATAMOLOL contains benzalkonium chloride: LATAMOLOL contains a preservative called benzalkonium chloride. This preservative may cause eye irritation or disruption to the surface of the eye. It can be absorbed by contact lenses and is known to discolour soft contact lenses. Therefore, avoid contact with soft contact lenses.
See the instructions for contact lens wearers in Dosage & Administration.
Driving and using machines: When the patient uses LATAMOLOL their vision may become blurred for a short time. If this happens to the patient, do not drive or use any tools or machines until the vision becomes clear again.
Do not use LATAMOLOL if the patient is pregnant unless the doctor considers it necessary. Tell the doctor immediately if the patient is pregnant, thinks she is pregnant or is planning to become pregnant.
Do not use LATAMOLOL if the patient is breast-feeding. LATAMOLOL may get into the milk. Ask the doctor for advice before taking any medicine during breast-feeding.
Like all medicines this medicine can cause side effects, although not everybody gets them.
The patient can usually carry on taking the drops, unless the effects are serious. If the patient is worried, talk to a doctor or pharmacist. Do not stop using LATAMOLOL without speaking to the doctor.
Listed as follows are the known side effects of using LATAMOLOL. The most important side-effect is the possibility of a gradual, permanent change in the eye colour. It is also possible that LATAMOLOL might cause serious changes in the way the heart works. If the patient notices changes in the heart rate or heart function they should speak to a doctor and tell them they have been using LATAMOLOL.
The following are known side effects of using LATAMOLOL: Very common effects (may affect more than 1 in 10 people): A gradual change in the eye colour by increasing the amount of brown pigment in the coloured part of the eye known as the iris. If the patient has mixed-colour eyes (blue-brown, grey-brown, yellow-brown or green brown) they are more likely to see this change than if they have eyes of one colour (blue, grey, green or brown eyes). Any changes in the eye colour may take years to develop. The colour change may be permanent and may be more noticeable if the patient uses LATAMOLOL in only one eye. There appears to be no problems associated with the change in eye colour. The eye colour change does not continue after LATAMOLOL treatment is stopped.
Common effects (may affect up to 1 in 10 people): Eye irritation (a feeling of burning, grittiness, itching, stinging or the sensation of a foreign body in the eye) and eye pain.
Uncommon effects (may affect up to 1 in 100 people): Headache.
Redness of the eye, eye infection (conjunctivitis), blurred vision, watery eyes, inflammation of the eyelids, irritation or disruption of the surface of the eye.
Skin rashes or itching (pruritus).
Other side effects: Although not seen with latanoprost-timolol combination, the following additional side effects have been seen with latanoprost and timolol as monotherapy and therefore might occur when the patient uses LATAMOLOL: The following side effects have been seen with latanoprost: Infections and infestations: Developing a viral infection of the eye caused by the herpes simplex virus (HSV).
Immune system disorders: Symptoms of allergic reaction (swelling and redness of the skin and rash).
Psychiatric disorders: Depression, memory loss, decreased sex drive, inability to sleep, nightmares.
Nervous system disorders: Dizziness, tingling or numbness in the skin, changes in blood flow to the brain, worsening of symptoms of myasthenia gravis (if the patient already suffers from this condition), sudden fainting or feeling the patient may faint (syncope).
Eye disorders: Changes to the eyelashes and fine hairs around the eye (increased number, length, thickness and darkening), changes to the direction of eyelash growth, swelling around the eye, swelling of the coloured part of the eye (iritis/uveitis), swelling at the back of the eye (macular oedema), inflammation/irritation of the surface of the eye (keratitis), dry eyes, fluid filled cyst within the coloured part of the eye (iris cyst), light sensitivity (photophobia), sunken eye appearance (deepening of the eye sulcus).
Ear disorders: Whistling/ringing in the ears (tinnitus).
Heart (cardiac) disorders: Worsening of angina, awareness of heart rhythm (palpitations).
Breathing (respiratory) disorders: Asthma, worsening of asthma, shortness of breath.
Skin disorders: Darkening of the skin around the eyes.
Muscle and skeletal disorders: Joint pain, muscle pain.
General disorders: Chest pain.
Like other medicines applied into eyes, LATAMOLOL is absorbed into the blood. The timolol portion of this combination may cause similar side effects as seen with intravenous and/or oral beta-blocking agents. Incidence of side effects after topical ophthalmic application is lower than when medicines are, for example, taken by mouth or injected. Listed side effects include reactions seen within the class of beta-blockers when used for treating eye conditions: Generalized allergic reactions including swelling beneath the skin that can occur in areas such as the face and limbs and can obstruct the airway which may cause difficulty swallowing or breathing, hives or itchy rash, localized and generalized rash, itchiness, severe sudden life threatening allergic reaction.
Low blood glucose levels.
Difficulty sleeping (insomnia), depression, nightmares, memory loss.
Fainting, stroke, reduced blood supply to the brain, increases in signs and symptoms of myasthenia gravis (muscle disorder), dizziness, unusual sensations like pins and needles, and headache.
Signs and symptoms of eye irritation (e.g. burning, stinging, itching, tearing, redness), inflammation of the eyelid, inflammation in the cornea, blurred vision and detachment of the layer below the retina that contains blood vessels following filtration surgery which may cause visual disturbances, decreased corneal sensitivity, dry eyes, corneal erosion (damage to the front layer of the eyeball), drooping of the upper eyelid (making the eye stay half closed), double vision.
Slow heart rate, chest pain, palpitations, oedema (fluid build up), changes in the rhythm or speed of the heartbeat, congestive heart failure (heart disease with shortness of breath and swelling of the feet and legs due to fluid build up), a type of heart rhythm disorder, heart attack, heart failure.
Low blood pressure, Raynaud's phenomenon, cold hands and feet.
Constriction of the airways in the lungs (predominantly in patients with pre-existing disease), difficulty breathing, cough.
Taste disturbances, nausea, indigestion, diarrhoea, dry mouth, abdominal pain, vomiting.
Hair loss, skin rash with white silvery coloured appearance (psoriasiform rash) or worsening of psoriasis, skin rash.
Muscle pain not caused by exercise.
Sexual dysfunction, decreased libido.
Muscle weakness/tiredness.
In very rare cases, some patients with severe damage to the clear layer at the front of the eye (the cornea) have developed cloudy patches on the cornea due to calcium build-up during treatment.
If the patient gets any side effects, talk to the doctor or pharmacist. This includes any possible side effects not listed in this monograph.
LATAMOLOL can affect or be affected by other medicines the patient is using, including other eye drops for the treatment of glaucoma. Tell the doctor if the patient is using or intends to use medicines to lower blood pressure, heart medicine or medicines to treat diabetes.
Tell the doctor or pharmacist if the patient is taking, has recently taken or might take any other medicines (including using eye drops).
In particular, speak to the doctor or pharmacist if the patient knows that they are taking any of the following types of medicine: Prostaglandins, prostaglandin analogues or prostaglandin derivates; Beta-blockers; Epinephrine; Drugs used to treat high blood pressure such as oral calcium channel blockers, guanethidine, antiarrhythmics, digitalis glycosides or parasympathomimetics; Quinidine (used to treat heart conditions and some types of malaria); Antidepressants known as fluoxetine and paroxetine.
LATAMOLOL with food and drink: Normal meals, food or drink have no effect on when or how the patient should use LATAMOLOL.
Do not throw away any medicines via wastewater or household waste. Ask the pharmacist how to throw away medicines no longer used. The measures will help protect the environment.
Store the unopened bottle of LATAMOLOL in a refrigerator (between 2°C to 8°C). After opening the bottle it is not necessary to store it in a refrigerator but store below 25°C and use within four weeks. When the patient is not using LATAMOLOL, keep the bottle in the outer carton, in order to protect from light.
S01ED51 - timolol, combinations ; Belongs to the class of beta blocking agents. Used in the treatment of glaucoma.
Eye drops (clear, colourless, aqueous solution) 2.5 mL x 1's.
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