The active substances are dorzolamide and timolol. Each ml contains 22.26 mg dorzolamide hydrochloride equivalent to 20 mg dorzolamide and 6.83 mg timolol maleate equivalent to 5 mg timolol.
LAMISOPT PLUS is a slightly opalescent, nearly colorless, slightly viscous solution, with pH from 5.0 to 6.0 and osmolality 240-325 mOsmol/ kg.
Excipients/Inactive Ingredients: The other ingredients are: Mannitol (E421), sodium citrate dehydrate (E331), hydroxyethyl cellulose, benzalkonium chloride, sodium hydroxide (E524) (for pH adjustment), water for injection.
LAMISOPT PLUS contains two medicines: dorzolamide and timolol.
Dorzolamide belongs to a group of medicines called "carbonic anhydrase inhibitors".
Timolol belongs to a group of medicines called "beta blockers".
These medicines lower the pressure in the eye in different ways.
LAMISOPT PLUS is prescribed to lower raised pressure in the eye in the treatment of glaucoma when beta-blocker eyedrop medicine used alone is not adequate.
Always use this medicine exactly as the doctor has told. Check with the doctor or Pharmacist if the patient is not sure. The appropriate dosage and duration of treatment will be established by the doctor.
The usual dose is one drop in the affected eye(s) in the morning and in the evening.
If the patient is using this medicine with another eye drop, the drops should be instilled at least 10 minutes apart.
Do not change the dose of the medicine without consulting the doctor.
Instructions for use: Do not touch the surface of the eye or its surrounding area with the dropper tip.
The eye drops may be contaminated with bacteria that cause eye infections if the product is handled improperly or if the dropper comes into contact with the eye and its surrounding area. Using a contaminated solution may cause serious damage to the eye and subsequent loss of vision. Wash the hands before use and avoid contact between the dropper and any surface in order to avoid possible contamination of the drops. If the patient suspects that the drops may be contaminated or they develop an eye infection, consult the doctor immediately regarding any further use. After application of LAMISOPT PLUS, press the inside corner of the eye against the nose for 2 minutes. This helps the active substances from getting into the system (into the rest of the body).
1. Before using the product for the first time, make sure that the safety strip on the front of the bottle is intact. There is a small gap between the bottle and the cap in an unopened bottle.
2. After tearing off the safety strip the cap can be removed.
3. To open the bottle, unscrew the cap by turning as indicated by the arrows on the top of the cap. The cap must not be pulled directly up and away of the bottle. Pulling the cap directly up, would prevent the dispenser from operating properly.
4. Tilt the head back and pull the lower eyelid down slightly to form a "pocket" between the eyelid and the eye.
5. The bottle should be inverted and pressed lightly with the thumb and index finger until one drop is applied in the eye, as instructed by the doctor. DO NOT TOUCH THE SURFACE OF THE EYE OR ITS SURROUNDING AREA WITH THE DROPPER TIP.
6. If drop dispensing is difficult after opening for the first time, replace the cap on the bottle and tighten (do not over-tighten), then remove it by turning the cap in the opposite direction, as indicated by the arrows on the top of the cap.
7. Repeat steps 4 and 5 with the other eye if instructed to do so by the doctor.
8. Replace the cap and tighten it so that it is securely closed. The arrow on the left side of the cap must be aligned with the arrow on the left side of the bottle label for proper closure. The cap must not be tightened excessively because the bottle and cap may get damaged.
9. The dispenser tip is designed to provide a single drop, therefore DO NOT ENLARGE THE HOLE of the dispenser tip.
10. After dispensing all doses, a small amount of the product will remain in the bottle. Do not worry about this at all, as a small amount of extra LAMISOPT PLUS has been added and the patient has used up the full amount of this medicine as the doctor has prescribed. Do not try to obtain the rest of the medicine from the bottle.
If the patient uses more LAMISOPT PLUS than they should: If the patient puts too many drops in the eye or swallow any of the contents of the container, among other effects, they may become light-headed, have difficulty breathing, or feel that the heart rate has slowed. Contact the doctor immediately.
If the patient forgets to use LAMISOPT PLUS: It is important to use this medicine as prescribed by the doctor.
If the patient misses a dose, use it as soon as possible. However, if it is almost time for the next dose, skip the missed dose and go back to the regular dosing schedule.
Do not use a double dose to make up for the forgotten dose.
If the patient stops using LAMISOPT PLUS: If the patient wants to stop using this medicine talk to the doctor first.
If the patient has any further questions on the use of this medicine, ask the doctor or pharmacist.
Do not use LAMISOPT PLUS if the patient is allergic to dorzolamide hydrochloride, timolol maleate or any of the other ingredients of this medicine (listed in Description); if the patient has now or had in the past respiratory problems, such as asthma or severe chronic obstructive bronchitis (severe lung disease which may cause wheeziness, difficulty in breathing and/or long-standing cough); if the patient has a slow heart beat, heart failure or disorders of heart rhythm (irregular heart beats); if the patient has severe kidney problems, or a prior history of kidney stones; if the patient has excess acidity of the blood caused by a build up of chloride in the blood (hyperchloraemic acidosis).
If the patient is not sure whether they should use this medicine, contact the doctor or pharmacist.
Tell the doctor about any medical or eye problems 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 heart beat; 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.
Tell the doctor before the patient has an operation that they are using LAMISOPT PLUS as timolol may change effects of some medicines used during anaesthesia.
Also tell the doctor about any allergies or allergic reactions including hives, swelling of the face, lips, tongue, and/or throat which may cause difficulty in breathing or swallowing.
Tell the doctor if the patient has muscle weakness or has been diagnosed as having myasthenia gravis.
If the patient develops any eye irritation or any new eye problems such as redness of the eye or swelling of the eyelids, contact the doctor immediately.
If the patient suspects that LAMISOPT PLUS is causing an allergic reaction or hypersensitivity (for example, skin rash, severe skin reaction, or redness and itching of the eye), stop using this medicine and contact the doctor immediately.
Tell the doctor if the patient develops an eye infection, receives an eye injury, has eye surgery, or develops a reaction including new or worsening symptoms.
When LAMISOPT PLUS is instilled into the eye it may affect the entire body. If the patient wears soft contact lenses, they should consult the doctor before using this medicine.
Use in patients with liver impairment: Tell the doctor about any liver problems the patient now has or has suffered from in the past.
LAMISOPT PLUS contains benzalkonium chloride: This preservative may be deposited in soft contact lenses and may possibly discolour the lenses. Remove contact lenses prior to application and wait at least 15 minutes before reinsertion. If the patient wears contact lenses, the patient should consult the doctor before using this medicine.
Driving and using machines: No studies on the effects on the ability to drive or use machines have been performed. There are side effects associated with LAMISOPT PLUS, such as blurred vision, which may affect the ability to drive and/or operate machinery. Do not drive or operate machinery until the patient feels well or the vision is clear.
Use in Children: There is limited experience with the combination of dorzolamide and timolol in infants and children.
Use in Elderly: In studies with the combination of dorzolamide and timolol, the effects of this medicine were similar in both elderly and younger patients.
If the patient is pregnant or breast-feeding, thinks she may be pregnant or is planning to have a baby, ask the doctor or pharmacist for advice before taking this medicine.
Use in pregnancy: Do not use LAMISOPT PLUS if the patient is pregnant unless the doctor considers it necessary.
Use in breast-feeding: Do not use LAMISOPT PLUS if the patient is breast-feeding. Timolol 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's worried, talk to a doctor or pharmacist. Do not stop using LAMISOPT PLUS without speaking to the doctor.
Generalised 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, localised and generalised rash, itchiness, severe sudden life-threatening allergic reaction.
The frequency of possible side effects listed as follows is defined using the following convention: Very common (affects more than 1 user in 10); Common (affects 1 to 10 users in 100); Uncommon (affects 1 to 10 users in 1,000); Rare (affects 1 to 10 users in 10,000); Not known (frequency cannot be estimated from the available data).
The following side effects have been reported with dorzolamide/timolol or one of its components either during clinical trials or during post-marketing experience: Very common: Burning and stinging of the eyes, unusual taste.
Common: Redness in and around the eye(s), watering or itching of the eye(s), corneal erosion (damage to the front layer of the eyeball), swelling and/or irritation in and around the eye(s), feeling of having something in the eye, decreased corneal sensitivity (not realising of getting something in the eye and not feeling pain), eye pain, dry eyes, blurred vision, headache, sinusitis (feeling of tension or fullness in the nose), feeling sick, also called nausea, weakness/tiredness, and fatigue.
Uncommon: Dizziness, depression, inflammation of the iris, visual disturbances including refractive changes (in some cases due to withdrawal of medication to treat excessive contraction of the pupil of the eye), slow heartbeat, fainting, difficulty breathing (dyspnoea), indigestion, and kidney stones (often marked by a sudden onset of excruciating, cramping pain in their low back and/or side, groin, or abdomen).
Rare: Systemic lupus erythematosus (an immune disease which may cause an inflammation of internal organs), tingling or numbness of the hands or feet, trouble sleeping, nightmares, memory loss, an increase in signs and symptoms of myasthenia gravis (muscle disorder), decreased sex drive, stroke, temporary short sightedness which may resolve when treatment is stopped, detachment of the layer below the retina that contains blood vessels following from filtration surgery which may cause visual disturbances, drooping of the eyelids (making the eye stay half closed), double vision, eyelid crusting, swelling of the cornea (with symptoms of visual disturbances), low pressure in the eye, ringing noises in the ear, low blood pressure, changes in the rhythm or speed of the heartbeat, congestive heart failure (heart disease with shortness of breath and swelling of feet and legs due to fluid build up), oedema (fluid build up), cerebral ischaemia (reduced blood supply to the brain), chest pain, palpitations (a quicker and/or irregular heartbeat), heart attack, Raynaud's phenomenon, swelling or coldness of the hands and feet and reduced circulation in the arms and legs, leg cramps and/or leg pain when walking (claudication), shortness of breath, feeling out of breath, runny or stuffed nose, nose bleed, constriction of the airways in the lungs causing difficulty in breathing, cough, throat irritation, dry mouth, diarrhoea, contact dermatitis, hair loss, skin rash with white silvery coloured appearance (psoriasiform rash), Peyronie's disease (which may cause a curvature of the penis), allergic type reactions such as rash, hives, itching, in rare cases possible swelling of the lips, eyes and mouth, wheezing, or severe skin reactions (Stevens Johnson syndrome, toxic epidermal necrolysis).
Like other medicines applied into the eyes, timolol is absorbed into the blood. This may cause similar side effects as seen with oral beta-blocking agents. Incidence of side effects after topical ophthalmic administration is lower than when medicines are, for example, taken by mouth or injected. Listed additional side effects include reactions seen within the class of beta-blockers when used for treating eye conditions: Not known: Low blood glucose levels, heart failure, a type of heart rhythm disorder, abdominal pain, vomiting, muscle pain not caused by exercise, sexual dysfunction.
Reporting of side effects: If the patient gets any side effects, talk to the doctor or pharmacist. This includes any possible side effects not listed in this monograph.
LAMISOPT PLUS 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. This is particularly important if the patient is: taking medicine to lower blood pressure or to treat heart disease (such as calcium channel blockers, beta-blockers or digoxin); taking medicines to treat a disturbed or irregular heartbeat such as calcium channel blockers, beta-blockers or digoxin; using another eyedrop that contains a beta-blocker; taking another carbonic anhydrase inhibitor such as acetazolamide; taking monoamine oxidase inhibitors (MAOIs) which are used to treat depression; taking a parasympathomimetic medicine which may have been prescribed to help the patient pass urine. Parasympathomimetics are also a particular type of medicine which is sometimes used to help restore normal movements through the bowel; taking narcotics such as morphine used to treat moderate to severe pain; taking medicines to treat diabetes; taking antidepressants known as fluoxetine and paroxetine; taking a sulfa medicine; taking quinidine (used to treat heart conditions and some types of malaria).
Do not throw away any medicines via wastewater or household waste. Ask the pharmacist on how to throw away medicines no longer used. These measures will help protect the environment.
This medicine does not require any special storage conditions.
LAMISOPT PLUS should be used within 28 days after the bottle is opened.
S01ED51 - timolol, combinations ; Belongs to the class of beta blocking agents. Used in the treatment of glaucoma.
Eye drops (slightly opalescent, nearly colorless, slightly viscous solution) 5 mL x 1's.
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