Details for: ACT LATANOPROST/TIMOLOL
Company: TEVA CANADA LIMITED
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02436256 | ACT LATANOPROST/TIMOLOL | LATANOPROST; TIMOLOL (TIMOLOL MALEATE) | 50 MCG / ML; 5 MG / ML | SOLUTION | OPHTHALMIC |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
ACT Latanoprost/Timolol is used to reduce eye pressure in patients with open angle glaucoma ocular hypertension. Both these conditions are related to an increase in pressure within the eye and eventually they may affect your eyesight.
What it does
ACT Latanoprost/Timolol is a combination of an ophthalmic prostaglandin drug (latanoprost) and an ophthalmic beta-blocking drug (timolol), both of which lower the pressure within the eye in different ways. The prostaglandin drug works by increasing the natural outflow of fluid from inside the eye. The beta- blocking drug works by decreasing the fluid production in the eye.
When it should not be used
When ACT Latanoprost/Timolol should not be used:
- if you have a reactive airway disease including bronchial asthma, a history of bronchial asthma, or severe chronic obstructive pulmonary disease.
- if you have heart problems such as a sinus bradycardia (low heart beat), sick sinus syndrome, sino-atrial block, second or third degree atrioventricular block not controlled with pace-maker, overt cardiac (heart) failure, or cardiogenic shock.
- if you have known hypersensitivity to latanoprost, timolol, benzalkonium chloride or any other ingredient in the product. (See What the medicinal ingredients are).
What the medicinal ingredient is
Each millilitre (mL) contains 50 micrograms of latanoprost and 5 milligrams of timolol as timolol maleate
What the non-medicinal ingredients are
Benzalkonium chloride (preservative), sodium chloride, sodium phosphate dibasic dodecahydrate, sodium phosphate monobasic dihydrate, purified water, phosphoric acid and sodium hydroxide.
What dosage form it comes in
ACT Latanoprost/Timolol is supplied in an 8 mL plastic ophthalmic dispenser bottle with a dropper tip, and screw cap with safety seal.
Warnings and precautions
Serious Warnings and Precautions
BEFORE you use ACT Latanoprost/Timolol talk to your doctor or pharmacist if:
- You are allergic to any of the ingredients in ACT Latanoprost/Timolol.
- You have a respiratory disease such as asthma, have a history of asthma, or have chronic obstructive pulmonary disease (severe lung disease which may cause wheeziness, difficulty in breathing and/or long-standing cough).
- You have disturbances of heart rate such as slow heart beat (bradycardia).
- You have certain heart diseases or conditions – symptoms can include chest pain or tightness, breathlessness or choking, heart failure, low blood pressure (hypotension).
- You have problems with your blood pressure or thyroid function.
- You have poor blood circulation disease (peripheral arterial disease such as Raynaud’s disease or Raynaud’s syndrome).
- You have diabetes or have low blood sugar levels.
- You have or have had muscle weakness or have been diagnosed as having myasthenia gravis.
- You are using any other eye drops or taking any other medication.
- You are pregnant, think you might be pregnant or you are planning a pregnancy.
- You are breast feeding or planning to breastfeed.
- You have or have had herpes simplex keratitis (inflammation of the cornea caused by the herpes simplex virus
- Your eyes are sensitive to light
- You are planning a surgery
- You have kidney or liver disease
Tell your doctor before you have an operation that you are using ACT Latanoprost/Timolol as Timolol Maleate may change effects of some medicines used during anaesthesia.
ACT Latanoprost/Timolol contains a preservative (benzalkonium chloride) that may be absorbed by contact lenses. The preservative may form a precipitate with an ingredient (thimerosal) present in several contact lens soaking solutions. If you wear contact lenses, remove them before using ACT Latanoprost/Timolol. Wait 15 minutes after applying the eye drops before putting your lenses back in. If you are using more than one type of eye drop medication, wait at least 5 minutes between each different eye drop.
Interactions with this medication
ACT Latanoprost/Timolol can affect or be affected by other medicines you are using, including other eye drops for the treatment of glaucoma. Tell your doctor if you are using or intend to use medicines to lower blood pressure, heart medicine or medicines to treat diabetes or other medicines including:
- calcium channel blockers, beta-adrenergic blocking agent
- antiarrhythmics ( e.g. amiodarone, quinidine),
- monoamine oxidase inhibitors
- narcotics
- digitalis, fluoxetine, paroxetine
Proper use of this medication
Always use ACT Latanoprost/Timolol exactly as your doctor has told you.
Usual Dose
Usual adult dose:
One drop of ACT Latanoprost/Timolol should be dropped into the affected eye(s) once daily.
Do not allow the dropper tip of the bottle to touch the eye or other surrounding structures, because this could contaminate the tip with common bacteria known to cause eye infections. Serious damage to the eye with subsequent loss of vision may result if you use eye drop solutions that have become contaminated. If you experience any type of eye condition or have surgery, immediately seek your doctor's advice concerning the continued use of the bottle you are using.
If you forget to use your eye drops at the usual time, wait until it is time for your next dose. If you put too many drops in your eye(s), you may feel some slight irritation.
Follow these steps to help you use ACT Latanoprost/Timolol properly:
- Wash your hands and sit or stand comfortably. If you wear contact lenses, remove them before using your eye drops.
- Twist off the screw cap. The screw cap should be retained.
- Once the bottle is opened, hold it in one hand and steady your thumb against your brow or the bridge of your nose.
- Use your index finger to gently pull down the lower eyelid of the affected eye(s) to create a pocket for the drop.
- Gently press, or lightly tap the side of the bottle to allow only a single drop to fall into the pocket. Do not let the tip of the bottle touch your eye.
- Close your eye for 2 to 3 minutes.
- If your doctor has told you to use drops in both eyes, repeat the process for the other eye.
- Put the screw cap back on the bottle.
ACT Latanoprost/Timolol should be used until your doctor tells you to stop.
ACT Latanoprost/Timolol is not recommended for use in children.
Overdose
If you think you have taken too much ACT Latanoprost/Timolol, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
Missed Dose
If you forget one dose of ACT Latanoprost/Timolol, continue with the next dose as normal. Do not double dose.
Side effects and what to do about them
In some patients, ACT Latanoprost/Timolol may cause a gradual change in eye color by increasing the amount of brown pigment in the iris (the colored part of the eye). This change may not be noticeable for several months to years. This effect may be more noticeable in patients with eye colors that are mixtures of green and brown, blue/gray and brown, or yellow and brown. The brown pigment may gradually spread outward toward the outside edge of the iris.
However, the entire iris or parts of it may become more brownish in appearance. This change may be more noticeable if you are only treating one eye. Therefore, there is the potential for permanent difference in the colour between the treated and the untreated eyes. Your doctor will examine you regularly to make sure that your medication is working and look for changes in eye color. If you should experience any changes in eye color, your doctor can stop treatment. However, any color change that has already occurred may be permanent, even after the medication is stopped.
ACT Latanoprost/Timolol may also cause your eye lashes to darken, appear thicker and longer than they usually do. A very small number of people may notice their eye lid skin looks darker after using ACT Latanoprost/Timolol for some time. These changes may be more noticeable if you are only treating one eye. ACT Latanoprost/Timolol may also cause your eye lashes to become ingrown.
ACT Latanoprost/Timolol may cause iris cyst (small cyst appearing in the colored part of the eye).
When using ACT Latanoprost/Timolol, you might feel as if there is something in your eye(s). Your eye(s) might water and become red. As with other eye drops, if your vision is blurred when you first put your drops in, wait until this wears off before you drive or operate machinery. A few people using latanoprost and timolol maleate ophthalmic solution have developed a skin rash.
A few people may experience changes in their vision, sometimes in combination with a red and sore/painful eye. These changes do not always occur right after administering the drops, and if they occur, you may find that reading and seeing fine details more difficult. Although unlikely, if you experience any of these changes, stop using ACT Latanoprost/Timolol and contact your doctor immediately.
ACT Latanoprost/Timolol may cause the following side effects as well
Common side effects: eye irritation, including burning and stinging, inflammation of the eye lid and eye pain, upper respiratory tract infection.
Effects on the body: headache and skin rash, loss of appetite, muscle pain, joint pain, chest pain, heart palpitations, asthma, low blood sugar in diabetics, dry eyes, nervous system effects including anxiety, nervousness, dizziness, confusion, disorientation, insomnia, hallucinations.
Be sure to tell your doctor (or pharmacist) if you notice any other unwanted side effects.
| Symptom / effect | Talk to your healthcare professional Only if severe | Talk to your healthcare professional In all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| Rare | |||
| Heart effects such as irregular heartbeat, high blood pressure and low blood pressure | ✔ | ||
| Severe respiratory reactions has been reported with administration of timolol | ✔ | ||
| Allergic reactions with symptoms such as swelling of the mouth, and throat, difficulty breathing, hives, itching, rash. | ✔ | ||
| Beta adrenergic blockers (e.g. timolol) have been reported to cause muscle weakness in those with myasthenia gravis or similar conditions | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking ACT Latanoprost/Timolol, contact your doctor or pharmacist.
How to store
Always keep medicine well out of the reach of children.
Before ACT Latanoprost/Timolol is first opened, keep it in a fridge (between 2°C and 8°C), out of direct light.
Once the bottle has been opened, ACT Latanoprost/Timolol can be kept at normal room temperature up to 25°C, out of direct light. ACT Latanoprost/Timolol must be used within 10 weeks after opening the bottle. Discard the bottle and/or unused contents after 10 weeks. ACT Latanoprost/Timolol should not be used after the expiry date on the bottle.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax; or
- Call toll-free at 1-866-234-2345
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available at MedEffect.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
More information
This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor,
Teva Canada Limited by
Phone: 1-800-268-4127 ext. 3;
Email: druginfo@tevacanada.com;
or Fax: 1-416-335-4472
This leaflet was prepared by:
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
www.tevacanada.com
Last revised: May 14, 2020