Consumer Information for: MYLAN-LATANOPROST/TIMOLOL

MYLAN-LATANOPROST/TIMOLOL is used to reduce eye pressure in patients with conditions called “open angle glaucoma” or “ocular hypertension”. Both these conditions are related to an increase in pressure within the eye. If the high pressure is not reduced, it could damage your eyesight.

MYLAN-LATANOPROST/TIMOLOL contains two drugs, latanoprost and timolol. Both of these drugs lower eye pressure.

Latanoprost works by increasing the natural outflow of fluid from inside the eye. Timolol works by decreasing the fluid production in the eye.

Medicinal ingredients: Each millilitre (mL) contains 50 micrograms of latanoprost and 5 milligrams of timolol as timolol maleate.

Non-medicinal ingredients: Benzalkonium chloride (preservative), disodium hydrogen phosphate anhydrous, hydrochloric acid, sodium chloride, sodium dihydrogen phosphate monohydrate, sodium hydroxide and water for injection.

MYLAN-LATANOPROST/TIMOLOL is supplied in a 5 mL plastic ophthalmic dispenser bottle with a dropper tip, screw cap and tamper proof overcap.

• you have a reactive airway disease including the following:

  • asthma

  • a history of asthma

  • severe chronic obstructive pulmonary disease (a condition where the lungs are inflamed)

• you have heart problems such as:

  • a sinus bradycardia (a condition where there is a low heart beat) o sick sinus syndrome (a heart rhythm disorder)

  • sino-atrial block (a condition in which there is a disorder in the normal rhythm of the heart)

  • second or third degree atrioventricular block not controlled with pace-maker o overt cardiac (heart) failure

  • cardiogenic shock (a serious condition in which your heart suddenly cannot pump enough blood)

• you are allergic to latanoprost, timolol, benzalkonium chloride, any other ingredient in the product or any part of the container. (See What are the ingredients in MYLANLATANOPROST/TIMOLOL?)

• have heart diseases or conditions such as:

  • chest pain or tightness,

  • breathlessness or choking,

  • heart failure,

  • low blood pressure (hypotension).

• have problems with your blood pressure or thyroid.

• have poor blood circulation disease (a condition called Raynaud’s disease or Raynaud’s syndrome).

• have diabetes or have low blood sugar levels.

• have or have had muscle weakness or have been diagnosed as having myasthenia gravis (a condition where your muscles are weaker).

• are using any other eye drops or taking any other medication.

• are pregnant, think you might be pregnant or you are planning a pregnancy.

• are breast feeding or planning to breastfeed.

• have or have had herpes simplex keratitis (a condition where the cornea is inflamed. This is caused by the herpes simplex virus)

• have eyes that are sensitive to light

• are planning a surgery

• have kidney or liver disease

MYLAN-LATANOPROST/TIMOLOL is not recommended for use in children.

Driving and Using Machinery:

Your sight may become blurred for a short period of time just after using MYLANLATANOPROST/TIMOLOL. Do NOT drive or use machines until your sight is clear again.

Surgery:

If you are planning to have surgery, tell your healthcare professional that you are using

MYLAN-LATANOPROST/TIMOLOL. MYLAN-LATANOPROST/TIMOLOL may change the effects of some medicines used during anaesthesia.

Contact Lenses:

MYLAN-LATANOPROST/TIMOLOL contains a preservative (benzalkonium chloride) that may be absorbed by contact lenses. The preservative may form a solid with an ingredient (thimerosal) present in many contact lens soaking solutions.

If you wear contact lenses, remove them before using MYLAN-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 medicine, wait at least 5 minutes between each different eye drop

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

Tell your healthcare professional if you are using or intend to use medicines to lower blood pressure, heart medicine or medicines to treat diabetes or other medicines including:

• Medicines used to treat blood pressure issues like calcium channel blockers.

• Medicines used to treat heart rhythm conditions like antiarrhythmics such as amiodarone or quinidine.

• Medicines used to treat depression like monoamine oxidase inhibitors, fluoxetine, and paroxetine.

• Medicines used to treat pain like narcotics.

• Medicines used to treat heart conditions like digitalis and beta-adrenergic blocking agents.

MYLAN-LATANOPROST/TIMOLOL can affect or be affected by other medicines you are using, including other eye drops for the treatment of glaucoma.

Always use MYLAN-LATANOPROST/TIMOLOL exactly as your healthcare professional has told you.

Usual adult dose:

1 drop of MYLAN-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 anything else. This could contaminate the tip with common bacteria known to cause eye infections. Serious damage to the eye and 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 talk to your healthcare professional about continuing to use MYLAN-LATANOPROST/TIMOLOL.

Follow these steps to help you use MYLAN-LATANOPROST/TIMOLOL properly:

1. Wash your hands and sit or stand comfortably. If you wear contact lenses, remove them before using your eye drops.

2. Twist off the outer protective cap from the bottle.

3. Unscrew the inner cap of the bottle.

4. Once the bottle is opened, hold it in one hand and steady your thumb against your brow or the bridge of your nose.

5. Use your index finger to gently pull down the lower eyelid of the affected eye(s) to create a pocket for the drop.

6. 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.

7. Close your eye for 2 to 3 minutes.

8. If your healthcare professional has told you to use drops in both eyes, repeat the process for the other eye. MYLAN-LATANOPROST/TIMOLOL should be used until your doctor tells you to stop.

If you think you, or a person you are caring for, have taken too much MYLAN-LATANOPROST/TIMOLOL contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.

If you forget one dose of MYLAN-LATANOPROST/TIMOLOL, continue with the next dose as normal. Do not take two doses to make up for the one that you missed. If you take too many doses, you may irritate your eye.

These are not all the possible side effects you may have when taking MYLANLATANOPROST/TIMOLOL. If you experience any side effects not listed here, tell your healthcare professional.

• Change in eye colour

• Longer eye lashes

• Iris cysts

• A feeling that something is in your eye

• Eye redness

• Blurred vision

• Skin rash

• Eye pain

• Eye irritation (for example, burning or stinging eyes)

• Eyelid inflammation

• Infection in nose, sinuses and/or throat

• Headache

• Loss of appetite

• Vomiting

• Nausea

• Muscle pain

• Joint pain

• Chest pain

• Fast-beating or fluttering heart beat

• Asthma

• Low blood sugar in diabetics

• Dry eyes

• Anxiety

• Nervousness

• Dizziness

• Confusion

• Disorientation

• Insomnia

• Hallucinations

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Keep out of reach and sight of children.

Before MYLAN-LATANOPROST/TIMOLOL is first opened, keep it in a fridge (between 2°C and 8°C).

Once the bottle has been opened, MYLAN-LATANOPROST/TIMOLOL can be kept at normal room temperature up to 25°C.

Protect from light.

MYLAN-LATANOPROST/TIMOLOL must be used within 10 weeks after opening the bottle. Discard the bottle and/or unused contents after 10 weeks.

MYLAN-LATANOPROST/TIMOLOL should not be used after the expiry date on the bottle.

• Talk to your healthcare professional

• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; the manufacturer’s website www.viatris.ca, or by calling 1-844-596-9526.

This leaflet was prepared by Mylan Pharmaceuticals ULC.

Last Revised: November 16, 2023

Mylan Pharmaceuticals ULC

Etobicoke, Ontario M8Z 2S6

© 2023 Mylan Pharmaceuticals ULC, a Viatris company.