Patient Medication Information: uses, side effects, how to take - Latanoprost Ophthalmic Solution (Sandoz Canada)
ABOUT THIS MEDICATION
What the medication is used for:
Latanoprost Ophthalmic Solution is used to treat ocular hypertension (high pressure in the eye) in patients with open-angle glaucoma or ocular hypertension. These conditions may eventually affect your eyesight.
What it does:
Latanoprost Ophthalmic Solution is a solution for use only in the eyes. The active ingredient in Latanoprost Ophthalmic Solution is one of a group of medications known as prostaglandins. It helps to lower the pressure within the eye by increasing the natural outflow of fluid from inside the eye.
When it should not be used:
Do not use Latanoprost Ophthalmic Solution if you have a known hypersensitivity to benzalkonium chloride or any other ingredient in this product (see What the medicinal ingredient is and What the nonmedicinal ingredients are).
What the medicinal ingredient is:
Latanoprost
What the nonmedicinal ingredients are:
Benzalkonium chloride, disodium phosphate (anhydrous), monobasic sodium phosphate, sodium chloride, water for injection.
What dosage forms it comes in:
Latanoprost Ophthalmic Solution is supplied in a 4 mL DROP-TAINER® bottle. Each bottle contains 2.5 mL of solution, approximately 80 drops. Each millilitre (mL) contains 50 micrograms of latanoprost.
WARNINGS AND PRECAUTIONS
BEFORE you use Latanoprost Ophthalmic Solution talk to your doctor or pharmacist if:
You are allergic to any of the ingredients in Latanoprost
Ophthalmic Solution.
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 have liver or kidney problems
- You have or have had eye inflammation (e.g. uveitis, iritis)
Latanoprost Ophthalmic Solution contains a preservative that may be absorbed by contact lenses and stains them a brown colour. Contact lenses can be reinserted 15 minutes after applying the eye drops.
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
Studies have shown that precipitation occurs when eye drops containing thimerosal are mixed with Latanoprost Ophthalmic Solution. If such drugs are used, they should be administered with an interval of at least 5 minutes between applications.
Only on your doctor’s advice, Latanoprost Ophthalmic Solution may be used concomitantly with other topical ophthalmic products to further lower intraocular pressure. If more than one topical ophthalmic drug is being used, the drugs should be administered at least 5 minutes apart.
PROPER USE OF THIS MEDICATION
Usual adult dose:
One drop of Latanoprost Ophthalmic Solution should be dropped into the affected eye(s) once daily. The best time to do this is in the evening.
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.
Latanoprost Ophthalmic Solution is not recommended for use in children.
Follow these steps to help you use Latanoprost Ophthalmic Solution properly:
How to Use:
- 1. Wash your hands.
- 2. Shake well before use.
- 3. Twist off the bottle cap.
- 4.
After the cap is removed: if tamper evident snap collar is
loose, remove before using product.
- 5.
If you wear contact lenses, remove them before using
your eye drops.
- 6.
Hold the bottle, pointing down, between your thumb and
fingers.
- 7. Tilt your head back.
- 8.
Pull down your lower eyelid with a clean finger until
there is a ‘pocket’ between the eyelid and your eye. The drop will go in here. (picture 1).
- 9.
Bring the bottle tip close to the eye. Do this in front of a
mirror if it helps.
- 10.
Do not touch your eye or eyelid, surrounding areas or
other surfaces with the dropper. It could infect the drops.
- 11.
Gently press on the base of the bottle to release one drop
of Latanoprost Ophthalmic Solution Ophthalmic Solution at a time.
- 12.
Do not squeeze the bottle: it is designed so that a gentle
press on the bottom is all that it needs (picture 2).
- 13.
After using Latanoprost Ophthalmic Solution, press a
finger into the corner of your eye, by the nose (picture 3). This helps to stop Latanoprost Ophthalmic Solution Ophthalmic Solution getting into the rest of the body. Close your eye for 2 to 3 minutes.
- 14.
If you use drops in both eyes, repeat the steps for your
other eye.
- 15. Close the bottle cap firmly immediately after use.
- 16. Use up one bottle before opening the next bottle.
- 17. If a drop misses your eye, try again.
Overdose:
In case of drug overdose, contact a healthcare practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
Missed Dose:
If one dose is missed, treatment should continue with the next dose the following day.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Latanoprost Ophthalmic Solution may change the colour of your eye. It may make your iris (the coloured part of your eye) more brown. This happens most commonly if your iris has mixed colours, i.e., blue-brown, grey-brown, green-brown or yellow-brown. If you use Latanoprost Ophthalmic Solution in one eye only, colour changes in the iris may appear only in the treated eye. These changes may be permanent.
Latanoprost Ophthalmic Solution may also cause your eye lashes to darken, appear thicker and longer than they usually do and increase in number. Latanoprost Ophthalmic Solution might cause
eye irritation due to the growth of misdirected eyelashes; tell your doctor if this happens. A very small number of people may notice their eyelids look darker after using Latanoprost Ophthalmic Solution for some time. These changes may be more noticeable if you are only treating one eye. Eyelash changes are reversible after treatment with Latanoprost Ophthalmic Solution is stopped. Eyelid skin darkening may be permanent.
When using Latanoprost Ophthalmic Solution, 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 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 is more difficult. Although unlikely, if you experience any of these changes, stop using Latanoprost Ophthalmic Solution and contact your doctor immediately.
Latanoprost Ophthalmic Solution may cause the following side effects as well.
Common Ocular Side Effects: burning and stinging, blurred vision, red eyes, foreign body sensation, itching, increased iris pigmentation, damage of the cornea in a pinpoint pattern, dry eyes, excessive tearing, eye pain, eye lid crusting, red and swollen eyelid, eyelid discomfort/ pain, photophobia (visual sensitivity to light).
Uncommon Ocular Side Effects: discharge from the eye, diplopia (doubled vision), conjunctivitis, iritis/uveitis (inflammation of the interior of the eye), darkening of the palpebral skin (skin related to the eyelid).
Common Systemic Side Effects: upper respiratory tract infection/ cold/ flu, pain in muscle/ joint/ back, chest pain/angina pectoris, rash/ allergic skin reaction.
Be sure to tell your doctor (or pharmacist) if you notice any other unwanted side effects.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | |||
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | |
| Only if severe | In all cases | ||
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | ||
| Only if severe | In all cases | |||
Uncommon ocular adverse events | Macular edema: blurred or wavy vision in the middle of the eye and colors perception changes | ✓ | ||
Herpetic keratitis: Infection and infestations of the eyes (blurred vision, pain, redness, tearing, discharge, sensitivity to lights) | ✓ | |||
Uncommon Systemic Adverse Events | Asthma/ Asthma aggravation/ Acute asthma attack/ Difficulty to breath | ✓ | ||
Severe skin reactions including rash and skin degradation in different parts of the body | ✓ | |||
This is not a complete list of side effects. For any unexpected effects while taking Latanoprost Ophthalmic Solution, contact your doctor or pharmacist.
HOW TO STORE IT
Before Latanoprost Ophthalmic Solution is first opened, keep it in a fridge (between 2°C and 8°C), out of direct light. Once the bottle has been opened, Latanoprost Ophthalmic Solution may be kept at room temperature up to 25°C. Latanoprost Ophthalmic Solution must be used within 6 weeks after opening the bottle. Discard the bottle and/or unused contents after 6 weeks. Latanoprost Ophthalmic Solution should not be used after the expiry date on the bottle.
Keep all medicines in a safe place, out of the reach of children.
REPORTING SUSPECTED SIDE EFFECTS
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
--------------------------------------------------------------------------
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
Mail to: Canada Vigilance Program Health Canada
Postal Locator 0701E
Ottawa, Ontario
K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. 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, Sandoz Canada Inc., at:
1-800-361-3062
or by written request at:
145 Jules-Léger Street
Boucherville Quebec
J4B 7K8
Or by e-mail at:
medinfo@sandoz.com
®Registered trademark used under license by Sandoz Canada Inc.