Mint-Dorzolamide/Timolol: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

MINT-DORZOLAMIDE/TIMOLOL is the brandname for the medication dorzolamide and timolol eye drops available only on prescription through your doctor. MINT-

DORZOLAMIDE/TIMOLOL is a combination of an ophthalmic carbonic anhydrase inhibiting drug and an ophthalmic beta-blocking drug, both of which lower the pressure in the eye in different ways.

Remember - This medicine is prescribed for the particular condition that you have.

Do not give this medicine to other people, nor use it for any other condition.

When it should not be used:

Do not use this medicine after the date shown on the container.

Do not use MINT-DORZOLAMIDE/TIMOLOL if you:

• are allergic to any of its components. See “What the important

  nonmedicinal ingredients are.”;

• have now or have had in the past certain serious breathing

  problems such as asthma;

• have chronic obstructive lung disease;

• have certain heart diseases or conditions (such as slow or

  irregular heartbeats);

• have severe kidney problems;
• are taking oral carbonic anhydrase inhibitors;

• are breast feeding or intend to breast feed.

What the medicinal ingredient is:

Each mL contains 20 mg dorzolamide (as dorzolamide hydrochloride) and 5 mg of timolol (as timolol

maleate).

What the important nonmedicinal ingredients are: Hydroxyethyl cellulose, mannitol, sodium citrate dihydrate, sodium hydroxide solution, and water for injection. Benzalkonium chloride is only added as a preservative to MINT-DORZOLAMIDE/TIMOLOL

Ophthalmic Solution.

What dosage forms it comes in:

MINT-DORZOLAMIDE/TIMOLOL (dorzolamide and

timolol eye drops) are sterile eye drops.

This medicine may not be suitable for some patients. So, tell your doctor if you think any of the following applies to you:

• If you have any medical problems now or have had any in the past, lung or breathing (such as asthma or chronic obstructive lung disease) problems or heart problems (such as coronary heart disease, heart failure or low blood pressure);
• If you have any allergies to any medications;
• MINT-DORZOLAMIDE/TIMOLOL Ophthalmic Solution contains the preservative benzalkonium chloride. If you wear contact lenses, you should consult your doctor before using MINT-DORZOLAMIDE/TIMOLOL. Do not administer while wearing (soft) contact lenses. Remove lenses before application and reinsert no earlier than 15 minutes after use.
• If you are pregnant or intend to become pregnant;
• If you are breast feeding or intend to breast feed;
• If you have now or have had in the past kidney problems.
• If you have now or have had in the past liver or thyroid problems.
• If you have now or have had in the past heart rate disturbances (such as slow or irregular heartbeats).
• If you have now or have had in the past poor blood circulation problems (such as Raynaud’s syndrome).
• If you have now or have had in the past diabetes or other blood sugar problems.
• If you have certain eye problems (i.e. corneal defects) or history of eye surgery.

• If you are planning major surgery, including eye surgery, as

  MINT-DORZOLAMIDE/TIMOLOL may change the effects of some medicines during anesthesia.

• If you are taking any other medications see INTERACTIONS

  WITH THIS MEDICATION.

If the following occur during treatment, consult your doctor immediately:

• allergic reaction such as skin rash or itching.
• develop any eye infection, swelling of the eyelid, redness or irritation.
• you have any eye surgery or suffer eye injury.
• severe skin reactions with symptoms such as blisters, peeling skin, red/purple rash, skin lesions and sores, and associated fever, sore throat

MINT-DORZOLAMIDE/TIMOLOL IS NOT RECOMMENDED FOR CHILDREN. In studies with dorzolamide and timolol eye drops, the effect of dorzolamide and timolol eye drops was similar in both elderly and younger adult patients.

INTERACTIONS WITH THIS MEDICATION

Your doctor also needs to know about drugs (including eye drops) that you are using or plan to use, including drugs obtained without a prescription. This is particularly important if you are taking medicine to lower blood pressure (i.e. calcium channel blockers, clonidine), or to treat heart disease (i.e. quinidine, beta-blockers), diabetes, or depression (i.e. selective serotonin reuptake inhibitors, SSRI’s). Also tell your doctor if you are taking large doses of acetylsalicylic acid or sulfa drugs.

Read the following information carefully. If you need any explanations, or further information, ask your doctor or pharmacist.

• Do not start taking any other medicines unless you

  have discussed the matter with your doctor.

• If you are using MINT-DORZOLAMIDE/TIMOLOL with

  another eye drop, the drops should be instilled at least 10 minutes apart.

• Do not change the dosage of the drug without consulting

  your doctor. If you must stop treatment, contact your doctor immediately.

• Do not allow the tip of the container to touch the eye or

  areas around the eye. It may become contaminated with bacteria that can cause eye infections leading to serious damage of the eye, even loss of vision. To avoid possible contamination of the container, keep the tip of the container away from contact with any surface.

Usual Adult dose:

The appropriate dosage and duration of treatment will be established by your doctor.

The usual dose is one drop in the affected eye(s) in the morning and in the evening.

Missed Dose:

It is important to apply MINT-DORZOLAMIDE/TIMOLOL as prescribed by your doctor. If you miss a dose, apply it as soon as possible. However, if it is almost time for the next dose, skip the missed dose and go back to your regular dosing schedule. Do not double dose.

Overdose:

In case of drug overdose, particularly oral ingestion, contact your health care professional, hospital emergency department or regional poison control centre, even if there are no symptoms.

If you feel you have taken too much MINT-

DORZOLAMIDE/TIMOLOL and symptoms may include shortness of breath, low heartbeat, dizziness, headache, etc, seek medical help.

INSTRUCTIONS FOR USE

MINT-DORZOLAMIDE/TIMOLOL Ophthalmic Solution

1. 1. Before using the medication for the first time, be sure the safety seal on the bottle is unbroken.
2. 2. Tear off the safety seal to break the seal.
3. 3. To open the bottle, unscrew the cap by turning. Do not pull the cap directly up and away from the bottle. Pulling the cap directly up will prevent your dispenser from operating properly.
4. 4. Tilt your head back and pull your lower eyelid down slightly to form a pocket between your eyelid and your eye.
5. 5. Invert the bottle and press lightly with the thumb or index (as shown) until a single drop is dispensed into the eye as directed by your doctor.

DO NOT TOUCH YOUR EYE OR EYELID WITH THE DROPPER TIP.

Ophthalmic medications, if handled improperly, can become contaminated by common bacteria known to cause eye infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated ophthalmic medications. If you think your medication may be contaminated, or if you develop an eye infection, contact your doctor immediately concerning continued use of this bottle.

1. 6.

   After using MINT-DORZOLAMIDE/TIMOLOL, press a finger

   into the corner of your eye, by the nose (as shown) for 2 minutes. This helps keep MINT-DORZOLAMIDE/TIMOLOL

   in your eye.

2. 7.

   If drop dispensing is difficult after opening for the first time,

   replace the cap on the bottle and tighten (DO NOT OVERTIGHTEN) and then remove by turning the cap in the opposite direction.

3. 8.

   Repeat steps 4 & 5 with the other eye if instructed to do so

   by your doctor.

4. 9.

   Replace the cap by turning until it is firmly touching the

   bottle. Do not overtighten or you may damage the bottle and cap.

5. 10.

   The dispenser tip is designed to provide a single drop; therefore,

   do NOT enlarge the hole of the dispenser tip.

6. 11.

   After you have used all doses, there will be some MINT-

   DORZOLAMIDE/TIMOLOL left in the bottle. You should not be concerned since an extra amount of MINT-DORZOLAMIDE/TIMOLOL has been added and you will get the full amount of MINT-DORZOLAMIDE/TIMOLOL that your doctor prescribed. Do not attempt to remove excess medicine from the bottle.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

• Any medicine may have unintended or undesirable effects,

  so-called side effects.

• You may experience eye symptoms such as burning and

  stinging, blurred vision, itching, tearing, redness of the eye(s). You may sense a bitter taste after putting in your eye drops. Kidney stones and rarely, rash may also occur.

• Also, other side effects that have been observed with the

  separate active ingredients in MINT-DORZOLAMIDE/TIMOLOL include: muscle pain, abdominal pain, headache, nosebleed, dry mouth, nausea, tiredness, swelling or crusting of the eyelids.

  Other side effects may also occur rarely, and some of these may be serious. These may include shortness of breath, severe skin reactions, visual changes, an irregular heartbeat and a slowing of your heart rate. If you develop a severe skin reaction with symptoms such as blisters, peeling skin, red/purple rash, skin lesions and sores, and associated fever, sore throat, stop taking this medication immediately and contact your physician.

  • Your doctor or pharmacist has a complete list of the possible side effects from this medication. Please tell your doctor or pharmacist promptly about any unusual symptom.
  • If you have blurred vision or tiredness, do not drive until the effects pass.
  • If the contents of the container are swallowed, you should contact your doctor immediately.

This is not a complete list of side effects. For any unexpected effects while taking MINT-DORZOLAMIDE/TIMOLOL, contact your physician or pharmacist.

HOW TO STORE IT

Store at room temperature 15°C – 30°C. Protect from light.

KEEP ALL MEDICINES 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:

• Call toll-free at 1-866-234-2345
• Report online at www.healthcanada.gc.ca/medeffect

• Complete a Canada Vigilance 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 the side effect, please contact your health care provider before notifying Canada Vigilance. The Canada Vigilance Program or Mint Pharmaceuticals Inc. 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, Mint Pharmaceuticals Inc. at: 1-877-398-9696.

Mint Pharmaceuticals Inc.,

Mississauga, Ontario L5T 1J6

Date of Revision: 15 July 2015