Details for: SANDOZ DORZOLAMIDE/TIMOLOL
Company: SANDOZ CANADA INCORPORATED
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02344351 | SANDOZ DORZOLAMIDE/TIMOLOL | DORZOLAMIDE (DORZOLAMIDE HYDROCHLORIDE); TIMOLOL (TIMOLOL MALEATE) | 20 MG / 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
Sandoz Dorzolamide/Timolol is the brandname for the medication dorzolamide hydrochloride and timolol maleate available only on prescription through your doctor. Sandoz Dorzolamide/Timolol is a combination of an ophthalmic carbonic anhydrase inhibiting drug and an ophthalmic betablocking 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 Sandoz Dorzolamide/Timolol if you:
- are allergic to any of its components (see: “What the 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 of dorzolamide (as dorzolamide hydrochloride USP) and 5 mg of timolol (as timolol maleate USP).
What the non-medicinal ingredients are
Benzalkonium chloride (as a preservative), hydroxyethyl cellulose, mannitol, sodium hydroxide, sodium citrate dihydrate and water for injection.
What dosage form it comes in
Sandoz Dorzolamide/Timolol are sterile eye drops supplied in a white LDPE plastic DROP-TAINER® bottle, a white dropper tip and a blue polypropylene cap.
Warnings and precautions
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.
- Sandoz Dorzolamide/Timolol contains the preservative benzalkonium chloride. If you wear contact lenses, you should consult your doctor before using Sandoz 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 Sandoz 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.
SANDOZ DORZOLAMIDE/TIMOLOL IS NOT RECOMMENDED FOR CHILDREN.
In studies with dorzolamide hydrochloride and timolol maleate, its effect 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.
Proper use of this medication
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 Sandoz Dorzolamide/Timolol with another eyedrop, 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.
Overdose
If you feel you have taken too much of Sandoz Dorzolamide/Timolol and symptoms may include shortness of breath, low heartbeat, dizziness, headache, etc., seek medical help.
Missed Dose
It is important to apply Sandoz 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.
How to Use The DROP-TAINER® * BOTTLE
The DROP-TAINER® * bottle is designed to assure the delivery of a precise dose of medication. Before using your DROP-TAINER® bottle, read the complete instructions carefully.
KEEP YOUR HEAD TILTED BACKWARD AND CLOSE YOUR EYE TO ALLOW ABSORPTION OF THE MEDICATION INTO THE EYE
After using Sandoz Dorzolamide/Timolol, press a finger into the corner of your eye, by the nose (as shown) for 2 minutes. This helps keep Sandoz Dorzolamide/Timolol in your eye.
10. Repeat 6, 7, 8, & 9 with other eye if instructed to do so.
11. Replace screw cap by turning until firmly touching the
bottle.
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 that your medication may be contaminated, or if you develop an eye infection, contact your doctor immediately concerning continued use of this bottle.
The dispenser tip is designed to provide a single drop; therefore, do NOT enlarge the hole of the dispenser tip.
After you have used all doses, there will be some Sandoz Dorzolamide/Timolol ophthalmic solution left in the bottle. You should not be concerned since an extra amount of Sandoz Dorzolamide/Timolol ophthalmic solution has been added and you will get the full amount of Sandoz Dorzolamide/Timolol ophthalmic solution 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 dorzolamide hydrochloride or timolol mateate separately, 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.
- Possible side effects such as visual disturbances may affect the ability to drive and use machines.
- If the contents of the container are swallowed, you should contact your doctor immediately.
| Symptom / effect | Talk with your doctor or pharmacist only if severe | Talk with your doctor or pharmacist in all cases | Stop taking drug and seek immediate emergency medical attention |
|---|---|---|---|
| Uncommon | |||
| Slow heartbeat | ✔ | ||
| Rare | |||
| Heart effects such as irregular heartbeat, heart block, low blood pressure | ✔ | ||
| Allergic reactions with symptoms such as swelling of mouth and throat, shortness of breath, hives, severe itching and rash | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking Sandoz Dorzolamide/Timolol, contact your doctor or pharmacist.
How to store
Store Sandoz Dorzolamide/Timolol at 2 - 25°C. Protect from light.
KEEP ALL MEDICINES OUT OF REACH OF CHILDREN
Reporting side effects
You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.
3 ways to report:
- Online at MedEffect
- By Calling 1-866-234-2345 (toll-free);
- By Completing a Patient Side Effect Reporting Form and sending it by:
- Fax toll-free to 1-866-678-6789, or
- Mail to: Canada Vigilance Program
Health Canada
Postal Locator 1908C
Ottawa ON
K1A 0K9
Postage paid labels, and the Patient Side Effect Reporting Form 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 obtained by contacting the sponsor, Sandoz Canada Inc., at: 1-800-361-3062
Or
by written request at:
145, Jules-Léger
Boucherville, (QC), Canada
J4B 7K8
or by e-mail at :
medinfo@sandoz.com
This leaflet was prepared by Sandoz Canada Inc
Last revised: November 2, 2017