Details for: SANDOZ BRIMONIDINE
Company: SANDOZ CANADA INCORPORATED
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02305429 | SANDOZ BRIMONIDINE | BRIMONIDINE TARTRATE | 0.2 % | 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 Brimonidine eye drops are used to reduce high pressure in the eye in patients with chronic open-angle glaucoma or ocular hypertension.
What it does
Sandoz Brimonidine is a preserved eye drop solution that reduces the amount of fluid flowing into the eye and increases the amount of fluid flowing out of the eye. This reduces the pressure inside the eye.
When it should not be used
Do not use Sandoz Brimonidine:
- If you are allergic to brimonidine tartrate or any of the other ingredients (See what the nonmedicinal ingredients are)
- If you are receiving monoamine oxidase (MAO) inhibitor therapy
- In neonates and infants below the age of 2 years
What the medicinal ingredient is
Brimonidine tartrate
What the non-medicinal ingredients are
0.005% benzalkonium chloride, as preservative, citric acid, polyvinyl alcohol, purified water, sodium chloride and sodium citrate. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH.
What dosage form it comes in
Ophthalmic solution, brimonidine tartrate 0.2%, w/v
Warnings and precautions
Sandoz Brimonidine may cause drowsiness and fatigue or blurred vision. Do not drive, use heavy machinery or engage in hazardous activities or activities requiring mental alertness, until these conditions have passed.
BEFORE you use Sandoz Brimonidine talk to your doctor or pharmacist if:
- you are breastfeeding a baby, pregnant or intend to become pregnant
- you have any allergies to this drug, or to similar drugs (ask your doctor) or to Sandoz Brimonidine’s ingredients or components of its container
- you are taking or intend to take other prescription or non-prescription drugs. This is particularly important if you are taking medicine to lower blood pressure or to treat heart disease
- you wear contact lenses. The preservative in Sandoz Brimonidine (benzalkonium chloride) may be absorbed by soft (hydrophilic) contact lenses. Lenses should be removed prior to using Sandoz Brimonidine and kept out for 15 minutes after use.
Interactions with this medication
Drugs that may interact with Sandoz Brimonidine include:
Central nervous system depressants (alcohol, barbiturates, opiates, sedatives, or anesthetics), heart and blood pressure medications such as alpha-agonists, medication such as beta-blockers (ophthalmic and/or systemic), antihypertensives, cardiac glycoside, tricyclic antidepressants and clonidine.
Drug interactions studies have not been done for Sandoz Brimonidine.
Proper use of this medication
Usual Dose
Normally, you should put one drop of Sandoz Brimonidine in each eye that needs treatment, twice every day, about 12 hours apart, following the instructions for use below.
You must not use the bottle if the tamper-proof seal on the cap is broken before you first use it.
Follow the following steps to help you use Sandoz Brimonidine
properly:
1. Wash your hands. Tilt your head back and look at the ceiling.
2. Gently pull down the lower eyelid to create a small pocket.
3. Turn the bottle upside down and squeeze it gently to release
one drop into each eye that needs treatment.
4. Let go of the lower lid, and close your eye for 30 seconds.
If a drop misses your eye, try again.
Sandoz Brimonidine contains a preservative called benzalkonium chloride which may discolour soft contact lenses. If you wear contact lenses, remove them before using Sandoz Brimonidine. Wait 15 minutes after using the drops before you put your lenses back in.
Always use Sandoz Brimonidine exactly as your doctor has instructed you. If you use Sandoz Brimonidine with another eye drop, leave at least five minutes between putting in Sandoz Brimonidine and then the other drops.
To help prevent infections, do not let the tip of the bottle touch your eye or anything else. Put the cap back on and close the bottle immediately after you have used it.
Overdose
If you accidentally use too many drops, just go back to your regular twice a day dosing the next day. If you have any concerns, talk to your doctor or pharmacist.
Missed Dose
If you forget to apply your eye drops at your normal time, simply apply them as soon as you remember. Then go back to the original schedule as directed by your doctor. Do not try to catch up on missed drops by applying more than one dose at a time.
Side effects and what to do about them
| Common | |||
|---|---|---|---|
| Very common | Occurs in more than 1 out of 10 patients | ||
| Common | Occurs in between 1 and 10 out of every 100 patients | ||
| Uncommon | Occurs in between 1 and 10 out of every 1000 patients | ||
The following side effects may be seen with Sandoz Brimonidine. If these persist or cause you concern, consult your doctor.
Very common:
- Dry mouth
- Irritation of the eye (eye redness, burning, stinging, a feeling of something in the eye)
- Blurred vision
- Headache
- Tiredness, sleepiness or drowsiness
Common:
- Local irritation (inflammation and swelling of the eyelid, pain and tearing)
- Sensitivity to light
- Erosion on the surface of the eye and staining
- Eye dryness
- Abnormal vision
- Dizziness
- Cold-like symptoms
- Symptoms involving the stomach and digestion
- Abnormal taste
- General weakness
| Symptom / effect | Talk with your doctor or pharmacist only if severe | Talk with your doctor or pharmacist in all cases | Stop taking drug and call your doctor or pharmacist |
|---|---|---|---|
| Uncommon | |||
| Bradycardia/ heart rate decreased | ✔ | ||
| Hypotension/ blood pressure decreased | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking Sandoz Brimonidine, contact your doctor or pharmacist.
How to store
Sandoz Brimonidine should be stored at 4°C to 30°C.
Do not use the drops after the expiry date (marked “Exp”) on the bottle and the box.
Keep out of reach of children.
Reporting 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 three 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 ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM 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
Boucherville QC
J4B 7K8
Or by e-mail at :
medinfo@sandoz.com
This leaflet was prepared by Sandoz Canada Inc.
Last revised: December 13, 2013