Details for: SANDOZ TIMOLOL
Company: SANDOZ CANADA INCORPORATED
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02166712 | SANDOZ TIMOLOL | TIMOLOL (TIMOLOL MALEATE) | 0.25 % | SOLUTION | OPHTHALMIC |
| 02166720 | SANDOZ TIMOLOL | TIMOLOL (TIMOLOL MALEATE) | 0.5 % | 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 Timolol is prescription eyes medication. It is used to lower high eye pressure in adults with glaucoma or other eyes diseases (e.g., ocular hypertension).
What it does
Sandoz Timolol is brand name. Sandoz Timolol contains the active ingredient timolol maleate. Timolol maleate belong to a class of medication called beta-blockers. It lowers eye pressure by causing the eye to make less fluid.
When it should not be used
- if you are allergic to:
- timolol or any ingredient in Sandoz Timolol (see What are the ingredients in Sandoz Timolol?).
- if you are allergic to any other beta-blockers such as atenolol, betaxolol, labetalol, levobunolol, metoprolol, nadolol, propranolol, sotalol.
- if you have or have had lung diseases or breathing problems such as asthma, chronic obstructive pulmonary disease (COPD).
- if you suffer from certain heart disease, such as a slow heart rate, an irregular heartbeat, or heart failure.
What the medicinal ingredient is
Sandoz Timolol contains the active ingredient timolol maleate. It is available in the following two strengths:
- Sandoz Timolol 0.25% - each mL contains 2.5 mg of timolol (as timolol maleate).
- Sandoz Timolol 0.5% - each mL contains 5.0 mg of timolol (as timolol maleate).
What the non-medicinal ingredients are
Benzalkonium chloride 0.01% (preservative), monobasic and dibasic sodium phosphate, sodium hydroxide and/or hydrochloric acid to adjust pH, and purified water.
What dosage form it comes in
Sandoz Timolol, 0.5% or 0.25% comes as a solution (liquid) to use as eye drops.
Sandoz Timolol, 0.5% is supplied in 5 mL and 10 mL bottle designed to deliver a precise quantity of the medication. Sandoz Timolol, 0.25% is supplied in a similar 10mL bottle.
Warnings and precautions
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Sandoz Timolol. Talk about any health conditions or problems you may have, including if you:
- have or have had diabetes or other blood sugar problems. Timolol may mask signs of low blood sugar;
- have or have had thyroid problems;
- have or have had diseases that causes weakness in your muscles. Beta-blockers have been reported to increase muscle weakness in some patients;
- have or have had heart diseases such as:
- coronary heart disease (narrowing of the small blood vessels that supply blood and oxygen to the heart causing chest pain or discomfort when you do certain activities);
- heart failure (weak heart);
- low blood pressure, heartbeat that is not normal, or a very slow heartbeat.
- have or have had lung or breathing problems (e.g., asthma, chronic obstructive lung disease);
- have or have had blood circulation problems such as Raynaud’s syndrome;
- have allergic problems such as eczema, hives or hay fever;
- have allergies to any other medications, foods or any other substances such as preservatives or dyes;
- wear contact lenses.
- are already using another beta-blocker eye drop. It is not recommended to use two beta-blocker eye drops at the same time;
- have or have had eye problems;
- are pregnant or planning to become pregnant;
- are breast feeding or planning to breast feed.
Other warnings you should know about:
While you are using Sandoz Timolol
- Driving and using machines: Sandoz Timolol may cause temporary blurred vision after using the drops. Make sure that your vision is clear before driving a car or operating machinery.
- If you wear contact lenses: Sandoz Timolol contains a preservative (benzalkonium chloride) which may cause eye irritation and discolour soft contact lenses. If you wear contact lenses, remove them before using Sandoz Timolol. Wait at least 15 minutes after using Sandoz Timolol to put your lenses back in.
- If you are planning a surgery: Timolol may change effects of some medicines used during anaesthesia. Anaesthesia is a treatment with certain medicines so that you do not feel pain during surgery.
- If you have an eye injury, or develop an eye infection while using Sandoz Timolol eye drops, tell your healthcare professional.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Interactions with this medication
- Adrenaline (epinephrine) (used to treat life-threatening allergic reactions).
- A group of medicines called oral calcium channel blockers such as diltiazem,verapamil.
- A group of medicines called Catecholamine-depleting drugs (e.g. reserpine).
- Beta-adrenergic blocking agents commonly referred to as beta-blockers such as atenolol, labetalol, metoprolol, nadolol, propranolol, sotalol.
- Medications used to treat certain type of abnormal heart rhythm such as amiodarone, digoxin, quinidine.
- Clonidine (a medication used to treat high blood pressure). Do not stop taking clonidine without talking to your healthcare professional.
- Cimetidine (a medication used to treat stomach problem), Fluoxetine and paroxetine [both medications are used to treat depression (low blood mood)]. Ask your healthcare professional if you are not sure if any of your medicines are listed above.
This is not a list of all drugs that interact with Sandoz Timolol.
Always keep a list of your medicines and show it to your healthcare professional when you get a new medicine. It is important that your healthcare professional reviews all medications and supplements you are taking before prescribing Sandoz Timolol.
Proper use of this medication
- Wash your hands before use. Remove contact lenses before using eye drops.
- Twist the cap off, being careful not to touch the dropper tip.
- Hold the bottle between the thumb and middle finger.
- Tilt head back.
- Pull the lower eyelid down to form a pocket below the eye.
- Gently press on the base of the bottle to release one drop. Do not squeeze the bottle.
- Close the eye for 2 or 3 minutes. If a drop misses the eye, try again.
- Repeat steps 3 to 7 for the other eye if required.
- After use, immediately put the cap back on the bottle and keep tightly closed when not in use.
- Be careful not to touch the dropper tip against your eye, eyelid or anything else to avoid contaminating the eye drops.
- If you are using another eye medication, use it at least 10 minutes before or after you use Sandoz Timolol.
Usual Dose
- Instill one drop in the affected eye(s) twice a day.
Follow the directions on your prescription label carefully, and ask your healthcare professional to explain any part you do not understand.
Use Sandoz Timolol exactly as directed. Do not start, stop, or change the dose of any drug without checking with your healthcare professional.
Overdose
If you use too many drops, you may feel light-headed or dizzy, you may faint, have a very slow pulse rate, or have wheezing or difficulty breathing.
Missed Dose
Use Sandoz Timolol at the same time of day. 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.
Side effects and what to do about them
- Stomach or bowel problems:
- Nausea and vomiting
- Dry mouth
- Discomfort in the upper belly or abdomen
- Change in taste
- Problems with your eye/s such as:
- Blurred vision
- Burning and stinging
- Dry eyes
- Pain in the eye
- Conjunctivitis (pink eye)
- Itching and redness of the eye
- Feeling of having something in the eye,
- Bleparitis (eyelids problem with signs such as irritated, itchy, reddened and swollen eyelids with dandruff-like debris builds up at the base of the eyelashes)
- Visual changes (e.g. double visions)
- Watery eyes
- Changes in the way your hands and feet feel such as:
- Raynaud’s phenomenon
- cold fingers or toes
- colour change in (white, blue then red) in fingers when exposed to the cold or stress
- numbness or tingling in the fingers or toes
- Paresthesia : abnormal sensation such as burning or prickling sensation that is usually felt in the hands or feet, but can also occur in other parts of the body
- Difficulty thinking or working because of:
- Headache
- Tiredness, weakness
- Difficulty sleeping, nightmares
- Changes in mood such as depression, memory loss
- Hair loss or thinning
- Less desire for sex
- Skin rash
Call your healthcare professional or get medical help if any of the side effects listed above bother you or do not go away.
These are not all the possible side effects you may feel when taking Sandoz Timolol. If you experience any side effects not listed here, contact your healthcare professional. Please also see Warnings and Precautions.
| Symptom / effect | Talk to your healthcare professional Only if severe | Talk to your healthcare professional In all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| dizziness and light-headedness, which may be due to low blood pressure | ✔ | ||
| swelling of the hands, feet, ankles or legs | ✔ | ||
Breathing problems:
|
✔ | ||
Heart problems:
|
✔ | ||
Allergic reactions:
|
✔ |
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
How to store
- Keep Sandoz Timolol:
- away from direct light.
- out of the reach and sight of children.
- Store at room temperature (15°C - 30°C).
- Write the date on the bottle when you open the eye drops and throw out any remaining solution one month after opening the bottle. The best way to dispose of your medication is through a medicine take-back program. Check with your pharmacist about how to throw out unused medicines.
- Do not use Sandoz Timolol after the expiry date on the bottle.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
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
- Talk to your doctor or pharmacist.
- Find the full Product Monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website; the manufacturer’s website www.sandoz.ca, or by calling 1-800-361-3062.
This leaflet was prepared by Sandoz Canada Inc.
Last Revised: November 07, 2017