Details for: TEVA-PINDOLOL
Company: TEVA CANADA LIMITED
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 00869007 | TEVA-PINDOLOL | PINDOLOL | 5 MG | TABLET | ORAL |
| 00869015 | TEVA-PINDOLOL | PINDOLOL | 10 MG | TABLET | ORAL |
| 00869023 | TEVA-PINDOLOL | PINDOLOL | 15 MG | TABLET | ORAL |
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
TEVA-PINDOLOL lowers high blood pressure
(hypertension). TEVA-PINDOLOL can be used alone or with
other medicines to treat this condition.
TEVA-PINDOLOL is also used to treat chest pains (angina)
due to ischemic heart disease (disease caused by plaque
building up along the inner walls of the arteries of the heart,
which narrows the arteries and reduces blood flow to the
heart).
What it does
TEVA-PINDOLOL belongs to a class of drugs called “betablockers”. These drugs block the action of certain chemicals on
the heart that increase blood pressure and increase heart rate.
This medicine does not cure your disease. It helps to control it.
Therefore, it is important to continue taking TEVA-PINDOLOL regularly even if you feel fine.
When it should not be used
Do not take TEVA-PINDOLOL if you:
- are allergic to pindolol or any other beta-blockers or any of the non-medicinal ingredients of TEVA-PINDOLOL listed under “What the non-medicinal ingredients are”.
- have or have had asthma or other lung diseases (such as Chronic obstructive pulmonary disease known as COPD)
- have heart failure
- have high blood pressure that affects the arteries in your lungs and the right side of your heart
- have reduced blood flow to the heart causing heaviness, tightness or pain in your chest
- have a slow heartbeat (less than 45 to 50 beats per minute)
- have had a condition where your heart suddenly could not pump enough blood causing:
- rapid heartbeat
- shortness of breath
- sweating
- loss of consciousness
- will have surgery where you will need general anesthesia
- have certain types of abnormal heart beat caused when the heart’s natural pacemaker doesn’t work properly
- have narrowed arteries that reduce the blood flow to your limbs. This can cause paleness or poor circulation in the arms and legs (cold hands and feet)
- have a tumor of the adrenal gland known as pheochromocytoma.
What the medicinal ingredient is
Pindolol
What the non-medicinal ingredients are
The non-medicinal ingredients are colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate and sodium starch glycolate.
What dosage form it comes in
Tablets; 5, 10 and 15 mg
Warnings and precautions
BEFORE you use TEVA-PINDOLOL talk to your doctor or pharmacist if you:
- have history of heart failure
- have any of the following:
- diabetes and are taking insulin or oral diabetes medicine
- severe kidney disease
- liver disease
- a condition causing overactivity of the thyroid gland
- psoriasis (a type of skin disease characterized by thickened patches of red/silver skin)
- have had a severe allergic reaction in the past
- are taking medications to treat high blood pressure
- have asthma, chronic bronchitis, and emphysema, or an inflammation in the nose due to allergies
- are undergoing surgery or dental treatment
- are pregnant, or plan to become pregnant
- are breastfeeding (TEVA-PINDOLOL may pass into your milk and harm your baby)
- are less than 18 years old
- are currently taking or have recently taken any other prescription or over-the-counter medications
Driving and using machines
Before you perform tasks which may require special attention, wait until you know how you respond to TEVA-PINDOLOL. Dizziness, and/or fatigue can especially occur after the first dose and when the dose is increased.
Slow heart beat
You may experience a slow heart beat while taking TEVAPINDOLOL. If this happens, contact your doctor. Your dose may need to be reduced.
Laboratory Tests
Your doctor may perform tests at regular intervals if you are taking TEVA-PINDOLOL for a long time.
Interactions with this medication
As with most medicines, interactions with other drugs are
possible. Tell your doctor, nurse, or pharmacist about all the
medicines you take, including prescription and over-the
counter medicines.
The following medicines may interact with TEVA-PINDOLOL:
- medicines used to treat the irregular rhythm of the heart such as digoxin and digitalis
- medicines found in some cold remedies and nose drops (e.g. noradrenaline isoprenaline, ephedrine, phenylephrine, phenylpropanolamine, xanthine derivative)
- medicines used to treat high blood pressure, including clonidine and calcium channel blockers (e.g. oral verapamil, diltizem). Your doctor should carefully monitor you if you are taking these in combination with TEVA-PINDOLOL.
- insulin or oral antidiabetic medicines,
- non-steroidal anti-inflammatory drugs (NSAIDs), used to reduce pain and swelling (such as ibuprofen, naproxen, celecoxib)
- ergot alkaloids, a class of medicines used in the prevention and treatment of migraine headaches
- cimetidine, used to relieve heartburn and gastrointestinal ulcers
- medicines used to treat depression, seizures, schizophrenia, or psychotic disorders (e.g., tricyclic antidepressants, barbiturates, phenothiazines, monoamine oxidase inhibitors)
- fingolimod, a medicine used to treat multiple sclerosis
- medicines used for anaesthesia such as cyclopropane, trichloroethylene.
Proper use of this medication
Your doctor will determine your dose based on your individual
medical needs and will tell you when and how to take TEVAPINDOLOL. Take TEVA-PINDOLOL exactly as prescribed.
It is recommended to take your dose at about the same time
every day.
TEVA-PINDOLOL should be taken with food.
Do not stop taking TEVA-PINDOLOL or change your
dose without first talking to your doctor. Serious side
effects, such as chest pain or heart attack can occur if you
abruptly stop taking this medication.
Usual Dose
To treat high blood pressure:
The usual starting dose is 5 mg twice a day. In some cases,
your doctor may prescribe a higher dose, up to a maximum of
45 mg each day.
To treat chest pain due to heart disease:
The usual starting dose is 5 mg, three times a day. In some
cases, your doctor may prescribe a higher dose if needed, up to
a maximum recommended dose of 40 mg each day.
Overdose
Missed Dose
If you miss a dose, skip the missed dose and carry on with the next one at the usual time. Do not double the dose.
Side effects and what to do about them
As with all medicines, patients taking TEVA-PINDOLOL may experience side effects. Keep track of your side effects and consult the table below for appropriate action.
| Symptom / effect | Talk with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist in all cases | Stop taking drug and seek immediate medical attention |
|---|---|---|---|
| Common | |||
| Nausea | ✔ | ||
| Uncommon | |||
| Dry eyes | ✔ | ||
| Unknown frequency | |||
| Allergic reaction: rash, hives, swelling of the face, lips, tongue or throat, difficulty swallowing or breathing | ✔ | ||
| Slow heartbeat | ✔ | ||
| Heart rhythm disturbance | ✔ | ||
| Heart failure | ✔ | ||
| Chest Pain: sudden and oppressive | ✔ | ||
| Coldness, burning, tingling or numbness in arms or legs | ✔ | ||
| Difficulty breathing with wheezing or coughing | ✔ | ||
| Hallucination: seeing or hearing things that are not there | ✔ | ||
| Low blood pressure | ✔ | ||
| Shortness of breath | ✔ | ||
| Tiredness | ✔ | ||
| Dizziness | ✔ | ||
| Headache | ✔ | ||
| Trembling | ✔ | ||
| Nausea | ✔ | ||
| Vomiting | ✔ | ||
| Abdominal pain | ✔ | ||
| Diarrhea | ✔ | ||
| Muscle cramp | ✔ | ||
| Sleep | ✔ | ||
| Depression | ✔ | ||
| Skin reaction | ✔ | ||
| Excessive sweating | ✔ | ||
| Aggravation of psoriasis (thick patches of red/silver skin) | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking TEVA-PINDOLOL, contact your doctor or pharmacist.
How to store
- Do not use after the expiry date shown on the box.
- Store at 15-30ºC in the original package, protect from light.
- Keep out of the reach and sight 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 Teva Canada
Limited by:
Phone: 1-800-268-4127 ext. 3;
Email: druginfo@tevacanada.com; or
Fax: 1-416-335-4472
This leaflet was prepared by:
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada, M1B 2K9
www.tevacanada.com
Last revised: April 23, 2019