Sandoz-Pindolol: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Sandoz Pindolol belongs to the group of medicines known as beta-adrenergic blocking agents (beta-blockers). It is used to treat high blood pressure, also called hypertension. It is also used to prevent a type of chest pain called Angina Pectoris.

What it does:

Sandoz Pindolol works by reducing your hearts workload in order to prevent chest pain and heart attacks.

With its ability to dilate blood vessels it is used to treat high blood pressure.

When it should not be used:

Do not take Sandoz Pindolol if you:

• are allergic to pindolol or any other beta blockers or any of

  the inactive ingredients of Sandoz Pindolol listed under “What the nonmedicinal ingredients are”.

• suffer from, or have suffered in the past from, bronchial

  asthma, or other lung diseases or trouble in breathing,

• suffer from a severe heart disease,

• have had an alteration in the structure and function of the right

  ventricle of the heart caused by a primary disorder of respiratory system (called Cor pulmonale),

• suffer from chest pain, mainly occurring at rest,

• suffer from irregular or unusually slow heartbeat (less than 45

  to 50 beats per minute),

• have had sudden loss of consciousness in the past,

• suffer from severe blood flow disturbances of your blood

  vessels causing paleness or poor circulation in the arms and legs (cold hands or feet)

• suffer from pheochromocytoma (a type of tumor of the

  adrenal glands).

What the medicinal ingredient is:

Pindolol

What the nonmedicinal ingredients are:

The nonmedicinal ingredients are cellulose microcrystalline, pregelatinized starch, magnesium stearate, silica colloidal

anhydrous.

What dosage forms it comes in:

Tablets; 5, 10 and 15 mg.

WARNINGS AND PRECAUTIONS

BEFORE you use Sandoz Pindolol talk to your doctor or pharmacist if:

1. 1.

   If you suffer from any of the following:

   • diabetes mellitus (sugar diabetes), and you are taking insulin or diabetes medicine by mouth,
   • severe kidney disease,
   • liver disease,
   • milder forms of circulatory disturbances of blood vessels (symptoms such as paleness, cold hands or feet),
   • overactive thyroid,
   • chronic bronchitis and emphysema,
   • psoriasis (a type of skin disease characterized by thickened patches of red/silver skin)
2. 2. you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
3. 3.

   you are pregnant, or plan to become pregnant.

4. 4. you are breastfeeding (the active ingredient may pass into your milk and harm your baby).
5. 5. you are having any kind of surgery or dental treatment.
6. 6. you are experiencing eye problems (symptoms like dry, gritty or burning eyes).

If any of these apply to you, tell your doctor before taking Sandoz Pindolol. The doctor will take these things into account before and during your treatment with Sandoz Pindolol and your doctor may need to monitor you more closely while you are using this medicine.

Driving and using machines

In some people, Sandoz Pindolol may cause dizziness or tiredness. If this happens to you, do not drive, use machinery, or perform other tasks that need full attention.

INTERACTIONS WITH THIS MEDICATION

Other medicines and Sandoz Pindolol may interfere with each other. These medicines include:

• medicines used to treat high blood pressure, chest pain

  (angina pectoris), disturbances of heart rhythm,

• digoxin and digitalis glycosides, a heart medicine,
• medicines containing adrenaline or similar substances, such as nose and eye drops, cough medicines, or remedies for the common cold (substances that raise blood pressure),
• insulin or antidiabetic medicines taken by mouth,

• medicines used to relieve pain or inflammation (especially

  non-steroidal anti-inflammatory drugs),

• ergot alkaloids, a class of medicines used in the prevention

  and treatment of migraine headaches,

• monoamine oxidase inhibitors (antidepressant drugs),

• medicine used to relieve heartburns and gastrointestinal ulcer

  (called as cimetidine),

• medicines used to treat anxiety and/or panic disorder,

  schizophrenia or psychosis

PROPER USE OF THIS MEDICATION

Follow your doctor’s instructions carefully. Do not exceed the recommended dose.

How much Sandoz Pindolol to take

The dose of this medicine will be different for different patients. Also, the number of doses you take each day and the time allowed between doses depend on the medical problem for which you are taking Sandoz Pindolol .

Treatment is usually started with the lowest dose. Depending on how you respond to the treatment, your doctor may suggest a higher or lower dose.

In general the average daily dosage for the tablets is in the following ranges:

Usual adult dose:

• High blood pressure

  5 to 15 mg once daily in the morning.

  Doses of 20 mg should be taken in 2 divided doses in the morning and the evening.

• Angina pectoris (chest pain) and Increased heart rate

  (tachycardia)

  10 to 30 mg daily in 3 or 4 divided doses.

• Hyperkinetic heart syndrome

  10 to 20 mg daily

Take Sandoz Pindolol at the same time each day. Swallow the table(s) with a little liquid with food. Do not stop taking this drug without your doctor’s advice.

This drug is not recommended for children under 18 years of age.

Patients at the age of 65 or over may experience more side effects than young patients. Close monitoring by your doctor may be required.

If you have questions about how long to take Sandoz Pindolol, talk to your doctor or your pharmacist.

Overdose:

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

If you accidentally take a lot more Sandoz Pindolol tablets than your doctor has prescribed, contact or go to the nearest hospital emergency department or your doctor immediately, or make sure that someone else can contact them for you.

Signs and symptoms caused by taking more of Sandoz Pindolol can be:

Abnormally low heartbeat, low blood pressure, low blood sugar; insufficient action of the heart to pump blood which may lead to loss of consciousness; irregular heart beat; heart failure; difficulty breathing with wheezing or coughing; shortness of breath; vomiting; convulsions (seizures); heart attack.

Missed Dose:

If you forget to take a dose of Sandoz Pindolol, take the missed dose as you notice it. However, if it is almost time for the next dose, skip the missed dose and go back to your regular dosage schedule. Do not double doses.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

As with all medicines, patients taking Sandoz Pindolol may experience side effects. Keep track of your side effects and consult the table below for appropriate action.

This is not a complete list of side effects. For any unexpected effects while taking Sandoz Pindolol, contact your doctor or pharmacist.

HOW TO STORE IT

• Do not use after the expiry date shown on the box.
• Store in the original package, protect from light.
• Keep out of the reach and sight 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:

--------------------------------------------------------------------------

• 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, 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 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 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

Last revised: February 2, 2012