PRZ-Propranolol: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

PRZ-PROPRANOLOL contains propranolol hydrochloride, one of a group of substances called beta-adrenergic receptor-blocking agents (beta blockers). It is used as:

• Treatment for patients with high blood pressure;
• Preventive treatment of angina pectoris (a condition associated with sharp chest pain and difficulty breathing, often associated with exercise);
• Treatment of abnormal heart rhythms;
• Prevention of migraine (severe headache often accompanied by nausea, vomiting, and sensitivity to light);
• Management of hypertrophic subaortic stenosis (a condition associated with stress-induced chest pain, pounding heart, and fainting);

• Management of adrenal gland

What it does:

PRZ-PROPRANOLOL acts to reduce high blood pressure and guard against angina pectoris.

It works by the effects it has on the heart and circulation and also on other parts of the body.

When it should not be used:

Do not use PRZ-PROPRANOLOL if you:

• are hypersensitive (allergic) to propranolol hydrochloride or another beta-blocker;
• are hypersensitive to any ingredient in the formulation or component of the container. For a complete listing, see What the important nonmedicinal ingredients are;
• have had or currently have bronchial asthma or bronchospasm (a sudden closing of muscles in the throat, making it hard to breathe);
• have allergic rhinitis (for example, runny nose during the pollen season);
• have a heart condition known as congestive heart failure (a condition where the heart is unable to pump enough blood);
• have pulmonary hypertension (high blood pressure in the arteries of the lungs, which lead to heart failure);
• are prone to having hypoglycaemia (episodes of low blood sugar);
• have any of the following heart or cardiovascular conditions:
• bradycardia (abnormally slow heart beat)
• hypotension (unusually low blood pressure)
• metabolic acidosis (when there is too much acid in the body’s fluids)
• poor blood circulation
• sick sinus syndrome (a group of heart rhythm disorders);
• untreated phaeochromocytoma (a tumour condition in the adrenal glands)
• uncontrolled heart failure
• Prinzmetal’s angina (a condition that produces chest pain and pressure while at rest)
• have one of the following rare hereditary diseases:
• Galactose intolerance
• Lapp lactase deficiency
• Glucose-galactose malabsorption

What the medicinal ingredient is:

Propranolol hydrochloride

What the nonmedicinal ingredients are: PRZ- PROPRANOLOL contains lactose, magnesium stearate, microcrystalline cellulose, and starch (20 mg, 40 mg and 80 mg).

For a full listing of nonmedicinal ingredients see Part 1 of the product monograph.

What dosage forms it comes in:

20 mg tablets: Blue coloured, round, biconvex tablet, debossed with 20 on one side, and a breakline on the other side.

40 mg tablets: Green coloured, round, biconvex tablet, debossed with 40 on one side, and a breakline on the other side.

80 mg tablets: Yellow coloured, round, biconvex tablet, debossed with 80 on one side, and a breakline on the other side.

WARNINGS AND PRECAUTIONS

PRZ-PROPRANOLOL should never be stopped abruptly. PRZ-PROPRANOLOL is not intended for emergency use. It can be used as a starting treatment. Your doctor will tell you how to take PRZ-PROPRANOLOL and will monitor your response regularly.

If you have been taking PRZ-PROPRANOLOL for angina pectoris, do not stop treatment or change the dose without directions from your doctor.

Use caution when driving or operating machinery while taking PRZ-PROPRANOLOL, as it may lead to fatigue or dizziness.

Before you use PRZ-PROPRANOLOL, talk to your doctor or pharmacist if you

• have a heart condition;
• have poor circulation;
• have a history of serious allergies;
• have a history of skin reactions;
• are prone to chronic bronchitis and emphysema not related to allergies;
• have diabetes;
• have a condition involving an over-active thyroid gland
• have or have had a severe allergic
• the eyes and skin;
• have liver or kidney problems;
• are to undergo surgery;

• are pregnant or intending to become pregnant;

• are nursing;
• are taking any other medications.

PRZ-PROPRANOLOL is not recommended for children.

If taken with some other medicines, the effects of PRZ- PROPRANOLOL or the other medication may change. Tell your doctor or pharmacist if you are taking or have recently taken any other medications, including non-prescription medicines, vitamins, minerals, natural supplements, or alternative medicines.

Examples of drugs or substances that may interact with PRZ- PROPRANOLOL include:

• Alcoholic beverages

  • Diuretics (drugs used to increase urine output, such as hydrochlorothiazide)
  • Drugs used to control heart rhythm, e.g., disopyramide, amiodarone, propafenone, quinidine
  • Warfarin (to thin the blood)
  • Insulin
  • Drugs used to reduce high blood pressure, e.g., guanethidine, clonidine, calcium channel blockers (verapamil, diltiazem, nifedipine)
  • Rizatriptan (a drug used to treat migraine headaches)
  • Digitalis (a drug used to control heart rate and rhythm)
  • Epinephrine (a drug used to treat severe allergic reactions)
  • Cimetidine (a drug used to treat stomach ulcers and pain)
  • Ergotamines (a class of drugs used to treat migraine headaches)
  • Chlorpromazine (one of a class of drugs used to treat psychoses)
  • Lidocaine (a drug used as a local anesthetic)
  • Pain relief or anti-inflammatory drugs available with or without prescriptions such as ibuprofen
  • Fingolimod, a medicine used to treat multiple sclerosis

Please check with your doctor or pharmacist before taking any other medications with PRZ-PROPRANOLOL.

Usual dose:

Take PRZ-PROPRANOLOL tablets

Serious Drug Interactions

Beta-blockers, like PRZ-PROPRANOLOL, should not be used together with other medicines used to lower blood pressure called calcium channel blockers (such as verapamil and diltiazem). If they are taken together they can cause serious side effects like very low blood pressure, slow heartbeat and heart failure. If you have taken a calcium channel blocker you must wait 48 hours before taking PRZ-PROPRANOLOL. If your healthcare professional has told you to stop taking PRZ-PROPRANOLOL, and has prescribed a calcium channel blocker, you must wait 48 hours before taking the calcium channel blocker.

INTERACTIONS WITH THIS MEDICATION

PROPER USE OF THIS MEDICATION

exactly as directed by your doctor and your doctor will determine which dose is right for you.

Overdose:

Missed Dose:

If you missed a dose of this medication, take it as soon as you remember. However, if it is almost time for your next dose, do not take the missed dose or take a double dose to make up for the missed tablet. Instead, go back to your regular dosing schedule.

Like all medicines, PRZ-PROPRANOLOL can cause side effects, although not everybody gets them.

The most common side effects are abdominal pain, nausea, vomiting, loss of appetite and diarrhea. Other side effects include dizziness, fatigue, disturbed sleep and nightmares, cold hands and feet, numbness and spasm in your fingers followed by warmth and pain (Raynaud’s phenomenon).

The most serious side effects with propranolol hydrochloride are congestive heart failure and bronchospasm (see When it should not be used and WARNINGS AND PRECAUTIONS).

The following table contains a list of side effects that may occur with PRZ-PROPRANOLOL. The table does not include a complete list. Therefore, check with your doctor immediately if you notice or are bothered by any unusual symptoms.

If you think you have taken too much PRZ- PROPRANOLOL, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

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

Store at room temperature (15°C to 30°C). Keep out of the reach and sight of children.

More Information

If you want more information about PRZ-PROPRANOLOL:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare

HOW TO STORE IT

SERIOUS SIDE EFFECTS AND WHAT TO DO ABOUT THEM

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 (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) 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.

• professionals and includes this Consumer Information by visiting the Health Canada website (https://www.canada.ca/en/healt h-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website (www.pharmaris.com) or by calling 1-866-913-7955.

Canada Inc.

Last revised: AUG 12, 2024