Patient Medication Information: uses, side effects, how to take - Apo-Propranolol
ABOUT THIS MEDICATION
What the medication is used for:
APO-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 tumours.
What it does:
APO-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 APO-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: APO-PROPRANOLOL contains lactose (20 mg and 120 mg), magnesium stearate, microcrystalline cellulose, and starch (10 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:
10 mg tablets: Orange, round, biconvex tablet. Scored & engraved APO over 10 on one side, other side plain. Bottles of 100 and 1000 tablets.
20 mg tablets: Blue, hexagonal, biconvex tablet. Scored & engraved APO over 20 on one side, other side plain. Bottles of 100 and 1000 tablets.
40 mg tablets: Green, round, biconvex tablet. Scored & engraved APO over 40 on one side, other side plain. Bottles of 100 and 1000 tablets.
80 mg tablets: Yellow, round, biconvex tablet. Scored & engraved APO over 80 on one side, other side plain. Bottles of 100 and 1000 tablets.
120 mg tablets: Reddish-pink, round, biconvex tablet. Scored & engraved APO over 120 on one side, other side plain. Bottles of 100 and 1000 tablets.
WARNINGS AND PRECAUTIONS
APO-PROPRANOLOL should never be stopped abruptly.
APO-PROPRANOLOL is not intended for emergency use. It can be used as a starting treatment. Your doctor will tell you how to take APO-PROPRANOLOL and will monitor your response regularly.
If you have been taking APO-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 APO-PROPRANOLOL, as it may lead to fatigue or dizziness.
Before you use APO-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 condition involving 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.
APO-PROPRANOLOL is not recommended for children.
INTERACTIONS WITH THIS MEDICATION
If taken with some other medicines, the effects of APO-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 APO-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 APO-PROPRANOLOL.
PROPER USE OF THIS MEDICATION
Usual dose:
Take APO-PROPRANOLOL tablets exactly as directed by your doctor and your doctor will determine which dose is right for you.
Overdose:
| If you think you have taken too much APO-PROPRANOLOL, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms. |
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.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Like all medicines, APO-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 APO-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.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | |||||||
|---|---|---|---|---|---|---|---|
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | |||||
| Only if severe | In all cases | ||||||
| Frequency unknown | Allergic reactions (skin rash, hives, itching, swelling of the lips, face, tongue, throat, trouble breathing or swallowing, wheezing, blisters of the skin, sores or pain in the mouth or eyes) | √ | |||||
| Difficulty breathing and swollen ankles (Congestive heart failure) | √ | ||||||
Abnormally low blood pressure, dizziness (particularly, when standing up), tiredness fainting | √ | ||||||
| Bronchospasm, asthma | √ | ||||||
| Weakness, insomnia, headache, fatigue | √ | ||||||
| Changes in mood, hallucinations, memory loss | √ | ||||||
| Dry eyes, visual disturbances | √ | ||||||
| Common | Abdominal pain, nausea, vomiting, diarrhea, loss of appetite | √ | |||||
| Uncommon | Ringing in the ears | √ | |||||
Low level of sugar in the blood (hypoglycemia) | √ | ||||||
This is not a complete list of side effects. For any unexpected effects while taking APO-PROPRANOLOL, contact your doctor or pharmacist.
HOW TO STORE IT
Store at room temperature (15oC to 30oC). Keep out of the reach and sight of children.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
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
If you want more information about APO-PROPRANOLOL:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website (https://health-products.canada.ca/dpd-bdpp/index-eng.jsp); the manufacturer’s website (http://www.apotex.ca/products), or by calling 1-800-667-4708.