Inderal LA - Consumer Medicine Information
|Condition:||Angina, Aortic Stenosis, Atrial Fibrillation, High Blood Pressure (Hypertension), Migraine Prevention (Migraine Prophylaxis), Mitral Valve Prolapse, Thyrotoxicosis, Ventricular Tachycardia|
|Class:||Group II antiarrhythmics, Non-cardioselective beta blockers|
|Ingredients:||propranolol hydrochloride, ethylcellulose, hydroxypropylmethylcellulose, microcrystalline cellulose, gelatin, titanium dioxide, FD&C Blue 1 colorant (all strengths), FD&C Red 28 colorant (60 mg strength) and FD&C Red 3 colorant (80 and 120 mg strengths)|
Propranolol Hydrochloride Extended-Release Capsules
About This Medication
What the Medication Is Used For
INDERAL - LA contains propranolol hydrochloride, one of a group of substances called beta-adrenergic receptor-blocking agents (beta blockers). It is in an extended release form, used as:
- Maintenance 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).
What It Does
INDERAL - LA 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 INDERAL -LA 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)
What the Medicinal Ingredient Is
What the Important Nonmedicinal Ingredients Are
INDERAL-LA capsules contain ethylcellulose, hydroxypropylmethylcellulose, microcrystalline cellulose. The capsules shells contain gelatin, titanium dioxide, FD&C Blue 1 colorant (all strengths), FD&C Red 28 colorant (60 mg strength) and FD&C Red 3 colorant (80 and 120 mg strengths). White ink is used for imprinting all strengths, while the 60 mg strength also uses blue ink.
For a full listing of nonmedicinal ingredients see Part 1 of the product monograph.
What Dosage Form It Comes In
60 mg capsules: Each white/light blue capsule, identified by 3 narrow white bands, and imprinted with “INDERAL LA 60” contains 60 mg propranolol hydrochloride. Bottles of 100 capsules.
80 mg capsules: Each light blue capsule, identified by 3 narrow white bands, and imprinted with “INDERAL LA 80” contains 80 mg propranolol hydrochloride. Bottles of 100 capsules.
120 mg capsules: Each light blue/dark blue capsule, identified by 3 narrow white bands, and imprinted with “INDERAL LA 120” contains 120 mg propranolol hydrochloride. Bottles of 100 capsules.
160 mg capsules: Each dark-blue capsule, identified by 3 narrow white bands and imprinted with “INDERAL LA 160” contains 160 mg propranolol hydrochloride. Bottles of 100 and 500.
Warnings and Precautions
INDERAL - LA should never be stopped abruptly.
INDERAL - LA is not intended for use as a starting treatment or for emergency use. It is intended as maintenance therapy only, once your condition has been stabilized. If you have been on a medication that needs to be taken several time daily, your doctor may switch you to INDERAL - LA which is taken just once daily. Your doctor will tell you how to take INDERAL - LA and will monitor your response regularly while you are getting used to INDERAL - LA.
If you have been taking INDERAL - LA 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 INDERAL - LA, as it may lead to fatigue or dizziness.
Before you use INDERAL - LA, 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.
INDERAL - LA is not recommended for children.
Interactions With This Medication
If taken with some other medicines, the effects of INDERAL - LA 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 INDERAL - LA 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)
- 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
Please check with your doctor or pharmacist before taking any other medications with INDERAL - LA.
Proper Use of This Medication
Take INDERAL - LA capsules exactly as directed by your doctor and your doctor will determine which dose is right for you.
Take INDERAL - LA once daily, either in the morning or the evening. Capsules must be swallowed whole and not chewed.
|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 miss a dose, talk to your doctor or pharmacist for advice. However, if it is almost time for your next dose, do not take themissed dose or take a double dose to make up for the missed capsule. Instead, go back to your regular dosing schedule.
Side Effects and What to Do About Them
Like all medicines, INDERAL - LA 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 common side effects include 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 INDERAL - LA are congestive heart failure and bronchospasm (see When it shouldnot be used and WARNINGS AND PRECAUTIONS).
The following table contains a list of side effects that may occur with INDERAL - LA. The table does not include a complete list. Therefore, check with your doctor immediately if younotice or are bothered by any unusual symptoms.
|Symptom / effect||Talk with your|
|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||✓|
|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 INDERAL - LA, contact your doctor or pharmacist.
How to Store It
Store at room temperature (15°C to 30°C)
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
Postal Locator 0701E
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.
This document plus the full product monograph, prepared for health professionals can be found at:
www.pfizer.ca or can be obtained by contacting the sponsor, Pfizer Canada Inc., at: