Mint-Labetalol: Uses, Side Effects and Dosage

What is MINT-LABETALOL used for?

MINT-LABETALOL is used to treat high blood pressure (also known as hypertension) in adults. MINT-LABETALOL can be used alone or with other medicines to treat this condition.

How does MINT-LABETALOL work?

MINT-LABETALOL belongs to a group of drugs called “beta-blockers”.

• It makes your heart beat more slowly and less forcefully.
• It lowers your blood pressure by relaxing your blood vessels so that your blood flows more easily.

This medicine does not cure your disease but helps to control it. Therefore it is important to continue taking MINT-LABETALOL regularly even if you feel fine.

What are the ingredients in MINT-LABETALOL?

Medicinal ingredient: labetalol hydrochloride

Non-medicinal ingredients: colloidal silicon dioxide, corn starch, croscarmellose sodium, hydroxypropyl methylcellulose, magnesium stearate, methylcellulose, polyethylene glycol and titanium dioxide.

The 100 mg tablets also contain: FD&C yellow #6 aluminum lake, iron oxide yellow, polysorbate 80 and quinoline yellow aluminium lake.

MINT-LABETALOL comes in the following dosage forms:

Tablets: 100 mg and 200 mg

Do not use MINT-LABETALOL if you:

• Are allergic or hypersensitive to labetalol hydrochloride or to any of the other ingredients in MINT-LABETALOL.
• Have heart failure and you notice that your symptoms are getting worse. For example, you feel more tired, are out of breath more often, or have swelling of the ankles.
• Have severe heart damage and your heart is not able to pump enough blood to meet your body’s needs.
• Have a slow or irregular heartbeat.
• Have a problem with your heart’s electrical conduction (that causes you to have chest pain, difficulty breathing, nausea, fatigue and fainting).
• Have asthma or other lung problems (like bronchitis or emphysema).
• Have serious problems with blood flow in your feet and legs (severe peripheral artery disease).
• Are less than 18 years old.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take MINT-LABETALOL. Talk about any health conditions or problems you may have, including if you:

• Have a history of heart problems.
• Have a history of fainting.
• Have diabetes and take medicine to control your blood sugar or have low blood sugar (hypoglycemia).
• Have a condition called pheochromocytoma (a tumour of the adrenal gland).
• Have thyroid problems.
• Have liver problems.
• Have had allergic reactions or have allergies.

• Are pregnant or trying to become pregnant. MINT-LABETALOL is not usually recommended for use during pregnancy. Your doctor will consider the benefit to you versus the risk to your unborn baby.

• Are breastfeeding. You should not breastfeed while using MINT-LABETALOL.
• Are scheduled for surgery and will be given an anesthetic.
• Develop a skin rash while taking MINT-LABETALOL.

Other warnings you should know about:

Do not stop taking MINT-LABETALOL suddenly. This could cause chest pain or a heart attack. If your doctor decides that you should stop taking MINT-LABETALOL, your dose may be reduced so that you need to use less and less before you stop the medicine completely.

The results of urine tests may be affected by taking MINT-LABETALOL. If you need to have a urine test, tell your doctor that you have been given MINT-LABETALOL tablets.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with MINT-LABETALOL:

• Drugs used to treat high blood pressure, such as:

  • Diuretics (“water pills”)
  • ACE inhibitors
  • Calcium channel blockers (e.g. diltiazem, verapamil)
• Anesthetic drugs used during surgery (e.g. halothane)
• Drugs used to prevent angina (e.g. nitroglycerin)
• Drugs used to treat heartburn and stomach ulcers (e.g. cimetidine)
• Drugs used to treat depression (e.g. tricyclic antidepressants)
• Drugs used to treat multiple sclerosis (e.g. fingolimod)

How to take MINT-LABETALOL:

Your doctor will determine your dose based on your individual medical needs and will tell you when and how to take MINT-LABETALOL. Take MINT-LABETALOL exactly as prescribed.

MINT-LABETALOL should be taken preferably after food.

Usual adult dose:

Starting daily dose: 100 mg twice a day

Daily maintenance dose: 200 to 400 mg twice a day

Maximum daily dose: 1200 mg per day (600 mg twice a day)

Your doctor may:

• Start you on a different dose or change your dose over time depending on how MINT-LABETALOL works for you.
• Add another medicine like a diuretic (“water pill”) or an ACE inhibitor for you to take along with MINT-LABETALOL to treat your high blood pressure.

Do not stop taking MINT-LABETALOL or change your dose without first consulting your doctor. This can be dangerous.

For elderly patients and patients with liver problems:

Smaller doses are generally used in older patients, and those with liver problems.

Overdose:

What are possible side effects from using MINT-LABETALOL?

These are not all the possible side effects you may feel when taking MINT-LABETALOL. If you experience any side effects not listed here, contact your healthcare professional. Please also see Warnings and Precautions.

Side effects may include:

• Dizziness
• Headache
• Nausea/Vomiting
• Tiredness

Serious side effects and what to do about them

If you think you have taken too much MINT-LABETALOL, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

Storage:

Store between 15 °C and 30 °C. Preserve in tight, light resistant containers.

Keep out of reach and sight of children.

If you want more information about MINT-LABETALOL:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website; the manufacturer’s website www.mintpharmaceuticals.com, or by calling 1-877-398-9696.

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.