Novo-Acebutolol (Type S): Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

$ NOVO-ACEBUTOLOL (TYPE S) (Acebutolol

hydrochloride) is used to lower blood pressure and reduce angina (chest pain).

What it does:

$ NOVO-ACEBUTOLOL (TYPE S) is in a class of drugs called

beta-blockers. Beta-blockers affect the heart and circulatory system (arteries and veins).

When it should not be used:

• You have ever had an allergic reaction to NOVO-

  ACEBUTOLOL (TYPE S) or to other beta-blockers, or to any of the other ingredients in this medicine (See “What the nonmedicinal ingredients are”).

• You have or have ever suffered from any heart conditions

  including heart failure which is not under control, second-or third-degree heart block

• You have ever suffered from very slow or very irregular

  heartbeats, very low blood pressure or very poor circulation

• You have high blood pressure in the circulation to the lungs

• You go into hospital to have an operation and will be given

  an anesthetic

What the medicinal ingredient is:

The medicinal ingredient in NOVO-ACEBUTOLOL (TYPE S) is “Acebutolol hydrochloride”.

What the nonmedicinal ingredients are:

NOVO-ACEBUTOLOL (TYPE S) tablets contain the following non medicinal ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone, sodium lauryl sulfate, and talc. In addition: NOVO-ACEBUTOLOL (TYPE S) 100 mg and 400 mg tablets contains polyethylene glycol, polyvinyl alcohol (partially hydrolyzed), talc and titanium dioxide, NOVO-ACEBUTOLOL (TYPE S) 200 mg tablets contains D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum 3% - 5% Lake, FD&C Blue #2 Aluminum 3% - 5% Lake, glyceryl triacetate, polyethylene glycol, polydextrose, hydropropyl methylcellulose, titanium dioxide.

What dosage forms it comes in: 100 mg, 200 mg and 400 mg Tablets

WARNINGS AND PRECAUTIONS

BEFORE you use NOVO-ACEBUTOLOL (TYPE S) talk to your doctor or pharmacist if:

$ you have or have ever suffered from any heart conditions including heart failure, second-or third-degree heart block

$ you have ever suffered from very slow or very irregular heartbeats, very low blood pressure or very poor circulation

$ you have thyrotoxicosis (a condition caused by an overactive thyroid gland). NOVO-ACEBUTOLOL (TYPE S) may hide the symptoms of thyrotoxicosis. $ you are pregnant, are trying to become pregnant or are breast-feeding

$ you have asthma, wheezing or any other similar breathing problems

$ you go into hospital to have an operation, tell the anaesthetist and/or the medical staff that you are taking NOVO-ACEBUTOLOL (TYPE S).

$ you are taking any other medicines, including any you have bought from the pharmacy

$ you have diabetes. NOVO-ACEBUTOLOL (TYPE S)

may modify your normal response to low blood sugar, which usually involves an increase in heart rate. $ you have problems with your kidneys. $ you have problems with your liver

You may notice that your pulse rate becomes slower while you are taking the tablets. This is normal, but if you are concerned, please tell your doctor about it.

Driving and using machines

• Your medicine is unlikely to affect your ability to drive or to operate machinery. However, some people may occasionally feel dizzy or tired when taking NOVO-ACEBUTOLOL (TYPE S). If this happens to you, ask your doctor for advice.

NOVO-ACEBUTOLOL (TYPE S) must not be given to children.

INTERACTIONS WITH THIS MEDICATION

Drugs that may interact with NOVO-ACEBUTOLOL (TYPE S) include:

• Clonidine (for hypertension or migraine). If you are taking clonidine and NOVO-ACEBUTOLOL (TYPE S) together, you must not stop taking clonidine unless your doctor tells you to do so. If you have to stop taking clonidine, your doctor will give you careful instructions how to do it.
• Reserpine

• Nasal decongestants or other cold remedies (including the

  ones you can buy in the pharmacy).

If you are taking any other medicines, including any you have bought from the pharmacy, you should tell your doctor.

PROPER USE OF THIS MEDICATION

Usual dose:

Your doctor will tell you how much NOVO-ACEBUTOLOL (TYPE S) to take each day and when to take them, depending on your condition. Also, read the label on the container. Your pharmacist can help you if you are not sure.

Swallow NOVO-ACEBUTOLOL (TYPE S) tablets with a drink of water.

Do not stop taking your medicine without talking to your doctor first. In some cases, it may be necessary to stop taking the medicine gradually.

Overdose:

If you accidentally take an overdose NOVO-ACEBUTOLOL (TYPE S) tablets, either call your doctor straight away, or go to your nearest hospital emergency department. Always take any remaining tablets, the container and the label with you, so that the medicine can be identified.

Missed Dose:

If you forget to take your NOVO-ACEBUTOLOL (TYPE S) tablets at the right time, take your dose when you remember and then take your next dose at the usual time. Don’t take two doses at the same time. If you are worried, ask your doctor or pharmacist for advice.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

As with all medicines, there may be some possible side effects while you are taking NOVO-ACEBUTOLOL (TYPE S).

If you experience any of the following serious side effects, stop taking NOVO-ACEBUTOLOL (TYPE S) and call your doctor immediately or seek emergency medical treatment:

• an allergic reaction (difficulty breathing; closing of the

  throat; swelling of the lips, tongue, or face; hives); ③ wheezing or shortness of breath;

• an unusually slow or irregular heartbeat; ③ swelling of the feet and/or lower legs; ③ leg pain or cramping;
• chest (heart) pain;
• blue or cold feet and hands; or
• a rash.

If you experience any of the following less serious side effects, continue taking acebutolol and talk to your doctor:

• fatigue or confusion;

  • headache or dizziness;
  • weak pulse or a mildly slow heart rate; ③ diarrhea, constipation, gas, nausea, or vomiting; ③ depression;
  • nightmares

This is not a complete list of side effects. For any unexpected effects while taking NOVO-ACEBUTOLOL (TYPE S), contact your doctor or pharmacist.

HOW TO STORE IT

Store between 15 – 30 ˚C. Protect from light.

REPORTING SUSPECTED SIDE EFFECTS

To monitor drug safety, Health Canada collects information on serious and unexpected effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Health Canada by:

toll-free telephone: 866-234-2345

toll-free fax 866-678-6789

By email: cadrmp@hc-sc.gc.ca

By regular mail:

National AR Centre

Marketed Health Products Safety and Effectiveness Information Division

Marketed Health Products Directorate

Tunney’s Pasture, AL 0701C

Ottawa ON K1A 0K9

NOTE: Before contacting Health Canada, you should contact your physician or pharmacist.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be found by contacting Novopharm Limited at:

at: 1-800-268-4127 ext. 5005

or druginfo@novopharm.com

Novopharm Limited

30 Novopharm Court

Toronto, Ontario

Canada, M1B 2K9

Last revised: May 11, 2007