NTP-Atenolol/Chlorthalidone: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

NTP-ATENOLOL/CHLORTHALIDONE

(atenolol/chlorthalidone) is used to reduce high blood pressure.

What it does:

NTP-ATENOLOL/CHLORTHALIDONE Tablets contain two active ingredients. Atenolol is one of a group of drugs called beta-blockers. It has effects on the heart and circulation. Chlortalidone is one of a group of drugs called diuretics. It increases the amount of urine produced by the kidneys. Exactly how NTP-ATENOLOL/CHLORTHALIDONE Tablets reduce blood pressure is not known.

When it should not be used:

• You have ever had an allergic reaction to NOVO-

  ATENOLTHALIDONE, atenolol, or chlorthalidone, or to drugs known as sulfonamides, or to any of the other ingredients in this medicine (See “What the nonmedicinal ingredients are”).

• You are pregnant, are trying to become pregnant or are

  breast-feeding.

• You have poor blood circulation, controlled heart failure or

  first-degree heart block.

• 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 high blood pressure in the circulation to the lungs.

• You have ever suffered from very slow or very irregular

  heartbeats, very low blood pressure or very poor circulation.

• You have ever been told that you have phaeochromocytoma

  (high blood pressure caused by a tumour, usually near the kidney which is not being treated).

• You have been told you have metabolic acidosis (abnormal

  levels of acid in your blood).

• You are unable to produce urine.

What the medicinal ingredient is:

Atenolol and chlorthalidone.

What the nonmedicinal ingredients are:

Magnesium stearate, microcrystalline cellulose, povidone and

sodium starch glycolate.

What dosage forms it comes in:

NTP-ATENOLOL/CHLORTHALIDONE is available in tablets 50/25 mg and 100/25 mg strengths.

WARNINGS AND PRECAUTIONS

BEFORE you use NTP-ATENOLOL/CHLORTHALIDONE talk to your doctor or pharmacist if:

• you are taking any other medicines, including any you have bought from the pharmacy.
• you have problems with your kidneys.
• you have asthma, wheezing or any other similar breathing problems, or you get allergic reactions, for example to insect stings. If you have ever had asthma or wheezing, you should not take these tablets unless you have discussed these symptoms with the doctor who first gave you the tablets.
• you have a type of chest pain (angina) called Prinzmetal's angina.
• you have diabetes. NTP-ATENOLOL/CHLORTHALIDONE may modify your normal response to low blood sugar, which usually involves an increase in heart rate.
• you have thyrotoxicosis (a condition caused by an overactive thyroid gland). NTP-ATENOLOL/CHLORTHALIDONE may hide the symptoms of thyrotoxicosis.
• you go into hospital to have an operation, tell the anaesthetist and/or the medical staff that you are taking NTP-ATENOLOL/CHLORTHALIDONE.

NTP-ATENOLOL/CHLORTHALIDONE must not be given to children.

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 NTP-

  ATENOLOL/CHLORTHALIDONE. If this happens to you, ask your doctor for advice.

INTERACTIONS WITH THIS MEDICATION

Drugs that may interact with NTP-

ATENOLOL/CHLORTHALIDONE include:

• Clonidine (for hypertension or migraine). If you are taking clonidine and NTP-ATENOLOL/CHLORTHALIDONE 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.

• Verapamil, diltiazem and nifedipine (which are used to treat

  hypertension or angina).

• Disopyramide (for irregular heartbeats).
• Digoxin (for heart failure).
• Norepinephrine (a heart stimulant).
• Ibuprofen and indomethacin (for pain and inflammation).
• Lithium (for certain psychiatric disturbances).
• Reserpine or guanethidine.

• 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 many NTP-

ATENOLOL/CHLORTHALIDONE tablets 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 NTP-ATENOLOL/CHLORTHALIDONE 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 NTP-

ATENOLOL/CHLORTHALIDONE 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 NTP-

ATENOLOL/CHLORTHALIDONE 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 NTP-ATENOLOL/CHLORTHALIDONE.

Occasionally, a few people may suffer from the following:

Cold hands and feet, tiredness, slow heartbeat, headache, dry mouth, nausea (feeling like vomiting), diarrhea, disturbed sleep, thinning of the hair, mood changes, confusion, delirium or hallucinations, tingling of the hands, dry eyes, disturbances of

vision, skin rashes, worsening of psoriasis, dizziness (particularly when standing up), impotence.

Some people may also suffer from numbness and spasm in the fingers (Raynaud’s phenomenon).

Other possible side effects are a reduction in the amount of sodium in the blood, which may cause weakness, vomiting and cramps, a reduction in the amount of potassium in the blood, an increase in the amount of uric acid in the blood or a reduction in the number of white blood cells. Your doctor may take blood samples every so often to check on these levels.

Do not stop or restart NTP-ATENOLOL/ CHLORTHALIDONE on your own.

Do not be alarmed by this list of possible side effects. You may not have any of them.

This is not a complete list of side effects. For any unexpected effects while taking NTP-ATENOLOL/CHLORTHALIDONE, contact your doctor or pharmacist.

HOW TO STORE IT

Store at room temperature between 15-30^oC.

Keep Out of the Reach of Children.

The tablets are only for you and must never be given to anyone else.

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 Teva Canada Limited

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

or druginfo@novopharm.com

Teva Canada Limited

30 Novopharm Court Toronto, Ontario

Canada, M1B 2K9

Last revised: July 12, 2013