NTP-Carvedilol: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

• NTP-CARVEDILOL is used in the treatment of heart failure.

• NTP-CARVEDILOL has been prescribed to you by your

  doctor to help manage your symptoms of heart failure.

What it does:

NTP-CARVEDILOL helps the heart to work more effectively in heart failure by blocking the action of certain hormones on the heart and blood vessels and reducing the resistance that the heart has to pump against.

When it should not be used:

• Do not use NTP-CARVEDILOL if you are allergic to it or

  any of the components of its formulation (see What the important non medicinal ingredients are).

• You should not take NTP-CARVEDILOL if you have any of

  the following health problems:

  • Severe heart failure that requires treatment with

    certain medications (usually given in the hospital)

  • Asthma, wheezing, bronchitis or other breathing

    problems

  • Certain types of abnormal heart beat (i.e., second- or

    third- degree AV block, or sick sinus syndrome) unless treated with a heart pacemaker

  • Shock, caused by weakened heart
  • Very low blood pressure
  • Very slow heart beat

  • Certain heart valve problems (i.e., primary

    obstructive valvular heart disease)

  • Liver disease

  • Inability to make decisions (for example, if you have

    dementia, alcohol or drugs problems), unless closely supervised by an appropriate caregiver

What the medicinal ingredient is:

Carvedilol

What the important nonmedicinal ingredients are:

colloidal silicon dioxide, copolyvidone, crospovidone, lactose monohydrate, microcrystalline cellulose, magnesium stearate,

polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide

What dosage forms it comes in:

NTP-CARVEDILOL is available as 3.125 mg, 6.25 mg, 12.5 mg and 25 mg tablets.

WARNINGS AND PRECAUTIONS

If you become unwell while taking NTP-CARVEDILOL tell your doctor at once. You should be especially careful when starting or changing the dose of NTP-CARVEDILOL.

BEFORE and while you use NTP-CARVEDILOL tell your doctor or pharmacist:

$ all your medical conditions, including a history of heart, kidney or liver problems, asthma or breathing difficulties; $ if you are pregnant or thinking of becoming pregnant, or if you are breast feeding. You should not take NTP-CARVEDILOL if you are pregnant or if you plan to become pregnant unless your doctor tells you so;

$ if you change the amount of any other medicine you are taking;

$ if you suffer from diabetes, thyroid problems, Raynaud's phenomenon (coldness/spasm in the hands or feet with changes in colour) or cramping pains in the leg when exercising:

• if you have diabetes, you could become less aware of symptoms of hypoglycaemia (low blood sugar). You should monitor your blood sugar more carefully while on NTP-CARVEDILOL. Tell your doctor if you see any significant changes;
• if you have certain types of thyroid problem, abrupt stopping of NTP-CARVEDILOL may lead to worsening symptoms;
• if you suffer from Raynaud’s phenomenon, an increase in symptoms of coldness/spasms in the hands or feet may be seen;

$ if you suffer have psoriasis (scaly red patches on the skin).

Psoriasis may occur or, if you already have psoriasis, it may become worse

If you see another physician other than your heart doctor for another condition, tell this physician that you are taking NTP-CARVEDILOL.

INTERACTIONS WITH THIS MEDICATION

• NTP-CARVEDILOL should not be taken with alcohol.

• Taking NTP-CARVEDILOL with certain medications

  (prescription or non prescription), especially anti-hypertensives, digoxin, insulin, hypoglycemics, stomach medication, tricyclic antidepressants, stomach medication, tricyclic antidepressants, clonidine, and rifampin, may cause unintended effects and you should discuss the possibilities with your doctor.

PROPER USE OF THIS MEDICATION

• It is very important that you take NTP-CARVERDILOL

  exactly as your doctor has instructed. The doctor will decide how many tablets you need to take each day, when and for how long. It may be necessary for the doctor to increase or decrease the dose.

• You should swallow the tablets whole with water. Do not

  chew or break your tablet.

• Take your tablets at the same time each day. You should take

  NTP-CARVEDILOL with food.

Do not stop taking NTP-CARVEDILOL without first consulting with your doctor.

Remember: This medicine is for the person named by the doctor. Do not give it to anybody else.

Overdose:

If you have taken more tablets than the recommended dose, tell your doctor or the nearest hospital emergency department immediately. Show the doctor your bottle of tablets and any other medications you are taking.

Missed Dose:

Take it as soon as you remember. If possible, take your next dose at the normal time, but do not take 2 doses within 6 hours of each other.

If you miss more than 2 doses of NTP-CARVEDILOL contact your doctor. Do not re-start NTP-CARVEDILOL until you have spoken to the doctor.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

$ Some people may have unwanted effects when taking NTP-

CARVEDILOL. Dizziness, headache and tiredness are the most common and often occur when NTP-CARVEDILOL is started or when the dose of NTP-CARVEDILOL is changed. These symptoms generally go away with continued use. If they do not or appear to become more severe then tell your doctor.

$ If you experience dizziness or fatigue while taking your

tablets, do not drive or operate machinery.

$ Other possible effects are: stomach complaints such as

diarrhea, constipation, nausea and vomiting, allergic reactions such as rashes and hot or itching skin, pain in the side, urinating more or less frequently, breathing problems such as wheezing, breathlessness and stuffy nose, depressed mood, sleep disturbance, dry mouth, slowing of heart rate, dizziness when standing up, fainting, cold or painful hands and feet, general swelling of parts of the body, weight gain, impotence, blurred vision, cramping pain on exercise.

$ If you develop any unusual discomfort, tell the doctor as soon

as possible, especially if you have unusual dizziness, ankle swelling, tiredness or breathlessness when you start use NTP-CARVEDILOL or when your dose is being increased. $ If you wear contact lenses you may suffer from dryness of the eyes while taking your tablets.

HOW TO STORE IT

$ Store your tablets at room temperature (15° - 30°C) in a dry place. Protect from high humidity and light. $ Keep container tightly closed.

$ Do not use the medicine if it has expired.

$ Keep out of reach of children.

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 at:

Teva Canada Limited

30 Novopharm Court

Toronto, Canada, M1B 2K9

Last revised: July 12, 2013