Chemmart Carvedilol

What this medicine is used for

The name of your medicine is Chemmart Carvedilol. It contains the active ingredient, carvedilol.

It is used to treat high blood pressure and, together with other medicines, to help treat congestive heart failure.

Ask your doctor if you have any questions about why this medicine has been prescribed for you.

Your doctor may have prescribed this medicine for another reason.

This medicine is available only with a doctor's prescription.

How it works

Carvedilol belongs to a group of medicines called beta-blockers.

These medicines work by relaxing tightened blood vessels and slowing the heart rate. Carvedilol has the additional effect of being an antioxidant.

Heart failure occurs when the heart can no longer pump blood strongly enough for the body's needs. Often the heart grows in size to try to improve the blood flow but this can make the heart failure worse.

Symptoms of heart failure include shortness of breath and swelling of the feet or legs due to fluid build-up.

Carvedilol reduces the pressure that the heart has to pump against as well as controlling your heart rate. Over 6 months or more, this will reduce the size of an oversized heart and increase its efficiency.

Carvedilol reduces the chances of you being admitted to hospital for this condition.

Carvedilol is often used with other medicines to treat heart failure.

There is no evidence that the medicine is addictive.

Use in children

There is not enough information to recommend using this medicine for children.

Before you take this medicine

When you must not take it

Do not take this medicine if:

Symptoms of an allergic reaction may include cough, shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue, throat or other parts of the body, rash itching or hives on the skin, fainting or hayfever-like symptoms.

If you think you are having an allergic reaction, contact your doctor immediately or go to the Accident and Emergency department at the nearest hospital.

Do not give this medicine to people under 18 years of age.

Safety and effectiveness in children have not been established.

Before you start to take it

Before you start taking this medicine, tell your doctor if:

• any other medicines
• any other substances, such as foods, preservatives or dyes.

• a growth on one of your adrenal glands ('phaeochromocytoma')
• angina or chest pain/tightness which occurs even when you are at rest (also called unstable angina or Prinzmetal's variant angina)
• slow heart rate (bradycardia)
• low blood pressure
• high blood pressure which varies widely or which is due to a different medical problem
• very poor circulation to your fingers and/or toes (also called peripheral vascular disease or Raynaud's phenomenon)
• poor kidney function
• heart problems
• liver problems
• chronic bronchitis, asthma, wheezing or emphysema causing breathing difficulties
• diabetes, or sudden low blood sugar levels (also called hypoglycaemia)
• thyroid problems, especially hyperthyroidism
• severe allergic reactions (e.g. sudden swelling, causing difficulty breathing or swallowing, swelling of the hands, feet and ankles or a severe rash)
• skin disease such as psoriasis (hardened patches of red skin), or a previous history of developing psoriasis when taking beta-blockers

It is not known whether carvedilol is harmful to an unborn baby when taken by a pregnant woman. If there is a need to take carvedilol when you are pregnant your doctor will discuss the risks and benefits to you and the unborn baby.

Carvedilol passes into breast milk. Your doctor will discuss the risks and benefits of taking carvedilol if you are breast-feeding.

You may not produce as many tears, so wearing contact lenses may be more difficult. Consider using artificial tears if this happens.

This medicine contains lactose.

Your surgeon and anaesthetist should know well ahead of the date of your surgery so they can allow for your condition and medications.

Some medicines may interact with carvedilol.

These include:

• rifampicin, a medicine used to treat tuberculosis (e.g. Rimycin^®, Rifadin^®)
• cimetidine, a medicine used to treat stomach ulcers or reflux
• digoxin, a medicine used to treat heart failure
• medicines used to treat depression, such as monoamine-oxidase inhibitors (MAOls), e.g. phenelzine (Nardil^®) , tranylcypromine (Parnate^®), and reserpine; or SSRIs such as fluoxetine and paroxetine.
• other monoamine oxidase inhibitors
• clonidine, a medicine used to treat high blood pressure, migraine or menopausal symptoms (e.g. Catapres^®)
• medicines used to treat blood pressure or heart problems, such as beta-blockers or diltiazem, disopyramide, quinidine, procainamide, mexiletine, lignocaine, flecainide amiodarone, tocainide, propafenone and verapamil
• drugs for diabetes, including tablets, and insulin injections,
• cyclosporin, a medicine used to treat certain problems with the immune system or after organ transplants to protect against rejection
• drugs used during anaesthetics, such as ether, cyclopropane and trichloroethylene
• medicines usually inhaled to treat asthma called beta agonists. These include salbutamol, terbutaline and salmeterol
• anti-inflammatory medicines for treating pain and inflammation, such as ibuprofen, naproxen, aspirin and diclofenac.

If you are taking any of these you may need a different dose or you may need to take different medicines or you may need to be closely monitored for side effects.

Other medicines not listed above may also interact with carvedilol.

Grapefruit juice may also affect your blood levels of carvedilol.

How to take this medicine

Follow carefully all directions given to you by your doctor or pharmacist. Their instructions may be different to the information in this leaflet.

How much to take

Your doctor or pharmacist will tell you how much of this medicine you should take. This will depend on your condition and whether you are taking any other medicines.

Heart Failure

The usual starting dose in heart failure is 3.125 mg twice daily. The dose is usually increased every two weeks to 6.25 mg twice daily, 12.5 mg twice daily and then 25 mg twice daily. However, this may be done more slowly if side effects occur. If the tablets slow your heart too much you may go back to a lower dose.

High Blood Pressure

The usual starting dose in high blood pressure is once daily.

The recommended dose for initiation of therapy is 12.5 mg a day for the first two days.

Thereafter, the recommended dosage is 25 mg once a day.

If necessary, the dosage may subsequently be increased at intervals of at least two weeks up to the recommended maximum daily dose of 50 mg given once a day or in divided doses (twice daily).

The recommended dose for initiation of therapy is 12.5 mg once daily, which has provided satisfactory control in some patients. If the response is inadequate, the dose may be titrated at intervals of at least two weeks up to the recommended maximum daily dose.

Your doctor will monitor you carefully each time the dose is increased.

Do not stop taking your medicine or change your dosage without first checking with your doctor.

How to take it

Swallow tablets whole or halved with a glass of water.

Do not crush or chew the tablets.

When to take it

Take this medicine during or immediately after a meal, at about the same time each day.

Taking it medicine at the same time each day will have the best effect. It will also help you remember when to take it.

If you take carvedilol on an empty stomach, it may increase the risk of some of the side effects.

How long to take it for

Continue taking your medicine for as long as your doctor tells you.

Make sure you have enough to last over weekends and holidays.

It is very important that you do not suddenly stop taking carvedilol. If you are to stop taking it, your doctor will advise you to reduce the dose slowly over approximately two weeks.

If you forget to take it

If it is almost time to take your next dose, skip the missed dose and take your next dose at the usual time. Otherwise take it as soon as you remember, and then go back to taking your medicine as you would normally.

Do not take a double dose to make up for missed doses.

This may increase the chance of unwanted side effects.

If you have trouble remembering to take your medicine, ask your pharmacist for some hints.

If you take too much (overdose)

If you think that you or anyone else may have taken too much of this medicine, immediately telephone your doctor or the Poisons Information Centre (Tel: 13 11 26 in Australia) for advice. Alternatively go to the Accident and Emergency Department at your nearest hospital.

Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

The following are some symptoms, which may or may not occur:

• low blood pressure, causing dizziness or fainting
• a very slow heart rate
• difficulty breathing
• vomiting
• shock
• seizures (fits).

While you are taking this medicine

Things you must do

Tell your doctor that you are taking this medicine if:

• you are about to be started on any new medicine
• you become pregnant or plan to breastfeed
• you are going to have surgery (tell your surgeon and anaesthetist)
• you develop a very slow heart rate
• you develop low blood pressure (light-headedness, fainting); this is most likely to happen when you first start taking carvedilol or when you increase the dose.
• you develop dark urine, jaundice and/or you have pain in your upper right side of your abdomen.
• you develop kidney problems

Your doctor may occasionally do blood or urine tests to make sure the medicine is working and to prevent side effects. Go to your doctor regularly for a check-up.

Monitor your blood glucose levels regularly if you are diabetic, especially when you start or stop taking this medicine or increase the dose.

Have regular eye examinations from your eye doctor.

Tell all doctors, dentists and pharmacists who are treating you that you take this medicine.

Make sure you drink enough water during exercise and hot weather, especially if you sweat a lot.

Tell your doctor if, for any reason, you have not taken your medicine exactly as prescribed.

Otherwise, your doctor may think that it was not effective and change your treatment unnecessarily.

Tell your doctor if you feel the tablets are not helping your condition.

Things you must not do

Do not:

Things to be careful of

Be careful driving or operating machinery until you know how this medicine affects you.

Carvedilol may affect your ability to drive a car or operate machinery when started or when the dosage is increased, or when it is taken with alcohol.

If you feel light-headed, dizzy or faint when getting out of bed or standing up, get up slowly.

If you wear contact lenses you may also notice a reduction in the amount of tear fluid in your eyes.

Consider using artificial tears to wet the eye if this happens.

When taken with grapefruit juice, the amount of carvedilol absorbed by your body may be increased.

If you need to stop taking carvedilol, follow your doctor's instructions and gradually discontinue it over 2 weeks. During this time limit the amount of exercise you do and tell your doctor if your blood pressure or heart failure symptoms get worse.

Possible side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking carvedilol or if you have any questions or concerns.

Carvedilol helps most people with heart failure but it may have unwanted side effects in a few people.

Do not be alarmed by the following lists of side effects. You may not experience any of them. All medicines can have side effects. Sometimes they are serious but most of the time they are not.

Tell your doctor or pharmacist if you notice any of the following and they worry you.

This list includes the more common side effects. Mostly, these are mild:

• tiredness, sleepiness, weakness, drowsiness or feeling lethargic
• dizziness or giddiness
• wind
• loss of appetite
• indigestion
• problems sleeping or getting to sleep
• problems concentrating
• headache (this is usually mild and happens at the start of your treatment)
• problems with sight (abnormal or blurry vision) or hearing
• diarrhoea, nausea, stomach pain or vomiting
• constipation
• pain in your back, muscles or joints
• muscle weakness
• stuffy nose
• mild rash
• leg or muscle cramps
• numbness or tingling in your fingers
• sore throat
• inflamed gums
• bruising
• hair loss
• memory loss
• dry mouth, increased sweating
• increase sensitivity to touch, sight or smell
• weight increase
• increase in cholesterol levels (shown by a blood test)
• being unable to get an erection (erectile dysfunction) or lacking sex drive

Tell your doctor as soon as possible if you notice any of the following.

These may be serious side effects. You may need medical attention. Most of these side effects are rare.

• feeling depressed
• problems with blood circulation in your arms and legs. The signs include cold hands and feet, whiteness, tingling and pain in your fingers and a pain in your leg which gets worse when you walk
• problems with your heart when increasing the dose. The signs include chest pains, tiredness, shortness of breath and swelling of your arms and legs
• breathing problems or coughing or chest infection such as bronchitis
• fever
• migraine
• thinking strange thoughts or feeling paranoid or emotionally unstable
• moderate skin rashes, feeling itchy and dry skin patches
• excessive sunburn-type rash after only a short time in the sun
• low numbers of all types of white blood cells. The signs include infections of the mouth, gums, throat and lungs
• low number of platelets in your blood. The signs include bruising easily and nose bleeds
• changes in your blood shown up by a blood test
• hyperkalaemia (too much potassium in your blood)
• anaemia
• high blood pressure (sometimes this can only be measured, but you may have a headache)
• fast,, slow or irregular heart rate
• low blood pressure The signs include feeling dizzy or light-headed, in particular after you stand up.
• fainting
• stuffy nose, wheezing and flu-like symptoms
• sore eyes
• pain when passing urine, blood in the urine or changes in how often or how much urine you pass
• black tarry stools
• high blood sugar levels or developing the signs of diabetes or having trouble controlling your blood sugar if you have diabetes
• some women may have difficulty with bladder control (urinary incontinence). This normally will get better when treatment is stopped.

If you experience any of the following, stop taking your medicine and contact your doctor immediately or go to the Accident and Emergency department at your nearest hospital.

These are very serious side effects and are usually very rare. You may need urgent medical attention or hospitalisation.

• itching, dark urine, loss of appetite, yellowing of skin or eyes, or feeling "flu-like" for no known reason
• convulsions or fits
• shortness of breath
• chest pain or tightness
• uneven or slow heart beating or other heart problems
• swelling of the feet or legs due to fluid build up
• serious rashes which cover much of your body and may have blisters or flaking patches of skin
• sudden onset of the symptoms of stroke - such as being unable to smile, having droopy mouth and/or eyes, problems speaking or understanding, confusion and/or unconsciousness.

Other side effects not listed above may occur in some patients.

Allergic reactions

If you think you are having an allergic reaction to carvedilol, stop taking this medicine and tell your doctor immediately or go to the Accident and Emergency department at your nearest hospital.

Symptoms of an allergic reaction may include some or all of the following:

• cough, shortness of breath, wheezing or difficulty breathing
• swelling of the face, lips, tongue, throat or other parts of the body
• rash, itching or hives on the skin
• fainting
• hayfever-like symptoms

Storage and disposal

Storage

Keep your medicine in its original packaging until it is time to take it.

If you take your medicine out of its original packaging it may not keep well.

Keep your medicine in a cool dry place, where the temperature will stay below 25°C. Protect it from light and moisture.

Do not store your medicine, or any other medicine, in the bathroom or near a sink.

Do not leave it on a window sill or in the car. Heat and dampness can destroy some medicines.

Keep this medicine where children cannot reach it.

A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor or pharmacist tells you to stop taking the tablets or it has passed its expiry date, your pharmacist can dispose of the remaining medicine safely.

 

Product description

What Chemmart Carvedilol looks like

3.125 mg tablets:

White oval shaped, film-coated tablets, imprinted with "P" logo on one side and plain on the other side.

Blister packs of 30 tablets.

Not all strengths, pack types and/or pack sizes may be available.

6.25 mg tablets:

White oval shaped, film-coated tablets, imprinted "6.25" on one side and "P" logo on the other side.

Blister packs of 30 and 60 tablets.

Not all strengths, pack types and/or pack sizes may be available.

12.5 mg tablets:

White oval shaped, film-coated tablets, imprinted "12.5" on one side and "P" logo on the other side.

Blister packs of 60 tablets.

Not all strengths, pack types and/or pack sizes may be available.

25 mg tablets:

White oval shaped, film-coated tablets, imprinted "25" on one side and "P" logo on the other side.

Blister packs of 60 tablets.

Not all strengths, pack types and/or pack sizes may be available.

Ingredients

Each tablet contains 3.125 mg, 6.25 mg, 12.5 mg or 25 mg of carvedilol as the active ingredient.

It also contains the following inactive ingredients:

• cellulose microcrystalline
• lactose
• crospovidone
• povidone
• silica-colloidal anhydrous
• magnesium stearate
• opadry II complete film coating system YS-22-18096 white.

This medicine is gluten-free, sucrose-free, tartrazine-free and free of other azo dyes.

Australian Registration Numbers

Chemmart Carvedilol 3.125 mg tablets

Blister pack: AUST R 133037.

Chemmart Carvedilol 6.25 mg tablets

Blister pack: AUST R 133038.

Chemmart Carvedilol 12.5 mg tablets

Blister pack: AUST R 133039.

Chemmart Carvedilol 25 mg tablets

Blister pack: AUST R 133040.