Consumer medicine information

Carvedilol Sandoz®

Carvedilol Sandoz®

Active ingredient(s): carvedilol


Consumer Medicine Information (CMI)

This leaflet provides important information about using Carvedilol Sandoz. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Carvedilol Sandoz.

Where to find information in this leaflet:

1. Why am I using Carvedilol Sandoz?
2. What should I know before I use Carvedilol Sandoz?
3. What if I am taking other medicines?
4. How do I use Carvedilol Sandoz?
5. What should I know while using Carvedilol Sandoz?
6. Are there any side effects?
7. Product details

1. Why am I using Carvedilol Sandoz?

Carvedilol Sandoz contains the active ingredient carvedilol.

Carvedilol Sandoz belongs to a group of medicines called beta-blockers. These medicines work by relaxing tightened blood vessels and slowing the heart rate. Carvedilol Sandoz has the additional effect of being an antioxidant.

Carvedilol Sandoz® is used to treat:

Heart Failure

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 Sandoz 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 Sandoz reduces the chances of you being admitted to hospital and/or dying from this condition.

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

Hypertension

All people have blood pressure. This pressure helps to push blood all around your body. Your blood pressure changes during the day, depending on how busy you are or how you are feeling.

You have hypertension (high blood pressure) when your blood pressure stays higher than is needed, even when you are calm and relaxed.

Regular blood pressure checks are the only way of knowing that you have hypertension. There are usually no symptoms of hypertension and you may feel fine. If hypertension is not treated, serious health problems such as stroke, heart disease and kidney failure may occur.

Carvedilol Sandoz helps to lower your blood pressure.

Your doctor, however, may have prescribed Carvedilol Sandoz for another purpose.

Ask your doctor if you have any questions about why Carvedilol Sandoz has been prescribed for you.

Carvedilol Sandoz is not addictive.

2. What should I know before I use Carvedilol Sandoz?

Warnings

Do not use Carvedilol Sandoz if:

  • you are allergic to carvedilol, or any of the ingredients listed at the end of this leaflet. Always check the ingredients to make sure you can use this medicine.
  • you are under 18 years of age.
  • you have asthma or other conditions which make you short of breath from time to time.
  • you have a history of allergic problems, including hay fever. Symptoms of an allergy may include: rash, itching, watery eyes, or sneezing.
  • you have a history of a very slow heart rate or uneven heart beating.
  • you have certain other heart conditions.
  • you have liver problems including liver failure.
  • you have very low blood pressure.
  • the package is torn or shows signs of tampering.
  • the expiry date (EXP) printed on the pack has passed or if the tablets appear damaged in some way

Use in Children

Do not give Carvedilol Sandoz to people under 18 years of age.

Safety and effectiveness in children have not been established.

Check with your doctor if you have other medical conditions, especially:

  • angina or chest pain/tightness which occurs even when you are at rest (also called unstable angina)
  • low blood pressure
  • high blood pressure which varies widely
  • very poor circulation to your fingers and/or toes (also called peripheral vascular disease)
  • a history of poor kidney function
  • chronic bronchitis or emphysema causing breathing difficulties
  • diabetes
  • sudden low blood sugar levels (also called hypoglycaemia)
  • thyroid disorders
  • severe allergic reactions causing swelling and/or difficulty breathing
  • a rare cancer of the adrenal gland called phaeochromocytoma which is not being treated with other medicines
  • skin disease such as psoriasis (hardened patches of red skin).

Check with your doctor if you take any medicines for any other condition

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

It is not known whether Carvedilol Sandoz is harmful to an unborn baby when taken by a pregnant woman. Your doctor will discuss the risks and benefits of using Carvedilol Sandoz during your pregnancy.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

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

Surgery

Check with your doctor if you plan to have surgery.

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

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins, or supplements that you buy without a prescription from your pharmacy, supermarket, or health food shop.

Some medicines may interfere with Carvedilol Sandoz and affect how it works. These medicines include:

  • rifampicin, a medicine used to treat tuberculosis
  • cimetidine, a medicine used to treat stomach ulcers or reflux
  • digoxin, a medicine used to treat heart failure
  • monoamine-oxidase inhibitors (MAOIs) such as phenelzine and tranylcypromine, medicines used to treat depression
  • clonidine, a medicine used to treat high blood pressure, migraine, or menopausal symptoms
  • diltiazem, a medicine used to treat high blood pressure or angina
  • verapamil, a medicine used to treat high blood pressure, angina, or fast heart rate
  • ciclosporin or tacrolimus, medicines used to treat certain problems with the immune system
  • aspirin and other pain relievers or non-steroidal anti-inflammatory medicines such as ibuprofen or naproxen medicines which may relieve asthma or help your breath better such as salbutamol and salmeterol.
  • fluoxetine or paroxetine, medicines used to treat depression and other conditions
  • drugs for when your heart doesn’t beat smoothly, including disopyramide, mexiletine, lignocaine, flecainide, and amiodarone
  • drugs for diabetes, including insulin injections, glibenclamide, metformin, gliclazide, glipizide
  • other medicines that may help lower your blood pressure.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins, or supplements you are taking and if these affect Carvedilol Sandoz.

You may need to use different amounts of your medicine, or you may need to take different medicines. Your doctor will advise you.

Your doctor or pharmacist has more information on medicines to be careful with or avoid while taking Carvedilol Sandoz.

4. How do I use Carvedilol Sandoz?

How much to take

  • Take Carvedilol Sandoz exactly as your doctor has prescribed.
  • Your doctor will tell you how many Carvedilol Sandoz tablets to take each day. This depends on your condition and whether or not you are taking other medicines.

Heart Failure:

  • The usual starting dose in heart failure is 3.125 mg (half a 6.25 mg tablet) 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:

  • Adults: 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 be increased every two weeks up to the recommended maximum daily dose of 50 mg given once a day or in divided doses (twice daily).
  • Elderly: 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 increased every two weeks up to the recommended maximum daily dose.
  • Your doctor will monitor you carefully each time the dose is increased.
  • Follow the instructions provided and use Carvedilol Sandoz until your doctor tells you to stop.

When to take Carvedilol Sandoz

  • Carvedilol Sandoz tablets should be taken with food at about the same time each day.
  • Taking your medicine at the same time each day will have the best effect. It will also help you to remember when to take it.
  • If you take Carvedilol Sandoz on an empty stomach, it may increase the risk of some of the side effects.

How to take Carvedilol Sandoz

  • Swallow the tablets whole or halved with a glass of water.
  • Do not crush or chew the tablets.

If you need to break Carvedilol Sandoz, hold tablet with both hands and snap along break line.

How to long to take Carvedilol Sandoz

  • 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 Carvedilol Sandoz is not ceased suddenly. If you are to stop taking Carvedilol Sandoz, your doctor will advise you to reduce the dose slowly over approximately two weeks.

If you forget to use Carvedilol Sandoz

Carvedilol Sandoz should be used regularly at the same time each day.

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Otherwise, take it as soon as you remember then go back to taking your medicine as you would normally.

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

This may increase the chance of you getting an unwanted side effect.

If you use too much Carvedilol Sandoz

If you think that you have used too much Carvedilol Sandoz, you may need urgent medical attention.

You should immediately:

  • phone the Poisons Information Centre
    (By calling 13 11 26), or
  • contact your doctor, or
  • go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

The following are some symptoms, which may or may not occur as a result of taking too much Carvedilol Sandoz:

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

5. What should I know while using Carvedilol Sandoz?

Things you should do

Make sure you drink enough water during exercise and hot weather when you are taking Carvedilol Sandoz, especially if you sweat a lot.

Tell your doctor that you are taking Carvedilol Sandoz if you are going to have any laboratory tests.

Remind any doctor, dentist, or pharmacist you visit that you are using Carvedilol Sandoz. You should also tell your surgeon and anaesthetist if you are having surgery.

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.

Be sure to keep all of your appointments with your doctor so that your progress can be checked.

Your doctor may examine your eyes and test your blood glucose and kidney function from time to time.

Call your doctor straight away if you:

  • feel light-headed, dizzy, or faint when getting out of bed or standing up, get up slowly.
  • become pregnant while taking Carvedilol Sandoz.

Things you should not do

  • Do not stop using this medicine suddenly.
  • Do not stop taking Carvedilol Sandoz or change the dose without first checking with your doctor.
  • Do not let yourself run out of medicine over the weekend or on holidays.
  • Carvedilol Sandoz should only be stopped by gradually reducing the amount over a two-week period.
  • Do not give Carvedilol Sandoz to anyone else even if they have the same condition as you.
  • Do not use Carvedilol Sandoz to treat other complaints unless your doctor says to.
  • Do not take any other medicines whether they require a prescription or not without first telling your doctor or consulting a pharmacist.

Contact lenses

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

Drinking grapefruit juice

  • When taken with grapefruit juice the amount of Carvedilol Sandoz absorbed by your body may be increased.

Drinking alcohol

Talk to your doctor about drinking alcohol before taking Carvedilol Sandoz

Alcohol can change how the medicine affects your condition. Your doctor may advise you to limit your alcohol intake.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how Carvedilol Sandoz affects you.

Carvedilol Sandoz may affect your ability to drive a car or operate machinery when started or when the dosage is increased.

Looking after your medicine

  • Keep your tablets in the blister pack until it is time to take them.
    If you take the tablets out of the blister pack, they may not keep well.

Follow the instructions in the carton on how to take care of your medicine properly.

Store it in a cool dry place below 30°C away from moisture, heat, or sunlight; for example, do not store it:

  • in the bathroom or near a sink, or
  • in the car or on window sills.

Keep it where young children cannot reach it.

When to discard your medicine

If your doctor tells you to stop taking Carvedilol Sandoz, or the tablets have passed their expiry date, ask your pharmacist what to do with any tablets that are left over.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Less serious side effects What to do
General well-being related:

  • headache (this is usually mild and happens at the start of your treatment)
  • unusual weakness
  • tiredness, drowsiness
  • faintness

Mood related:

  • hallucination
  • depression

Heart related:

  • low blood pressure. The signs include feeling dizzy or lightheaded especially after you stand up.
  • slow heart rate

Eye related:

  • abnormal or blurry vision
  • dry or irritated eyes

Gut related:

  • diarrhoea
  • nausea or vomiting
  • indigestion
  • stomach pain or discomfort

Bladder related:

  • frequent need to urinate, difficulty or pain when passing urine

Lungs related:

  • asthma

Infection related:

  • bronchitis

Others:

  • fluid retention (the signs include overall swelling of parts of your body for example your hands, feet, ankles and legs.)
  • unusual hair loss or thinning
  • excessive sweating
  • loss of control of blood sugar in diabetics
  • general pain or discomfort, pain in extremities
  • weight increase
Speak to your doctor if you have any of these less serious side effects and they worry you.

These are the more common side effects of Carvedilol Sandoz. Mostly these are mild and will decrease as you get used to your medicine.

Serious side effects

Serious side effects What to do
Infection related:

  • Fever, chills, shortness of breath and a cough produce yellow green phlegm and occasionally blood.

Heart related:

  • Irregular heartbeat, slow heartbeat, or heartbeat pause/stops, especially in older people or people with other heart conditions.

Breathing related:

  • Difficulty breathing or breathlessness usually worsens on lying down.
  • Chest tightness

Allergy related:

  • Shortness of breath or swelling of the mouth of tongue.

Blood related:

  • Bleeding or bruising more easily than normal

Others:

  • Itching, dark urine, loss of appetite, yellowing of skin or eyes, or feeling “flu-like” with no clear cause.
  • Severe blisters and bleeding in the lips, eyes, mouth, nose, and genitals.
  • Swelling of the feet or legs due to fluid build up
Call your doctor straight away or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

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

What Carvedilol Sandoz contains

Active ingredient
(Main ingredient)
  • Each Carvedilol Sandoz 6.25mg tablet contains 6.25mg carvedilol.
  • Each Carvedilol Sandoz 12.5mg tablet contains 12.5mg carvedilol.
  • Each Carvedilol Sandoz 25mg tablet contains 25mg carvedilol.
Other ingredients
(Inactive ingredients)
  • lactose monohydrate
  • microcrystalline cellulose
  • crospovidone
  • povidone
  • colloidal anhydrous silica
  • magnesium stearate
  • iron oxide yellow (6.25 and 12.5mg)
  • iron oxide red (12.5mg).
Potential allergens This medicine contains sugars as lactose

Do not take this medicine if you are allergic to any of these ingredients.

What Carvedilol Sandoz looks like

Carvedilol Sandoz 6.25mg tablets: a yellow, round, convex, scored tablet, coded C2 on one side. (AUST R 104391)

Carvedilol Sandoz 12.5mg tablets: a red-brown, round, convex, scored tablet, coded C3 on one side. (AUST R 104396)

Carvedilol Sandoz 25mg tablets: a white to almost white, round, convex, scored tablet, coded C4 on one side. (AUST R 104399)

Carvedilol Sandoz is available in 60 tablet blister packs.

Who distributes Carvedilol Sandoz

Sandoz Pty Ltd
ABN 60 075 449 553
54 Waterloo Road
Macquarie Park, NSW 2113
Tel: 1800 726 369

This leaflet was prepared in June 2022