Consumer medicine information

GenRx Metoprolol

Contains the active ingredient metoprolol (as metoprolol tartrate)

Consumer Medicine Information

For a copy of a large print leaflet, Ph: 1800 195 055

What is in this leaflet

Read this leaflet carefully before taking your medicine.

This leaflet answers some common questions about metoprolol. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

The information in this leaflet was last updated on the date listed on the last page. More recent information on this medicine may be available.

Ask your doctor or pharmacist:

  • if there is anything you do not understand in this leaflet,
  • if you are worried about taking your medicine, or
  • to obtain the most up-to-date information.

You can also download the most up to date leaflet from www.apotex.com.au.

All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you.

Pharmaceutical companies cannot give you medical advice or an individual diagnosis.

Keep this leaflet with your medicine. You may want to read it again.

What this medicine is used for

The name of your medicine is GenRx Metoprolol. It contains the active ingredient metoprolol.

It is used to:

  • lower higher blood pressure (hypertension)
  • prevent angina (a type of chest pain)
  • treat or prevent heart attacks, or reduce the risk of heart complications following a heart attack (myocardial infarction)
  • prevent migraines.

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

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

It works by affecting the body’s response to some nerve impulses, especially in the heart. As a result, it decreases the heart’s need for blood and oxygen and therefore reduces the amount of work the heart has to do. It also widens the blood vessels in the body, causing blood pressure to fall.

There is no evidence that this medicine is addictive.

Use in children

This medicine should not be used in children.

Before you take this medicine

When you must not take it

Do not take this medicine if:

  • You have or have had any of the following:
    – sudden loss of consciousness
    – asthma, wheezing, difficulty breathing or other severe lung problems
    – allergic problems, including hay fever
    – a very slow heart beat, less than 45 to 50 beats per minute
    – low blood pressure
    – a severe blood vessel disorder causing poor circulation in the arms and legs
    – severe drop in blood pressure, dizziness, fast heart beat, rapid and shallow breathing, cold clammy skin
    – phaeochromocytoma (a rare tumour of the adrenal gland) which is not already being treated with other medicines
    – sudden and oppressive chest pain, sign of heart attack
    – irregular heart beat
    – swollen ankles and/or tiredness due to heart disease or certain other heart conditions
    – heart disorders
    – poor blood circulation in your limbs (for example, very cold, pale hands or feet, or pain in your leg muscles when you walk).
    – undergo an operation where an anesthetic is used during treatment with respiratory diseases such as asthma
    – oculomucocutaneous syndrome (signs include severe conjunctivitis and skin rash and ear infection)
    – sensitivity to any other beta blocker medicine.
  • You are intolerant or allergic to lactose.
  • You are hypersensitive to, or have had an allergic reaction to, metoprolol or any of the ingredients listed at the end of this leaflet.
    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 hay fever-like symptoms.
    If you think you are having an allergic reaction, do not take any more of the medicine and contact your doctor immediately or go to the Accident and Emergency department at the nearest hospital.
  • The expiry date (EXP) printed on the pack has passed.
  • The packaging is torn, shows signs of tampering or it does not look quite right.

Before you start to take it

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

  1. You have allergies to:
  • any other medicines
  • any other substances, such as foods, preservatives or dyes.
  • bee or wasp stings.
  1. You have or have had any medical conditions, especially the following:
  • chest pain when you are at rest or certain types of angina, such as Prinzmetal angina or variant angina
  • diabetes
  • kidney or liver problems
  • an overactive thyroid gland.
  1. You are currently pregnant or you plan to become pregnant. Do not take this medicine whilst pregnant until you and your doctor have discussed the risks and benefits involved.
  2. You are currently breastfeeding or you plan to breast-feed. Do not take this medicine whilst breastfeeding until you and your doctor have discussed the risks and benefits involved.
  3. You have recently been vaccinated or plan to get a vaccination.
  4. You are planning to have surgery or an anaesthetic.
  5. You are currently receiving or are planning to receive dental treatment.
  6. You are taking or are planning to take any other medicines. This includes vitamins and supplements that are available from your pharmacy, supermarket or health food shop.

Some medicines may interact with metoprolol. These include:

  • other beta-blocker medicines
  • other medicines used to treat high blood pressure such as calcium channel blockers and clonidine
  • some medicines used to treat angina
  • adrenaline or similar substances, which are often found in eye or nose drops, or in some cough and cold medicines
  • other medicines used to treat irregular heart beat (arrhythmias)
  • medicines for diabetes
  • quanethidine, a medicine used to treat certain heart conditions
  • some local and general anaesthetics used during surgery
  • monoamine-oxidase inhibitor (MAOI) medicines
  • warfarin, a medicine used to prevent blood clots
  • non-steroidal anti-inflammatory drugs such as COX-2 inhibitors to relieve pain or inflammation
  • cimetidine, a medicine for stomach ulcers
  • some antibiotics (e.g. rifampicin)
  • some antivirals (e.g. ritonavir)
  • some antihistamines (e.g. diphenhydramine)
  • some antidepressant medications (e.g. fluoxetine, paroxetine or bupropion)
  • some antifungals (e.g. terbinafine)
  • ergot alkaloids, a class of medicines used in the prevention and treatment of migraine headaches
  • dipyridamole, a medicine use to reduce the risk of blood clots.

If you are taking any of these you may need a different dose or you may need to take different medicines.

Other medicines not listed above may also interact with metoprolol.

How to take this medicine

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

How much to take

Your doctor 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.

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

High blood pressure (hypertension):
The usual dose is from 50 mg to 200 mg each day, either as a single dose or divided into two doses.

Angina:
The usual dose is from 100 mg to 300 mg each day, divided into two or three doses.

Heart attack (myocardial infarction):
The usual dose is 200 mg each day, divided into two doses.

To prevent migraine:
The usual dose is from 100 mg to 150 mg each day, divided into two doses (morning and evening).

How to take it

Swallow the tablet(s) with a full glass of water.

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

When to take it

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

It does not matter if you take it before, with or after food.

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.

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 you experiencing side effects.

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

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. Symptoms of an overdose may include feeling sick and vomiting, bluish skin and nails, very low blood pressure, slow heart beat, difficulty breathing, fainting, convulsions (fits) or coma.

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 plan to have any vaccinations or immunisations
  • you are pregnant or are planning to become pregnant
  • you are breastfeeding or are planning to breast-feed
  • you are about to have any blood tests
  • you are going to have surgery or an anaesthetic or are going into hospital
  • you have an allergic reaction to a food, another medicine or an insect sting while you are taking this medicine.

If you are being treated for diabetes, make sure you check your blood sugar level regularly and report any changes to your doctor.

Metoprolol may change how well your diabetes is controlled. It may also cover up some of the symptoms of low blood sugar, called hypoglycaemia, such as fast heart beat. It may make low blood sugar last longer. Your doses of diabetic medicines may need to change.

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

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

Things you must not do

Do not:

  • Give this medicine to anyone else, even if their symptoms seem similar to yours.
  • Take your medicine to treat any other condition unless your doctor tells you to.
  • Stop taking your medicine, or change the dosage, without first checking with your doctor.

Things to be careful of

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

As with other beta-blocker medicines, this medicine may cause dizziness, light-headedness or decreased alertness in some people.

If you have any of these symptoms, do not drive or do anything else that could be dangerous. If these symptoms do not go away, talk to your doctor.

Be careful to dress warmly during cold weather, especially if you will be outside for a long time. Like other beta-blocker medicines, this medicine may make you more sensitive to cold temperatures, especially if you have problems with your blood circulation. These medicines tend to decrease blood circulation in the skin, fingers and toes.

Possible side effects

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

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 if you notice any of the following. Mostly, these are mild:

  • tiredness, drowsiness, decreased alertness
  • dizziness, spinning sensation (vertigo), light-headedness or fainting
  • headache or other aches and pains
  • difficulty sleeping, nightmares
  • depression or other changes in mood
  • confusion or loss of memory
  • stomach ache or upset, nausea (feeling sick) or vomiting
  • diarrhoea or constipation
  • dry or irritated eyes, blurred
  • vision
  • buzzing or ringing in the ears, or
  • other difficulty hearing
  • dry mouth
  • increased sweating
  • runny or blocked nose
  • problems with sexual function
  • numbness, tingling in the extremities
  • weight gain
  • hair thinning
  • worsening of psoriasis
  • muscle cramps or painful joints
  • a tingling sensation
  • abnormal triglycerides or cholesterol values, or liver function tests
  • sleepiness during the day or troubled sleep
  • diarrhoea or constipation.

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 side effects could be serious and you may need urgent medical attention or hospitalisation:

  • chest tightness, wheezing, rattly breathing
  • shortness of breath, sometimes with tiredness, weakness or reduced ability to exercise
  • swelling of the feet or legs due to fluid build-up
  • coldness, burning, numbness or pain in arms and legs
  • chest pain
  • pain behind the breastbone (different from angina)
  • changes in heart rate (fast, slow, irregular)
  • yellowing of the skin or eyes (jaundice), sometimes with pain in the abdomen
  • constant “flu-like” symptoms (chills, fever, sore throat, aching joints, swollen glands, tiredness or lack of energy)
  • unusual bleeding or bruising
  • skin reactions (rash, itching, worsening of psoriasis)
  • symptoms of sunburn (redness, itching, swelling, blistering) that happen much more quickly than normal
  • abnormal thinking or hallucinations (seeing or hearing things that are not there)
  • breathlessness, difficulty breathing when lying down, swelling of the feet or legs, signs of heart disorders.

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

Allergic reactions

If you think you are having an allergic reaction to metoprolol, do not take any more of 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
  • hay fever-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 from light.

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

Product description

What GenRx Metoprolol looks like

  • 50 mg:
    White, round tablets, scored on one side.
    Available in blister packs of 100 tablets.
  • 100 mg:
    White, round tablets, scored on one side.
    Available in blister packs of 60 tablets.

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

Ingredients

Each tablet contains 50 or 100 mg of metoprolol as the active ingredient.

It also contains the following inactive ingredients:

  • lactose
  • maize starch
  • microcrystalline cellulose
  • magnesium stearate
  • colloidal anhydrous silica
  • hydroxypropylcellulose
  • calcium hydrogen phosphate
  • crospovidone.

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

Australian Registration Numbers

  • GenRx Metoprolol 50 mg tablets (blisters): AUST R 78855.
  • GenRx Metoprolol 100 mg tablets (blisters): AUST R 78856.

Sponsor

Apotex Pty Ltd
16 Giffnock Avenue
Macquarie Park NSW 2113

GenRx is a registered trademark of Apotex Pty Ltd.

This leaflet was last updated in:
July 2012.

Published by MIMS October 2012