Sotacor Concentrate for infusion (beta blocker medicines)

Sotacor Concentrate for infusion (beta blocker medicines) is a brand of medicine containing the active ingredient sotalol hydrochloride (beta blocker medicines).

Find out more about active ingredients.

Consumer medicine information (CMI) leaflet

Developed by the pharmaceutical company responsible for this medicine in Australia, according to TGA regulations.

SOTACOR®

Sotalol hydrochloride


Consumer Medicine Information

What is in this leaflet?

This medicine your doctor has prescribed for you is called SOTACOR

The information in this leaflet will answer some of the questions you may have about SOTACOR.

This leaflet does not tell you everything about SOTACOR. Your doctor and pharmacist have more information and can answer any questions you have.

This leaflet is no substitute for talking with your doctor or pharmacist. You should follow all advice from your doctor when being treated with this medicine. This information is not intended to replace your doctor's advice.

You should read this leaflet carefully before starting SOTACOR and keep it in a safe place to refer to later.

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What is SOTACOR?

SOTACOR is the brand name of the medicine sotalol hydrochloride. This medicine is present in the tablets or the injection that your doctor has prescribed for you.

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What is SOTACOR used for?

SOTACOR is used to treat "arrhythmias", which is a problem when the heart beats too quickly or with the wrong rhythm.

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How does SOTACOR work?

SOTACOR contains sotalol hydrochloride, which belongs to the family of drugs known as beta-blockers. SOTACOR slows down and steadies the heart beat, reducing the effort the heart has to put into pumping blood.

Your doctor will have explained why you are being treated with SOTACOR and told you what dose to take. Follow his directions carefully. They may differ from the information contained in this leaflet.

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What should I tell my doctor before I take SOTACOR?

  • Make sure your doctor knows what other medicines you are already taking including ones you have bought yourself at the chemist or supermarket.
  • In particular remind your doctor if you have asthma, bronchitis or any allergies such as hay fever, food allergies or are allergic to bee or wasp stings.
  • Make sure your doctor is aware of any kind of heart disease, diabetes, phaeochromocytoma, kidney disease or thyroid disease that you have or have had, or if you have been told that your pulse is slow or irregular.
  • Tell your doctor if you have ever had trouble with the levels of salts like potassium or magnesium in your blood.
  • Remind your doctor if you are going to have surgery involving a general anaesthetic even if it is only minor.
  • Tell your doctor if you are pregnant, if you are planning to become pregnant, or if you are breast feeding.
  • Tell your doctor if you have been given SOTACOR (or any other beta-blocker) before and if you had any problems.
  • Remind your doctor if you have hardening of the arteries (cold fingers and toes or pain in the back of your legs when you walk).

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What should I know before I take SOTACOR?

  • You should not take SOTACOR if you have asthma.
  • You should not take SOTACOR if you have allergies, or problems with your kidneys or thyroid gland, unless you have discussed it with your doctor.
  • You must not suddenly stop taking SOTACOR, particularly if you also have angina, have had a previous heart attack, or have any other heart problems, since stopping SOTACOR could bring on or worsen these conditions.
  • You should not take SOTACOR if you are pregnant or are breast feeding, or if you may become pregnant or intend to breast feed.
  • If you have any problems with your heart or circulation, discuss them with your doctor before starting SOTACOR.
  • You should not take SOTACOR with any other medicines or drugs which your doctor does not know about, particularly if they are to control high blood pressure, heart conditions, depression, hayfever, allergies, infections or diabetes.
  • You should contact your doctor if you have any diarrhoea or other illness while taking SOTACOR.

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Should I drive or operate machinery while taking SOTACOR?

Be careful driving or operating machinery until you know how SOTACOR affects you. As with other medicines SOTACOR may cause dizziness, light-headedness or drowsiness in some people. If this occurs do not drive or operate machinery or undertake any other activity that could be dangerous if you are dizzy, light-headed or drowsy.

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How should I take SOTACOR?

If you have been prescribed SOTACOR tablets, you must be sure to follow your doctor's instructions very carefully.

Do not stop taking SOTACOR tablets suddenly, the dose needs to be reduced gradually over 7 to 14 days.

Your doctor will decide on the dose of SOTACOR tablets for you, and may need to change the dose a few times to get the best level for you.

The usual dose is 80mg to 160mg twice a day. Your doctor may need to increase this as a very few patients may need up to three to four 160mg tablets spread over a day. The dosage may need to be different if you have a kidney problem.

You should take SOTACOR TABLETS with water one to two hours before meals. Do not take SOTACOR with milk or meals.

It is important not to miss a dose of SOTACOR but if you do, take your next dose at the normal time and with the normal amount.

If you have been prescribed SOTACOR injection, you will most likely be in hospital. Your doctor will have worked out the dose you require and the injection will be given to you by a doctor or a nurse. It will be given into a vein. The injection may be repeated if necessary.

You should not drink alcohol while you are on SOTACOR.

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Should I take SOTACOR with other medicines?

Some medicines can affect the way SOTACOR works. You should always tell your doctor about any other medicines you take, even those bought without a doctor's prescription. It is especially important that you tell your doctor if your are taking any of the following :

  • medicines which lower blood pressure (including other beta-blockers)
  • any other medicine used to treat an irregular heart rhythm or beat.
  • digoxin, a medicine used for heart failure.
  • medicines used to treat angina or other heart conditions.
  • antidepressants (medicines used to treat depression).
  • insulin or other drugs used to control diabetes
  • medicines used to control or prevent asthma (inhalers or tablets) or to control allergies or which are used for other lung problems
  • antihistamine medicines including terfenadine and astemizole that may be used to treat hayfever, allergies or to relieve symptoms of colds and flu.
  • quinolone antibiotics (medicines used to treat infections)
  • diuretics (water tablets)
  • some medicines used during surgery or emergency situations, such as anaesthetics.

If you are not sure whether you are taking any of these medicines, check with your doctor or pharmacist.

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What side effects might SOTACOR cause?

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking SOTACOR.

SOTACOR helps most people with arrhythmia, but it may have unwanted side effects in some people. Rarely, serious heart problems can develop while you are taking normal doses of SOTACOR but you must remember that you are taking SOTACOR because your heart already has a serious problem. It is very important that your doctor keeps a check on your progress.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

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

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor if you notice any of the following and they worry you:

  • dizziness, lightheadedness or fainting, especially when you get up from a sitting or lying position. Getting up slowly may help.
  • tiredness, lack of energy, weakness
  • headache, fever
  • irritated eyes, blurred vision, worsening of eyesight, increased sensitivity of the eyes to sunlight
  • feeling sick, vomiting, stomach upset, diarrhoea, wind
  • change in taste sensation
  • anxiety, depression, mood changes
  • problems with sexual function
  • sleep problems, unusual dreams
  • worsening of psoriasis
  • hearing disturbances
  • tingling or numbness in the hands or feet, cold limbs

Tell your doctor immediately or go to casualty at the nearest hospital if you notice any of the following:

  • chest tightness, wheezing, shortness of breath
  • very slow heart beat
  • fast, irregular heart beat, palpitations
  • chest pain
  • any type of skin rash, itching
  • shortness of breath (sometimes with tiredness, weakness and reduced ability to exercise), which may occur together with swelling of the feet or legs due to fluid build up

This is not a complete list of all possible side effects. Others may occur in some people and there may be some side effects not yet known.

Tell your doctor if you notice anything that is making you feel unwell while you are taking, or soon after you have finished taking SOTOCOR, even if it is not on this list.

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What should I do if someone takes an overdose of SOTACOR?

Immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26), if you think that you or anyone else may have taken too much Sotacor. Do this even if there are no signs of discomfort or poisoning.

Too much SOTACOR will cause your blood pressure and heart rate to drop to dangerous levels. Serious heart problems may develop and this could be fatal.

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Is there any other information that I should know about?

SOTACOR is not addictive or habit forming. SOTACOR is only available upon prescription form your doctor.

Do not give SOTACOR to anyone else, even if they have the same condition as you.

Do not take SOTACOR to treat any other complaints unless your doctor tells you to.

Do not let yourself run out of tablets over weekends or on holidays.

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How should I store SOTACOR?

Store SOTACOR tablets safely in a cool dry place. Protect from light and moisture.

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

Do not leave it in the car on hot days or on window sills. Heat and dampness can destroy some medicines.

Keep your tablets in the original bottle they are provided in until it is time to take them. If you take the tablets out of the bottle they will not keep well.

The expiry date for SOTACOR is printed on the pack. Do not take SOTACOR tablets after the expiry date or if SOTACOR tablets have changed in appearance colour or taste.

KEEP ALL MEDICINES OUT OF THE REACH OF CHILDREN.

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

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Product description.

What it looks like -

SOTACOR 80mg tablets are light blue, biconvex, capsule shaped tablets, with "BMS 621" and a score bar engraved on one side and plain on the other side.

From November 1999 SOTACOR 160mg tablets may be either:

round and white tablets with 160 engraved on one side and a score bar on the other side

or

light blue biconvex, capsule shaped tablets with "BMS160" and a score bar engraved on one side and plain on the other

SOTACOR injection is a clear liquid in an ampoule

Active ingredients -

SOTACOR 80mg tablets contain 80mg sotalol hydrochloride per tablets

SOTACOR 160mg tablets contain 160mg sotalol hydrochloride per tablet

SOTACOR injection contains 40mg sotalol hydrochloride in 4mLs of liquid in each ampoule.

Additives -

Light blue SOTACOR 80mg or 160mg tablets also contain microcrystalline cellulose, magnesium stearate, maize starch, lactose (anhydrous) stearic acid, colloidal anhydrous silica and indigo carmine (CI 73015), aluminium lake.

White round SOTACOR 160mg tablets also contain microcrystalline cellulose, magnesium stearate, maize starch and pregelatinised maize starch.

SOTACOR injection also contains sodium chloride, glacial acetic acid, sodium hydroxide and water for injections.

How current is this information and where can I find out more?

This leaflet was produced in October 1999 and was based on information then known to Bristol-Myers Squibb Australia Pty Ltd. You need to consult your doctor regularly as your doctor has access to information on any changes which may affect you.

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Who makes SOTACOR?

SOTACOR is made by Bristol-Myers Squibb Company.
The tablets are made in Australia by
Bristol-Myers Squibb Australia Pty Ltd
556 Princes Highway
Noble Park, Victoria, 3174
The injection is made in Italy by
Bristol-Myers Squibb S.p.A
Anagni
Italy.
Light blue SOTACOR Tablets 80mg AUST R 68963 in bottles of 60 tablets
Light blue SOTACOR Tablets 160mg AUST R 68965 in bottles of 60 tablets
White SOTACOR Tablets 160 mg AUST R 11979 in bottles of 60 tablets
SOTACOR Injection 40mg/4mL AUST R 54089 in cartons containing 5 ampoules
® Registered Trademark. SOTACOR is a Squibb Trademark
VersSotacor4

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CMI provided by MIMS Australia, December 2014  

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