Sevikar (Olmesartan & Amlodipine) 20mg/5mg Tablets (Pack of 30)

Acenorm*

contains the active ingredient captopril

CONSUMER MEDICINE INFORMATION

What is in this leaflet

This leaflet answers some common questions about Acenorm.

It does not contain all of the available information.

It does not take the place of talking to your doctor or pharmacist.

All medicines have benefits and risks. Your doctor has weighed the risks of you taking Acenorm against the benefits expected for you.

If you have any concerns about taking this medicine, talk to your doctor or pharmacist.
Keep this leaflet with your medicine.

You may need to read it again.

  • What Acenorm is used for

    Acenorm is used to treat:

  • high blood pressure (hypertension)
  • heart failure
  • kidney problems in some people who have type 1 or insulin-dependent diabetes.

    • Acenorm is also used to improve the survival of some people who have had a heart attack.

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

    Your doctor may have prescribed Acenorm for another reason.

    Acenorm belongs to a group of medicines called angiotensin converting enzyme (ACE) inhibitors.

    ACE inhibitors lower blood pressure by widening blood vessels, making it easier for the heart to pump blood around the body.

    Widening of the blood vessels also increases the supply of blood and oxygen to the heart. This allows your heart to cope better when you place extra demands on it, such as during exercise, so you may not get short of breath as easily (if you have heart failure).

    By increasing the supply of oxygen to your heart, your heart does not have to work as hard, which may reduce the risk of further damage to the heart after a heart attack.

    Acenorm also improves blood flow through the kidneys, and as a result helps to slow down the kidney damage caused by type 1 insulin-dependent diabetes.

    Acenorm is not recommended for use in children.

    Safety and effectiveness of Acenorm in children have not been clearly established. However, Acenorm may be necessary for a child with hypertension and kidney problems. If this is the case, your doctor will discuss all the possible risk and benefits to the child before starting treatment.

    Acenorm is available only with a doctor`s prescription.

    There is no evidence that Acenorm is addictive.

    Before you take Acenorm

    When you must not take it

    Do not take Acenorm if you are allergic to:

  • captopril or any other ACE inhibitor medicine
  • any of the ingredients listed at the end of this leaflet.

    • Some of the symptoms of an allergic reaction may include skin rash, itching or hives; swelling of the face, lips or tongue, difficulty swallowing or breathing; wheezing or shortness of breath.

    Do not take Acenorm if you have:

  • idiopathic angioedema
  • hereditary angioedema.

    • In idiopathic angioedema; swelling of the face, lips, mouth, tongue or throat, which may cause difficulty in swallowing or breathing; can occur for no apparent reason. While in people with hereditary angioedema, people are born with this condition.

    Do not take Acenorm if you are pregnant or plan to become pregnant.

    Acenorm is not recommended for use in pregnancy as it may affect your developing baby.

    Do not take Acenorm if the expiry date (EXP) printed on the pack has passed.
    Do not take Acenorm if the packaging shows signs of tampering or the tablets do not look quite right.

    Before you start to take it

    Tell your doctor if you are allergic to any other medicines, foods, dyes or preservatives.
    Tell your doctor if you are breastfeeding or wish to breastfeed.

    It is recommended that you do not continue to breastfeed while taking Acenorm because it passes into breast milk. Your doctor will discuss the risks and benefits of taking Acenorm when breastfeeding.

    Tell your doctor if you are having dialysis or plan to have surgery.
    Tell your doctor if you have, or have had, any medical conditions, especially the following:

  • kidney problems
  • liver problems
  • ischaemic heart disease (eg. angina)
  • heart failure
  • cerebrovascular disease, a condition that affects the blood vessels of the brain
  • diabetes
  • systemic lupus erythematosus (SLE), scleroderma or other autoimmune diseases
  • neutropenia, a blood disorder where there is a lack of white blood cells
  • a recent bout of diarrhoea or vomiting, or are dehydrated.

    • If you have not told your doctor about any of the above, tell them before you start taking Acenorm.

    Taking other medicines

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

    Some medicines may be affected by Acenorm, or may affect how well it works. These include:

  • other medicines used to treat high blood pressure
  • diuretics (also known as fluid tablets), including spironolactone (Aldactone, Spiractin), triamterene (found in Hydrene), amiloride (eg. Kaluril, Midamor)
  • medicines used to treat angina
  • potassium supplements (eg. Slow-K, KSR) or potassium-containing salt substitutes
  • non-steroidal anti-inflammatory drugs (NSAIDs), medicines used to relieve pain, swelling and other symptoms of inflammation, including arthritis, such as indomethacin (Indocid, Arthrexin)
  • lithium (eg. Lithicarb), a medicine used to treat mood swings and some types of depression
  • some medicines used for coughs, colds, hayfever, sinus problems
  • allopurinol (eg. Zyloprim, Progout), a medicine used to prevent gout
  • immunosuppressants, medicines that lower your immunity to infections.

    • Your doctor can tell you what to do if you are taking any of these medicines.

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

    Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking Acenorm.

    How to take Acenorm

    Follow all directions given to you by your doctor and pharmacist carefully.

    They may differ from the information contained in this leaflet.

    If you do not understand the instructions on the pack, ask your doctor or pharmacist.

    How much to take

    The dose varies from person to person.

    The usual dose ranges from 12.5 mg to 50 mg, two or three times a day. However, your doctor may ask you to take a different dose depending on your condition (for example if you have kidney problems) and your response to Acenorm.

    How to take Acenorm

    Swallow the tablets with a glass of water.

    Tablets can be divided along the breakline if advised by your doctor.

    When to take Acenorm

    Take Acenorm at about the same time each day.

    Taking your tablets at the same time each day will have the best effect.

    Take Acenorm on an empty stomach, for example, 1 hour before food.

    Food can interfere with the absorption of Acenorm.

    How long to take Acenorm for

    Keep taking Acenorm for as long as your doctor recommends.

    To properly control your condition, it is important that you take Acenorm every day, even if you feel well.

    If you forget to take Acenorm

    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 the missed dose as soon as you remember, and then go back to taking your tablets as you would normally.
    Do not take a double dose to make up for the dose you missed.
    If you are not sure what to do, ask your doctor or pharmacist.
    If you have trouble remembering to take your tablets, ask your pharmacist for some hints.

    If you take too much Acenorm (overdose)

    Immediately telephone your doctor, or the Poisons Information Centre (telephone 13 11 26), or go to Accident and Emergency at the nearest hospital, if you think you or anyone else may have taken too much Acenorm.
    Do this even if there are no signs of discomfort or poisoning.

    You may need urgent medical attention.

  • While you are taking Acenorm

    Things you must do

    Before starting any new medicine, tell your doctor or pharmacist that you are taking Acenorm.
    Tell all the doctors, dentists and pharmacists who are treating you that you are taking Acenorm.
    If you become pregnant while taking Acenorm, tell your doctor immediately.
    Make sure you drink enough water during exercise and hot weather, especially if you sweat a lot.

    If you do not drink enough water while taking Acenorm, you may feel faint, lightheaded or sick. This is because your body does not have enough fluid and your blood pressure is low. If you continue to feel unwell, tell your doctor.

    If you have severe vomiting or diarrhoea while taking Acenorm, tell your doctor.

    This may cause you to lose too much water and salt, and your blood pressure may become too low.

  • If you plan to have surgery, including dental surgery, tell your doctor or dentist that you are taking Acenorm.

    This is especially important if your doctor or dentist will be giving you an anaesthetic.

    If you plan to have desensitisation therapy for an allergy (eg. to an insect bite), tell your doctor that you are taking Acenorm.

    Your doctor may want to take special care.

    If you have to have any urine tests, tell your doctor that you are taking Acenorm.

    Acenorm may affect the results of some tests.

    Visit your doctor regularly so that they can check on your progress.

    Your doctor may want you to have some tests to check your kidneys, blood and other body functions.

    Things you must not do

    Do not stop taking Acenorm, or lower the dose, without checking with your doctor.
    Do not use Acenorm to treat any other conditions unless your doctor tells you to.
    Do not give Acenorm to anyone else, even if they have the same condition as you.

    Things to be careful of

    Be careful getting up from a sitting or lying position.

    Dizziness, lightheadedness or fainting may occur, especially when you get up quickly. This is more likely to occur when you start taking Acenorm, or if the dose is increased. Getting up slowly may help.

    These symptoms can be dangerous, especially in people with heart failure, angina or cerebrovascular disease.

    If these symptoms continue or become worse, tell your doctor.

  • Be careful driving or operating machinery until you know how Acenorm affects you.

    Acenorm may cause dizziness or lightheadedness in some people. If this occurs, do not drive, operate machinery or do anything else that could be dangerous.

    Side effects

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

    Acenorm helps most people, but it may have unwanted side effects in some people. 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, faintness
  • dry cough
  • change in taste.

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

  • signs of frequent infections such as fever, chills, sore throat or mouth ulcers
  • bleeding or bruising more easily than normal
  • red raised, itchy skin rash with or without fever or joint pain
  • yellowing of the skin and/or eyes (jaundice)
  • symptoms of a high blood potassium level, such as:
  • –confusion, nervousness
  • –irregular heart beat
  • –numbness or tingling in the hands, feet or lips
  • –shortness of breath or difficulty breathing
  • –weakness or heaviness of the legs
  • passing little or no urine.

    • The above list includes serious side effects which may require medical attention.

    If any of the following happen, stop taking Acenorm and tell your doctor immediately, or go to Accident and Emergency at the nearest hospital:

  • fast or irregular heart beat
  • fainting within a few hours of taking a dose
  • swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing
  • swelling of the hands or feet
  • stomach pain with or without nausea and vomiting
  • shortness of breath, chest pain
  • pink or red itchy spots on the skin which may blister and progress to form raised, red, pale-centred marks
  • blisters or bleeding in the lips, eyes, mouth, nose and genitals.

    • The above list includes very serious side effects. You may need urgent medical attention or hospitalisation.

    Tell your doctor if you notice anything that is making you feel unwell.

    Other side effects not listed above may also occur in some people.

  • After taking Acenorm

    Storage

    Keep Acenorm 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.

    Keep your tablets in a cool dry place where the temperature stays below 30 degrees C.
    Do not store Acenorm or any other medicine in the bathroom or near a sink.
    Do not leave Acenorm in the car or on window sills.

    Heat and dampness can destroy some medicines.

  • Disposal

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

  • Product description

    What it looks like

    Acenorm tablets are available in three strengths:

  • 12.5 mg – white capsule-shaped tablet, marked “CL” on one side and scored on the other.
  • 25 mg – white square tablet, marked “CL” over “25” on one side and cross-scored on the other.
  • 50 mg – white oval tablet, marked “CL 50” on one side and scored on the other.

    • Each pack contains 90 tablets.

  • Ingredients

    The active ingredient in Acenorm tablets is captopril:

  • each Acenorm 12.5 mg tablet contains 12.5 mg of captopril
  • each Acenorm 25 mg tablet contains 25 mg of captopril
  • each Acenorm 50 mg tablet contains 50 mg of captopril.

  • Acenorm tablets also contain:

  • lactose
  • maize starch
  • microcrystalline cellulose
  • stearic acid.

    • The tablets are gluten free.

    Supplier

    Acenorm is supplied by:

    Alphapharm Pty Limited

  • (ABN 93 002 359 739)
  • Chase Building 2
  • Wentworth Park Road
  • Glebe NSW 2037
  • Phone: (02) 9298 3999
  • www.alphapharm.com.au
  • Medical Information
  • Phone: 1800 028 365
  • Australian registration numbers:
  • 12.5 mg tablets – AUST R 65271
  • 25 mg tablets – AUST R 54091
  • 50 mg tablets – AUST R 54092
  • This leaflet was prepared on
  • 24 May 2004.
  • Acenorm* is a Registered Trade Mark of Bristol-Myers Squibb Company.

    • ENQUIRE

    1800 200 736