Phenobarbitone Tablets 30MG Pack Of 200

PHENOBARBITONE TABLETS

(FEN-O-BARB-IT-OWN)
Phenobarbitone Sodium (Fen-o-barb-it-own so-dee-um)
Consumer Medicine Information

What is in this leaflet

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

All medicines have risks and benefits. Your doctor has weighed the risks of you taking PHENOBARBITONE tablets against the benefits he/she expect it will have.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

What is PHENOBARBITONE

The name of your medicine is PHENOBARBITONE tablets.

The active ingredient is called Phenobarbitone Sodium.

Phenobarbitone Sodium belongs to a group of medicines called barbiturates. Barbiturates act by inducing sleep and stopping convulsion.

What PHENOBARBITONE is used for

PHENOBARBITONE is used for:

  • Epileptic fits
  • Sedation
  • Your doctor, however, may have prescribed PHENOBARBITONE for another purpose.

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

    If you have any concerns, you should discuss this with your doctor.

    PHENOBARBITONE tablets are available only with a doctors prescription.

    The use of barbiturates may lead to dependence on the medicine.

  • Before you take PHENOBARBITONE tablets

    When you must not take it

    Do not take PHENOBARBITONE if you are allergic to:

  • PHENOBARBITONE tablets or any of their ingredients (see Product description)
  • Some of the symptoms of an allergic reaction to PHENOBARBITONE may include red, itchy skin rashes, difficulty breathing, hay fever, swelling of the face or throat or faintness.

    PHENOBARBITONE should not be used if you have , or have had any of the following medical conditions:

  • Porphyria, a rare blood pigment disorder
  • Anaemia, a disease of the blood with reduced number of red blood cells
  • Uncontrolled severe asthma
  • Uncontrolled diabetes mellitus or sugar diabetes
  • Alcoholism or drug dependence
  • Liver or kidney problems
  • Severe depression or suicidal tendencies
  • Short or long term pain
  • PHENOBARBITONE should not be given to unusually overactive children.

    Do not take PHENOBARBITONE tablets after the expiry date (EXP.) printed on the pack.

    If you take it after the expiry date has passed, it may have no effect at all, or worse, there may be an entirely unexpected effect.

    Do not purchase or use PHENOBARBITONE tablets if the packaging is torn or shows signs of tampering.

    Tell your doctor if you are pregnant or intend to become pregnant.

    PHENOBARBITONE may effect your developing baby if you take it during pregnancy. However, it is very important to control your fits while you are pregnant. If it is necessary for you to take PHENOBARBITONE, your doctor can help you decide whether or not to take it during pregnancy.

    Tell your doctor if you are breast-feeding or plan to breast-feed.

    Do NOT breast-feed while taking Phenobarbitone Sodium. This medication passes into breast milk. There is a possibility that the breast-fed baby may be affected.

    Elderly patients are more likely to have less effective kidney or liver function due to age. This may increase the risk of side effects. You should discuss how much PHENOBARBITONE to take with your doctor or pharmacist.

    Before you start to take it

    You must tell your doctor if you are:

  • 1.allergic to any other medicines or any foods, dyes or preservatives.
  • 2.you have any other medical conditions/ health problems, including:
  • low blood pressure
  • heart problems
  • lung problems
  • hyperthyroidism, an overactive thyroid gland
  • hypoadrenalism (borderline), an underfunction of the adrenal gland
  • a depressive illness
  • asthma
  • 3.you are a heavy drinker
  • 4.you have a drug dependency
  • If you have not told your doctor about any of the above, tell them before you take any PHENOBARBITONE tablets.

    Taking other medicines

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

    Some medicines may interact with PHENOBARBITONE tablets. These include:

  • other medications used to treat epilepsy
  • anticoagulants, medicines used to treat clots eg. warfarin
  • painkillers, paracetamol and stronger narcotic agents
  • antidepressants, medicines used to treat depression
  • anti-arrhythmics, medicines used to treat irregular heart beats eg. Quinidine, disopyramide
  • antibiotics and antifungal agents, medicines used to treat infections including AIDS
  • calcium channel blockers, medicines used to treat high blood pressure and angina
  • antipsychotics, medicines used to treat certain mental and emotional conditions
  • chemotherapy drugs, used to treat cancer
  • corticosteroids, such as prednisolone, cortisone
  • medicines used to treat heart failure eg. digoxin
  • oral contraceptives
  • St John`s Wort
  • immunosuppressive medicines, used to lower your body`s resistance to disease eg. cyclosporin, tacrolimus
  • medicines used to stop you from feeling pain, eg, anaesthetic agents
  • disulfiram, a medicine used to treat alcoholism
  • urinary alkalinisers
  • antihistamines, medicines used to prevent or relieve symptoms of allergy.
  • Theophylline, medicine used to treat asthma.
  • Beta-blockers e.g. propranolol, used to treat high blood pressure and heart conditions.
  • The above medicines may either reduce the effectiveness of PHENOBARBITONE tablets, reduce their own effectiveness and/ or react with PHENOBARBITONE resulting in untoward or sometimes dangerous side effects.

    This list is not exhaustive. Your doctor or pharmacist has more information on medicines to be careful with or avoid while taking PHENOBARBITONE tablets.

  • How to take PHENOBARBITONE tablets

    a) how much to take

    The recommended doses of PHENOBARBITONE tablets are:

    Sedative dose

  • Adults: 1 – 4 tablets as a single daily dose or as 2 to 3 divided doses per day.
  • Anticonvulsant dose

  • Adults: 2 to 8 tablets as a single daily dose or as 2 to 3 divided doses per day.
  • Tablets should be swallowed with a glass of water.

  • Children: Your doctor will advise you of the correct dose, depending on the weight of your child.
  • b) how to take it

    The tablets should be swallowed whole with a glass of water, as directed.

    c) how long to take it

    Continue taking PHENOBARBITONE tablets as long as your doctor recommends it.

    Do not stop taking PHENOBARBITONE tablets without checking with your doctor. Do not let yourself run out of medicine over the weekend or on holidays.

    Stopping PHENOBARBITONE tablets may cause unwanted effects or make your condition worse. Your doctor will slowly reduce your dose before you can stop taking it completely.

    If symptoms persist, see your doctor.

    d) If you forget to take it

    Take your dose as soon as you remember, and then go back to taking it as you would normally.

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

    If you are unsure about whether to take your next dose, speak to your doctor or pharmacist.

    Do not try to make up for missed doses by taking more than one dose at a time. This may increase the chance of you getting an unwanted effect.

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

    If you take too much (Overdose):

    Immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26) for advice, or go to casualty at your nearest hospital, if you think that you or anyone else may have taken too much PHENOBARBITONE. Do this even if there are no signs of discomfort or poisoning. Also report any other medicine or alcohol (including any barbiturates or narcotics) which has been taken. You may need urgent medical attention.

    Keep telephone numbers for these places handy

    If you take too much PHENOBARBITONE you may have symptoms of weakness, dizziness, lethargy, nausea, vomiting, sweating, underbreathing, impairment of consciousness, collapse of circulation, mental confusion and low blood pressure.

  • While you are taking PHENOBARBITONE

    Things you must do:

    Take PHENOBARBITONE tablets exactly as directed or as your doctor has prescribed.

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

    Your doctor needs to check your progress and see whether you need to keep taking PHENOBARBITONE tablets.

    Tell your doctor if you want to take oral contraceptives while taking PHENOBARBITONE tablets. You may need a higher dose of oral contraceptives than usual to prevent pregnancy, or you may need to consider other forms of contraception.

    If you need any medical tests while you are taking PHENOBARBITONE tablets, tell your doctor as it may affect the results of some tests.

    If you become pregnant while you are taking PHENOBARBITONE tablets, tell your doctor.

    Always discuss with your doctor any problems or difficulties during or after taking PHENOBARBITONE tablets.

    Your doctor may want to take some tests from time to time to help prevent unwanted side effects.

    Things you must not do:

    Do not take any other medicines while you are taking PHENOBARBITONE tablets without first telling your doctor.

    Do not drive or operate machinery until you know how PHENOBARBITONE tablets affects you.

    PHENOBARBITONE may cause dizziness in some people and therefore may affect alertness.

    Do not give this medicine to anyone else, even if their symptoms seem similar to yours.

    Things to be careful of:

    Be careful drinking alcohol while taking PHENOBARBITONE tablets. If you drink alcohol, it could make some of the unwanted side effects of PHENOBARBITONE worse.

    Your doctor may suggest that you avoid alcohol completely or reduce the amount of alcohol you drink while you are taking PHENOBARBITONE tablets.

    Some people may experience side effects such as nausea, vomiting, constipation, drowsiness, dizziness, which may further affect the risk when driving or using dangerous machinery.

  • Side effects

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

    PHENOBARBITONE tablets help most people with medical conditions listed in the beginning of this leaflet, but it may have unwanted side effects in some people, especially in elderly patients or those with underlying disorders.

    All medicines 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.

    Ask your doctor or pharmacist any questions you may have.

    Common Side Effects:

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

  • rapid heartbeat
  • nausea (feeling sick)
  • constipation
  • dizziness
  • lethargy
  • ?vomiting
  • skin rashes
  • sweating
  • dry mouth
  • confusion
  • faintness
  • irritability
  • restlessness
  • dependency (habit-forming)
  • mood changes
  • drowsiness
  • hyperexcitability
  • hangover
  • sleep disturbances
  • Tell your doctor immediately or go to Accident and Emergency at your nearest hospital if you notice any of the following:

  • sore throat
  • fever
  • easy or unusual bleeding or bruising under the skin
  • nose bleed
  • other signs of infection e.g. swollen glands, mouth ulcers
  • sudden signs of allergy (listed on page 1)
  • severe skin rash, itching, hives, blisters or peeling skin
  • Other side effects not listed above may occur in some patients. Tell your doctor or pharmacist if you notice anything that is making you feel unwell.

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

    After taking PHENOBARBITONE tablets

    Storage

    Keep it 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 PHENOBARBITONE tablets in a cool dry place where the temperature stays below 30 degrees C and protect from light. Do not store it, or any other medicines, in a bathroom or near a sink.
    Do not leave it in the car or on windowsills.

    Heat and dampness can destroy some medicines. Do not take PHENOBARBITONE if the tablets do not look quite right.

    Keep your tablets in the bottle they were provided in until it is time to take them.

    Disposal

    If your doctor tells you to stop taking this medication OR it has passed their expiry date, ask your pharmacist what to do with any left over.

    Product description

    a) What it looks like

    PHENOBARBITONE tablets are

    white scored tablets and are available in bottles of 200. Each Phenobarbitone tablet contains the active ingredient, phenobarbitone 30 mg.

    b) Ingredients

    PHENOBARBITONE tablets contain the following excipients: lactose, acacia, starch – wheat, magnesium stearate.

    Sponsor or Supplier

  • Sigma Pharmaceuticals Pty Ltd
  • 1408 Centre Road
  • Clayton Victoria 3168
  • Australia
  • Telephone: 03 – 9839 2800
  • The Australian Registration Number for PHENOBARBITONE tablets is:
  • AUST R 19758
  • This leaflet was prepared on 9th November 1999 and updated in March 2000 and June 2000.
  • ENQUIRE

    1800 200 736