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NALTREXONE GENERICHEALTH


Consumer Medicine Information

What is this leaflet?

This leaflet answers some common questions about Naltrexone generichealth. It does not contain all of the available information.

All medicines have risks and benefits. Your doctor has weighed the risks of your taking Naltrexone generichealth against the benefits they expect it will have for you. If you have any concerns about taking Naltrexone generichealth, ask your doctor or pharmacist.

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

What is Naltrexone generichealth used for?

Naltrexone generichealth is used to help opiate drug addicts kick the habit. It is also used to help alcoholics dry out and remain abstinent.

Naltrexone generichealth tablets contain the active ingredient, naltrexone hydrochloride. It is an opiate antagonist. This means it fights the effects of opiate drugs like heroin on the body, and blocks euphoria (or “high”) due to these opiates.

Your doctor may have prescribed Naltrexone generichealth for another use. Ask your doctor if you have any questions about why Naltrexone generichealth has been prescribed for you.

Naltrexone generichealth is not addictive.

Before you take Naltrexone generichealth

Naltrexone generichealth is not suitable for everyone.

When you must not take it

  • Do not take Naltrexone generichealth if you have had an allergic reaction to Naltrexone generichealth or any of the ingredients.
    Symptoms of an allergic reaction may include, but are not limited to, swelling of the face or tongue, difficulty in breathing, wheezing or an itchy skin rash.
  • Do not take Naltrexone generichealth if you are still using heroin or drugs like it. If you take Naltrexone generichealth right after taking an opiate you will suffer withdrawal symptoms (cold turkey) (such as nausea, vomiting, shakiness, sweating and anxiety) which may be severe.
  • Do not take Naltrexone generichealth if you are on certain pain killers. Ask your doctor or pharmacist.
  • Do not take Naltrexone generichealth if you have hepatitis or liver failure.
    Hepatitis is liver disease with nausea, vomiting, loss of appetite, feeling generally unwell, fever, itching, yellowing of the skin and eyes, and dark coloured urine.
  • Do not take Naltrexone generichealth if you are pregnant or breast feeding unless your doctor tells you it is safe.
  • Do not take Naltrexone generichealth if you are experiencing withdrawal symptom
  • Do not take Naltrexone generichealth after the expiry date printed on the packaging.
  • Do not take Naltrexone generichealth if the packaging is torn or seems to have been opened, or the tablets do not look quite right. (See Product Description.)

Before you start to use it

Tell your doctor if you have any allergies.

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

Tell your doctor if you have or have had any liver disease.

Your doctor may give you a test called a NARCAN challenge. This is to see if you are still using heroin or drugs like it.

Taking other medicines

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

Naltrexone generichealth may reduce or stop the effect of some cough and cold medicines, some medicines that treat loose bowel motions and some pain killers. If this happens, do not take larger doses of these other medicines. If you do, you may become very sick. Talk to your doctor. Your doctor will advise you.

How to take Naltrexone generichealth

Do not take Naltrexone generichealth to treat any condition other than that directed by your doctor.

Do not give Naltrexone generichealth to anyone else, even if their symptoms seem the same as yours. It may harm them

How much to take

The usual adult dose is one tablet every day. Sometimes your doctor may tell you to take 2 or 3 tablets three times a week. You will usually take Naltrexone generichealth for at least 3 months, but it may be much longer. The time depends on how quickly you recover from alcohol or heroin addiction.

If you forget to take Naltrexone generichealth

If you forget to take a dose of Naltrexone generichealth, take it as soon as you remember. If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

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

If you take too much Naltrexone generichealth

Telephone your doctor or go to the emergency department at your nearest hospital immediately if you think that you or anyone else may have taken too much Naltrexone generichealth even if there are no signs of discomfort or poisoning.

While you are taking Naltrexone generichealth

Things you must do

Make sure that all of your doctors, dentists and pharmacists know about your use of Naltrexone generichealth. Remind them if any new medicines are about to be started, or if you are about to have a medical or dental procedure.

Things that you must not do

Do not use any other medicines while using Naltrexone generichealth unless you have discussed this with your doctor or pharmacist. This includes medicines you can buy without a prescription from a pharmacy, supermarket or health food shop or street drugs.

Naltrexone generichealth may not protect you if you take large amounts of an opiate in an attempt to overcome the blocking effects of Naltrexone generichealth. Large doses of opiate can lead to difficulty in breathing and even to death from opiate overdose.

Do not use Naltrexone generichealth to treat any complaint other than that directed by your doctor. It may not be safe to use Naltrexone generichealth for another complaint.

Naltrexone generichealth should only be used by the person for whom it was prescribed. Do not give Naltrexone generichealth to someone else even if the symptoms are the same. It may not be safe for another person to use Naltrexone generichealth. Do not give your tablets to people who are known to be dependent on opiate drugs because a withdrawal syndrome “cold turkey” may be precipitated.

Signs and symptoms (such as nausea, vomiting, shakiness, sweating and anxiety) which may be severe may develop within five minutes. If this happens, call a doctor.

Side Effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Naltrexone generichealth. Like all medicines, Naltrexone generichealth can cause side effects. Sometimes they are serious, most of the time they are not.

Side-effects can include:

  • Nausea, vomiting, diarrhoea, constipation, stomach pain or cramps.
  • Headache, dizziness, nervousness, drowsiness.
  • Chest pain, joint and muscle pain.
  • Rash.
  • Tiredness, feeling anxious or irritable, difficulty sleeping, thirsty, loss of appetite, delayed ejaculation, sweating, increased tears, feeling down, chills, increased energy.
  • If you have stomach pain lasting more than a few days, white bowel movements, dark urine, or yellowing of your eyes, you should stop taking Naltrexone generichealth immediately and see your doctor as soon as possible.

Naltrexone generichealth may affect your ability to drive or operate machinery. Be careful driving or operating machinery until you know how Naltrexone generichealth affects you. If you drink alcohol while you are taking Naltrexone generichealth, your blood alcohol level increases in the same way just as it would if you are not taking Naltrexone generichealth.

As this level rises, you can become physically and mentally impaired. The use of Naltrexone generichealth will not change this.

Other side effects not listed above may also occur in some patients. Tell your doctor if you notice anything else 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 using Naltrexone generichealth

If you stop taking Naltrexone generichealth and restart your heroin habit, you are at risk of being more sensitive to opiates. Therefore restarting your heroin habit after stopping Naltrexone generichealth can lead to death from opiate overdose. You should talk to your doctor before you stop taking Naltrexone generichealth and before you start taking heroin again.

Storage

  • Keep Naltrexone generichealth in its packaging until it is time to take it. If you take the tablets out of their packaging, they may not keep well.
  • Keep Naltrexone generichealth in a cool dry place where the temperature stays below 25°C. Do not freeze.
  • Do not store it or any other medicine in the bathroom or near a sink.
  • Do not leave it in the car on hot or cold days.
  • Keep Naltrexone generichealth where children cannot reach it.

Disposal

Return any unused medicine to your pharmacist.

Product description

What Naltrexone generichealth looks like

Naltrexone generichealth tablets are beige, film-coated and capsule shaped. They are marked with a line on both sides.

Ingredients

Each Naltrexone generichealth tablet contains 50 mg of naltrexone hydrochloride as the active ingredient.

It also contains the following inactive ingredients:

  • lactose
  • microcrystalline cellulose
  • silica-colloidal anhydrous
  • magnesium stearate
  • crospovidone
  • hypromellose
  • macrogol (4000)
  • titanium dioxide
  • iron oxide black CI77499
  • iron oxide red CI77491
  • iron oxide yellow CI77492

Naltrexone generichealth tablets are available in blister strips of aluminium foil backing packed in cardboard. Each carton contains 30 tablets.

Distributor

Naltrexone generichealth is distributed in Australia by:
Generic Health Pty Ltd
Suite 1, 1175 Toorak Road
Camberwell, Victoria, 3127
www.generichealth.com.au

Under license from:
AOP Orphan Pharmaceuticals AG.

This leaflet was prepared in May 2009.

Australian Registration Number:
Naltrexone generichealth AUST R 128710

Naltrexone generichealth is supplied by Generic Health Pty Ltd under licence from AOP Orphan Pharmaceuticals AG, Vienna, Austria

Published by MIMS/myDr March 2010

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