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INFORMATION FOR CONSUMERS

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Consumer Medicine Information

ELTROXIN™

Thyroxine tablets 50µg, 100µg

What is in this leaflet

Please read this leaflet carefully before you start taking ELTROXIN tablets.

This leaflet answers some common questions about ELTROXIN tablets. 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 risks and benefits. Your doctor has weighed the expected benefits of you taking ELTROXIN against the risks this medicine could have for you.

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

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

What ELTROXIN is used for

ELTROXIN contains the active ingredient thyroxine.

ELTROXIN is used to treat hypothyroidism, a disease in which the thyroid gland is underactive and does not produce enough thyroxine, a hormone, which is important for controlling your metabolism. Symptoms of hypothyroidism include tiredness, muscle weakness, cramps, feeling the cold, a slow heart rate, dry and flaky skin, hair loss, a deep husky voice and weight gain.

ELTROXIN is also used to treat children born with hypothyroidism (congenital), those who develop hypothyroidism in the first year of life (neonatal) and children who have hypothyroidism as part of juvenile myxoedema, a condition in which the amount of thyroxine produced by the body is low.

Your doctor may have prescribed ELTROXIN for another purpose.

ELTROXIN belongs to a small group of medicines called thyroid hormones, which work by replacing the body's low levels of thyroxine.

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

ELTROXIN is available only with a doctor's prescription.

Before you take ELTROXIN

When you must not take it

Do not take ELTROXIN if:

Before you start taking ELTROXIN

Tell your doctor if:

If you have not told your doctor about any of the above, please do so before taking ELTROXIN.

Taking other medicines

Some medicines may affect the way others work.

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

If you are taking any of the following types of medicines, please let your doctor know before taking ELTROXIN:

Your doctor or pharmacist will be able to tell you more about what to do when taking ELTROXIN with other medicines.

Taking ELTROXIN

How much to take

Take ELTROXIN exactly as your doctor has prescribed.

Your doctor will tell you how many ELTROXIN tablets to take each day.

Your doctor will calculate the dose based on your weight.

Never take more tablets than your doctor has prescribed.

Your doctor may vary your dose depending on how you respond to ELTROXIN.

In adults, the usual dose is 50µg to 100µg daily, increased every 3 to 4 weeks as needed. The maximum dose is 200µg daily.

The dose for adults is reduced in children according to their weight and age. Elderly people usually need a smaller dose because they are more sensitive to the effects of thyroxine.

Many people need treatment with ELTROXIN long term.

Your doctor will do regular blood tests to make sure ELTROXIN is working for you.

How to take it

Swallow tablets whole with a glass of water. Tablets should be taken on an empty stomach, preferably at least 30 minutes before breakfast.

If you forget to take it

Do not take an extra dose. Wait until the next dose and take your normal dose then.

Do not try to make up for the dose that you missed by taking more than one dose at a time.

If you are not sure what to do, ask your doctor or pharmacist.

In case of an overdose

Immediately telephone your doctor or the National Poisons Information Centre [Ph 0800 POISON or 0800 764 766] for advice, or go to Accident and Emergency at your nearest hospital, if you think that you or anyone else has taken too much ELTROXIN. Do this even if there are no signs of discomfort or poisoning.

You may need urgent medical attention.

Keep phone numbers for these places handy.

An overdose of ELTROXIN can cause agitation, confusion, irritability, hyperactivity, sweating, headaches, fever, widened pupils, fits, palpitations and diarrhoea.

If you are not sure what to do, contact your doctor or pharmacist.

While you are taking ELTROXIN

Things you must do

Tell all doctors and pharmacists involved in your health care that you are taking ELTROXIN.

Tell your doctor if you are pregnant or planning to become pregnant or are breastfeeding while taking ELTROXIN.

Tell your doctor if, for any reason, you have not taken ELTROXIN exactly as prescribed. Otherwise, your doctor may think it is not working for you and change your ELTROXIN dose unnecessarily.

Tell your doctor if you feel that ELTROXIN is not helping your condition.

Things you must not do

Do not stop taking ELTROXIN or change the dose without first checking with your doctor, or your symptoms could return.

Do not let yourself run out of medicine over the weekend or on holidays.

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

Do not take any other medicines whether they require a prescription or not without first asking your doctor or a pharmacist.

Do not drive or operate machinery until you know how your ELTROXIN dose is affecting you.

Side-Effects

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

Ask your doctor or pharmacist to answer any questions you may have. Be sure that your doctor or pharmacist knows as soon as possible if you do not feel well while you are taking ELTROXIN.

If you think you are having an allergic (hypersensitivity) reaction to ELTROXIN, TELL YOUR DOCTOR IMMEDIATELY.

Symptoms include:

However, these symptoms do not necessarily mean that you are allergic to ELTROXIN.

Tell your doctor if you notice any of the following:

The above side effects are rare with ELTROXIN and usually mean that your daily ELTROXIN dose is too high.

Your doctor may recommend that you change your dose of ELTROXIN if you experience any of these side effects.

Tell your doctor if you notice anything else that is making you feel unwell, even if it is not on this list.

Ask your doctor or pharmacist if you do not understand anything on this list.

After taking ELTROXIN

Storage

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

If you take the tablets out of the bottle they may not keep well.

Keep ELTROXIN in a cool dry place away from light where the temperature stays below 25°C.

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

Do not leave it in a car or on a window sill.

Heat and dampness can destroy some medicines. Keep ELTROXIN where young 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 ELTROXIN, or the medicine has passed its expiry date, ask your pharmacist what to do with any tablets that are left.

Product description

What ELTROXIN looks like

Ingredients

50µg tablets
Thyroxine, Microcrystalline cellulose, Pregelatinised maize starch, Talc, Colloidal anhydrous silica and Magnesium stearate.

100µg tablets
Thyroxine, Microcrystalline cellulose, Pregelatinised maize starch, Talc, Colloidal anhydrous silica and Magnesium stearate.

Further information

Your doctor is the best person to give you advice on the treatment of your illness. You may also be able to find general information about hypothyroidism and its treatment from other sources, for example, books in public libraries and on the Internet.

Manufacturer

ELTROXIN is supplied by:

Pharmacy Retailing (NZ) Limited
Trading as Healthcare Logistics
58 Richard Pearse Drive
Airport Oaks
Auckland
New Zealand

Date of revision: June 2009