Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about taking this medicine,
speak to your doctor or pharmacist.
1. Why am I taking LEVOTHOX?
LEVOTHOX contains the active ingredient Levothyroxine sodium. LEVOTHOX is used to
treat thyroid hormone deficiency also known as Hypothyroidism and TSH-responsive tumours
of the thyroid.
2. What should I know before I take LEVOTHOX?
Do not take if you have ever had an allergic reaction to LEVOTHOX or any of the ingredients
listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.
3. What if I am taking other medicines?
Some medicines may interfere with LEVOTHOX and affect how it works.
4. How do I take LEVOTHOX?
Your doctor will calculate the right dose for you.
5. What should I know while taking LEVOTHOX?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are taking LEVOTHOX.
Do not switch or interchange with other brands unless advised by your doctor.
Use it exactly as directed or as your doctor has prescribed.
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Things you should not do
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Do not stop using this medicine suddenly.
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Driving or using machines
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Be careful before you drive or use any machines or tools where alertness is required,
until you know how LEVOTHOX affects you.
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Drinking alcohol
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Tell your doctor if you drink alcohol.
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Looking after your medicine
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Store the medicine in a cool dry place where the temperature stays below 25°C. Protect
from light.
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6. Are there any side effects?
There is a number of common side effects associated with the use of LEVOTHOX, if they
worry you talk to your doctor or pharmacist. There are no serious side effects associated
with LEVOTHOX.
Active ingredient(s):
Levothyroxine sodium
Full Consumer Medicine Information (CMI)
This leaflet provides important information about taking LEVOTHOX. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about taking LEVOTHOX.
Where to find information in this leaflet:
1. Why am I taking LEVOTHOX?
LEVOTHOX contains the active ingredient Levothyroxine sodium. Levothyroxine sodium is a thyroid hormone. It is used as replacement therapy in the
treatment of thyroid hormone deficiency.
LEVOTHOX is used to treat:
1. Thyroid hormone deficiency also known as Hypothyroidism.
Hypothyroidism is a disease in which the thyroid gland is underactive and does not
produce enough levothyroxine, a hormone, which is important for controlling your metabolism.
Symptoms of hypothyroidism include tiredness, muscle weakness, and cramps, feeling
the cold, a slow heart rate, dry and flaky skin, hair loss, a deep husky voice and
weight gain.
2. TSH-responsive tumours (certain tumours of the thyroid gland) of the thyroid.
For these conditions to be treated, patients need a supply of thyroid hormones in
their body. LEVOTHOX replaces the shortage of thyroid hormones.
Your doctor may have prescribed LEVOTHOX for another reason. Ask your doctor if you
have any questions about why this medicine has been prescribed for you.
2. What should I know before I take LEVOTHOX?
Warnings
Do not take LEVOTHOX if:
you are allergic to Levothyroxine sodium thyroid hormone (eg. Tertroxin)
you are allergic to any of the ingredients listed at the end of this leaflet. Always
check the ingredients to make sure you can take this medicine. Some of the symptoms
of an allergic reaction may include:
difficulty in breathing
faintness
swelling of the face, lips, tongue or other parts of the body
red, itchy skin rashes
Do not take LEVOTHOX tablets if the tablet's colour has changed.
Do not take this medicine after the expiry date printed on the pack or if the packaging
is torn or shows signs of tampering.
Check with your doctor if you:
if you have allergies to any other medicines, foods, preservatives or dyes.
take any medicines for any other condition
if you have or have had any other medical conditions/health problems, including:
Over active thyroid gland
Adrenal gland problem
Hyperthyroidism
Heart problems such as cardiovascular disorder
High blood pressure
Diabetes
Long-standing hypothyroidism, an under active thyroid gland
Problems absorbing nutrients from the gastrointestinal tract
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant. Levothyroxine levels will need to be watched carefully during pregnancy. Your dosage
of LEVOTHOX may need to be increased while you are pregnant.
Ask your doctor about the risks and benefits of taking LEVOTHOX during pregnancy.
Talk to your doctor if you are breastfeeding or intend to breastfeed. Although small amounts of LEVOTHOX are found in breast milk, women who are breastfeeding
should continue treatment with LEVOTHOX.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines may interfere with LEVOTHOX and affect how it works.
Anticoagulants, medicines used to thin your blood (e.g. Warfarin)
Antidepressants, medicines used to treat depression (e.g. Lithium, SSRIs, Tricyclic
antidepressants)
Antivirals, medicines used to treat HIV/AIDS infection (e.g. ritonavir)
Antimalarials, medicines used to treat and prevent malaria (e.g. chloroquine and proguanil)
Medicines used to treat diabetes (e.g. insulin)
Beta-blockers, medicines used to treat high blood pressure and heart conditions (e.g.
propranolol)
Ion-exchange resins, medicines used to decrease cholesterol in the blood (e.g. colestyramine)
Corticosteroids, anti-inflammatory medicines (e.g. prednisolone and dexamethasone)
Oral contraceptives and hormone replacement medicines such as estrogens, androgens
or anabolic steroids
Medicines used for epilepsy (e.g. phenytoin and carbamazepine)
Medicines used to treat heart failure (e.g. digoxin)
Iron supplements
Calcium, magnesium and aluminium supplements
Rifampicin, an antibiotic used to treat tuberculosis and other serious infections
Ciprofloxacin, an antibiotic used to treat various infections
Soyabean flour (e.g. some infant formula and other products)
Antacids (e.g. aluminium hydroxide, magnesium hydroxide and calcium carbonate) and
proton pump inhibitors, used to reduce stomach acid
Amiodarone, a medicine used to treat irregular heart beat
Oral contrast agents, used before X-ray and scans
Propylthiouracil, a medicine used to treat overactive thyroid and Graves disease
Non-steroidal anti-inflammatory drugs (NSAIDs), medicines used to relieve pain and/or
inflammatory conditions including arthritis.
Weight loss drugs (e.g. orlistat)
These medicines may affect how well LEVOTHOX works, or react with it resulting in
unwanted or sometimes serious side effects.
This list is not exhaustive. Your doctor or pharmacist has more information on medicines
to be careful with or avoid while taking it.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect LEVOTHOX.
4. How do I take LEVOTHOX?
How much to take
Your doctor will calculate the right dose for you.
The usual starting dose for adults is 50 to 100 micrograms daily.
The dose may be increased over time. The average adult maintenance dose is 100 to 200 micrograms.
Lower doses are used in the elderly and children.
Take LEVOTHOX only as directed.
Follow your doctor’s instructions carefully, as they may differ from the information contained in this leaflet.
It may take a few weeks for LEVOTHOX to begin working. Until it begins working you
may not notice any change in your symptoms.
Do not change your dosage unless your doctor tells you to do so.
Your doctor will monitor your blood tests to make sure LEVOTHOX is working for you.
Use LEVOTHOX, until your doctor tells you to stop.
Talk to your doctor if you have any questions.
Swallow LEVOTHOX tablets with a glass of water.
When to take LEVOTHOX
LEVOTHOX tablets should be taken first thing in the morning on an empty stomach, at least 30 minutes and preferably 60 minutes before any food or other medications.
If you forget to take LEVOTHOX
LEVOTHOX should be used regularly at the same time each day.
If you miss your dose at the usual time, and 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 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 you missed.
If you are unsure about whether to take your next dose, speak to your doctor or pharmacist.
If you have trouble remembering when to take your medicine, ask your pharmacist for
some hints.
If you use too much LEVOTHOX
If you think that you have used too much LEVOTHOX, you may need urgent medical attention.
If you take too much you may have the following symptoms: restlessness; vomiting;
flushing; breathing difficulties; chest pain; convulsions or paralysis.
You should immediately:
phone the Poisons Information Centre
(by calling 13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while taking LEVOTHOX?
Things you should do
Do not switch or interchange with other brands unless advised by your doctor.
Immediately stop taking LEVOTHOX if a skin rash or other allergic reaction occurs.
Use it exactly as directed or as your doctor has prescribed.
Tell your doctor if you feel LEVOTHOX is not helping your condition.
Always discuss with your doctor any problems or difficulties during or after taking
it.
Visit your doctor regularly. Your doctor needs to check your progress.
Ensure you do not run out of medicine over the weekend or on holidays.
Call your doctor straight away if you:
plan to have surgery.
are about to start taking any new medicines.
Remind any doctor, dentist or pharmacist you visit that you are using LEVOTHOX.
Things you should not do
Do not stop using this medicine suddenly.
Do not give this medicine to anyone else, even if his or her symptoms seem similar
to yours.
Driving or using machines
Be careful before you drive or use any machines or tools where alertness is required,
until you know how LEVOTHOX affects you.
Drinking alcohol
Tell your doctor if you drink alcohol.
Looking after your medicine
Store in the original package
Store the medicine in a cool dry place where the temperature stays below 25°C. Protect
from light.
Do not take LEVOTHOX tablets if the tablet's colour has changed.
Follow the instructions on how to take care of your medicine properly.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do
not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Keep it where young children cannot reach it.
When to discard your medicine
Store If your doctor tells you to stop taking this medicine or it has passed its expiry
date, ask your pharmacist what to do with any left over.
Getting rid of any unwanted medicine
If you no longer need to take this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not take this medicine after the expiry date.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
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Less serious side effects
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What to do
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General disorders:
Nervousness
Anxiousness
Excitation
Restlessness
Increased blood pressure
Muscle weakness and cramps
Inability to sleep
Sleep disturbance
Unusual movements, including tremor
Headache
Lack of concentration
Heat intolerance
Excessive sweating
Flushing
Weight loss
Fever
Hair loss
Irritability
Tiredness
Gastrointestinal disorders:
Diarrhoea
Stomach cramp
Nausea
Vomiting
Increased appetite
Respiratory tract disorders:
Shortness of breath
Rapid breathing
Irregular heart beats
Chest pain
Skin and subcutaneous tissue disorders:
Allergic reaction such as skin rash
Reproductive system disorders:
Menstrual irregularities
Decreased libido
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Speak to your doctor if you have any of these less serious side effects and they worry
you.
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Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell
even if you do not think the problems are connected with medicine or are not listed
in this leaflet.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What LEVOTHOX contains
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Active ingredient
(main ingredient)
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Levothyroxine sodium
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Other ingredients
(inactive ingredients)
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microcrystalline cellulose
light magnesium oxide
sodium starch glycollate
sodium stearyl fumarate
The coating contains Lake blend as below:
25 microgram tablets: Sunset yellow FCF Aluminium lake.
75 microgram tablets: Lake Blend LB-505008 Purple (ID#110747)
88 microgram tablets: Lake Blend LB-510028 Green (ID#117692)
100 microgram tablets: Lake Blend LB-520044 Yellow (ID#117693)
112 microgram tablets: Lake Blend LB-540042 Pink (ID#117694)
125 microgram tablets: Lake Blend LB-575003 Brown (ID#110743)
137 microgram tablets: Brilliant Blue FCF Aluminium Lake
150 microgram tablets: Indigo Carmine Aluminium Lake
175 microgram tablets: Lake Blend LB-500017 Purple (ID#117689)
200 microgram tablets: Allura
Red AC Aluminium Lake
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Potential allergens
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Not applicable
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Do not take this medicine if you are allergic to any of these ingredients.
What LEVOTHOX looks like
LEVOTHOX 50 microgram: Round shaped, White coloured, uncoated tablets, break line
on both sides and debossed with "P" and "2" on one side and plain on other side (AUST
R 364022).
LEVOTHOX 75 microgram: Round shaped, Violet coloured, uncoated tablets, break line
on both sides and debossed with "P" and "3" on one side and plain on other side (AUST
R 363982).
LEVOTHOX 100 microgram: Round shaped, Yellow coloured, uncoated tablets, break line
on both sides and debossed with "P" and "14" on one side and plain on other side (AUST
R 364002).
LEVOTHOX 200 microgram: Round shaped, Pink coloured, uncoated tablets, break line
on both sides and debossed with "P" and "11" on one side and plain on other side (AUST
R 364009).
Who distributes LEVOTHOX
Sponsor
Accord Healthcare Pty Ltd
Level 24, 570 Bourke St
Melbourne VIC 3000
Australia
Phone: 1800 134 988
Distributor
LEVOTHOX is distributed in Australia by:
Alphapharm Pty Ltd trading as Viatris
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Phone: 1800 274 276
This leaflet was prepared in June 2023