Active ingredient
- levothyroxine sodium
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 12762/0016.
Eltroxin 25mcg Tablets
Package leaflet: Information for the user
Eltroxin® 25 micrograms Tablets
levothyroxine sodium
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
What is in this leaflet
1. What Eltroxin Tablets are and what they are used for
2. What you need to know before you take Eltroxin Tablets
3. How to take Eltroxin Tablets
4. Possible side effects
5. How to store Eltroxin Tablets
6. Contents of the pack and other information
1. What Eltroxin Tablets are and what they are used for
Thyroxine is a hormone which is produced naturally in the body by the thyroid gland. Levothyroxine is a synthetic version of this hormone. Thyroxine controls how much energy your body uses. When the thyroid gland does not produce enough thyroxine (a condition known as hypothyroidism), many of the body’s functions slow down. Some of the most common symptoms of hypothyroidism are:
Eltroxin Tablets are used to replace the thyroxine that your thyroid gland cannot produce and prevent the symptoms of hypothyroidism. Before starting your treatment your doctor will carry out a blood test to work out how much levothyroxine you need.
2. What you need to know before you take Eltroxin Tablets
Do not take Eltroxin Tablets
If any of these apply to you, do not take this medicine and go back to your doctor to discuss your treatment.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Eltroxin Tablets
Subclinical hyperthyroidism (where the thyroid gland makes too much thyroxine) may occur if your dose is too high and this could be associated with bone loss (osteoporosis). This will usually disappear after reducing the dose or stopping the tablets. However, you must not change the dose or stop the tablets without talking to your doctor first.
Patients occasionally find that they feel less well when changing from one levothyroxine medicine to another. You should tell your doctor if you get any side effects so that your blood can be checked for levels of thyroid hormone. If your symptoms persist you may need a specific brand of levothyroxine to be prescribed.
Blood tests:
Before you start taking levothyroxine your doctor will do a blood test to see how much thyroxine your thyroid gland is making and what dose of the medicine you will need. Once you start taking the medicine your doctor will want you to have regular blood tests to see how well the medicine is working.
Children
Blood pressure will be regularly monitored when levothyroxine treatment is started in very low birth weight preterm neonates because rapid fall in blood pressure (known as circulatory collapse) may occur.
Children receiving thyroid agent may experience partial loss of hair may occur during the first few months of therapy, but this effect is usually temporary and subsequent regrowth usually occurs.
Other medicines and Eltroxin Tablets:
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes over the counter medicines, herbal remedies and vitamin supplements. Many medicines affect the way levothyroxine works. The effects of other drugs may also be affected by levothyroxine
The following may affect the way that levothyroxine works:
The following may be affected by levothyroxine:
Pregnancy and breast-feeding:
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will decide if you should continue treatment with levothyroxine whilst you are pregnant, particularly in the first three months of your pregnancy.
Driving and using machines
This medicine should not affect your ability to drive and use machines.
Eltroxin Tablets contain lactose
This medicine also contains lactose, a sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Information on sodium content
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
3. How to take Eltroxin Tablets
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. You may be taking this medicine for the rest of your life.
Your dose will be decided by your doctor and will depend on the results of your blood tests. The dose you should take will be on the label attached by your pharmacist. Swallow the tablets with plenty of water. You should usually take your tablets before breakfast or your first meal of the day.
Adults:
The recommended starting dose is 50 – 100 micrograms every day. Your doctor may increase the dose you take every 3 – 4 weeks by 50 micrograms until your thyroxine levels are correct. Your final daily dose maybe up to 100 – 200 micrograms daily.
Patients over 50 years of age:
The recommended starting dose will be no more than 50 micrograms every day. The dose may then be increased by 50 micrograms every 3 – 4 weeks until your thyroxine levels are correct. Your final daily dose will be between 50 – 200 micrograms daily.
Patients over 50 years of age with heart problems:
The recommended starting dose will be 25 micrograms every day or 50 micrograms every other day. The dose may be increased by 25 micrograms every 4 weeks until your thyroxine levels are correct.
Your final daily dose will usually be between 50 – 200 micrograms daily.
Use in children and adolescents:
For young children, your doctor is likely to prescribe Levothyroxine Oral Solution instead of tablets
Congenital hypothyroidism in infants:
This is a condition where your baby has been born with a thyroid gland that does not produce enough thyroxine. The starting dose is 10 -15 micrograms/kg bodyweight per day for the first three months. The dose will then be adjusted depending on how your baby responds to the treatment.
Acquired hypothyroidism in children:
This is a condition where your child’s thyroid gland stops working properly because it has been attacked by their immune system, e.g. in children with an autoimmune disease or following a viral infection. The starting dose is 12.5 – 50 micrograms per day. The dose will then be increased every 2 - 4 weeks depending on how your child responds to the medicine.
Juvenile myxoedema:
This is a condition where children and adolescents develop severe hypothyroidism (produce very low levels of thyroid hormones). The starting dose is 25 micrograms every day. The dose will then be increased by 25 micrograms every 2 – 4 weeks until your child shows mild symptoms of hyperthyroidism (a condition where the thyroid gland produces too much thyroxine). The dose will then be reduced slightly.
If you take more Eltroxin Tablets than you should:
If you (or someone else) swallow a lot of the tablets at the same time, or you think a child may have swallowed some, contact your nearest hospital casualty department or tell your doctor immediately. Signs of an overdose may include: fever, chest pain (angina), racing or irregular heartbeat, muscle cramps, headache, restlessness, flushing, sweating, diarrhoea, shaking (tremor), difficulty sleeping (insomnia) and very high temperature (hyperpyrexia). These signs can take up to 5 days to appear. Take any remaining tablets and this leaflet with you so that the medical staff knows exactly what you have taken.
If you forget to take Eltroxin Tablets:
If you forget to take a dose take it as soon as you remember unless it is nearly time for your next dose. Do not take a double dose to make up for a forgotten dose. If you forget to give your child their dose, contact your doctor or pharmacist for further advice.
If you stop taking Eltroxin Tablets:
These tablets are for long term use. You may need to take them for the rest of your life. Do not stop taking the tablets unless your doctor has told you to do so.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Stop taking the tablets and go to hospital at once if you have:
Some patients may experience a severe reaction to high levels of thyroid hormone. This is called a “thyroid crisis” and you should contact your doctor immediately if you have any of the following symptoms:
Tell your doctor or pharmacist if any of the following side effects continue, get worse or if you notice any other side effects not listed.
Most of the side effects are similar to the symptoms of hyperthyroidism (where the thyroid gland makes too much thyroxine) and are due to your dose of the medicine being too high. They will usually disappear after reducing the dose or stopping the tablets. However, you must not change the dose or stop the tablets without talking to your doctor first.
Not known: frequency cannot be estimated from the available data
Reporting of side effects:
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store .
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Eltroxin Tablets
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
Do not store above 25°C. Store in the original package in order to protect from light and moisture.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Eltroxin Tablets contain:
What Eltroxin Tablets look like and contents of the pack:
Each tablet is engraved on one side with LT and engraved on the other with 25.
They are packed in a blister pack of 28, 56 or 112 tablets and polypropylene containers of 28, 56, 100, 112, 500 or 1000 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Manufacturer:
This leaflet was last revised in May 2022
Eltroxin is a registered trademark of Mercury Pharma Group Limited.
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