Eltroxin 25 mcg Tablets

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

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

Do not take Eltroxin Tablets

• if you are allergic to levothyroxine or any of the other ingredients of this medicine (listed in section 6)
• if you suffer from an overactive thyroid gland that produces too much thyroid hormone (thyrotoxicosis)
• if you have any condition that affects your adrenal glands (your doctor will be able to advise you if you are not sure).

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

• if you have suffered with an under active thyroid gland for a long time
• if you suffer from heart problems including angina, coronary artery disease or high blood pressure. The doctor may require ECG before starting treatment with levothyroxine, as changes induced by hypothyroidism may be confused with evidence of ischaemia (decreased oxygen in a tissue)
• if you have epilepsy (fits). Fits have been rarely reported when starting the treatment with levothyroxine
• if you have a particular hormonal disorder called panhypopituitarism
• if you are being treated for diabetes. The dose of your anti-diabetic medicine may need to be changed as levothyroxine can raise blood sugar levels
• if you are over 50 years of age.

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:

• medicines for epilepsy such as carbamazepine, phenytoin, primidone and barbiturates
• sertraline – used to treat depression and anxiety disorders
• antacids – used to treat indigestion
• medicines containing calcium salts
• cimetidine – used to reduce excess stomach acid
• proton pump inhibitors such as omeprazole, lansoprazole and pantoprazole - used to reduce the amount of acid produced by the stomach
• sucralfate – used to treat and prevent stomach and duodenal ulcers
• cholestyramine and colestipol – used to treat high level of fat in the blood
• polystyrene sulphone resin – used to reduce high levels of potassium in the blood
• medicines containing iron that are taken by mouth
• rifampicin – used to treat infections
• imatinib – used to treat certain types of cancer
• beta blockers such as atenolol and sotalol – used to treat high blood pressure and heart problems
• oestrogen containing medicines for hormone replacement therapy (HRT) and contraception (the ‘pill’)
• androgen containing medicines for male hormone replacement therapy
• corticosteroids such as hydrocortisone and prednisolone – used to treat inflammation
• amiodarone – used to treat an irregular heart beat
• orlistat – used to treat obesity
• ritonavir- used to control HIV and chronic hepatitis C virus

The following may be affected by levothyroxine:

• anticoagulant medicines to prevent blood clots such as warfarin
• medicines to treat diabetes such as insulin and metformin
• tricyclic antidepressants such as amitriptyline, imipramine and dosulepin
• medicines that stimulate the sympathetic nervous system such as adrenaline (used to treat severe allergic reactions) or phenylephrine (a decongestant found in many cold and flu treatments)
• digoxin – used to treat heart problems
• anti-inflammatory medicines such as phenylbutazone or aspirin
• propanolol – used to treat high blood pressure and heart problems
• ketamine – used as an anaesthetic. If you need to have an operation, please tell your doctor or anaesthetist that you are taking 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’.

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.

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.

What Eltroxin Tablets contain:

• The active substance is anhydrous levothyroxine sodium. Each tablet contains 25 micrograms of anhydrous levothyroxine sodium.
• The other ingredients are sodium citrate, lactose, maize starch, acacia powder and magnesium stearate.

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.

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