Levothyroxine 50 micrograms Tablets

• 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.

1. What Levothyroxine Tablets are and what they are used for
2. What you need to know before you take Levothyroxine Tablets
3. How to take Levothyroxine Tablets
4. Possible side effects
5. How to store Levothyroxine Tablets
6. Contents of the pack and other information

• 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 you have the following diseases or conditions:
  • an acute myocardial infarction,
  • acute inflammation of the heart muscle (myocarditis),
  • acute inflammation of all the heart walls (pancarditis)

During pregnancy levothyroxine must not be used at the same time with medicines against an overactive thyroid gland (antithyroid drugs).

If any of these apply to you, do not take this medicine and go back to your doctor to discuss your treatment.

Talk to your doctor, pharmacist or nurse before taking Levothyroxine 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.

Thyroid hormones are not suitable for weight reduction. Intake of thyroid hormones will not reduce your weight, if your thyroid hormone level is in a normal range. Serious or even life threatening side effects may occur if you increase the dose without special advice from your doctor, especially when taken together with other medicines for weight reduction.

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.

If you are about to undergo laboratory testing for monitoring your thyroid hormone levels, you must inform your doctor and/or the laboratory personnel that you are taking or have recently taken biotin (also known as vitamin H, vitamin B7 or vitamin B8). Biotin may affect results of your laboratory tests. Depending on the test, the results may be falsely high or falsely low due to biotin. Your doctor may ask you to stop taking biotin before performing laboratory tests. You should also be aware that other products that you may take, such as multivitamins or supplements for hair, skin, and nails could also contain biotin. This could affect the results of laboratory tests. Please inform your doctor and/or the laboratory personnel, if you are taking such products.

(Please note the information in section Other medicines and Levothyroxine Tablets).

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.

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
• poton pump inhibitors (such as omeprazole, esomeprazole, pantoprazole, rabeprazole, and lanzoprazole) are used to reduce the amount of acid produced by the stomach, which may reduce the absorption of levothyroxine from the intestine and thereby make it less effective. If you are taking levothyroxine while receiving treatment with proton pump inhibitors, your doctor should monitor your thyroid function and may have to adjust the dose of *TM*.
• 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.
• products containing St. John’s Wort (a herbal medicinal product)

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.

If you are taking or have recently taken biotin, you must inform your doctor and/or the laboratory personnel when you are about to undergo laboratory testing for monitoring your thyroid hormone levels. Biotin may affect results of your laboratory tests (see warnings and precautions).

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.

This medicine should not affect your ability to drive and use machines.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

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 may be up to 100 – 200 micrograms daily.

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.

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.

For young children, your doctor is likely to prescribe Levothyroxine Oral Solution instead of tablets.

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.

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.

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 (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 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.

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.

• a rare allergic reaction such as swelling of the face, tongue, lips and throat, difficulty breathing, severe itching of your skin with raised lumps, joint pain, sensitivity to the sun, general feeling of being unwell. You may need urgent medical attention.

• very high temperature; fast heart rate; irregular heartbeat; low blood pressure; heart failure; jaundice; confusion; fits and coma.

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

• headache
• flushing
• high temperature, sweating
• hair loss
• weight loss
• tremor, restlessness, excitability, difficulty sleeping (insomnia)
• increased pressure around the brain in children that is not caused by a tumour or other diseases (benign intracranial hypertension)
• chest pain (angina), pounding, irregular or fast heartbeat
• diarrhoea, vomiting
• muscle cramps, muscle weakness
• deformity of the skull in infants caused by the early closure of joints in the skull bone (craniostenosis)
• growth in children may slow or stop due to changes in bone growth
• irregular periods
• intolerance to heat and temporary hair loss in children.

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 at: 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.

• The active substance is anhydrous levothyroxine sodium.
• The other ingredients are Microcrystalline Cellulose (E460), Croscarmellose Sodium, Light Magnesium Oxide (E530), Sodium Stearyl Fumarate.

Levothyroxine Tablets are white to off-white, round shaped uncoated tablets approximately 7.00 mm in size.

25 microgram tablets are debossed with ‘G 01´ on one side and plain on the other side.

50 microgram tablets are debossed with ‘G 02´ on one side and plain on the other side.

100 micrograms tablets are debossed with ‘G 03´ on one side and plain on the other side.

Levothyroxine Tablets are packed in blisters supplied in boxes containing 28, 30, 50, 56, 60, 84, 100 and 112 tablets and also packed in HDPE bottles with oxygen absorbing canister; sealed with polypropylene child resistant screw cap and heat seal linear containing 28, 56, 100, 112 and 1000 tablets.

Not all pack sizes may be marketed.