LEVOTHYROXINE 50 MICROGRAMS / 5ML ORAL SOLUTION - patient leaflet, side effects, dosage

25 micrograms/5ml, 50 micrograms/5ml

PACKAGE LEAFLET: INFORMATION FOR THE USER

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 or pharmacist.

• – 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

IN THIS LEAFLET:

1. What Levothyroxine is and what it is used for

2. What you need to know before you take Levothyroxine

3. How to take Levothyroxine

4. Possible side effects

5. How to store Levothyroxine

6. Contents of the pack and other information

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WHAT LEVOTHYROXINE IS AND WHAT IT IS USED FOR

Levothyroxine is used to treat hypothyroidism, a condition in which the thyroid gland is underactive and so does not make enough thyroxine for the body's needs.

Levothyroxine is also used to treat thyroid cancer and diffuse non-toxic goitre or Hashimoto's thy­roiditis, conditions in which the thyroid gland becomes enlarged causing a swelling in the front of the neck.

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WHAT YOU NEED TO KNOW BEFORE YOU TAKE LEVOTHYROXINE

Do NOT take Levothyroxine:

• If you are allergic to levothyroxine, sodium methyl parahydroxybenzoate or any of the other ingredients of this medicine (listed in section 6)
• If you suffer from underactive adrenal glands (adrenal insufficiency) and you do not have an adequate replacement treatment.
• If you have a heart attack (acute myocardial infarction), inflammation of the heart muscle (acute myocarditis) or inflammation of the sac surrounding the heart (acute pancarditis)

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Levothyroxine:

• If you have heart disease, problems with your circulation or high blood pressure
• If you are suffering from an overactive thyroid gland (hyperthyroidism), an underactive adrenal gland (adrenal insufficiency), diabetes, or have had an underactive thyroid gland for some time.
• If you experience signs of psychotic disorders (you may need closer monitoring and dose adjustment)
• If you have epilepsy (fits). Fits have been rarely reported when starting the treatment with levothyroxine
• If you start or stop taking orlistat, or change the treatment with orlistat (medication to treat obesity; you may need closer monitoring and dose adjustment) 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. Thyroid imbalance may occur if you need to change your medication to another levothyroxine containing product. Talk to your doctor if you have any questions about changing your medication. A close monitoring (clinical and biological) is required during the transition period. You should tell your doctor if you get any side effects as this may indicate that your dose needs to be adjusted up or down.

Children

Partial loss of hair may occur during the first few months of therapy, but this effect is usually temporary and subsequent re-growth usually occurs.

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.

Other medicines and Levothyroxine

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any other medicines. Levothyroxine can interfere with the action of some other drugs and some drugs can have an effect on Levothyroxine. In particular inform your doctor or pharmacist about the use of the following drugs:

• medication to stop your blood clotting (for example Warfarin)
• medication for depression (for example Sertraline, Imipramine, Amitriptyline)
• medication for epilepsy (for example Phenytoin, Phenobarbital, Carbamazepine)
• medication for diabetes
• Rifampicin (for infections, particularly tuberculosis)
• Digoxin or Amiodarone (for your heart)
• Propranolol (for high blood pressure), Lovastatin (for high cholesterol levels) or Phenylbutazone or Acetylsalicylic acid (anti-inflammatory drugs)
• Oestrogen, oestrogen containing products and oral contraceptives, androgens or corticosteroids
• Sucralfate, Cimetidine or aluminium hydroxide for a stomach ulcer, Colestyramine or Colesevelam to lower your cholesterol levels, sodium polystyrene sulphonate, calcium or iron supplements. Levothyroxine can be taken with these medicines but not at the same time.
• Chloroquine or Proguanil for the prevention of malaria
• Protease inhibitors (for example Ritonavir, Indinavir and Lopinavir) used to treat HIV and chronic hepatitis C virus infections
• Sevelamer (used to treat high levels of phosphate in the blood in patients with renal failure)
• Tyrosine kinase inhibitors (for example Imatinib, Sunitinib, Sorafenib, Motesanib) used to treat cancer
• Propylthiouracil (used to treat hyperthyroidism)
• Beta blockers (used to treat high blood pressure and heart problems)
• Sympathomimetic agents (medicines that work by stimulating the sympathetic nervous system)
• Glucocorticoids (steroid hormones used to treat adrenal insufficiency and other diseases)
• Iodine containing contrast media (used to enhance the visibility of vascular structures and organs during radiographic procedures)
• Orlistat (medicine to treat obesity)

If you go into hospital to have an operation, tell the anaesthetist or the medical staff that you are taking Levothyroxine. It may react with an anaesthetic (Ketamine) which you may be given before an operation.

Levothyroxine with food, and drink

Soy-containing products can decrease absorption of 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.

If you are pregnant while taking this medicine your doctor will monitor you closely.

The amount of thyroid hormone passing into breast milk during lactation is very low. Levothyroxine can be used during lactation. Driving and using machines

Your medicine is unlikely to affect your ability to drive or to operate machinery.

Levothyroxine contains sodium methyl parahydroxybenzoate and sodium.

Sodium methyl parahydroxybenzoate (E219) may cause allergic reactions (possibly delayed). This medicine contains less than 1 mmol sodium (23mg) per 5 ml solution, that is to say essentially ‘sodium-free’.

r^l HOW TO TAKE LEVOTHYROXINE

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Levothyroxine should be swallowed.

Your doctor will have decided what dose you should take each day depending on your condition. Your doctor will take blood samples at regular intervals to monitor your response to treatment.

If you are switching from the oral solution to the tablet version of levothyroxine or from the tablet version to the oral solution of levothyroxine your doctor will monitor you more closely. The same also applies when you are switching brands of different levothyroxine containing oral solutions.

For hypothyroidism the usual daily dosages are:

Adults and children over 12 years:

The starting dose is 50 to 100 micrograms a day, increasing by 25 to 50 micrograms every 3–4 weeks, until you are taking the right amount for your condition. The usual maintenance dose is 100 to 200 microgram­s daily.

210 mm

For diffuse non toxic goitre or Hashimoto’s thy­roiditis the recommended dose is 50 to 200 micrograms per day.

For the treatment of thyroid cancer the recommended dose is 150 to 300 micrograms per day.

Elderly (over 50 years of age):

The starting dose is 12.5 micrograms a day, increasing by 12.5 micrograms every 2 weeks until the correct dose is obtained. The usual final dose is between 50 and

200 micrograms daily. This dose also applies to patients with severe hypothyroidism, and to those with heart disease.

Children under 12 years:

The dose for children depends on their age, weight and the condition being treated. Your child will be monitored to make sure he/she gets the right dose. Give your child this medicine at least half an hour before the first meal of the day. Congenital hypothyroidism in infants:

Initially 10 to 15 micrograms/kg body weight a day for the first 3 months. The dose will then be adjusted depending on response to treatment.

Acquired hypothyroidism in children:

Initially 12.5 to 50 micrograms a day. The dose should be increased gradually every 2 to 4 weeks depending on response to treatment.

Method of administration

You should take your Levothyroxine on an empty stomach, usually before breakfast..

Please use the enclosed spoon or the oral syringe (see instructions below) provided to deliver your specific dose. For example if your dose is 50 micrograms daily then the corresponding volume would be:

For the 25 microgram/5 ml strength – 2 × 5 ml (10 ml in total) For the 50 microgram/5 ml strength – 5 ml

For the 100 microgram/5 ml strength – 2.5 ml

How to use the oral syringe:

• 1. Shake the bottle well, making sure the cap is firmly on the bottle.

• 2. Remove the cap. Note: Keep the cap nearby to close the bottle after each use.

• 3. Push the plastic adapter into the neck of the bottle. Note: The adapter must always stay in the bottle.

• 4. Take the syringe and check the plunger is fully down.

• 5. Keep the bottle upright and insert the oral syringe firmly into the plastic adapter

• 6. Turn the whole bottle with the syringe upside down.

• 7. Slowly pull the plunger down fully so that the syringe fills with medicine. Push the plunger back up completely to expel any large air bubbles that may be trapped inside the oral syringe.

• 8. Then pull the plunger slowly back to the volume you need for your dose.

• 9. Turn the whole bottle with the syringe the right way up and take the syringe out of the bottle.

• 10. The dose of medicine can now be swallowed directly from the oral syringe. Please ensure that you are sitting upright and the plunger must be pushed slowly to allow you to swallow the dose.

• 11. Replace the child resistant cap after use, leaving the adapter in place.

• 12. Cleaning: After use, wipe the outside of the syringe with a dry, clean tissue.

Duration of treatment

The duration of treatment is usually for life if you are being treated for hypothyroidism, non toxic diffuse goitre or Hashimoto’s thy­roiditis.

If you take more Levothyroxine than you should

If you accidentally take an overdose of your medicine, either call your doctor straight away, or go to your nearest hospital casualty department. Symptoms of overdose include fever, irregular heart beat, muscle cramps, headache, restlessness, flushing, sweating or diarrhoea. Always take any remaining medicine, the container and the label with you, so that the medicine can be identified.

If you forget to take Levothyroxine

If you forget to take your medicine, take your dose when you remember and then take your next dose at the usual time. Do not take a double dose to make up for a forgotten dose. If you have forgotten several doses tell your doctor when you have your next check-up or blood test. It can be dangerous to stop taking your medicine without your doctor's advice.

If you are worried, ask your doctor or pharmacist for advice.

If you stop taking Levothyroxine

For your treatment to be successful, you must take Levothyroxine regularly at the dosage prescribed by your doctor. On no account should you change, suspend or stop the prescribed treatment without talking to your doctor. Symptoms of disease may return if you suspend or stop treatment before you should. The nature of these symptoms depends on the underlying disease.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist..

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POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

These usually only happen if the dose you are taking is too high. If any of the following happen, stop taking Levothyroxine and tell your doctor immediately or go to the casualty department at your nearest hospital

• Swelling of the hands, feet, ankles, face, lips, mouth, or throat which may cause difficulty in swallowing or breathing (angioedema)
• Hives (urticaria)
• Fainting
• Yellowing of the skin and eyes also called jaundice. These are all very serious side effects. If you have them, you may have a serious allergic reaction to Levothyroxine. You may need urgent medical attention or hospitalisation. All of these very serious side effects are very rare.

r5k HOW TO STORE LEVOTHYROXINE

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 label and 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. Levothyroxine Oral solution is odourless. Do not use this medicine if you notice that the solution has an odour. Talk to your pharmacist.

Dispose of any remaining medicine 8 weeks after opening.

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.

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CONTENTS OF THE PACK AND OTHER INFORMATION

What Levothyroxine contains:

The active substance is Levothyroxine sodium. Each 5 ml of oral solution contains Levothyroxine equivalent to Levothyroxine sodium anhydrous 25 micrograms, 50 micrograms or 100 micrograms.

The other ingredients are: Glycerol, citric acid monohydrate, sodium methyl parahydroxybenzoate (E219), sodium hydroxide and purified water.

What Levothyroxine looks like and contents of the pack

Levothyroxine Oral solution is a clear colourless liquid. Each bottle contains 100 ml of oral solution. A double ended 5 ml and 2.5 ml polypropylene spoon or a plastic dosing syringe (pipette) is also included to help measure the dose.

Marketing Authorisation Holder

TEVA UK Limited, Eastbourne, BN22 9AG, UK.

Manufacturer

Delpharm Bladel B.V., Industrieweg 1, 5531 AD Bladel, The Netherlands.

This leaflet was last revised in March 2020

PL 00289/1593

PL 00289/1594

PL 00289/1595

REG0091487

Version 5.2

Approved

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