LEVOTHYROXINE 25MICROGRAMS / 5ML ORAL SOLUTION - Patient leaflet, side effects, dosage

Levothyroxine 25 micrograms/5 ml Oral Solution

Levothyroxine sodium

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.

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------ The name of your medicine is Levothyroxine

• 25 micrograms/5 ml Oral Solution but it will be referred to as Levothyroxine throughout this leaflet.

What is in this leaflet

• 1. What Levothyroxine is and what it is used for

• 2. What you need to know before you take Levothyroxine 2^^— 3. How to take Levothyroxine

• 4. Possible side effects

• 5. How to store Levothyroxine

------6. Contents of the pack and other information

1. what levothyroxine is and what it is used for

Levothyroxine Oral Solution contains the active ingredient levothyroxine sodium. It 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.

2. what you need to know before you take levothyroxine

Do not take Levothyroxine if:

• ► you are allergic to levothyroxine or any of the other ingredients of this medicine (listed in section 6)

• ► you suffer from adrenal insufficiency and you do not have adequate corticosteroid co­ver

• ► 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)

• ► you are pregnant do not take this medicine in combination with medicines to treat hyperthyroidism (see the section on Pregnancy and breast-feeding).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Levothyroxine if you:

• ► have heart disease, problems with your circulation or high blood pressure

• ► are suffering from an overactive thyroid gland (hyperthyroidism), an underactive adrenal gland, diabetes or have had an underactive thyroid gland for some time.

Children

Levothyroxine is not suitable for children under five years of age due to the amount of the ingredient propylene glycol in the medicine (see section 6 and “Levothyroxine contains” in section 2 of this leaflet).

Other medicines and Levothyroxine

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. Levothyroxine can interfere with the action of some other drugs and some drugs can have an effect on Levothyroxine. In particular tell your doctor or pharmacist if you take 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 Aspirin (antiinflamma­tory drugs)

• ► Oestrogen, oestrogen containing products and oral contraceptives, androgens or corticosteroids

• ► Sucralfate, Cimetidine or aluminium hydroxide for a stomach ulcer, Colestyramine to lower your cholesterol levels or calcium carbonate or iron supplements

• ► Chloroquine or proguanil for the prevention of malaria ► Protease inhibitors (for example ritonavir, indinavir and lopinavir) used to treat HIV

• ► Sevelamer (used to treat high levels of phosphate in the blood in patients with renal failure)

• ► Tyrosine kinase inhibitors (for example imatinib and sunitinib) used to treat cancer

• ► Propylthiouracil (used to treat hyperthyroidism)

• ► Beta-sympatholytics (used to treat cardiac arrest and low blood pressure)

• ► Glucocorticoids (steroid hormones used to treat adrenal insufficiency and other diseases)

• ► Soy-containing products (these can decrease absorption of levothyroxine)

• ► Orlistat (used to treat obesity).

Let your doctor or pharmacist know. Levothyroxine can be taken with these medicines but not at the same time.

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.

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

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.

Driving and using machines

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

Levothyroxine contains

Liquid maltitol (E965): If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Sodium methyl parahydroxybenzoate (E219) and sodium propyl parahydroxybenzoate (E217): May cause allergic reactions (possibly delayed).

Propylene glycol (E1520): This medicine contains 100 mg propylene glycol in each 5 ml oral solution which is equivalent to 20 mg/ml. If your child is less than 5 years old, talk to your doctor or pharmacist before giving them this medicine, in particular if they use other medicines that contain propylene glycol or alcohol. If you are pregnant or breast-feeding, do not take this medicine unless recommended by your doctor. Your doctor may carry out extra checks while you are taking this medicine. If you suffer from a liver or kidney disease, do not take this medicine unless recommended by your doctor. Your doctor may carry out extra checks while you are taking this medicine.

Sodium: This medicine contains less than 1 mmol sodium (23 mg) per 5 ml of dose, that is to say essentially ‘sodium-free’.

3. 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.

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.

Recommended dose

For hypothyroidism:

Adults and children over 12 years:

The recommended starting dose is 50 to 100 micrograms (10 ml to 20 ml) a day, increasing by 25 to 50 micrograms (5 ml to 10 ml) every 3–4 weeks, until you are taking the right amount for your condition. The usual maintenance dose is 100 to 200 micrograms (20 ml to 40 ml) daily.

For diffuse non-toxic goitre or Hashimoto’s thy­roiditis the recommended dose is 50–200 micrograms (10 ml to 40 ml) per day. For the treatment of thyroid cancer the recommended dose is 150–300 micrograms (30 ml to 60 ml) per day.

Older patients (over 50 years of age):

The recommended starting dose is 12.5 micrograms (2.5 ml) a day, increasing by 12.5 micrograms (2.5 ml) every 2 weeks until the correct dose is obtained. The usual final dose is between 50 and 200 micrograms (10 ml to 40 ml) daily. This dose also applies to patients with severe hypothyroidism and to those with heart disease. ^^^in

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Children between 5–12years:

The dose for children depends on their age or weight.

They will be monitored to make sure they get the right dose. The dose of 5 micrograms (1 ml) per kg bodyweight may be used as a guide.

Children under five years:

Levothyroxine is not suitable for children under five years of age due to the amount of the ingredient propylene glycol in the medicine (see section 6 and “Levothyroxine Oral Solution contains” in section 2 of this leaflet).

The duration of treatment is usually for life treated for hypothyroidism, non toxic diffuse goitre or Hashimoto's thy­roiditis.

Please use the oral syringe provided to deliver your specific dose (see instructions below). The syringe can be used to measure your dose by drawing the liquid to the correct mark on the syringe. For example, if your dose is 50 micrograms daily thenthe corresponding volume would be:

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

For the 50 micrograms/5 ml strength – 5 ml

For the 100 micrograms/5 ml strength – 2.5 ml

Route and method of administration

• ► This medicine must be taken orally.

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

• ► Use of higher strengths is recommended when a dose volume more than 20 ml has to be given.

Instructions for the use of syringe:

Open the bottle: press the cap and turn it anticlockwise (figure 1). Separate the adaptor from the syringe (figure 2).

• 2. Insert the adaptor into the bottle neck (figure 3). Ensure it is properly fixed. Take the syringe and put it in the adaptor opening (figure 4).

  
  
  
  

• 3. Turn the bottle upside down. Fill the syringe with a small amount of syrup by pulling the piston down (figure 5A), then push the piston upwards in order to remove any possible bubble (figure 5B). Pull the piston down to the graduation mark corresponding to the quantity in millilitres (ml) prescribed by your doctor (figure 5C).

• 4. Turn the bottle the right way up (figure 6A). Remove the syringe from the adaptor (figure 6B).

  
  
  
  

• 5. Empty the contents of the syringe into the patient’s mouth by pushing the piston to the bottom of the syringe (figure 7). The contents of the syringe should be emptied into the side cheek of the patient’s mouth to avoid a choking hazard.Leave the syringe adaptor in place after first use. Close the bottle with the plastic screw cap. Wash the syringe with water (figure 8).

  
  
  
  

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 checkup or blood test.

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

If you stop taking Levothyroxine

It can be dangerous to stop taking your medicine without your doctor's advice.

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. These usually only happens 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

• ► Hives

• ► 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.

Tell your doctor if you notice any of the following side effects:

Not known (frequency cannot be estimated from the available data)

• ► fast or irregular heartbeats

• ► palpitations

• ► chest pain

• ► muscle cramps or weakness

• ► headache

• ► restlessness

• ► excitability

• ► flushing

• ► sweating

• ► diarrhoea

• ► vomiting

• ► fever

• ► menstruation problems

• ► tremor

• ► sleeplessness

• ► excessive weight loss

• ► rash

• ► itching

• ► puffiness.

Additional side effects in children and adolescents

• ► heat intolerance

• ► high blood pressure in the cranium

• ► hair loss at beginning of the treatment (temporary).

If you feel unwell in any other way, tell your doctor as soon as you can.

Do not be alarmed by this list of possible events. You may not have any of them.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

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 at: 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 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 carton and bottle after EXP. The expiry date refers to the last day of that month.

• ► Do not store above 25°C.

• ► Keep the container in the outer carton in order to protect from light.

• ► Discard 60 days after first opening.

• ► Do not use this medicine if you notice that the solution becomes discoloured or shows any signs of deterioration. Seek the advice of your pharmacist.

• ► 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 informationwhat levothyroxine containsthe active substance is levothyroxine sodium.

Each 5 ml of oral solution contains 25 micrograms of levothyroxine as levothyroxine sodium.

The other ingredients are propylene glycol (E1520), sodium hydroxide, sodium methyl parahydroxybenzoate (E219), sodium propyl parahydroxyben­zoate, citric acid monohydrate, liquid maltitol (E965) and purified water.

What Levothyroxine looks like and contents of the pack

Levothyroxine is a clear colourless solution supplied in 100 ml amber glass bottle with a tamper evident, child resistant plastic cap and a 5 ml oral syringe having 0.1 ml graduation mark for measuring the dose and a syringe adaptor.

Marketing Authorisation Holder and Manufacturer:

SyriMed,

Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK

If this leaflet is hard to see or read, please call +44 (0) 208 515 3700 for help.

This leaflet was last revised in 07/2021.

PIL/UK/MFG086­/04/SMD/v2