Levothyroxine Brillpharma 50 microgram/5ml Oral Solution

• 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 Brillpharma is and what it is used for
2. What you need to know before you take Levothyroxine Brillpharma
3. How to take Levothyroxine Brillpharma
4. Possible side effects
5. How to store Levothyroxine Brillpharma
6. Contents of the pack and other information

• If you are allergic to levothyroxine or any of the ingredients of this medicine (listed in section 6)
• If you suffer from adrenal insufficiency and you do not have adequate corticosteroid cover
• 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)
• If you are pregnant do not take this medicine in combination with medicines to treat hyperthyroidism (see the section on Pregnancy and breast-feeding)

Information on sodium content

This medicine contains less than 1 mmol sodium (23 mg) per maximum dose of 300 microgram, that is to say essentially ‘sodium-free’.

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

The recommended dose is

For hypothyroidism:

Adults and children over 12 years:

The recommended starting dose is 50 to 100 microgram a day, increasing by 25 to 50 microgram every 3-4 weeks, until you are taking the right amount for your condition. The usual maintenance dose is 100 to 200 microgram daily. For diffuse non-toxic goitre or Hashimoto’s thyroiditis the recommended dose is 50-200 microgram per day. For the treatment of thyroid cancer the recommended dose is 150-300 microgram per day

Older patients (over 50 years of age):

The recommended starting dose is 12.5 microgram a day, increasing by 12.5 microgram every 2 weeks until the correct dose is obtained. The usual final dose is between 50 and 200 microgram 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 or weight. They will be monitored to make sure they get the right dose. The following is a guide:

Age Microgram per kg bodyweight

Up to 1 month 5-10 microgram

Over 1 month 5 microgram

The duration of treatment is usually for life if you are being 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 microgram daily then the corresponding volume would be:

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

For the 50 microgram/5ml strength – 5ml

For the 100 microgram/5ml strength – 2.5 ml

You should use the enclosed 5 ml oral syringe (graduated at every 0.1 ml) together with the enclosed adaptor to attach the syringe to the bottle.

This helps you to take a dose from the bottle.

Open the bottle: press the cap and turn it anticlockwise (figure 1)

• Separate the adaptor from the syringe (figure 2). Insert the adaptor into the bottle neck (figure 3). Ensure it is well fixed.
• Take the syringe and put it in the adaptor opening (figure 4). Turn the bottle upside down (figure 5).
• Fill the syringe with a small amount of solution by pulling the piston down (figure 5A), then push the piston upward in order to remove any possible bubble (figure 5B). Pull the piston down to the graduation mark corresponding to the quantity in milliliters (ml) prescribed by your doctor (figure 5C).
• Turn the bottle the right way up (figure 6A). Remove the syringe from the adaptor (figure 6B).
• Close the bottle with the plastic screw cap.
• Empty the contents of the syringe into your mouth. Please ensure that you are sitting upright and the plunger must be pushed slowly to allow you to swallow the dose.
• After dosing, wash the syringe with water (figure 7).

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 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 have any further questions of the use of this medicine ask your doctor or pharmacist.

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

• 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

• very high temperature; fast heart rate; irregular heartbeat; low blood pressure; heart failure; yellowing of the skin and eyes also called jaundice; confusion; fits, coma.

These are all very serious side effects. If you have them, you may have a serious allergic reaction to Levothyroxine Brillpharma. 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
• pain in joint
• muscle cramps or weakness
• headache
• restlessness
• excitability
• flushing
• sweating
• diarrhoea
• vomiting
• fever
• feeling unwell
• 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)
• deformity of the skull in infants caused by the early closure of joins in the skull bone (craniostenosis)
• growth in children may slow or stop due to changes in bone growth.

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, 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 by searching for MHRA yellowcard 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 levothyroxine sodium. Each 5 ml of oral solution contains levothyroxine sodium equivalent to 25 microgram, 50 microgram, 75 microgram or 100 microgram. The other ingredients are glycerol (E422), citric acid monohydrate (E330) (for pH adjustment), Sodium Hydroxide (for pH ajustment), sodium methyl parahydroxy benzoate (E219) and purified water.

Levothyroxine Brillpharma is a clear, colourless liquid.

This medicine is supplied in 100 ml amber coloured glass bottle with a child resistant closure and a 5 ml oral syringe (graduated at every 0.1 ml) with adaptor and packed in a carton.

Marketing Authorisation Holder

Name and address:

Manufacturer:

Levothyroxine Brillpharma 25 microgram/5 ml Oral Solution;

PL 40496/0016

Levothyroxine Brillpharma 50 microgram/5 ml Oral Solution;

PL 40496/0017

Levothyroxine Brillpharma 75 microgram/5 ml Oral Solution;

PL 40496/0018

Levothyroxine Brillpharma 100 microgram/5 ml Oral Solution;

PL 40496/0019