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

Instructions for use

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 take more Levothyroxine Brillpharma 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 Brillpharma

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.

If you stop taking Levothyroxine Brillpharma

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.

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 Brillpharma 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 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
• 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

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 at: . 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.

• 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 to protect from light.
• Discard after 60 days of first opening. Store in the original packaging after first opening.
• Levothyroxine Brillpharma is colourless and odourless.
• Do not use this medicine if you notice that the solution has an odour 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.

What Levothyroxine Brillpharma looks like and contents of the pack

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 and Manufacturer Marketing Authorisation Holder

Name and address:

Brillpharma Limited,

6 Sovereign Park, Luton, LU4 8EL, United Kingdom

Email:

Manufacturer:

LM Manufacturing Limited

Sandretto Building,

Cavalry Hill Industrial Park, Weedon,

Northampton, NN7 4PP, United Kingdom

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

This leaflet was last revised in March 2021.

To request a copy of this leaflet in Braille, large print or audio format then please contact the marketing authorisation holder at the address (or email) above.

200 mm

200 mm