Patient leaflet - HELMROXIN 25MCG/5ML ORAL SOLUTION
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
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– Keep this leaflet. You may need to read it again.
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– If you have any further questions, ask your doctor or pharmacist.
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– 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.
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– 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.
What is in this leaaflet
1. What Helmroxin is and what it is used for
2. What you need to know before you take Helmroxin
3. How to take Helmroxin
4. Possible side effects
5. How to store Helmroxin
6. Contents of the pack and other information
1. what helmroxin is and what it is used for
Helmroxin contains levothyroxine which 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.
Helmroxin 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 helmroxin- if you are allergic to levothyroxine or any of the other ingredients of this medicine (listed in
section 6);
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– If you suffer from adrenal insufficiency and you do not have adequate corticosteroid cover;
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– 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);
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– If you are pregnant do not take this medicine in combination with other medicines to treat
hyperthyroidism (see the section on Pregnancy and breast-feeding).
Warnings and precautions
Talk to your doctor or pharmacist before taking Helmroxin:
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– If you have heart disease, problems with your circulation or high blood pressure;
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– If you are suffering from an overactive thyroid gland (hyperthyroidism), an underactive
adrenal gland, diabetes, or have had an underactive thyroid gland for some time.
Children
In low birth weight premature neonates, the doctor will monitor very carefully for heart problems when starting Helmroxin treatment (see section 4. “Possible side effects”).
Other medicines and Helmroxin
Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. 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:
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– medication to stop your blood clotting (for example warfarin)
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– medication for depression (for example sertraline, imipramine, amitriptyline)
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– medication for epilepsy (for example phenytoin, phenobarbital, carbamazepine, primidone)
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– medication for diabetes
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– rifampicin (for infections, particularly tuberculosis)
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– digoxin or amiodarone (for your heart)
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– propranolol (for high blood pressure)
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– lovastatin (for high cholesterol levels)
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– phenylbutazone or aspirin (anti-inflammatory drugs)
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– oestrogen, oestrogen containing products and oral contraceptives
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– androgens or corticosteroids
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– sucralfate, cimetidine or aluminium hydroxide for stomach ulcer,
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– colestyramine or colesevelam to lower your cholesterol levels.
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– sodium polystyrene sulphonate (to lower your potassium levels) or calcium or iron
supplements.
Helmroxin can be taken with these medicines but not at the same time:
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– chloroquine or proguanil for the prevention of malaria
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– protease inhibitors (for example ritonavir, indinavir and lopinavir) used to treat HIV
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– sevelamer (used to treat high levels of phosphate in the blood in patients with kidney failure)
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– tyrosine kinase inhibitors (for example imatinib and sunitinib) used to treat cancer
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– propylthiouracil (used to treat hyperthyroidism)
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– sympathomimetic agents (medicines that work by stimulating the sympathetic nervous system,
such as adrenaline and phenylephrine)
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– beta-sympatholytics (used to treat cardiac arrest and low blood pressure)
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– glucocorticoids (steroid hormones used to treat adrenal insufficiency and other diseases)
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– soy-containing products (these can decrease absorption of levothyroxine)
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– other aluminium-containing drugs
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– iodine containing contrast media (used to enhance the visibility of vascular structures and
organs during radiographic procedures)
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– orlistat (medicine to treat obesity)
Let your doctor or pharmacist know you are taking Helmroxin.
If you go into hospital to have an operation, tell the anaesthetist or the medical staff that you are taking Helmroxin. 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.
Helmroxin with food, drink and alcohol
Products that contain soy (namely soy supplements) may interact with levothyroxine, ask your doctor or pharmacist for advice.
You should take your Helmroxin on an empty stomach, usually before breakfast.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
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.
Helmroxin contains methyl parahydroxybenzoate
Helmroxin contains sodium methyl parahydroxybenzoate (E219) which may cause allergic reactions (possibly delayed).
3. how to take helmroxin
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. 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 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.
Administration
You should take your Helmroxin on an empty stomach, usually before breakfast.
Dosage
The usual daily dosages are:
Adults and children over 12 years:
For hypothyroidism, 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.
For diffuse non toxic goitre or Hashimoto’s thyroiditis the recommended dose is 50–200 micrograms per day.
For the treatment of thyroid cancer the recommended dose is 150–300 micrograms per day.
Older patients (over 50 years of age) and patients with severe hypothyroidism or heart disease: The starting dose is 12.5 micrograms a day, increasing by 12.5 micrograms every 4 weeks until the correct dose is obtained. The usual final dose is between 50 and 200 micrograms daily.
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. Infants should be given this medicine in the morning, at least half an hour before the first meal of the day.
For congenital hypothyroidism in infants, the initial dose is 10 to 15 micrograms per kg body weight a day for the first 3 months. The dose will then be adjusted depending on response to treatment.
For acquired hypothyroidism in children, the initial dose is 12.5 to 50 micrograms a day. The dose should be increased gradually every 2 to 4 weeks depending on response to treatment.
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 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
1. Shake the bottle well, making sure the cap is firmly on the bottle.
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2. Remove the cap. Note: Keep the cap nearby to close the bottle after each use.
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3. Push the plastic adapter into the neck of the bottle. Note: The adapter must always stay in the bottle.
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4. Take the syringe and check the plunger is fully down.
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5. Keep the bottle upright and insert the oral syringe firmly into the plastic adapter
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6. Turn the whole bottle with the syringe upside down.
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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.
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8. Then pull the plunger slowly back to the volume you need for your dose.
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9. Turn the whole bottle with the syringe the right way up and take the syringe out of the bottle.
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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.
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11. Replace the child resistant cap after use, leaving the adapter in place.
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12. Cleaning: After use, wipe the outside of the syringe with a dry, clean tissue
If you take more Helmroxin 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 heartbeat, 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 Helmroxin
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 Helmroxin
For your treatment to be successful, you must take Helmroxin regularly at the dosage prescribed by your doctor. Do not 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.
4. 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 Helmroxin and tell your doctor immediately or go to the casualty department at your nearest hospital
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– Swelling of the hands, feet, ankles, face, lips, mouth, or throat which may cause difficulty in
swallowing or breathing, itchy rash (hives), fainting
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– Yellowing of the skin and eyes also called jaundice
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– Very high temperature, fast and irregular heartbeat, dizziness or fainting, fits and confusion,
caused by high levels of thyroid hormones (known as a “thyroid crisis”)
These are all very serious side effects. If you have them, you may have a serious reaction to Helmroxin. 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:
Fast or irregular heartbeats, palpitations, chest pain, muscle cramps or weakness, headache, restlessness, excitability, flushing, sweating, diarrhoea, vomiting, fever, menstruation problems, headaches and vision problems due to high blood pressure in the brain, tremor, sleeplessness, heat intolerance and excessive weight loss. Rash, itching and puffiness may also occur.
If you feel unwell in any other way, tell your doctor as soon as you can.
Additional side effects in children
In premature newborn infants, severe heart problems can occur when starting treatment. Children may have some hair loss at the beginning of treatment, however this is usually temporary and the hair returns.
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 Website: 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 helmroxin
Keep this medicine out of the sight and reach of children.
Expiry date
Dispose of any remaining medicine 2 months after opening.
Do not use after the expiry date which is stated on the label and carton after EXP (month, year). The expiry date refers to the last day of that month.
Storage conditions
Do not store above 25°C.
Store in the original package in order to protect from light.
Do not use Helmroxin if you notice that the appearance or smell of your medicine has changed. Talk to 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 information- 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.
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– It also contains the following inactive ingredients: glycerol (E422), citric acid monohydrate, sodium methyl parahydroxybenzoate (E219) and purified water.
What Helmroxin looks like and contents of the pack
Helmroxin is a clear colourless liquid. Each bottle contains 75 ml or 100 ml of levothyroxine oral solution. Helmroxin is available in packs containing one or two glass bottles, each filled with 75 ml oral solution or one glass bottle filled with 100 ml oral solution. A 5 ml medication syringe is also included to help measure the dose.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Helm AG
Nordkanalstrasse 28
20097 Hamburg
Germany
PL 20897/0121
PL 20897/0122
PL 20897/0123
Manufacturer
Galenica Pharmaceutical Industry S.A.
3rd km Old National Road Chalkida-Athens
Glifa Chalkida Eubia
34100
Greece
This leaflet was last revised in June 2021