Pharmacy Guide

Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.

Pharmacy Guide

Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.

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Levothyroxine IBSA Soft Capsules 150 microgram POM

What it is and what it is used for

Levothyroxine IBSA contains the active ingredient levothyroxine sodium 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. Levothyroxine IBSA 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.

What you need to know before you take it

• If you are allergic to levothyroxine or any of the other 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 recently suffered from 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).

Warnings and precautions Talk to your doctor, pharmacist or nurse before taking Levothyroxine IBSA:

• 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, diabetes or have had an underactive thyroid gland for some time • if you have epilepsy (fits). Fits have been rarely reported when starting the treatment with levothyroxine.

Other medicines and Levothyroxine IBSA

If you are about to undergo laboratory testing for monitoring your thyroid hormone levels, you must inform your doctor and/or the laboratory personnel that you are taking or have recently taken biotin (also known as vitamin H, vitamin B7 or vitamin B8). Biotin may affect results of your laboratory tests. Depending on the test, the results may be falsely high or falsely low due to biotin. Your doctor may ask you to stop taking biotin before performing laboratory tests. You should also be aware that other products that you may take, such as multivitamins or supplements for hair, skin, and nails could also contain biotin. This could affect the results of laboratory tests. Please inform your doctor and/or the laboratory personnel, if you are taking such products (Please note the information in section Other medicines and Levothyroxine IBSA).

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 medicines and some medicines can have an effect on levothyroxine. In particular tell your doctor or pharmacist if you take the following medicines:

• 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 (anti-inflammatory 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) • ritonavir (used to control HIV and chronic hepatitis C virus) • products containing St. John's Wort (an herbal medicinal product) • proton pump inhibitors: proton pump inhibitors (such as omeprazole, esomeprazole, pantoprazole, rabeprazole, and lanzoprazole) are used to reduce the amount of acid produced by the stomach, which may reduce the absorption of levothyroxine from the intestine and thereby make it less effective. If you are taking levothyroxine while receiving treatment with proton pump inhibitors, your doctor should monitor your thyroid function and may have to adjust the dose of Levothyroxine IBSA.

If you are taking or have recently taken biotin, you must inform your doctor and/or the laboratory personnel when you are about to undergo laboratory testing for monitoring your thyroid hormone levels. Biotin may affect results of your laboratory tests (see Warnings and precautions). Levothyroxine IBSA 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 takingLevothyroxine IBSA. It may react with an anaesthetic (Ketamine) which you may be given before an operation.

Dose:

Pregnancy and breast-feeding Pregnancy 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 IBSA contains sodium This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially 'sodiumfree'.

How to take it

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Levothyroxine IBSA should be swallowed whole. 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 or the tablet version to soft capsule of levothyroxine or from the soft capsule to tablet version or the oral solution of levothyroxine your doctor will monitor you more closely.

For individual treatment, Levothyroxine IBSA soft capsules are available with a graduated content of 13−200 micrograms of levothyroxine sodium, so you generally only have to take one capsule a day.

Adults, children over 12 years: For hypothyroidism the recommended dose is 50-100 micrograms a day, increasing by 25-50 micrograms every 3-4 weeks, until you are taking the right amount for your condition. The usual maintenance dose is up to 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 (micrograms) per day. Older patients (over 50 years of age):

The recommended starting dose is 13 micrograms a day, increasing by 13 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. The child will be monitored to make sure he/she gets the right dose. Acquired hypothyroidism in children: This is a condition where your child's thyroid gland stops working properly because it has been attacked by their immune system, e.g. in children with an autoimmune disease or following a viral infection. The starting dose is 13 – 50 micrograms per day. The dose will then be increased every 2 - 4 weeks depending on how your child responds to the medicine . Juvenile myxoedema in children: This is a condition where children and adolescents develop severe hypothyroidism (produce very low levels of thyroid hormones). The starting dose is 25 micrograms every day. The dose will then be increased by 25 micrograms every 2 – 4 weeks until your child shows mild symptoms of hyperthyroidism (a condition where the thyroid gland produces too much thyroxine). The dose will then be reduced slightly. For young children under 5 years of age, your doctor is likely to prescribe levothyroxine as an oral solution instead of a soft capsule. Route and/or method of administration:

breakfast or the first meal of the day.

If you take more Levothyroxine IBSA 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 a fast heart beat, feeling anxious or nervous, feeling hyperactive, having uncontrollable muscle movements. Always take any remaining medicine, the container and the label with you, so that the medicine can be identified.

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 IBSA and tell your doctor immediately or go to the casualty department at your nearest hospital

− Swallow the capsule whole with adequate liquid (e.g. half a glass of water) − Levothyroxine IBSA is best taken as a single dose on an empty stomach, usually before

If you forget to take Levothyroxine IBSA 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. If you are worried, ask your doctor or pharmacist for advice. If you stop taking Levothyroxine IBSA 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.

• Swelling of the hands, feet, ankles, face, lips, mouth, or throat which may cause difficulty in swallowing or breathing • Hives • Fainting Some patients may experience a severe reaction to high levels of thyroid hormone. This is called a "thyroid crisis" and you should contact your doctor immediately if you have any of the following symptoms: • 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 Levothyroxine IBSA. You may need urgent medical attention or hospitalisation. All of these very serious side effects are very rare. Tell your doctor or pharmacist 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 • weight loss • rash • itching • puffiness. Additional side effects in children and adolescents • heat intolerance • high blood pressure in the skull • hair loss at beginning of the treatment (temporary) • deformity of the skull in infants caused by the early closure of joints in the skull bone (craniostenosis) • growth in children may slow or stop due to changes in bone growth

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.

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 outer carton after EXP. The expiry date refers to the last day of that month.

Do not store above 25°C. Do not throw away any medicine via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

How to store it

The soft capsules of Levothyroxine IBSA 200 micrograms are marked by the letter "Y".

Levothyroxine IBSA is packaged in PVC-polychlorotrifluoroethylene (PCTFE)/aluminium blister packs of 30, 50 or 100 soft capsules. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer

IBSA Farmaceutici Italia S.r.l. Via Martiri di Cefalonia 2, 26900 - Lodi (Italy) Manufacturer IBSA Pharma Limited Units 4-6 Colonial Business Park, Colonial Way Watford WD24 4PR United Kingdom This leaflet was last revised in 05/2026

Contents of the pack and other information

1 soft capsule of Levothyroxine IBSA 13 micrograms contains 13 micrograms of levothyroxine sodium. 1 soft capsule of Levothyroxine IBSA 25 micrograms contains 25 micrograms of levothyroxine sodium. 1 soft capsule of Levothyroxine IBSA 50 micrograms contains 50 micrograms of levothyroxine sodium. 1 soft capsule of Levothyroxine IBSA 75 micrograms contains 75 micrograms of levothyroxine sodium. 1 soft capsule of Levothyroxine IBSA 100 micrograms contains 100 micrograms of levothyroxine sodium. 1 soft capsule of Levothyroxine IBSA 125 micrograms contains 125 micrograms of levothyroxine sodium. 1 soft capsule of Levothyroxine IBSA 150 micrograms contains 150 micrograms of levothyroxine sodium. 1 soft capsule of Levothyroxine IBSA 175 micrograms contains 175 micrograms of levothyroxine sodium. 1 soft capsule of Levothyroxine IBSA 200 micrograms contains 200 micrograms of levothyroxine sodium. The other ingredients are: gelatin (pork and beef origin), glycerol, purified water

What Levothyroxine IBSA looks like and contents of the pack

Levothyroxine IBSA are amber-coloured, round, oval soft capsules. Each capsule is marked by a letter identifying the strength. The soft capsules of Levothyroxine IBSA 13 micrograms are marked by the letter "A". The soft capsules of Levothyroxine IBSA 25 micrograms are marked by the letter "E". The soft capsules of Levothyroxine IBSA 50 micrograms are marked by the letter "G". The soft capsules of Levothyroxine IBSA 75 micrograms are marked by the letter "H". The soft capsules of Levothyroxine IBSA 100 micrograms are marked by the letter "K". The soft capsules of Levothyroxine IBSA 125 micrograms are marked by the letter "N". The soft capsules of Levothyroxine IBSA 150 micrograms are marked by the letter "S". The soft capsules of Levothyroxine IBSA 175 micrograms are marked by the letter "U".

You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard 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.

Frequently asked questions about Levothyroxine IBSA Soft Capsules 150 microgram POM

How do I take Levothyroxine IBSA Soft Capsules 150 microgram POM?

Levothyroxine IBSA Soft Capsules 150 microgram POM comes as capsule containing 150 microgram. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.

What is the active substance in Levothyroxine IBSA Soft Capsules 150 microgram POM?

The active substance in Levothyroxine IBSA Soft Capsules 150 microgram POM is levothyroxine.

Where does this information come from?

This leaflet reproduces the patient information leaflet approved for Levothyroxine IBSA Soft Capsules 150 microgram POM, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.

Can I get Levothyroxine IBSA Soft Capsules 150 microgram POM without a prescription?

Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.

About this leaflet

The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.

Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

Medicines with the same active substance: Levothyroxine (8 medicines)
See every medicine containing this substance, or browse the full A–Z of active substances.
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
Technical information intended for healthcare professionals (doctors and pharmacists). The Summary of Product Characteristics (SmPC) is the official document approved by the MHRA/EMA. It does not replace the patient leaflet or a doctor’s advice.

4.1. Therapeutic indications

Levothyroxine IBSA Soft Capsules are indicated for:

 - hypothyroidism (including also acquired hypothyroidism in children and juvenile myxoedema)

 - diffuse non toxic goitre

 - goitre associated with Hashimoto's thyroiditis

 - Suppression therapy in thyroid carcinoma

4.2. Posology and method of administration

Posology

The treatment of any thyroid disorder should be determined on an individual basis, taking account of clinical response, biochemical tests and regular monitoring. To ensure that patients can be treated according to their individual needs, soft capsules are available with dosage strengths ranging from 13 to 200 micrograms of levothyroxine sodium, so that ideally only one soft capsule a day has to be taken.

The individual daily dose should be determined on the basis of laboratory tests and clinical examinations. As a number of patients show elevated concentrations of T4 and fT4, basal serum concentration of thyroid-stimulating hormone provides a more reliable basis for following treatment course.

Patients switching between the oral solution, the tablet form and the soft capsules form should be monitored closely.

Hypothyroidism

Adults, children over 12 years

Initial dose:

50 - 100 micrograms daily.

Usual maintenance dose:

up to 100- 200 micrograms daily.

The initial dose is adjusted by 25 to 50 microgram increments at 3 – 4 week intervals until clinical response and measurements of plasma thyroxine and thyroid stimulating hormone indicate that the thyroid deficiency is corrected and a maintenance dose established.

Diffuse non toxic goitre or goitre associated with Hashimoto's thyroiditis

The recommended dose is 50-200 micrograms /day.

Suppression therapy in thyroid carcinoma

The recommended dose is 150-300 micrograms /day.

In elderly patients, in patients with coronary heart disease, and in patients with severe or long- existing hypothyroidism, special caution is required when initiating therapy with thyroid hormones, that is, a low initial dose (for example 13 microgram/day) should be given which should then be increased slowly and at lengthy intervals (e.g. a gradual increment of 13 microgram/day fortnightly) with frequent monitoring of thyroid hormones. A dosage, lower than optimal dosage giving complete replacement therapy, consequentially not resulting in a complete correction of TSH level, might therefore need to be considered.

Paediatric population

The maintenance dose is generally 100 to 150 micrograms per m² body surface area.

Acquired hypothyroidism in children:

For children with acquired hypothyroidism, the initial recommended dosage is 13-50 micrograms per day. The dose should be increased gradually every 2 to 4 weeks according to the clinical findings and thyroid hormone and TSH values until the full replacement dose is reached.

Juvenile myxoedema in children:

The initial recommended dosage is 25 micrograms daily. In such conditions, the daily dose may be increased by 25 micrograms at intervals of every 2 – 4 weeks, until mild symptoms of hyperthyroidism are seen. The dose will then be reduced slightly.

In children under 5 years of age, unable to swallow an intact capsule, the administration of capsules is not recommended. Capsules are to be swallowed whole and cannot be crushed and dispersed in water or other liquids. In this group of patients it is preferable to administer an approved oral solution of levothyroxine.

Duration of Treatment

Duration of treatment is usually for life in the case of hypothyroidism, non-toxic goitre and goitre associated with Hashimoto's thyroiditis.

For patients with non-toxic diffuse goitre and normal T4 and TSH levels treatment with levothyroxine can be considered. If no discernible decrease in size of the goitre occurs after 6 to 12 months, thyroxine therapy should be stopped.

Method of administration

Oral

Levothyroxine IBSA is best taken as a single dose on an empty stomach, usually before breakfast.

4.3. Contraindications

- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

- Adrenal insufficiency without adequate corticosteroid cover.

- Treatment with Levothyroxine IBSA Soft Capsules must not be initiated in acute myocardial infarction, acute myocarditis, and acute pancarditis.

- Combination therapy of levothyroxine and an antithyroid agent for hyperthyroidism is not indicated during pregnancy (see section 4.6).

4.5. Interaction with other medicinal products and other forms of interaction

• The effects of warfarin, dicoumarol, acenocoumarol, phenindione and probably other anticoagulants are increased by the concurrent use of thyroid compounds.

• The antidepressant response to imipramine, amitriptyline and possibly other tricyclic antidepressants can be accelerated by the concurrent use of levothyroxine.

• The absorption of levothyroxine is reduced by sucralfate, sodium polystyrene sulphonate, colestyramine or binding within the gut.

• Cimetidine, aluminium hydroxide, calcium carbonate and ferrous sulphate also reduce absorption of levothyroxine from the G.I. tract.

• Dosages should be separated by an interval of several hours.

• The concurrent use of carbamazepine, phenytoin, phenobarbital, primadone or rifampicin with levothyroxine have been found to increase levothyroxine metabolism.

• A possible interaction occurs with hypoglycaemic agents, hence diabetic patients should be monitored for increased requirements of insulin or oral hypoglycaemic agents.

• If levothyroxine therapy is initiated in digitalised patients, the dose of digoxin may require adjustment. Hyperthyroid patients may need their digoxin dosage gradually increased as treatment proceeds, because initially patients are relatively sensitive to digoxin.

• Isolated reports of marked hypertension and tachycardia has been reported with concurrent ketamine administration.

• Lovastatin has been reported to cause one case each of hypothyroidism and hyperthyroidism in two patients taking levothyroxine.

• Levothyroxine accelerates the metabolism of propranolol.

• Oestrogen, oestrogen containing products and oral contraceptives may increase the requirement of thyroid therapy dosage.

• Conversely, androgens and corticosteroids may decrease serum concentrations of thyroxine-binding globulins.

• Amiodarone may reduce the effects of thyroid hormones used in the treatment of hypothyroidism.

• Effects of levothyroxine may be decreased by concomitant sertraline. Some drugs such as lithium act directly on the thyroid gland and inhibit the release of thyroid hormones leading to clinical hypothyroidism.

• Increased thyroid-stimulating hormone concentration has been noted after the use of chloroquine with proguanil for malaria prophylaxis in a patient stabilised on levothyroxine.

• False low total plasma concentrations have been observed with concurrent anti- inflammatory treatment such as phenylbutazone or acetylsalicylic acid and levothyroxine therapy.

• Thyroid drugs increase metabolic demands and should therefore be used with caution with other drugs known to influence cardiac function, such as the sympathomimetics as they may enhance this effect. In addition, thyroid hormones may increase receptor sensitivity to catecholamines.

• Anti-obesity drugs such as orlistat may decrease levothyroxine absorption which may result in hypothyroidism (monitor for changes in thyroid function).

• Protease inhibitors (e.g. ritonavir, indinavir, lopinavir) may influence the effect of levothyroxine. Close monitoring of thyroid hormone parameters is recommended. If necessary, the levothyroxine dose has to be adjusted. Post-marketing cases have been reported indicating a potential interaction between ritonavir containing products and levothyroxine. Thyroid-stimulating hormone (TSH) should be monitored in patients treated with levothyroxine at least the first month after starting and/or ending ritonavir treatment.

• Sevelamer may decrease levothyroxine absorption. Therefore, it is recommended that patients are monitored for changes in thyroid function at the start or end of concomitant treatment. If necessary, the levothyroxine dose has to be adjusted.

• Tyrosine kinase inhibitors (e.g. imatinib, sunitinib) may decrease the efficacy of levothyroxine. Therefore, it is recommended that patients are monitored for changes in thyroid function at the start or end of concomitant treatment. If necessary, the levothyroxine dose has to be adjusted.

• Propylthiouracil, glucocorticoids, beta-sympatholytics, amiodarone and iodine containing contrast media: these substances inhibit the peripheral conversion of T4 to T3. Due to its high iodine content amiodarone can trigger hyperthyroidism as well as hypothyroidism. Particular caution is advised in the case of nodular goitre with possibly unrecognized autonomy.

• Enzyme inducing medicinal products such as barbiturates, carbamazepine or products containing St John's Wort (Hypericum perforatum L.) can increase hepatic clearance of levothyroxine. Therefore, patients on thyroid replacement therapy may require an increase in their dose of thyroid hormone if these products are given concurrently.

• Proton pump inhibitors (PPIs):

Co-administration with PPIs may cause a decrease in the absorption of the thyroid hormones, due to the increase of the intragastric pH caused by PPIs.Regular monitoring of thyroid function and clinical monitoring is recommended during concomitant treatment. It may be necessary to increase the dose of thyroid hormones.

Care should also be taken when treatment with PPI ends.

• Soy-containing compounds can decrease the intestinal absorption of levothyroxine. Therefore, a dosage adjustment of Levothyroxine IBSA Soft Capsules may be necessary, in particular at the beginning or after termination of nutrition with soy supplements.

• Interferences with laboratory test: Biotin may interfere with thyroid immunoassays that are based on a biotin/streptavidin interaction, leading to either falsely decreased or falsely increased test results (see section 4.4).

4.6. Fertility, pregnancy and lactation

Pregnancy

Women on a maintenance dose for hypothyroidism who become pregnant, must be monitored closely. Levothyroxine sodium does not readily cross the placenta in the second and third trimester, but may do so in the first. Levothyroxine sodium is not known to have either carcinogenic or teratogenic effects.

Treatment with levothyroxine should be given consistently during pregnancy and breast-feeding in particular. Dosage requirements may even increase during pregnancy.

Experience has shown that there is no evidence of drug-induced teratogenicity and/or foeto- toxicity in humans at the recommended therapeutic dose level. Excessively high dose levels of levothyroxine during pregnancy may have a negative effect on foetal and postnatal development.

Combination therapy of hyperthyroidism with levothyroxine and anti-thyroid agents is not indicated in pregnancy. Such combination would require higher doses of anti-thyroid agents, which are known to pass the placenta and to induce hypothyroidism in the infant.

Thyroid suppression diagnostic tests should not be carried out during pregnancy, as the application of radioactive substances in pregnant women is contraindicated.

Breast-feeding

Levothyroxine is secreted into breast milk during lactation but the concentrations achieved at the recommended therapeutic dose level are not sufficient to cause development of hyperthyroidism or suppression of TSH secretion in the infant. Levothyroxine can be used during breast-feeding.

Fertility

No data available.

4.7. Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed. However, since levothyroxine is identical to the naturally occurring thyroid hormone, it is not expected that Levothyroxine IBSA Soft Capsules have any influence on the ability to drive and use machines.

4.9. Overdose

Symptoms

An elevated T3 value is a more reliable indicator of overdose than elevated T4 or fT4 values.

In the event of an overdose, symptoms displaying a marked increase in metabolic activity occur (see section 4.8).

Symptoms may manifest themselves as marked beta-adrenergic effects, such as tachycardia, anxiety states, agitation and hyperkinesis. The symptoms may be reduced by beta-receptor blockers

Following overdose in humans (with suicidal intent) doses of 10 mg levothyroxine were tolerated without complications.

There are some reports of sudden cardiac death in patients who have misused levothyroxine over many years.

Management

Depending on the extent of the overdose, it is recommended that the patient stops taking the product and undergoes a check-up.

Overdosage following recent ingestion can be treated using gastric lavage/emesis. Propranolol and other supportive measures are used to maintain the circulation.

Antithyroid drugs such as propylthiouracil and lithium are unlikely to be of benefit to prevent thyrotoxic crisis due to delayed absorption/onset of action.

At extreme doses, plasmapheresis may be useful.

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