- 1. Name of the medicinal product
- 2. Qualitative and quantitative composition
- 3. Pharmaceutical form
- 4. Clinical particulars
- 4.1 Therapeutic indications
- 4.2 Posology and method of administration
- 4.3 Contraindications
- 4.4 Special warnings and precautions for use
- 4.5 Interaction with other medicinal products and other forms of interaction
- 4.6 Pregnancy and lactation
- 4.7 Effects on ability to drive and use machines
- 4.8 Undesirable effects
- 4.9 Overdose
- 5. Pharmacological properties
- 5.1 Pharmacodynamic properties
- 5.2 Pharmacokinetic properties
- 5.3 Preclinical safety data
- 6. Pharmaceutical particulars
- 6.1 List of excipients
- 6.2 Incompatibilities
- 6.3 Shelf life
- 6.4 Special precautions for storage
- 6.5 Nature and contents of container
- 6.6 Special precautions for disposal and other handling
- Administrative data
- 7. Marketing authorisation holder
- 8. Marketing authorisation number(s)
- 9. Date of first authorisation/renewal of the authorisation
- 10. Date of revision of the text
PosologyIt is recommended that the tablets should be administered before breakfast or your first meal of the day.Adults: Initially 50-100 micrograms daily, then adjusted at 3-4 week intervals by 50 microgram increments until normal metabolism is steadily maintained. This may require doses of up to 100-200 micrograms daily.
Patients over 50 years:It is not advisable to exceed 50 micrograms a day initially. The dose may then be increased by 50 micrograms every 3-4 weeks until thyroxine levels are correct. A final dose is between 50-200 micrograms daily.In younger patients, and in the absence of heart disease, a serum levothyroxine (T4) level of approximately 70-160 nanomoles/litre or a serum thyrotrophin level of less than 5 milli-units/litre should be aimed at. In those aged over 50, and/or in the presence of heart disease, clinical response is probably a more acceptable criterion of dosage than serum levels.A pre-therapy ECG is valuable, as changes induced by hypothyroidism may be confused with ECG evidence of ischaemia. If too rapid an increase of metabolism is produced, dosage should be reduced or withheld for a day or two, then recommenced at a lower level.
Patients over 50 years with heart disease:Where there is cardiac disease, 25 micrograms daily, or 50 micrograms on alternate days is more suitable. In this condition the daily dosage may be increased by 25 microgram increments at intervals of maybe 4 weeks. A final dose is between 50-200 micrograms daily.Paediatric patients: The maintenance dose is generally 100 to 150micrograms per m² body surface area. For neonates and infants with congenital hypothyroidism, where rapid replacement is important, the initial recommended dosage is 10 to 15micrograms per kg BW per day for the first 3 months. Thereafter, the dose should be adjusted individually according to the clinical findings and thyroid hormone and TSH values. For children with acquired hypothyroidism, the initial recommended dosage is 12.5-50micrograms 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. Infants should be given the total daily dose at least half an hour before the first meal of the day. Juvenile myxoedema: A suitable starting dose is 25micrograms levothyroxine daily, with increments of 25micrograms every 2-4 weeks until mild toxic symptoms appear. Dosage should then be slightly reduced. The starting dose for children older than one year may be 2.5-5micrograms/kg bodyweight daily.When applicable: Tablets are to be disintegrated in some water (10 to 15ml) and the resultant suspension, which must be prepared freshly as required, is to be administered with some more liquid (5 to 10ml).
Method of AdministrationFor oral administration.
• Hypersensitivity to levothyroxine or any other ingredients in the tablets.• Thyrotoxicosis.• Patients with adrenal insufficiency without adequate corticosteroid cover.
Blood testsThe treatment of any thyroid disorder should be determined on an individual basis, taking account of clinical response, biochemical tests and regular monitoring.Levothyroxine should be administered with caution where there are symptoms of myocardial insufficiency including angina, coronary artery disease or ECG evidence of myocardial infarction and hypertension. A pre-therapy ECG is valuable as changes induced by hypothyroidism may be confused with evidence of ischaemia.Thyroid replacement therapy should be introduced gradually in patients over 50 years of age, and those with severe long standing hypothyroidism.Patients with adrenal insufficiency or other causes predisposing to it such as panhypopituitarism may react unfavourably to levothyroxine treatment so it is advisable to initiate corticosteroid therapy before giving levothyroxine. Caution should also be exercised when administering levothyroxine to diabetics (mellitus or insipidus) or digitalised patients.Subclinical hyperthyroidism may be associated with bone loss. To minimise the risk of osteoporosis, dosage of levothyroxine sodium should be titrated to the lowest possible effective level.Parents of children receiving a thyroid agent should be advised that partial loss of hair may occur during the first few months of therapy, but this effect is usually transient and subsequent regrowth usually occurs.Levothryroxine contains lactose and therefore should not be used by patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
PregnancyWomen 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.
LactationMinimal concentrations of levothyroxine are excreted in breast milk and may cause hypothyroidism in a newborn baby. It is considered that there is insufficient thyroid hormone in breast milk to meet the needs of a suckling infant with a non-functioning thyroid gland.
Reporting of suspected adverse reactionsReporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
Blister packs:Do not store above 25°C.Store in the original package.Keep container in the outer carton.
Polypropylene containers, polyethylene containers and amber glass bottles:Do not store above 25°C.Store in the original container.Keep the container tightly closed.
Actavis UK Ltd
Whiddon Valley, Barnstaple, Devon, EX32 8NS, UK
+44 (0)1271 346 106
+44 (0)1271 311 200
+44 (0)1271 311 257