ELTROXIN Tablet (2019)
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Περιεχόμενα
Name of the medicinal product
Eltroxin 25mcg tablets. Levothyroxine 25mcg tablets.
Qualitative and quantitative composition
Each tablet contains 25 micrograms Levothyroxine sodium anhydrous. Excipients with known effect: Lactose 30.49mg per tablet. For the full list of excipients, see section 6.1.
Pharmaceutical form
Tablet. Each tablet is engraved on one face with LT and 25 on the other.
Therapeutic indications
<u>Recommended clinical indications:</u> Control of hypothyroidism, congenital hypothyroidism in infants, acquired hypothyroidism in children and juvenile myxoedema.
Posology and method of administration
Posology In younger patients, and in the absence of heart disease, a serum Levothyroxine (T4) level of 70 to 160 nanomols per litre, or a serum thyrotrophin level of less than 5 milli-units per litre should ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Thyrotoxicosis. Adrenal gland disorder or adrenal insufficiency.
Special warnings and precautions for use
Levothyroxine should be introduced very gradually in patients aged over 50 years (see section 4.2) and those with long standing hypothyroidism to avoid any sudden increase in metabolic demands. Patients ...
Interaction with other medicinal products and other forms of interaction
Interactions affecting other drugs Levothyroxine increases the effect of anticoagulants (Warfarin) and it may be necessary to reduce the anticoagulation dosage if excessive, hypoprothrombinaemia and bleeding ...
Pregnancy and lactation
Pregnancy The safety of Levothyroxine treatment during pregnancy is not known, but any possible risk of foetal abnormalities should be weighed against the risk to the foetus of untreated hypothyroidism. ...
Effects on ability to drive and use machines
Levothyroxine has no or negligible influence on the ability to drive and use machines.
Undesirable effects
Side-effects are usually indicative of excessive dosage and usually disappear on reduction of dosage or withdrawal of treatment for a few days. Adverse reactions listed below have been observed during ...
Overdose
Symptoms In most cases there will be no features. Signs of an overdose may include: chest pain (angina), tachycardia or arrythmia, muscle cramps, headache, restlessness, flushing, sweating, diarrhoea, ...
Pharmacodynamic properties
Pharmacotherapeutic group: Thyroid hormones ATC Code: H03AA01 Eltroxin is a tablet containing Levothyroxine sodium used for the treatment of hypothyroidism. The thyroid gland is dependent upon 2 active ...
Pharmacokinetic properties
Levothyroxine sodium is incompletely and variably absorbed from the gastrointestinal tract. It is almost completely bound to plasma proteins and has a half-life in the circulation of about a week in healthy ...
Preclinical safety data
No further data of relevance.
List of excipients
Sodium citrate Lactose Maize starch Powdered acacia Magnesium stearate
Incompatibilities
None known.
Shelf life
24 months.
Special precautions for storage
Do not store above 25°C. Store in the original package in order to protect from light and moisture.
Nature and contents of container
Polypropylene container with tamper-evident low density polyethylene lid, containing 28, 56, 100, 112, 500 or 1000 tablets. Aluminium foil with PVC/PVdC film blisters containing 28, 56 or 112 tablets. ...
Special precautions for disposal and other handling
No special requirements for disposal. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Mercury Pharmaceuticals Ltd, Capital House, 85 King William Street, London EC4N 7BL, UK
Marketing authorization number(s)
PL 12762/0016
Date of first authorization / renewal of the authorization
17/11/1999
Date of revision of the text
26/03/2019
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