OROXINE Tablet (2021)
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Περιεχόμενα
1. Name of the medicinal product
Oroxine 25 microgram tablets.
2. Qualitative and quantitative composition
Each tablet of Oroxine 25 microgram contains 27.8 microgram of levothyroxine sodium pentahydrate equivalent to 25 microgram of levothyroxine sodium.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablets.
Levothyroxine sodium 25 microgram tablets are round, 6.5mm in diameter, white coloured, flat, bevelled tablets debossed with '25' on the one side and a breakline on the other sid...
4.1. Therapeutic indications
Levothyroxine 25–200 micrograms:
Hypothyroidism,
Prophylaxis against goitre recurrence following resection of euthyroid goitre,
Benign, euthyroid goitre,
Suppression and replacement therapy in thyr...
4.2. Posology and method of administration
Thyroid hormone therapy/replacement
Posology
The dosing information serves as a guideline. The individual daily dose should be determined by laboratory diagnostic tests and clinical examinations. I...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1,
Untreated hyperthyroidism,
Untreated subclinical (suppressed serum TSH level with normal T3 and T4 levels...
4.4. Special warnings and precautions for use
Thyroid hormones must not be given for weight reduction. In euthyroid patients, normal doses do not cause any weight reduction. Higher doses may cause serious or even life-threatening undesirable e...
4.5. Interaction with other medicinal products and other forms of interaction
Interactions decreasing levothyroxine absorption
Ion exchange resins
Cholestyramine, calcium, aluminium, magnesium, iron supplements, polystyrene sulfonates, sucralfate, lanthanum, bile acid seques...
4.6. Pregnancy and lactation
Pregnancy
Levothyroxine has been taken by a large number of pregnant women and women of childbearing age without any form of definite disturbances in the reproductive process having been observed s...
4.7. Effects on ability to drive and use machines
There are no available studies on the effects on the ability to drive and use machines. As levothyroxine is identical to the naturally occurring thyroid hormone, Levothyroxine sodium is not expecte...
4.8. Undesirable effects
All adverse reactions are listed by system organ class and frequency; rare (≥1/10,000 to <1/1,000) and not known (cannot be estimated from the available data).
System Organ class
Frequency
Adver...
4.9. Overdose
Symptoms
Hyperthyroidism may result from treatment imbalance or levothyroxine overdose. An increased T
3
level is a more reliable sign of an overdose than elevated T
4
or fT
4
levels.
In additio...
5.1. Pharmacodynamic properties
Pharmacotherapeutic group:
Thyroid therapy; Thyroid hormones
ATC:
H03AA01
Mechanism of action
The action of synthetic levothyroxine contained in Levothyroxine sodium is identical to that of the ...
5.2. Pharmacokinetic properties
Absorption
Depending to a large extent on the type of galenic formulation, up to ≤80% of orally administered levothyroxine is absorbed when taken in the fasting state, mainly from the upper small i...
5.3. Preclinical safety data
Adverse effects observed in single and repeated dose toxicity studies only occurred at high doses.
Acute toxicity
Acute toxicity of levothyroxine is very low.
Chronic toxicity
Chronic toxicity stud...
6.1. List of excipients
Microcrystalline cellulose PH101 (E460)
Pregelatinised maize starch
Talc (E553b)
Colloidal anhydrous silica (E551)
Magnesium stearate (E470b)
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
2 years.
For Oroxine 25 and 50 microgram tablets:
After opening of the HDPE container the tablets should be used within 2 months.
For Oroxine 75, 100, 125, 150, 175, 200 microgram tablets:
After op...
6.4. Special precautions for storage
Store below 25°C.
6.5. Nature and contents of container
High density polyethylene (HDPE) bottles, closed with white polypropylene (PP) screw caps with foil heat induction seals, and with a 1.0 g white polypropylene canister containing oxygen absorber. T...
6.6. Special precautions for disposal and other handling
No special requirements.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. Marketing authorization holder
Aspen Pharma Trading Limited, 3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland
8. Marketing authorization number(s)
PA1691/013/001
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 12
th
September 2014
Date of last renewal: 10
th
April 2019
10. Date of revision of the text
April 2021
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