HYDROCORTONE Tablet (2020)
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Περιεχόμενα
1. Name of the medicinal product
Hydrocortone 10 mg Tablets.
2. Qualitative and quantitative composition
Each tablet contains 10 mg Hydrocortisone. <u>Excipient:</u> Contains 191.1mg Lactose Monohydrate per tablet. For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablet. White, oval-shaped tablets quartersected on one side and imprinted with HYD 10 on the other side. The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal ...
4.1. Therapeutic indications
Corticosteroid. For use as replacement therapy in primary, secondary or acute adrenocortical insufficiency. Pre-operatively, and during serious trauma or illness in patients with known adrenal insufficiency ...
4.2. Posology and method of administration
Dosage must be individualized according to the response of the individual patient. The lowest possible dosage should be used. Patients should be observed closely for signs that might require dosage adjustment, ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients. Acute infectious processes: viral infections and systemic fungal infections (bacterial infections, see also 'Special warnings and precautions ...
4.4. Special warnings and precautions for use
Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered ...
4.5. Interaction with other medicinal products and other forms of interaction
Phenytoin, ephedrine, rifabutin, carbamazepine, aminoglutethimide, barbiturates, and rifampicin may enhance the metabolic clearance of corticosteroids, resulting in decreased blood levels and lessened ...
4.6. Pregnancy and lactation
Since human reproduction studies have not been done with corticosteroids, the use of these drugs in pregnancy, or women of child-bearing potential requires that the possible benefits of the drug be weighed ...
4.7. Effects on ability to drive and use machines
There are some side effects associated with this product that may affect some patients' ability to drive and operate machinery. When driving vehicles or operating machinery, it should be taken into account ...
4.8. Undesirable effects
The frequencies of adverse events are ranked according to the following: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to < 1/100), rare (≥1/10,000 to < 1/1,000), very rare (<1/10,000), ...
4.9. Overdose
Anaphylactic and hypersensitivity reactions may be treated with adrenaline, positive-pressure artificial respiration and aminophylline. The patient should be kept warm and quiet. Treatment is probably ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> corticosteroids for systemic use <b>ATC Code:</b> H02AB09 Hydrocortisone is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally-occurring and ...
5.2. Pharmacokinetic properties
Hydrocortisone is readily absorbed from the gastro-intestinal tract and 90% or more of the drug is reversibly bound to protein. The binding is accounted for by two protein fractions. One, corticosteroid-binding ...
5.3. Preclinical safety data
No relevant information.
6.1. List of excipients
Lactose monohydrate Magnesium stearate Maize starch
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
Store below 25°C. Store in the original package.
6.5. Nature and contents of container
Blister packs of opaque PVC lidded with aluminium foil containing 30 tablets, presented in an outer carton.
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Teva B.V., Swensweg 5, 2031GA Haarlem, Netherlands
8. Marketing authorization number(s)
PA1986/054/001
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 1 April 1978 Date of last renewal: 1 April 2008
10. Date of revision of the text
September 2020
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