DORALESE Film-coated tablets (2020)
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Περιεχόμενα
Name of the medicinal product
Doralese Tiltab Tablets 20 mg. Indoramin 20 mg Tablets.
Qualitative and quantitative composition
Each film-coated tablet contains indoramin hydrochloride equivalent to 20 mg of indoramin base. Excipient with known effect: Each film-coated tablet contains 152 mg lactose monohydrate. For the full list ...
Pharmaceutical form
Film-coated tablets (tablets). Pale yellow, triangular film-coated tablet, bearing a raised kite shape on each face.
Therapeutic indications
Conditions for which alpha blockade is indicated. Management of urinary outflow obstruction due to benign prostatic hyperplasia.
Posology and method of administration
Posology Hyperplasia Adults 20 mg twice daily. Dosage may be increased in 20 mg increments at two-weekly intervals up to max. 100 mg per day if required. Elderly 20 mg at night may be adequate. Paediatric ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 Patients with established heart failure. Patients already under treatment with a monoamine oxidase inhibitor. ...
Special warnings and precautions for use
Incipient cardiac failure should be controlled before treatment with indoramin. Caution should be observed in prescribing indoramin for patients with hepatic or renal insufficiency. A few cases of extrapyramidal ...
Interaction with other medicinal products and other forms of interaction
Do not use indoramin in patients being treated with a monoamine oxidase (MAO) inhibitor. Concomitant use of indoramin with antihypertensive drugs or drugs with hypotensive properties e.g. antidepressants, ...
Pregnancy and lactation
Pregnancy Animal experiments indicate no teratogenic effects but indoramin tablets should not be prescribed for pregnant women unless considered essential by the physician. Breast-feeding There are no ...
Effects on ability to drive and use machines
Drowsiness is sometimes seen in the initial stages of treatment with indoramin or when dosage is increased too rapidly. If drowsiness occurs, patients should be warned not to drive or operate machinery ...
Undesirable effects
Drowsiness or sedation can occur on starting treatment with indoramin, and also if dosage is increased too rapidly. Less commonly, dry mouth, nasal congestion, weight gain, dizziness, failure of ejaculation, ...
Overdose
Information available at present of the effects of acute overdosage in human beings with indoramin is limited. Effects seen have included deep sedation leading to coma, hypotension and fits. Results of ...
Pharmacodynamic properties
Pharmacotherapeutic group: Alpha-adrenoreceptor antagonists ATC code: C02CA02 Mechanism of action Indoramin is an alpha adrenoceptor blocking agent. It acts selectively and competitively on post-synaptic ...
Pharmacokinetic properties
Absorption Indoramin is rapidly absorbed from indoramin tablets and has a half-life of about five hours. Distribution There is little accumulation during long-term treatment. Biotransformation When three ...
Preclinical safety data
Not applicable.
List of excipients
Lactose monohydrate Microcrystalline cellulose Amberlite IRP-88 Magnesium stearate Film-coating: Opadry OY-3736 Purified water Carnauba wax
Incompatibilities
Not applicable.
Shelf life
3 years.
Special precautions for storage
Store below 25°C.
Nature and contents of container
Blister packs packs of 60.
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Chemidex Pharma Ltd., T/A Essential Generics, Chemidex House, Egham Business Village, Crabtree Road, Egham, Surrey, TW20 8RB, United Kingdom
Marketing authorization number(s)
PL 17736/0089
Date of first authorization / renewal of the authorization
25<sup>th</sup> February 1998
Date of revision of the text
28<sup>th</sup> February 2020
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