BENDROFLUMETHIAZIDE Tablet (2019)
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Περιεχόμενα
Name of the medicinal product
BENDROFLUMETHIAZIDE TABLETS BP 2.5mg.
Qualitative and quantitative composition
Each tablet contains 2.5mg Bendroflumethiazide PhEur. Excipient with known effect: Each 2.5mg tablet contains 50.00mg Lactose. For the full list of excipients, see section 6.1.
Pharmaceutical form
White uncoated tablets.
Therapeutic indications
Bendroflumethiazide is indicated for: Cases where the reduction of fluid retention by diuresis is required; oedema of cardiac, renal or hepatic origin and iatrogenic oedema. Bendroflumethiazide produces ...
Posology and method of administration
Posology It is recommended that the tablets should be taken in the morning to avoid nocturia. Adults and children aged 12 years and over <u>Oedema:</u> Initially 5-10mg once daily or on alternate days. ...
Contraindications
Hypersensitivity to the active substance, to thiazides or to any of the excipients listed in section 6.1. Severe renal or hepatic insufficiency. Hypercalcaemia; refractory hypokalaemia; hyponatraemia; ...
Special warnings and precautions for use
Bendroflumethiazide may raise serum uric acid levels with consequent exacerbation of gout in susceptible patients. Thiazide diuretics should be used with caution in patients with mild or moderate renal ...
Interaction with other medicinal products and other forms of interaction
<u>Allopurinol:</u> Bendroflumethiazide may antagonise the action of allopurinol by causing retention of urate in the kidney. Caution is advised when using this combination. <u>Anion exchange resins:</u> ...
Pregnancy and lactation
Pregnancy Bendroflumethiazide is best avoided for the management of oedema or hypertension in pregnancy as it crosses the placenta and its use may be associated with hypokalaemia, increased blood viscosity ...
Effects on ability to drive and use machines
As bendroflumethiazide can cause dizziness, patients should make sure they are not affected before driving or operating machinery.
Undesirable effects
The following undesirable effects have been divided into the following categories: 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, ...
Overdose
Symptoms Nausea, vomiting, diarrhoea, dehydration, dizziness, weakness, muscle cramps, diuresis, increased frequency of micturition with polyuria and thirst. Extreme cases may show depletion of intravascular ...
Pharmacodynamic properties
Pharmacotherapeutic group: low-ceiling diuretics, thiazides ATC code: C03AA01 The mechanism whereby the thiazides exert their antihypertensive effect has not been clearly established. Bendroflumethiazide ...
Pharmacokinetic properties
Absorption Bendroflumethiazide has been reported to be completely absorbed from the gastrointestinal tract. Diuresis is initiated in about 2 hours and lasts for 12-18 hours or longer. Distribution Bendroflumethiazide ...
Preclinical safety data
Not applicable.
List of excipients
<u>Also contains:</u> Lactose Magnesium stearate Maize starch Pregelatinised maize starch Stearic acid Water
Incompatibilities
None known.
Shelf life
Four years from the date of manufacture (PVC blister packs). Three years from the date of manufacture (polypropylene containers; polyethylene containers; amber glass bottles.
Special precautions for storage
Store below 25°C in a dry place.
Nature and contents of container
The product containers are rigid injection moulded polypropylene or injection blow-moulded polyethylene containers with polyfoam wad or polyethylene ullage filler and snap-on polyethylene lids; in case ...
Special precautions for disposal and other handling
Not applicable.
Marketing authorization holder
Accord-UK Ltd (Trading style: Accord), Whiddon Valley, Barnstaple, Devon, EX32 8NS
Marketing authorization number(s)
PL 0142/0380
Date of first authorization / renewal of the authorization
27.6.94
Date of revision of the text
29/05/2019
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