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HYGROTON Tablets (2014)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Hygroton Tablets 50mg. Chlortalidone 50mg Tablets.

Qualitative and quantitative composition

Chlortalidone Ph.Eur 50mg.

Pharmaceutical form

Pale yellow, round, flat tablets with bevelled edges, impressed Geigy on one side with a breakline, and the letters Z/A on the other side.

Therapeutic indications

Treatment of arterial hypertension, essential or nephrogenic or isolated systolic. Treatment of stable, chronic heart failure of mild to moderate degree (New York Heart Association, NYHA: functional class ...

Posology and method of administration

The dosage of Hygroton/Chlortalidone should be individually titrated to give the lowest effective dose; this is particularly important in the elderly. Hygroton/Chlortalidone should be taken orally, preferably ...

Contraindications

Known hypersensitivity to chlortalidone or any of the excipients. Anuria, severe hepatic or renal failure (creatinine clearance <30ml/min), hypersensitivity to chlortalidone and other sulphonamide derivatives, ...

Special warnings and precautions for use

Warnings Hygroton/Chlortalidone should be used with caution in patients with impaired hepatic function or progressive liver disease since minor changes in the fluid and electrolyte balance due to thiazide ...

Interaction with other medicinal products and other forms of interaction

Diuretics potentiate the action of curare derivatives and antihypertensive drugs (e.g. guanethidine, methyldopa, β-blockers, vasodilators, calcium antagonists and ACE inhibitors). The hypokalaemic effect ...

Pregnancy and lactation

Diuretics are best avoided for the management of oedema or hypertension in pregnancy as their use may be associated with hypovolaemia, increased blood viscosity and reduced placental perfusion. There have ...

Effects on ability to drive and use machines

Patients should be warned of the potential hazards of driving or operating machinery if they experience side effects such as dizziness.

Undesirable effects

Frequency estimate: very rare <0.01%, rare ≤0.01% to ≤0.1%;uncommon ≤0.1% to <1%; common ≤1% to <10%; very common ≥10%. Electrolytes and metabolic disorders Very common: mainly at higher doses, hypokalaemia, ...

Overdose

Signs and symptoms In poisoning due to an overdosage the following signs and symptoms may occur: dizziness, nausea, somnolence, hypovolaemia, hypotension and electrolyte disturbances associated with cardiac ...

Pharmacodynamic properties

Chlortalidone is a benzothiadiazine (thiazide)-related diuretic with a long duration of action. Thiazide and thiazide-like diuretics act primarily on the distal renal tubule (early convoluted part), inhibiting ...

Pharmacokinetic properties

Absorption and plasma concentration The bioavailability of an oral dose of 50mg Hygroton/Chlortalidone is approximately 64%, peak blood concentrations being attained after 8 to 12 hours. For doses of 25 ...

Preclinical safety data

There are no pre-clinical data of relevance to the prescriber which are additional to those already included in other sections of the Summary of Product Characteristics.

List of excipients

Microcrystalline cellulose Silicon dioxide Maize starch Magnesium stearate, Sodium carboxymethyl cellulose Yellow iron oxide (E172)

Incompatibilities

None known.

Shelf life

Five years.

Special precautions for storage

None.

Nature and contents of container

Aluminium/PVC blister packs of 28 tablets.

Special precautions for disposal and other handling

None.

Marketing authorization holder

Alliance Pharmaceuticals Limited, Avonbridge House, Bath Road, Chippenham, Wiltshire, SN15 2BB

Marketing authorization number(s)

PL16853/0007

Date of first authorization / renewal of the authorization

25 June 1998

Date of revision of the text

23/09/2014

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