Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Chlortalidone may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
for Hylaton Tablets belong to a group of medicines called thiazide diuretics. Thiazide diuretics help to reduce the amount of water in your body. They do this by increasing the amount of water that you pass as urine. They are sometimes called 'water tablets'. Hylaton Tablets are used to:
e Hylaton Tablets Do not take Hylaton Tablets:
Hylaton Tablets Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Your doctor will choose a suitable starting dose for your particular condition and monitor your progress. If necessary, this dose can be increased or reduced. Whilst you are taking Hylaton Tablets, your doctor may want to carry out a number of tests from time to time. This is quite usual and nothing to worry about. It is best to take Hylaton Tablets in the morning with food. Swallow your tablets whole with a drink of water. Adults The usual doses for adults are as follows:
Children Your doctor will choose a suitable dose based on your child's age and weight. Elderly patients or those with kidney problems Your doctor may give you a lower dose because your body may not get rid of Hylaton Tablets as quickly as normal. If you are not sure how many tablets to take, ask your doctor or pharmacist. Do not stop taking your tablets suddenly. Ask your doctor first. If you take more Hylaton Tablets than you should If you accidentally take more Hylaton Tablets than you should tell your doctor immediately or contact your nearest accident and emergency department. Show any left-over medicines or the empty packet to the doctor. If you forget to take Hylaton Tablets If you forget to take a dose, take it as soon as possible, unless it is almost time to take the next dose. Do not take a double dose. Then go on as before. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse. 4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. If you get any of the following effects tell your doctor or pharmacist immediately: Very common (may affect more than 1 in 10 people):
Do not use this medicine after the expiry date which is stated on the carton or container after "EXP". The expiry date refers to the last day of that month. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
Hylaton Tablets This medicinal product does not require any special storage conditions. Keep this medicine out of the sight and reach of children. M0351LAMUKNAB1-P1-001
What Hylaton Tablets contain
Uncommon side effects (may affect up to 1 in 100 people)
Hylaton 12.5mg Tablets comes as tablet containing 12.5mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Hylaton 12.5mg Tablets is chlortalidone.
This leaflet reproduces the patient information leaflet approved for Hylaton 12.5mg Tablets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
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 II or III)
Oedema of specific origin
Ascites due to cirrhosis of the liver in stable patients under close control. Oedema due to nephrotic syndrome.
Diabetes Insipidus.
Posology
The dosage of Hylaton / Chlortalidone Tablets should be individually titrated to give the lowest effective dose; this is particularly important in the elderly.
Chlortalidone should be taken orally, preferably as a single daily dose at breakfast time.
Adults:
Hypertension
The recommended starting dose is 25mg/day. This is sufficient to produce the maximum hypotensive effect in most patients. If the decrease in blood pressure proves inadequate with 25mg/day, then the dose can be increased to 50mg/day.
If a further reduction in blood pressure is required, additional hypertensive therapy may be added to the dosage regime.
Stable, chronic heart failure (NYHA: functional class II /III):
The recommended starting dose is 25 to 50mg/day. In severe cases it may be increased up to 100 -200 mg/day. The usual maintenance dose is the lowest effective dose, e.g. 25- 50 mg/day either daily or every other day. If the response proves inadequate, digitalis or an ACE inhibitor, or both, may be added. (See Section 4.4 “Special warnings and precautions for use”).
Oedema of specific origin (see Section 4.1 “Therapeutic indications”)
The lowest effective dose is to be identified by titration and administered over limited periods only. It is recommended that doses should not exceed 50mg/day.
Diabetes insipidus
Initially 100 mg twice daily but reducing where possible to a daily maintenance dose of 50 mg.
Paediatric population
The lowest effective dose should also be used in children. For example, an initial dose of 0.5 to 1 mg/kg/48hours and a maximum dose of 1.7 mg/kg/48hours have been used.
Elderly patients and patients with renal impairment:
The lowest effective dose of Hylaton /Chlortalidone Tablets is also recommended for patients with mild renal insufficiency and for elderly patients (see Section 5.2 “Pharmacokinetic properties”).
In elderly patients, the elimination of chlortalidone is slower than in healthy young adults, although absorption is the same. Therefore, a reduction in the recommended adult dosage may be needed. Close medical observation is indicated when treating patients of advanced age with chlortalidone.
Chlortalidone and the thiazide diuretics lose their diuretic effect when the creatinine clearance is <30ml/min.
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, refractory hypokalaemia, hyponatraemia and hypercalcaemia, symptomatic, hyperuricaemia (history of gout or uric acid calculi), hypertension during pregnancy, untreated Addison's disease and concomitant lithium therapy.
Warnings:
Hylaton / Chlortalidone Tablets 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 diuretics may precipitate hepatic coma, especially in patients with liver cirrhosis (see Section 4.3 “Contra-indications”).
Chlortalidone should also be used with caution in patients with severe renal disease. Thiazides may precipitate azotaemia in such patients, and the effects of repeated administration may be cumulative.
Choroidal effusion, acute myopia and secondary angle-closure glaucoma:
Sulfonamide or sulfonamide derivative drugs can cause an idiosyncratic reaction resulting in choroidal effusion with visual field defect, transient myopia and acute angle-closure glaucoma. Symptoms include acute onset of decreased visual acuity or ocular pain and typically occur within hours to weeks of drug initiation. Untreated acute angle-closure glaucoma can lead to permanent vision loss. The primary treatment is to discontinue drug intake as rapidly as possible. Prompt medical or surgical treatments may need to be considered if the intraocular pressure remains uncontrolled. Risk factors for developing acute angle-closure glaucoma may include a history of sulfonamide or penicillin allergy.
Precautions:
Electrolytes:
Treatment with thiazide diuretics has been associated with electrolyte disturbances such as hypokalaemia, hypomagnesaemia, hypercalcemia and hyponatraemia. Since the excretion of electrolytes is increased, a very strict low-salt diet should be avoided.
Hypokalaemia may increase the excitability of the heart or exaggerate its response to the toxic effects of digitalis.
Like all thiazide diuretics, kaluresis induced by chlortalidone is dose dependent and varies in extent from one subject to another. With 25 to 50 mg/day, the decrease in serum potassium concentrations averages 0.5mmol/l.
Periodic serum electrolyte determinations should be carried out, particularly in digitalised patients.
If necessary, Hylaton / Chlortalidone Tablets may be combined with oral potassium supplements or with a potassium- sparing diuretic (e.g. triamterene).
If hypokalaemia is accompanied by clinical signs (e.g. muscular weakness, paresis and ECG alteration), Hylaton / Chlortalidone Tablets should be discontinued.
Combined treatment consisting of Hylaton / Chlortalidone Tablets and a potassium salt or a potassium-sparing diuretic should be avoided in patients treated with ACE inhibitors.
Monitoring of serum electrolytes is particularly indicated in the elderly, in patients with ascites due to liver cirrhosis, and in patients with oedema due to nephrotic syndrome. There have been isolated reports of hyponatraemia with neurological symptoms (e.g. nausea, debility, progressive disorientation and apathy) following thiazide treatment.
For nephrotic syndrome, chlortalidone should be used only under close control in normokalaemic patients with no signs of volume depletion.
Metabolic effects:
Chlortalidone may raise the serum uric acid level, but attacks of gout are uncommon during chronic treatment.
As with the use of other thiazide diuretics, glucose intolerance may occur; this is manifest as hyperglycaemia and glycosuria. Chlortalidone may very seldom aggravate or precipitate diabetes mellitus; this is usually reversible on stopping therapy.
Small and partly reversible increases in plasma concentrations of total cholesterol, triglycerides, or low- density lipoprotein cholesterol were reported in patients during long-term treatment with thiazides and thiazide-like diuretics. The clinical relevance of these findings is a matter for debate.
Hylaton / Chlortalidone Tablets should not be used as a first-line drug for long-term treatment in patients with overt diabetes mellitus or in subjects receiving therapy for hypercholesterolaemia (diet or combined).
As with all antihypertensive agents, a cautious dosage schedule is indicated in patients with severe coronary or cerebral arteriosclerosis.
Other effects:
The antihypertensive effect of ACE inhibitors is potentiated by agents that increase plasma renin activity (diuretics). It is recommended that the diuretic be reduced in dosage or withdrawn for 2 to 3 days and/or that the ACE inhibitor therapy be started with a low initial dose of the ACE inhibitor. Patients should be monitored for several hours after the first dose.
Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
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 of diuretics may be potentiated by corticosteroids, ACTH, ß2 – agonists, amphotericin and carbenoxolone.
It may prove necessary to adjust the dosage of insulin and oral anti-diabetic agents.
Thiazide-induced hypokalaemia or hypomagnesaemia may favour the occurrence of digitalis-induced cardiac arrhythmias (see Section 4.4 “Special warnings and precautions for use”).
Concomitant administration of certain non-steroidal anti-inflammatory drugs (e.g. indometacin) may reduce the diuretic and antihypertensive activity of chlortalidone; there have been isolated reports of a deterioration in renal function in predisposed patients.
The bioavailability of thiazide-type diuretics may be increased by anticholinergic agents (e.g. atropine, biperiden), apparently due to a decrease in gastrointestinal motility and stomach-emptying rate.
Absorption of thiazide diuretics is impaired in the presence of anionic exchange resins such as colestyramine. A decrease in the pharmacological effect may be expected.
Concurrent administration of thiazide diuretics may increase the incidence of hypersensitivity reactions to allopurinol, increase the risk of adverse effects caused by amantadine, enhance the hyperglycaemic effect of diazoxide, and reduce renal excretion of cytotoxic agents (e.g. cyclophosphamide, methotrexate) and potentiate their myelosuppressive effects.
The pharmacological effects of both calcium salts and vitamin D may be increased to clinically significant levels if given with thiazide diuretics. The resultant hypercalcaemia is usually transient but may be persistent and symptomatic (weakness, fatigue, anorexia) in patients with hyperparathyroidism.
Concomitant treatment with cyclosporin may increase the risk of hyperuricaemia and gout-type complications.
Thiazide and related diuretics can cause a rapid rise in serum lithium levels as the renal clearance of lithium is reduced by these compounds.
Pregnancy
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 been reports of foetal bone marrow depression, thrombocytopenia, and foetal and neonatal jaundice associated with the use of thiazide diuretics.
Breastfeeding
Chlortalidone passes into the breast milk; mothers taking chlortalidone should refrain from breast-feeding their infants.
Patients should be warned of the potential hazards of driving or operating machinery if they experience side effects such as dizziness.
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, hyperuricaemia, and rise in blood lipids.
Common: hyponatraemia, hypomagnesaemia and hyperglycaemia.
Uncommon: gout.
Rare: hypercalcaemia, glycosuria, worsening of diabetic metabolic state.
Very rare: hypochloraemic alkalosis.
Skin:
Common: urticaria and other forms of skin rash.
Rare: photosensitisation.
Liver
Rare: intrahepatic cholestasis or jaundice.
Cardiovascular system:
Common: postural hypotension.
Rare: cardiac arrhythmias.
Central nervous system:
Common: Dizziness.
Rare: paraesthesia, headache.
Gastro-intestinal tract;
Common: loss of appetite and minor gastrointestinal distress.
Rare: mild nausea and vomiting, gastric pain, constipation and diarrhoea.
Very rare: pancreatitis.
Blood:
Rare: Thrombocytopenia, leucopenia, agranulocytosis and eosinophilia.
Eye disorders:
Frequecncy unknown: choroidal effusion
Other effects:
Common: impotence
Rare: Idiosyncratic pulmonary oedema (respiratory disorders), allergic interstitial nephritis.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
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 arrhythmias and muscle spasms.
Treatment
There is no specific antidote to chlortalidone. Gastric lavage, emesis or activated charcoal should be employed to reduce absorption. Blood pressure and fluid and electrolyte balance should be monitored and appropriate corrective measures taken Intravenous fluid and electrolyte replacement may be indicated.
Medicines sold in Romania with the same active substance: Cunoscut în România ca
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
Medicines sold in Poland with the same active substance: W Polsce znany jako
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
Ask anything about Hylaton 12.5mg Tablets. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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