Hygroton 50mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Chlortalidone

Available from:

Alliance Pharmaceuticals Ltd

ATC code:

C03BA04

INN (International Name):

Chlortalidone

Dosage:

50mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02020100; GTIN: 5036631850610

Patient Information leaflet

PATIENT INFORMATION LEAFLET
HYGROTON
® 50 MG TABLETS
(chlortalidone)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their symptoms are the same as
yours.
• If any of the side effects get serious, or if you notice any side
effects not listed in this leaflet please tell your doctor or
pharmacist.
The information in this leaflet has been divided into the following
sections:
1. WHAT HYGROTON 50 MG TABLETS IS AND WHAT IT IS TAKEN FOR
2. CHECK BEFORE YOU TAKE HYGROTON 50 MG TABLETS
3. HOW TO TAKE HYGROTON 50 MG TABLETS
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE HYGROTON 50 MG TABLETS
6. FURTHER INFORMATION
1. WHAT HYGROTON 50 MG TABLETS IS AND WHAT IT IS TAKEN FOR
Hygroton 50 mg Tablets belongs 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'.
Hygroton 50 mg Tablets is used to:
• treat high blood pressure (hypertension)
• treat heart failure
• help reduce the fluid retention that occurs with some kidney or
liver diseases
• treat diabetes insipidus (a condition in which an individual
produces large amounts of dilute urine and is constantly thirsty).
2. CHECK BEFORE YOU TAKE HYGROTON 50 MG TABLETS
DO NOT TAKE HYGROTON 50 MG TABLETS:
• if you are allergic (hypersensitive) to chlortalidone,
sulphonamides such as sulfamethoxazole or any of the ingredients of
Hygroton 50
mg Tablets (see Section 6 Further information)
• if you are not passing any urine at all
• if you have severe kidney or liver problems
• if you have low blood levels of potassium which can cause muscle
weakness, muscle twitching or abnormal heartbeat
• if you have low blood levels of sodium which can cause tiredn

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Hygroton Tablets 50mg
Chlortalidone 50mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Chlortalidone Ph.Eur 50mg.
3.
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.
4.
CLINICAL PARTICULARS
4.1.
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 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.
4.2
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 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 to 200mg/day. The usual maintenance dose is the
lowest
effective dose, eg 25 to 50mg/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
adm