Xaqua 5mg tablets

国家: 英国

语言: 英文

来源: MHRA (Medicines & Healthcare Products Regulatory Agency)

有效成分:

Metolazone

可用日期:

Renascience Pharma Ltd

ATC代码:

C03BA08

INN（国际名称）:

Metolazone

剂量:

5mg

药物剂型:

Oral tablet

给药途径:

Oral

类:

No Controlled Drug Status

处方类型:

Caution - AMP level prescribing advised

產品總結:

BNF: 02020100; GTIN: 5060512180053

资料单张

200MM
320MM
Code reading direction
Code reading direction
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
-
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 only. Do not pass it on to
others. It may harm them, even if their symptoms are
the same as yours.
-
If you get any of the side effects, talk to your doctor or
pharmacist. This includes any possible side effects not listed in
this
leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Xaqua is and what it is used for
2.
What you need to know before you take Xaqua
3.
How to take Xaqua
4.
Possible side effects
5.
How to store Xaqua
6.
Contents of the pack and other information
1. WHAT IS XAQUA AND WHAT IS IT USED FOR
Xaqua is a diuretic drug containing the active substance metolazone.
It is used for the treatment of:
•
fluid retention (oedema) related to the heart and kidneys by
increasing the flow of urine.
•
high blood pressure, taken alone or with other medication.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE XAQUA
DO NOT TAKE XAQUA
•
if you are allergic (hypersensitive) to Metolazone, to thiazides, to
sulfonamides or any of the other ingredients of this
medicine (listed in section 6).
•
if you are no longer able to urinate
•
in case of coma or comatose conditions which is caused by liver
cirrhosis
•
in case of severe disturbances to the balance of salts or chemicals in
the blood
WARNING AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Xaqua:
•
If you have severe kidney or liver disease.
•
If you are elderly, your doctor may want to monitor you more closely.
•
If you have a fluid or electrolyte imbalance in your blood (e.g.
sodium, calcium or potassium), your doctor may want to
monitor you more closely. Symptoms can include thirst, nausea,
vomiting, disorientation, drowsiness, muscle cramps, low
blood pressure and irregular heart rate.
•

产品特点

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Xaqua 5 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg metolazone.
Excipients with known effect: Each tablet contains 53 mg lactose
monohydrate. For a
full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Round, biplanar, white to off-white tablets with bevelled edges and
single score-line,
diameter: 7.0 mm
The tablets can be divided into equal halves.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Xaqua is indicated for the treatment of
•
oedema related to kidney diseases, including the nephrotic syndrome
and states of
impaired renal function
•
oedema related to congestive heart failure
Xaqua is also indicated for the treatment of mild and moderate
hypertension, alone or
in combination with other antihypertensive medicines of a different
class.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_IMPORTANT NOTE:_ Xaqua tablets bioavailability may be different from
other metolazone
preparations (see section 5.2). Therefore, the recommended doses
(expressed in mg)
can differ from other metolazone products. A dose adjustment may be
necessary and
individualised titration based on patient’s response and
tolerability is advised if
switching from Xaqua tablets to another metolazone product, or vice
versa.
Posology
_Adults _
_Treatment of Oedema _
Metolazone should generally be administered once daily
The tablet should always be taken at the same time in relation to
food.
The following dosages should serve as guidelines:
Oedema related to congestive heart failure and kidney disease: 2.5-5
mg/day.
The therapy should be initiated with a dose of 2.5 mg/day and the dose
must be
adjusted according to the individual reaction of the patient. Once the
desired
therapeutic effect has been achieved, it may be advisable to reduce
the maintenance
dose if possible
_Hypertension _
Mild and moderate hypertension: 2.5mg-5mg/day
The recommended initial dose in mild and moderate hypertension is 2.5
mg/day, and
the dose must be adj