Lasilix 40mg scored Tablets

Nchi: Malta

Lugha: Kiingereza

Chanzo: Medicines Authority

Viambatanisho vya kazi:

FUROSEMIDE

Inapatikana kutoka:

Sanofi S.R.L Viale L. Bodio, 37/b 20158, Milan, Italy

ATC kanuni:

C03CA01

INN (Jina la Kimataifa):

FUROSEMIDE 40 mg

Dawa fomu:

TABLET

Tungo:

FUROSEMIDE 40 mg

Dawa ya aina:

POM

Eneo la matibabu:

DIURETICS

Idhini hali ya:

Withdrawn

Idhini ya tarehe:

2006-02-27

Taarifa za kipeperushi

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LASILIX 40 MG, SCORED TABLET
Furosemide
_ _
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 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 LASILIX 40 mg scored tablet is and what it is used for
2.
What you need to know before you take LASILIX 40 mg scored tablet
3.
How to take LASILIX 40 mg scored tablet
4.
Possible side effects
5.
How to store LASILIX 40 mg scored tablet
6.
Contents of the pack and other information
1.
WHAT LASILIX 40 MG SCORED TABLET IS AND WHAT IT IS USED FOR
Pharmacotherapeutic group: ATC code C03CA01.
LOOP DIURETIC.
This medicine is indicated in the treatment:
•
Oedema of cardiac or renal origin,
•
Oedema of hepatic origin, most often in combination with a
potassium-sparing diuretic,
•
Hypertension in patients with chronic renal failure, in case of
contraindication to thiazide
diuretics (particularly when creatinine clearance is less than 30
ml/min).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LASILIX 40 MG SCORED TABLET
DO NOT TAKE LASILIX 40 MG SCORED TABLET:
•
If you are allergic to the active substance (furosemide) or any of the
other ingredients of this
medicine (listed in section 6).
•
If you suffer from sudden failure of kidney function (acute kidney
failure).
•
If you have significant difficulty urinating because of a blockage of
urine flow (urinary tract
obstruction).
•
If you have a decrease in the total volume of blood in your body.
•
If you are dehydrated.
•
If you have an excessive decrease in potassium in the blood (see
section 4 “Possible sid

Tabia za bidhaa

Translated from the French by Sanofi Regulatory Translation Services
under Tracking No. SA-PH-RTS13311 on March 27, 2019
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
LASILIX 40 MG SCORED TABLETS
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Furosemide
..................................................................................................................................
40.00 mg
For one tablet.
Excipient with known effect: lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Scored tablets.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
•
Cardiac or renal edema.
•
Hepatic edema, usually in combination with potassium-sparing
diuretics.
•
Hypertension in patients with chronic renal failure, when thiazide
diuretics are contraindicated
(especially when creatinine clearance is less than 30 mL/min).
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
METHOD OF ADMINISTRATION
Oral use.
POSOLOGY
Dosage should be adjusted according to the indication and severity of
the disease.
Adults
Cardiac, renal or hepatic edema:
•
Moderate: 1/2 to 1 x 40 mg furosemide tablet daily.
•
Severe: 2 to 3 x 40 mg furosemide tablets per day in 1 or 2 doses;
3 to 4 x 40 mg furosemide tablets per day in 2 doses.
Hypertension in patients with chronic renal failure:
When used in combination with other antihypertensive treatments
(especially renin-angiotensin system
antagonists), the usual recommended doses range from 20 mg/day to 120
mg/day taken as a single or
divided doses.
Children
Cardiac, renal or hepatic edema: the daily dose is 1 to 2 mg/kg
bodyweight, in 1 dose to 2 divided
doses.
4.3.
CONTRAINDICATIONS
This medicinal product must NEVER be used in the following situations:
•
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1,
•
Functional acute renal failure,
•
Hepatic encephalopathy,
•
Obstruction of the urinary tract,
•
Hypovolemia or dehydration,
_CIS: 6 560 674 3 – outgoing 2019013000124 _
_Q11ADOC034 v.02 _
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