FUROSEMIDE 40 BIOTECH CAPSULES

Land: Suður-Afríka

Tungumál: enska

Heimild: South African Health Products Regulatory Authority (SAHPRA)

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16-11-2023

Fáanlegur frá:

Biotech Laboratories (Pty) Ltd

Skammtar:

See ingredients

Lyfjaform:

CAPSULES

Samsetning:

EACH CAPSULE CONTAINS FUROSEMIDE 40,0 mg

Leyfisstaða:

Registered

Leyfisdagur:

1990-01-11

Upplýsingar fylgiseðill

                                Biotech Laboratories (Pty) Ltd
Patient Information Leaflet
Furosemide 40 Biotech, capsules
Each capsule contains 40 mg furosemide
Page
1
of
11
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS:
FUROSEMIDE 40 BIOTECH, CAPSULE
FUROSEMIDE
CONTAINS SUGAR (LACTOSE 90 MG PER CAPSULE)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING FUROSEMIDE
40 BIOTECH
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor, pharmacist
nurse or other healthcare provider.
•
Furosemide 40 Biotech has been prescribed for you personally and you
should not share your medicine
with other people. It may harm them, even if their symptoms are the
same as yours.
WHAT IS IN THIS LEAFLET
1. What Furosemide 40 Biotech is and what it is used for
2. What you need to know before you take Furosemide 40 Biotech
3. How to take Furosemide 40 Biotech
4. Possible side effects
5. How to store Furosemide 40 Biotech
6. Contents of the pack and other information
1. WHAT FUROSEMIDE 40 BIOTECH IS AND WHAT IT IS USED FOR
Furosemide capsules is one of a group of medicines called diuretics
(water tablets).
Your doctor has prescribed Furosemide 40 Biotech capsules to treat a
condition called oedema where there
is too much water in your body. This could be due to problems with
your heart, lungs, kidneys, liver, blood
S3
Biotech Laboratories (Pty) Ltd
Patient Information Leaflet
Furosemide 40 Biotech, capsules
Each capsule contains 40 mg furosemide
Page
2
of
11
vessels or high blood pressure. Furosemide 40 Biotech helps your
kidneys to get rid of the extra water that
is not needed in your body.
_ _
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FUROSEMIDE 40 BIOTECH
DO NOT TAKE FUROSEMIDE 40 BIOTECH IF:
•
you are allergic (hypersensitive) to furosemide, sulphonamides or any
of the other ingredients in
Furosemide 40 Biotech capsules (see section 6)
•
you have elevated levels of urea and other nitrogen compounds in your
blood
•
you have a condition which is characterised by low blood volume (with
or without
                                
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                                Biotech Laboratories (Pty) Ltd
Professional Information
Furosemide 40 Biotech, capsules
Each capsule contains 40 mg furosemide
Page
1
of
13
SCHEDULING STATUS
S3
1.NAME OF THE MEDICINE
Furosemide 40 Biotech (Capsules)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 40 mg furosemide.
_Excipient with known effect: _
Each capsule contains 90,0 mg lactose.
For full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Capsules
Opaque white body/opaque turquoise blue cap, size ‘2’ snap-fit
capsule containing white, lump-free
powder.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of oedema of cardiac, hepatic or renal origin. In the
management of refractory oedema, it
may be used in conjunction with other types of diuretics, particularly
the potassium-sparing medicines.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
In most cases 40 mg daily will suffice. If no response is obtained,
this dose may be increased after 6
Biotech Laboratories (Pty) Ltd
Professional Information
Furosemide 40 Biotech, capsules
Each capsule contains 40 mg furosemide
Page
2
of
13
hours to 80 mg and - if necessary - after another 6 hours to 120 mg.
Daily doses of more than 120 mg
should preferably be distributed over 2 - 3 individual doses. After
mobilising the oedema, maintenance
therapy is continued i.e., 20 to 40 mg daily. Children generally
receive daily oral doses of 1 mg/kg
body weight. If necessary, this dose may be increased step by step to
a maximum of 3 mg/kg body
weight per day. A dose of 120 mg per day should not be exceeded with
children.
METHOD OF ADMINISTRATION
For oral administration.
4.3 CONTRAINDICATIONS
Patients who exhibit hypersensitivity to furosemide, sulphonamides, or
to any of the excipients as
listed in section 6.1.
Furosemide 40 Biotech is contraindicated if increasing azotaemia and
oliguria occurs during treatment
of severe progressive renal disease, anuria, hypokalaemia,
hyponatraemia, hypovolaemia with or
without hypotension, dehydration - in these cases the medicine should
be di
                                
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