Furosemide 40mg tablets

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: MHRA (Medicines & Healthcare Products Regulatory Agency)

Nunua Sasa

Taarifa za kipeperushi Taarifa za kipeperushi (PIL)
20-04-2020
Tabia za bidhaa Tabia za bidhaa (SPC)
05-07-2016

Viambatanisho vya kazi:

Furosemide

Inapatikana kutoka:

Sun Pharma UK Ltd

ATC kanuni:

C03CA01

INN (Jina la Kimataifa):

Furosemide

Kipimo:

40mg

Dawa fomu:

Oral tablet

Njia ya uendeshaji:

Oral

Darasa:

No Controlled Drug Status

Dawa ya aina:

Valid as a prescribable product

Bidhaa muhtasari:

BNF: 02020200

Taarifa za kipeperushi

                                PACKAGE LEAFLET: INFORMATION FOR THE USER
FUROSEMIDE 20MG TABLETS
FUROSEMIDE 40MG TABLETS
(furosemide)
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 only. Do not pass it on to
others.
It may harm them, even if their signs of illness are the same as
yours.
-
If you get any side effects, talk to your doctor or pharmacist or
nurse.
This includes any possible side effects not listed in this leaflet.
See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Furosemide Tablets are and what are they used for
2. What you need to know before you take Furosemide Tablets
3.
How to take Furosemide Tablets
4.
Possible side effects
5.
How to store Furosemide Tablets
6.
Contents of the pack and other information
1.
WHAT FUROSEMIDE TABLETS ARE AND WHAT ARE THEY USED
FOR
Furosemide Tablets contain furosemide as the active ingredient. This
belongs to a
group of medicines called diuretics (also called water tablets).
Furosemide Tablets
are used to treat oedema (fluid retention) caused by heart failure,
mild to moderate
hypertension (high blood pressure) and certain liver and kidney
disorders. They are
also used to manage a condition called oliguria where the body
produces an
abnormally small amount of urine, due to kidney disease.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE FUROSEMIDE
TABLETS
DO NOT TAKE FUROSEMIDE TABLETS IF YOU:
•
are allergic to furosemide or any of the other ingredients of this
medicine (listed
in section 6). Signs of an allergic reaction include: a rash,
swallowing or
breathing problems, swelling of the lips, face, throat or tongue.
•
are allergic to amiloride, sulfonamides or sulphonamide derivatives,
such as
sulfadiazine or cotrimoxazole
•
have a low blood volume or are dehydrated (with or without
accompanying low
blood pressure)
•
have too little potassium or sodium in your blood (shown in blood
test)
•
have already
                                
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                                SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Furosemide 40mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Furosemide 40mg.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
White-to off white, flat, uncoated tablets with beveled edges,
debossed
on one side and breakline on the other side
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Furosemide is a potent diuretic with rapid action.
Furosemide tablets are indicated for:
•
The treatment of fluid retention associated with heart failure,
including
left ventricular failure, cirrhosis of the liver and renal disease,
including
nephrotic syndrome.
•
The treatment of mild to moderate hypertension when brisk diuretic
response is required. Alone or in combination with other anti-
hypertensive agents in the treatment of more severe cases.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration.
Adults: The initial adult dose is 40mg daily, reduced to 20mg daily or
40mg on
alternative days. In some patients daily doses of 80mg or higher
(given in divided
doses) may be required.
Elderly: Caution is advised as furosemide is excreted more slowly in
the elderly.
Treatment should be started with 20mg and titrated upwards as required
(see section
4.4).
Children: Contra-indicated (see section 4.3)
4.3. CONTRAINDICATIONS
-
Hypersensitivity to furosemide, amiloride, sulphonamides or
sulphonamide
derivatives, and/or any of the excipients of the product.
-
Hypovolaemia and dehydration (with or without accompanying
hypotension)
(see section 4.4)
-
Severe hypokalaemia: severe hyponatraemia (see section 4.4).
-
Comatose or pre-comatose states associated with hepatic cirrhosis (see
section
4.4).
-
Anuria or renal failure with anuria not responding to furosemide,
renal failure
as a result of poisoning by nephrotoxic or hepatotoxic agents or renal
failure
associated with hepatic coma
-
Impaired renal function with a creatinine clearance below 30ml/min per
1.73
m
2
body surface area (see section 4.
                                
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