Frusene 50mg/40mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Triamterene; Furosemide

Available from:

Orion Pharma (UK) Ltd

ATC code:

C03EB01

INN (International Name):

Triamterene; Furosemide

Dosage:

50mg ; 40mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02020400; GTIN: 6432100002389 6432100002396

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
FRUSENE TABLETS
(Furosemide and triamterene)
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 signs of illness 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.
IN THIS LEAFLET:
1. What Frusene is and what it is used for
2. What you need to know before you take Frusene
3. How to take Frusene
4. Possible side effects
5. How to store Frusene
6. Contents of the pack and other information
1. WHAT FRUSENE IS AND WHAT IT IS USED FOR
The active ingredients of Frusene belong to a group of medicines known
as
diuretics. They work on your kidneys to get rid of excess water from
the body.
You may have gone to your doctor with problems such as swollen ankles
or
feeling breathless. These and other symptoms often occur because there
is
excess water in your body.
• You have been prescribed these tablets to help get rid of this
excess water and
you will notice that you pass more urine soon after you take your
tablets.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FRUSENE
DO NOT TAKE FRUSENE IF:
•
you are allergic (hypersensitive) to furosemide, triamterene or any of
the other
ingredients of this medicine (listed in section 6)
•
you are allergic to sulfonamides, a type of antibiotic
•
you have kidney or serious liver problems
•
you have been told that you have high levels of potassium or low
sodium in
your blood.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Frusene if:
•
you have a folic acid deficiency
•
you have an enlarged prostate (hyperplasia of the prostate)
•
you have or think you have dementia
•
you are taking any

Summary of Product characteristics

OBJECT 1
FRUSENE TABLETS
Summary of Product Characteristics Updated 04-Feb-2016 | Orion Pharma
(UK) Limited
1. Name of the medicinal product
Frusene Tablets
2. Qualitative and quantitative composition
Furosemide 40.0 mg
Triamterene 50.0 mg
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablet.
Pale-yellowish, convex, scored, uncoated tablet, diameter 9 mm.
4. Clinical particulars
4.1 Therapeutic indications
For the treatment of oedematous conditions, where a prompt diuresis is
required and where potassium
conservation is important: congestive heart failure, pulmonary oedema,
cardiac oedema, hepatic oedema
and ascites.
A fixed ratio combination should only be used if titration with
component drugs separately indicates that
this product is appropriate.
4.2 Posology and method of administration
Posology
The dosage depends on individual requirements.
Adults:
The usual adult dose is ½ to 2 tablets, taken in the morning. Maximum
daily dose is 6 tablets (300 mg of
triamterene).
Paediatric population:
Not recommended for use in children.
Older people:
In older people there is normally no requirement for dosage
adjustments unless a clinically significant
impairment of renal or hepatic function also exists. Triamterene may
accumulate and dosage may need to
be reduced. Creatinine and serum electrolytes should be monitored.
Patients with renal insufficiency
Treatment must be avoided in patients with moderate to severe renal
insufficiency due to the risk of
accumulation of triamterene and hyperkalaemia.
Patients with hepatic insufficiency:
Treatment must be initiated using a small dose with careful monitoring
of the serum electrolyte
concentrations (see section 4.4). The natriuretic potency of
furosemide may be weakened in patients with
hepatic insufficiency but the kaliuretic potency usually remains.
Elimination of triamterene is slowed
down and its efficacy is increased in severe hepatic insufficiency.
Method of administration
The tablets should be taken with a sufficient quantity of liquid,
usual