Triamterene 50mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Triamterene

Available from:

A A H Pharmaceuticals Ltd

ATC code:

C03DB02

INN (International Name):

Triamterene

Dosage:

50mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02020300

Patient Information leaflet

PATIENT INFORMATION LEAFLET
DYTAC
®
50MG CAPSULES
TRIAMTERENE
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. Do not pass it on to
others. It may harm them, even if their
symptoms are the same as yours.
If any of the side effects become serious, or if you notice any side
effects not listed in this leaflet, please tell your
doctor or pharmacist.
IN THIS LEAFLET:
1.
What Dytac 50mg Capsules are and what they are used for
2.
Before you take Dytac 50mg Capsules
3.
How to take Dytac 50mg Capsules
4.
Possible side effects
5.
How to store Dytac 50mg Capsules
6.
Further information
1. WHAT DYTAC 50MG CAPSULES ARE AND WHAT THEY ARE USED FOR
Dytac 50mg Capsules belong to a group of medicines called diuretics.
They help the kidneys remove water from the
body. Dytac 50mg Capsules act by stopping potassium being lost from
the body. The capsules are used to treat
oedema which is a build-up of fluid in the body. This may occur in
many situations, for instance during treatment with
steroids, with liver and kidney problems or with heart failure (when
the heart doesn’t pump efficiently).
Dytac 50mg Capsules can be used with another type of diuretic which
normally allows potassium to be lost from the
body. This combination increases the amount of water being removed and
prevents potassium loss at the same time.
2. BEFORE YOU TAKE DYTAC 50MG CAPSULES
DO NOT TAKE DYTAC 50MG CAPSULES IF YOU:
• know that you are allergic to triamterene or any of the other
ingredients of Dytac 50mg Capsules (see section
6 of this leaflet).
• have a serious liver or kidney disorder (your doctor will advise
you)
• have high levels of potassium in your blood have (hyperkalaemia).
Your doctor will advise you.
• have a disease of the adrenal glands causing weakness, weight loss
and a deficiency of hormones in the blood
(Addison’s disease)
• you are allergic to S

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Dytac 50mg Capsules
Triamterene 50mg Capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 50mg triamterene EP.
3.
PHARMACEUTICAL FORM
Opaque, maroon-coloured capsules containing as a yellow, granular
powder.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Triamterene is a potassium-conserving diuretic, thought to act by
directly
inhibiting the exchange of sodium for potassium and hydrogen in the
distal
renal tubule.
Potassium-conserving diuretic for the control of oedema in cardiac
failure,
cirrhosis of the liver or the nephrotic syndrome, and in that
associated with
corticosteroid treatment. When Dytac is used as an adjuvant to
potassium-
depleting diuretics, such loss may be inhibited and diuresis enhanced.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
METHOD OF ADMINISTRATION
Oral
DOSAGE
Adults only: When given alone, the usual dosage range is from 3 to a
maximum of 5 Dytac capsules a day. The optimal daily dosage is 4
capsules,
given
in
divided
doses
after
breakfast
and
lunch.
After
the
first
week,
treatment should preferably be given on alternate days to ensure
satisfactory
maintenance diuresis without an increase in blood urea levels. When
given
with another diuretic, lower dosages of both should be used initially.
Elderly: A lower dosage may be sufficient. The normally occurring
reduction
in glomerular filtration with age should be borne in mind.
4.3
CONTRAINDICATIONS
Hyperkalaemia, progressive renal failure, increasing hepatic
dysfunction, addison’s
disease,
known
hypersensitivity
to
the
drug
and
anuria.
Routine
concomitant
administration
of
potassium
supplements,
or
other
potassium-conserving
drugs,
including ACE inhibitors.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Use with caution in patients with diabetes mellitus, hepatic or renal
insufficiency; in
those predisposed to gout since Dytac has been shown in rare instances
to elevate uric
acid levels; with hypotensive agents since an additive effect may
result;