Aldactide 25 tablets

Страна: Великобритания

Язык: английский

Источник: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активный ингредиент:

Hydroflumethiazide; Spironolactone

Доступна с:

Pfizer Ltd

код АТС:

n/a

ИНН (Международная Имя):

Hydroflumethiazide; Spironolactone

дозировка:

25mg ; 25mg

Фармацевтическая форма:

Oral tablet

Администрация маршрут:

Oral

класс:

No Controlled Drug Status

Тип рецепта:

Valid as a prescribable product

Обзор продуктов:

BNF: 02020400; GTIN: 5012882007768

тонкая брошюра

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Aldactide
®
25 mg/25 mg
film-coated tablets
Aldactide
®
50 mg/50 mg
film-coated tablets
(spironolactone and hydroflumethiazide)
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.
WHAT IS IN THIS LEAFLET
1. What Aldactide is and what it is used for
2. What you need to know before you take
Aldactide
3. How to take Aldactide
4. Possible side effects
5. How to store Aldactide
6. Contents of the pack and other information
1. WHAT ALDACTIDE IS AND WHAT IT IS
USED FOR
Aldactide is a diuretic medicine (“water
tablet”) used for the treatment of Congestive
Heart Failure.
You may have gone to your doctor because
of symptoms like swollen ankles and
breathlessness. This can happen when your
heart’s pumping action has become weak
because of too much fluid in your body. This
is called ‘congestive heart failure’. Pushing
extra fluid around your body means your
heart has to work harder. This may lead
to weakness. Your doctor has given you
Aldactide to help you lose the extra fluid from
your body. This will mean your heart has to
do less work. You lose the extra fluid as urine,
so you may need to go to the toilet more
often while you are taking Aldactide.
You must talk to a doctor if you do not feel
better or if you feel worse.
2. WHAT YOU NEED TO KNOW BEFORE YOU
TAKE ALDACTIDE
DO NOT TAKE ALDACTIDE IF:
you are allergic to spironolactone, thiazide,
diuretics or sulphonamides (a type of
antibiotic) or any of the other ingredients of
this medicine (listed in section 6)
you have Addison’s disease (a

Характеристики продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Aldactide 25 mg/25 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 25 mg spironolactone and 25 mg hydroflumethiazide
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Buff, biconvex tablets, approximately 9.5 mm in diameter and engraved
“SEARLE 101” on
one side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Congestive cardiac failure.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
ADULTS Most patients will require an initial dosage of 100mg spironolactone
daily. The dosage
should be adjusted as necessary and may range from 25 mg to 200 mg
spironolactone daily.
ELDERLY It is recommended that treatment is started with the lowest dose and
titrated upwards as
required to achieve maximum benefit. Care should be taken with severe
hepatic and renal
impairment which may alter drug metabolism and excretion.
PAEDIATRIC POPULATION Although clinical trials using Aldactide have not been carried out in
children, as a guide, a
daily dosage providing 1.5 mg to 3 mg of spironolactone per kilogram
body weight given in
divided doses, may be employed.
METHOD OF ADMINISTRATION
Administration of Aldactide once daily with a meal is recommended.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substances or thiazide diuretics or to
other sulphonamide
derived drugs or to any of the excipients listed in section 6.1.
Aldactide is contraindicated in patients with anuria, acute renal
insufficiency, rapidly
deteriorating
or
severe
impairment
of
renal
function,
hyperkalaemia,
significant
hypercalcaemia or Addison’s disease.
Aldactide should not be administered with other potassium conserving
diuretics and
potassium supplements should not be given routinely with Aldactide as
hyperkalaemia
may be induced.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Concomitant use of Aldactide with other potassium-sparing diuretics,
angiotensin-converting
enzyme (ACE) inhibitors, nonsteroidal a