PAMID TABLETS

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

INDAPAMIDE

Available from:

CTS CHEMICAL INDUSTRIES LTD, ISRAEL

ATC code:

C03BA11

Pharmaceutical form:

TABLETS

Composition:

INDAPAMIDE 2.5 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

CTS CHEMICAL INDUSTRIES LTD, ISRAEL

Therapeutic group:

INDAPAMIDE

Therapeutic area:

INDAPAMIDE

Therapeutic indications:

Diuretic for the treatment of hypertension and fluid retention.

Authorization date:

2014-11-30

Patient Information leaflet

PATIENT LEAFLET IN ACCORDANCE
WITH THE PHARMACISTS’ REGULATIONS
(PREPARATIONS) – 1986
The medicine is dispensed with a doctor's prescription only
PAMID TABLETS
2.5 MG
Each tablet contains: Indapamide 2.5 mg
Inactive ingredients and allergens in the preparation – see
the subsection “Important information about some of the
ingredients of the medicine” and section 6.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE
MEDICINE. This leaflet contains concise information about
the medicine. If you have any other questions, refer to the
doctor or the pharmacist.
This medicine has been prescribed for treatment of your
illness. Do not pass it on to others. It may harm them even
if it seems to you that their medical condition is similar.
This medicine is not intended for children and adolescents
under the age of 18.
1. WHAT IS THE MEDICINE INTENDED FOR?
A diuretic for the treatment of hypertension and edema.
THERAPEUTIC CLASS: The active ingredient belongs to the
group of sulfonamide diuretics.
2. BEFORE USING THE MEDICINE
DO NOT USE THIS MEDICINE IF:
•
You are sensitive (allergic) to the active ingredient,
to other sulfonamides or to any of the additional
ingredients the medicine contains (see section 6).
•
You are suffering from severe kidney failure.
•
You have a severe liver disease or you suffer from
hepatic encephalopathy (a liver problem that affects
the brain and nervous system).
•
You have a low level of potassium in the blood. SPECIAL WARNINGS REGARDING THE USE OF THE MEDICINE:
BEFORE TREATMENT WITH PAMID, INFORM THE DOCTOR IF:
•
You have a liver and/or kidney problem.
•
You have a heart rate problem.
•
You have diabetes.
•
You have gout (severe swelling and pain in the joints).
•
You have a parathyroid gland disease.
•
Your vision is deteriorating or you have eye pain. These
may be symptoms of fluid accumulation in the eye’s
vascular layer (choroidal effusion) or of increased
intraocular pressure, which may occur within hours to
a week from taking Pamid. Without treatment, this ma

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pamid Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2.5 mg Indapamide
For the full list of excipients see section 6.1
3 PHARMACEUTICAL FORM
tablet
White, convex, scored in one side
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Diuretic for the treatment of
hypertension and fluid retention
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Oral use
Adults:
The dosage of one tablet, containing 2.5mg indapamide, to be taken
daily in the
morning.
_Renal failure (see sections 4.3 and 4.4) _
In severe renal failure (creatinine clearance below 30 ml/min),
treatment is
contraindicated.
Thiazides and related diuretics are fully effective only when renal
function is normal
or only minimally impaired.
_Elderly (see section 4.4): _
As for adults.
In the elderly, the plasma creatinine must be adjusted in relation to
age, weight and
gender. Elderly patients can be treated with indapamide when renal
function is normal
or only minimally impaired.
_Hepatic impairment (see sections 4.3 and 4.4) _
In severe hepatic impairment, treatment is contraindicated.
_Children and adolescents: _
Indapamide is not recommended for use in children and adolescents due
to a lack of
data on safety and efficacy.
The action of indapamide is progressive and the reduction of blood
pressure may
continue and not reach a maximum until several months after the start
of therapy. A
larger dose than 2.5mg indapamide daily is not recommended as there is
no
appreciable additional anti-hypertensive effect but a diuretic effect
may become
apparent. If a single daily tablet of indapamide does not achieve a
sufficient reduction
in blood pressure, another antihypertensive agent may be added such as
beta-blockers,
ACE inhibitors, methyldopa, clonidine and other adrenergic blocking
agents.
The co-administration of indapamide with diuretics which may cause
hypokalaemia is
not recommended.
There is no evidence of rebound hypertension on withdrawal of
indapamide.
Pamid tablets are fo