MICRO KALIUM PROLONGED RELEASE CAPSULES

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

POTASSIUM CHLORIDE

Available from:

A.L. MEDI-MARKET LTD.

ATC code:

A12BA01

Pharmaceutical form:

CAPSULES PROLONGED RELEASE

Composition:

POTASSIUM CHLORIDE 600 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

G.L. PHARMA GMBH, AUSTRIA

Therapeutic area:

POTASSIUM CHLORIDE

Therapeutic indications:

Treatment and prevention of hypokalemia

Authorization date:

2022-08-30

Patient Information leaflet

PATIENT PACKAGE INSERT IN ACCORDANCE WITH
THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986
This medicine is dispensed with a doctor’s prescription only
Micro Kalium
Prolonged release capsules
600 mg
Active ingredient:
Each capsule contains:
Potassium chloride 600 mg
For inactive ingredients, please refer to section 6- -“Additional
Information”.
Read
the
leaflet
carefully
in
its
entirety
before
using
the
medicine.
This leaflet contains concise information about the medicine. If you
have any further questions, ask your
doctor or pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It may harm them,
even if it seems to you that their illness is similar.
Micro Kalium is not intended for children and adolescents under the
age of 18.
1.
What the medicine is intended for?
For the treatment or prevention of low levels of potassium in the
blood (hypokalemia).
Additional intake of potassium can be necessary in patients who either
do not get enough potassium
through usual diet, or who have lost too much potassium due to a
disease or treatment with certain
medicines.
The intake of too much potassium can lead to health problems as well.
Therefore, it is important to take
this medicine exactly according to your doctor's instructions.
Micro Kalium capsules contain potassium chloride. It has a
slow-release system that releases your
medicine evenly throughout the day.
Therapeutic group
Potassium supplement
2.
Before using the medicine
Do not use this medicine if:
•
you are sensitive (allergic) to the active ingredient (potassium) or
to any of the other ingredients this
medicine contains (please refer to section 6-“Additional
Information”).
•
you are hypersensitive to the administration of potassium, e.g. if you
suffer from a disease called
Adynamia episodica hereditaria (a congenital disease with suddenly
appearing attacks of flaccid
paralysis as well as increased potassium blood levels during such an
attack) or Eulenburg disease
(a congenital disease with muscular

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Micro Kalium prolonged-release capsules
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 capsule contains 600 mg of potassium chloride corresponding to 8
mmol (315 mg) of
potassium ions.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Prolonged-release capsule, hard
Maroon opaque hard capsules
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Treatment and prevention of hypokalaemia.
4.2 Posology and method of administration
Posology
_ _
_Potassium deficiency prevention: _
The recommended dose is 16-24 mmol (2-3 capsules) daily.
_Existing potassium deficiency treatment: _
The recommended dose is 16-32 mmol (2-4 capsules) 2-3 times daily.
Overall: 32-96 mmol (4-12 capsules) daily.
The dose should be adapted to serum potassium levels.
_ _
_Children and adolescents _
The safety and effectiveness of Micro-Kalium have not been established
for children and
adolescents.
Method of administration
Oral use.
The capsules should not be chewed and should be taken during or after
meals with plenty of
fluid. The capsules should also not be sucked.
4.3 Contraindications
-
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
-
Hypersensitivity
to
a
potassium
dose,
e.g. for
adynamia
episodica
hereditaria
and
paramyotonia congenita.
-
All types of hyperkalaemia as a further potassium intake can lead to
arrhythmias and even
cardiac arrest.
-
Hyperkalaemia can also lead to complications in the following
diseases: marked renal
failure, diseases with considerable cell destruction (e.g. trauma,
burns, severe haemolysis,
rhabdomyolysis, dissolution of tumour tissue), untreated Addison's
disease, hyporeninemic
hypoaldosteronism and decompensated metabolic acidosis and acute
dehydration states.
-
Marked renal failure even if there is no evident hyperkalaemia
present.
-
Concomittant use of potassium-sparing diuretics (spironolactone,
triamterene, amiloride).
-
As with all potassium preparations, this medicinal p