Potassium aspartate Pharmatex

Package leaflet: Information for the user

POTASSIO ASPARTATO PHARMATEX 1 mEq/ml concentrate for solution for infusion and for

oral use
POTASSIO ASPARTATO PHARMATEX 3 mEq/ml concentrate for solution for infusion and for
oral use
Potassium aspartate
Generic medicine
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What POTASSIO ASPARTATO PHARMATEX is and what it is used for
2. What you need to know before using POTASSIO ASPARTATO PHARMATEX
3. How to use POTASSIO ASPARTATO PHARMATEX
4. Possible side effects
5. How to store POTASSIO ASPARTATO PHARMATEX
6. Contents of the pack and other information

1. What POTASSIO ASPARTATO PHARMATEX is and what it is used for

This medicinal product contains the active substance potassium aspartate, a salt which, in this form, acts as a mineral supplement capable of restoring normal potassium levels in the body.
POTASSIO ASPARTATO PHARMATEX is indicated in cases of:

• low levels of potassium in the blood (hypokalaemia);
• high levels of ammonia in the blood (hyperammonaemia).

2. What you need to know before using POTASSIO ASPARTATO PHARMATEX

Do not use POTASSIO ASPARTATO PHARMATEX

• if you are allergic to potassium aspartate or to any of the other ingredients of this medicine (listed in section 6);
• if you have severe kidney problems (severe renal insufficiency) or adrenal gland problems (severe adrenal insufficiency);
• if you suffer from an inherited disease characterized by loss of muscle strength (hereditary hypokalemic periodic paralysis);
• if you are experiencing acute severe fluid deficiency in the body (acute dehydration);
• if you have high levels of potassium in the blood (hyperkalaemia).

Warnings and precautions
Talk to your doctor or pharmacist before you are given POTASSIO ASPARTATO PHARMATEX. This medicine must be used strictly according to the instructions for use (See section "How to use POTASSIO ASPARTATO PHARMATEX").
During treatment, your doctor should carefully monitor your blood potassium levels (potassaemia).
If you do not have kidney problems (normal renal function), administration of potassium aspartate should not cause serious adverse effects, as your kidneys are able to eliminate any excess of the medicine.
During treatment with this medicine, avoid:

• ingesting large amounts of food rich in potassium;
• using medicines that increase urine elimination and retain potassium (potassium-sparing diuretics) (See section "Other medicines and POTASSIO ASPARTATO PHARMATEX").

Children
There are no data on the safety and efficacy of this medicine in children and adolescents. Therefore, extreme caution must be exercised when administering Potassio Aspartato Pharmatex to individuals in this age group.

Use in elderly patients
Administration of Potassio Aspartato Pharmatex in elderly patients should occur only when clearly necessary and always under medical supervision.

Use in patients with cardiac or renal disease
Intravenous infusion of Potassio Aspartato Pharmatex may also cause fluid overload, which is of particular concern in patients with heart or kidney disease.

Other medicines and POTASSIO ASPARTATO PHARMATEX
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Tell your doctor if you have recently taken or might take:

• medicines that increase urine elimination (diuretics), particularly:
• loop diuretics or salt-excreting diuretics, as this may lead to decreased potassium levels in the blood (hypokalaemia);
• medicines that retain potassium, such as potassium-sparing diuretics and aldosterone antagonists, as potassium levels in the blood may become excessively elevated (hyperkalaemia);
• medicines such as suxamethonium, angiotensin-converting enzyme inhibitors (ACE-i), tacrolimus, cyclosporine, and heparin, as these may cause an increase in blood potassium levels (hyperkalaemia).

Concomitant use of potassium aspartate with diuretics that increase urine elimination and retain potassium (potassium-sparing diuretics such as amiloride, spironolactone, triamterene) is not recommended.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
This medicine does not have negative effects on pregnancy and fetal development.

Driving and using machines
POTASSIO ASPARTATO PHARMATEX does not impair the ability to drive or operate machinery.

3. How to use POTASSIUM ASPARTATE PHARMATEX

Use this medicine exactly as prescribed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
THIS MEDICINE MUST ALWAYS BE DILUTED BEFORE USE, AS ADMINISTRATION WITHOUT DILUTION MAY LEAD TO DEATH.
THE MEDICINE MUST BE SHAKEN BEFORE PREPARATION AND PRIOR TO USE.
Your doctor will determine the dose based on your condition and the degree of potassium deficiency to be corrected in the blood.
Administration can be performed via:

• intravenous infusion, drop by drop (slow intravenous infusion), after diluting the medicine with physiological saline solution (100 ml of physiological saline per 10 mEq of potassium);
• subcutaneous infusion (hypodermoclysis), after diluting the medicine with physiological saline solution (100 ml of physiological saline per 10 mEq of potassium);
• oral administration, after diluting the medicine in fruit juice or other beverages.

If you use more POTASSIUM ASPARTATE PHARMATEX than you should
After taking an excessive dose of this medicine, symptoms due to increased potassium levels in the blood (hyperkalaemia) may occur (see section “Possible side effects”).
If you have taken or ingested more than the prescribed dose, contact your doctor immediately or go to the nearest hospital.
If you have any doubts about the use of this medicine, contact your doctor or nurse immediately.
If you forget to use POTASSIUM ASPARTATE PHARMATEX
Do not take a double dose to make up for the forgotten dose.
If you have any doubts about the use of this medicine, contact your doctor or pharmacist immediately.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Frequency not known (frequency cannot be estimated from the available data)

• symptoms due to increased levels of potassium in the blood (hyperkalaemia): nerve and muscle problems (neuromuscular disturbances), altered sensation in arms and legs (paraesthesias), loss of muscle tone (flaccid paralysis), weakness, confusion, low blood pressure (hypotension), heart problems (arrhythmias, conduction disorders, disappearance of the P wave, widening of the QRS complex on the electrocardiogram, cardiac arrest); abdominal pain, nausea and vomiting (gastrointestinal disturbances).
• fever;
• chills;
• injection site reactions (irritations);
• phlebitis (venous irritation). Following the instructions provided in this leaflet reduces the risk of side effects.

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store POTASSIUM ASPARTATE PHARMATEX

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "EXP.".
The expiry date refers to the last day of that month. This date applies to the product in its original, undamaged packaging and properly stored.
Store below 25°C. Do not refrigerate or freeze.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

What POTASSIO ASPARTATO PHARMATEX 1 mEq/ml concentrate for solution for infusion and oral use contains

• The active substance is d,l-potassium aspartate. Each vial contains 1.711 g of d,l-potassium aspartate, corresponding to 1.331 g of aspartic acid and 0.390 g (10 mEq) of potassium.
• The other component is water for injections.

What POTASSIO ASPARTATO PHARMATEX 3 mEq/ml concentrate for solution for infusion and oral use contains

• The active substance is d,l-potassium aspartate. Each vial contains 5.133 g of d,l-potassium aspartate, corresponding to 3.993 g of aspartic acid and 1.170 g (30 mEq) of potassium.
• The other component is water for injections.

Description of the appearance of POTASSIO ASPARTATO PHARMATEX and contents of the pack

POTASSIO ASPARTATO PHARMATEX 1 mEq/ml concentrate for solution for infusion and oral use.
Box containing 10 vials of 10 ml each.

POTASSIO ASPARTATO PHARMATEX 3 mEq/ml concentrate for solution for infusion and oral use.
Box containing 10 vials of 10 ml each.

Marketing Authorization Holder
PHARMATEX ITALIA S.r.l. – Via San Paolo 1 – 20121 Milano – Italy
Manufacturer and Final Controller
FISIOPHARMA S.r.l. - Industrial Area – 84020 Palomonte (SA) – Italy