Electrolyte rehydration solution Monico

Package leaflet: Information for the user

elettrolitica reidratante monico

Infusion solution I
sodium lactate 60%, sodium chloride, potassium chloride
Equivalent medicine
Please read all of this leaflet carefully before you start using this medicine, as it contains important information for you.

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

Contents of this leaflet:

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

1. What Elettrolitica reidratante monico is and what it is used for

Elettrolitica reidratante monico is a combination of three active substances: sodium lactate 60%, sodium chloride,
and potassium chloride, which are sodium and potassium salts. These components play a fundamental role in the
proper functioning of the nervous system, heart, muscles, and in maintaining the balance of salts and other substances in the blood (electrolyte balance, acid-base balance).
Elettrolitica reidratante monico is indicated for the treatment of deficiency of fluids and salts in the body
(replacement of fluids and electrolytes), and for the treatment of non-severe conditions in which there is an increase
of acidic substances in the blood (mild to moderate states of metabolic acidosis).

2. What you need to know before using Electrolyte Rehydrating Monico

Do not use Electrolyte Rehydrating Monico

• if you are allergic to sodium chloride, potassium chloride, sodium lactate, or any of the other ingredients of this medicine (listed in section 6);
• if you have severe kidney problems (severe renal insufficiency);
• if your blood sodium levels are high (hypernatremia);
• if you have excessive amounts of salts or fluids in your blood (hypervolemia);
• if your blood potassium levels are high (hyperkalemia) or your body is unable to eliminate potassium (potassium retention);
• if you suffer from a disease characterized by insufficient hormone production by the adrenal gland and are not receiving treatment for it (untreated Addison's disease);
• if you have severe fluid loss (acute dehydration);
• if you experience painful, brief muscle cramps (heat cramps);
• if your blood is more acidic than normal due to lactic acid buildup (lactic acidosis);
• if you have severe heart and circulatory problems (shock, hypoxemia, impaired oxidative processes preventing lactate utilization);
• if you have an accumulation of basic substances in your blood (metabolic and respiratory alkalosis).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Electrolyte Rehydrating Monico.
Due to the presence of sodium, this medicine should be administered with particular caution if:

• you have severe heart problems (heart failure, congestive cardiac failure);
• you have severe kidney problems (reduced renal function, severe renal insufficiency);
• you have swelling due to fluid accumulation around the lungs (pulmonary edema), or around the ankles and legs (peripheral edema), with poor elimination of fluids and salts (fluid and salt retention);
• you are taking medicines used to treat heart conditions (cardiac inotropic agents), inflammation, or allergies (corticosteroids), or medicines that stimulate the production of steroid hormones (corticotropins) (see section "Other medicines and Electrolyte Rehydrating Monico");
• you have high blood pressure (hypertension);
• you are pregnant and suffer from a condition called pre-eclampsia, characterized by high blood pressure, swelling due to fluid accumulation, and presence of protein in the urine;
• you are in a condition characterized by poor sodium excretion from the body (sodium retention) (see section "Other medicines and Electrolyte Rehydrating Monico").

Due to the presence of potassium, this medicine should be administered with caution if:

• you have kidney problems (renal insufficiency), as this may impair potassium elimination (potassium retention);
• you have heart problems (heart failure), especially if you are taking medicines for certain heart conditions (digitalized patients);
• you have severe adrenal gland (adrenal insufficiency) or liver problems (hepatic insufficiency);
• any of your family members suffer from a disorder characterized by sudden episodes of muscle weakness (familial periodic paralysis);
• you have a congenital condition causing prolonged muscle contractions (congenital myotonia);
• you have recently undergone surgery (early post-operative phase).

The medicine must be administered immediately after opening the vial, in a single, uninterrupted administration, and only if the solution is clear, colorless, and free from visible particles.
Any unused medicine must be discarded.
This medicine must be administered via slow intravenous infusion (intravenous infusion), as potassium intoxication may occur, which could lead to death due to impaired heart function (cardiac depression), irregular heartbeat (arrhythmias), or cessation of heart activity (cardiac arrest) (see section "How to use Electrolyte Rehydrating Monico").
During treatment with this medicine, your doctor should monitor:

• your heart activity through specific tests (serial electrocardiograms);
• your fluid levels (fluid balance), electrolyte levels, and other substances in your body (plasma osmolarity, acid-base balance).

Children
There are insufficient data to establish the safety and efficacy of this medicine in children.

Other medicines and Electrolyte Rehydrating Monico
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicine.
Use caution and inform your doctor, who should closely monitor your blood potassium levels, if you are taking:

• medicines that promote urine elimination while reducing potassium loss (potassium-sparing diuretics). When taken together with Electrolyte Rehydrating Monico, especially if you have kidney problems (renal dysfunction), these medicines may cause increased blood potassium levels (hyperkalemia); therefore, blood potassium levels should be closely monitored;
• medicines used to lower blood pressure (ACE inhibitors, which reduce aldosterone hormone levels), as they may reduce the body’s ability to eliminate potassium (potassium retention).

Additionally, use extreme caution and inform your doctor if you are being treated with medicines used for allergies and inflammation (corticosteroids), as fluid retention (edema) and increased blood pressure (hypertension) may occur (see section "Possible side effects").

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor, pharmacist, or nurse before using this medicine.
If you are pregnant or breastfeeding, use this medicine only when strictly necessary and under close medical supervision.

Driving and using machines
This medicine does not affect your ability to drive vehicles or operate machinery.

3. How to use Elettrolitica reidratante monico

This medicine must be administered exactly as directed by your doctor, pharmacist, or nurse. If you have any doubts, consult your doctor, pharmacist, or nurse.
Before administration, this medicine must be shaken well.
Elettrolitica reidratante monico must be administered by intravenous infusion (intravenous infusion) at a controlled rate (not exceeding 10 mEq potassium/hour) and with great caution (see section “Warnings and precautions”).
The dose will be determined by your doctor based on your age, body weight, and health condition.
Generally, the recommended dose is 2 litres per day, administered at a rate of 300 ml per hour.

Use in patients with kidney problems
If you have kidney problems, the use of this medicine is not recommended for you.

If you use more Elettrolitica reidratante monico than you should
Following administration of an excessive dose of this medicine, the following may occur:

• increased sodium levels in the blood (hypernatraemia) and sodium retention, particularly in the presence of kidney problems, which may lead to dehydration of certain internal organs, especially the brain, and fluid accumulation causing swelling (oedema), which may affect the lungs (pulmonary oedema), the brain, legs, and ankles (peripheral oedema);
• increased volume of circulating fluids (hypervolaemia), causing circulatory disturbances;
• increased potassium levels in the blood (hyperkalaemia), which may lead to cardiac death due to reduced heart function (cardiac depression), irregular heartbeat (arrhythmias), and loss of heart activity (cardiac arrest).

If you have taken or received an excessive amount of this medicine, stop treatment immediately and contact your doctor or go to the nearest hospital without delay.

If you forget to use Elettrolitica reidratante monico
Do not use a double dose to make up for the forgotten dose.
If you have any doubts about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, monico rehydration electrolyte may cause side effects, although not everyone experiences them.
The side effects that may occur are listed below.
Frequency not known (frequency cannot be estimated from available data):

• Gastrointestinal disorders, thirst, reduced salivation, nausea, vomiting, diarrhoea, abdominal pain;
• Nervous and muscular disorders (neuromuscular disorders), altered sensation in arms and legs (paraesthesia), loss of muscle tone (flaccid paralysis), weakness, confusion, headache (cephalalgia), dizziness, restlessness, fever, irritability, weakness, muscle rigidity, seizures, coma, death;
• Severe heart problems (arrhythmias, conduction disorders, disappearance of the P wave, widening of the QRS complex on the electrocardiogram, cardiac arrest, tachycardia);
• Drowsiness, confusional states;
• Breathing difficulties (dyspnoea), respiratory arrest, swelling due to fluid accumulation around the lungs (pulmonary oedema);
• Hospital-acquired hyponatraemia (reduced sodium concentration in the blood), which may cause irreversible brain damage and death;
• Hyponatraemic encephalopathy (brain damage caused by reduced sodium concentration in the blood);
• Reduced tear production;
• Kidney problems (renal failure);
• Low or high blood pressure (hypotension, hypertension), swelling due to fluid accumulation in the legs and ankles (peripheral oedema);
• Increased levels of sodium (hypernatraemia), chloride (hyperchloraemia), and acidic substances (metabolic acidosis) in the blood; increased blood volume (hypervolaemia), alteration of certain blood parameters (hyperosmolarity), reduced calcium levels in the blood (hypocalcaemia);
• Fever (febrile episodes), infection at the infusion site, pain or allergic reactions near the injection site, vein irritation, formation of blood clots in the veins (venous thrombosis), inflammation of the veins (venous phlebitis), leakage of the injected solution from the vein (extravasation), tissue damage and tissue death (tissue necrosis).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please consult your doctor or pharmacist. You may also report side effects directly via the national reporting system at 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 Electrolyte Rehydration Monico

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.
Store this medicine in the original packaging and in a tightly closed container.
Do not refrigerate or freeze.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What elettrolitica reidratante monico – solution for infusion I contains

• The active substances are sodium lactate 60%, sodium chloride, potassium chloride. 1000 ml of solution contain: 9.72 g of 60% sodium lactate solution, 4.00 g of sodium chloride, 2.70 g of potassium chloride. Each litre of solution contains: 120 mEq of sodium, 36 mEq of potassium, 104 mEq of chloride and 52 mEq of lactate. pH 5.5 ÷ 7.0.
• The other component is water for injections.

Description of the appearance of elettrolitica reidratante monico and contents of the pack
Glass vials of 50, 100, 250, 500, 1000 ml.
Plastic bags of 100, 250, 500, 1000 ml.

Marketing Authorization Holder and Manufacturer
Monico spa
Via Ponte di Pietra 7, 30173 Venezia Mestre - Italy

The following information is intended exclusively for healthcare professionals

Warnings and precautions
Monitoring of serum sodium is particularly important for physiologically hypotonic solutions.
Elettrolitica reidratante monico - solution for infusion I may become extremely hypotonic after
administration.
Patients with non-osmotic release of vasopressin (e.g. during the acute phase of illness, pain, post-operative stress, infections, burns and central nervous system disorders), patients with cardiac, hepatic or renal diseases, and patients treated with vasopressin agonists are particularly at risk of acute hyponatremia following infusion of hypotonic solutions.
Acute hyponatremia may cause acute hyponatremic encephalopathy (cerebral edema), characterized by headache, nausea, seizures, lethargy and vomiting. Patients with cerebral edema are at particular risk of severe, irreversible and life-threatening brain injury.
Children, women of childbearing age, and patients with reduced cerebral compliance (e.g. meningitis, intracranial hemorrhage, and cerebral contusion) are particularly at risk of severe, life-threatening cerebral edema caused by acute hyponatremia.

Interactions
Medicinal products that may increase the risk of hospital-acquired hyponatremia due to inadequately balanced intravenous fluid therapy include:

• drugs stimulating vasopressin release, e.g.: chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3,4-methylenedioxy-N-methamphetamine, ifosfamide, antipsychotics, narcotics;
• drugs potentiating the action of vasopressin, e.g.: chlorpropamide, NSAIDs, cyclophosphamide;
• vasopressin analogues: desmopressin, oxytocin, vasopressin, terlipressin.

Other drugs that increase the risk of hyponatremia also include diuretics in general and antiepileptic drugs such as oxcarbazepine.

Pregnancy
Elettrolitica reidratante monico - solution for infusion I should be administered with particular caution to pregnant women during labor, especially if administered concomitantly with oxytocin, due to the risk of hyponatremia.

Package leaflet: information for the user

electrolyte rehydration monico

infusion solution III
sodium chloride, potassium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate, sodium acetate trihydrate,
sodium citrate
Equivalent medicine
Please read this leaflet carefully before using this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• 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 could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What electrolyte rehydration monico is and what it is used for
2. What you need to know before using electrolyte rehydration monico
3. How to use electrolyte rehydration monico
4. Possible side effects
5. How to store electrolyte rehydration monico
6. Package contents and other information

1. What Elettrolitica reidratante monico is and what it is used for

Elettrolitica reidratante monico is a combination of sodium, potassium, magnesium and calcium salts. These
elements play a fundamental role in the proper functioning of the nervous system (nerve signal
transmission), heart and muscle contraction, kidney function, respiration, and in maintaining
the balance of salts and other substances in the blood (electrolyte balance, acid-base balance). In addition,
calcium is a fundamental component of bones.
Elettrolitica reidratante monico is indicated for the treatment of deficiency of fluids and salts in the body
(fluid and electrolyte repletion), and for the treatment of non-severe conditions in which an increase
in acidic substances in the blood occurs (mild to moderate metabolic acidosis).

2. What you need to know before using Electrolyte Rehydration Monico

Do not use Electrolyte Rehydration Monico

• if you are allergic to sodium chloride, potassium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate, sodium acetate trihydrate, sodium citrate, or any of the other ingredients of this medicine (listed in section 6);
• if you have high levels of calcium in your blood (hypercalcemia) or in your urine (hypercalciuria);
• if you suffer from severe kidney problems (severe renal failure);
• if your blood sodium levels are high (hypernatremia);
• if you have an excessive amount of salts or fluids in your blood (hypervolemia);
• if your blood potassium levels are high (hyperkalemia) or your body cannot eliminate potassium (potassium retention);
• if you have a heart rhythm disorder (ventricular fibrillation), because calcium worsens this condition;
• if you suffer from severe liver problems (severe hepatic insufficiency, inability to metabolize the acetate ion);
• if you have an accumulation of alkaline substances in your blood (metabolic and respiratory alkalosis);
• if you suffer from kidney stones;
• if you suffer from a disease called sarcoidosis, characterized by cough, associated with bleeding and difficulty breathing;
• if you have blood circulation problems (hypercoagulability);
• if you are taking medicines used to treat certain heart disorders (cardiac glycosides);
• if you suffer from a disease characterized by insufficient hormone production by the adrenal gland and are not receiving treatment for it (untreated Addison's disease);
• if you have severe fluid loss (acute dehydration);
• if you experience muscle cramps that are painful and short-lived (heat cramps); if the patient is a newborn (≤ 28 days of age), Electrolyte Rehydration Monico (or other solutions containing calcium) must not be administered simultaneously with ceftriaxone (an antibiotic), even if separate infusion lines are used. There is a risk of fatal particle formation in the newborn's bloodstream.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Electrolyte Rehydration Monico.
This medicine must be administered to you via a very slow infusion, as potassium intoxication may occur, which can lead to death due to loss of heart function (cardiac depression), heart rhythm disturbances (arrhythmias), up to complete cessation of heart activity (cardiac arrest) (see section "How to use Electrolyte Rehydration Monico").
The medicine must be administered immediately after opening the container, through a single, uninterrupted administration, and only if the solution appears clear, colorless, and free of particles.
Any unused medicine must be discarded.
Due to the presence of sodium, this medicine must be administered with particular caution if:

• you suffer from severe heart problems (heart failure, congestive cardiac decompensation);
• you suffer from high blood pressure (hypertension);
• you suffer from severe kidney problems (reduced kidney function, severe renal failure);
• you experience swelling due to fluid accumulation around the lungs (pulmonary edema), or around the ankles and legs (peripheral edema), with poor elimination of fluids and salts (fluid and electrolyte retention);
• you are taking medicines used to treat heart problems (cardiotonic inotropic drugs), inflammation and allergies (corticosteroids), or medicines that stimulate steroid hormone production (corticotropins) (see section "Other medicines and Electrolyte Rehydration Monico");
• you are pregnant and suffer from a condition called pre-eclampsia, characterized by high blood pressure, swelling due to fluid accumulation, and presence of proteins in the urine.

Due to the presence of potassium, this medicine must be administered with particular caution if:

• you suffer from severe kidney problems (renal failure, adrenal insufficiency);
• you suffer from heart problems (heart failure);
• you are taking medications for the treatment of certain heart disorders (digitalized patients). In this case, especially if the medicine is used for prolonged periods, serious heart rhythm disturbances may occur;
• you suffer from liver problems (hepatic insufficiency);
• someone in your family suffers from a disorder characterized by sudden episodes of muscle weakness (familial periodic paralysis);
• you have been born with a severe condition characterized by prolonged muscle contractions (congenital myotonia);
• you have recently undergone surgery (early post-operative phase).

Due to the presence of calcium, this medicine must be administered with caution if:

• you suffer from kidney problems (renal diseases);
• you suffer from heart problems (cardiac diseases), as this increases the risk of heart rhythm disturbances and may cause low blood pressure (vasodilation-induced hypotension);
• you have received a blood transfusion;
• you suffer from lung problems that may cause heart enlargement (pulmonary heart disease);
• you have an increased level of blood acidity (respiratory acidosis) and experience severe breathing difficulty (respiratory failure); since calcium is a substance that increases blood acidity, be cautious as all these conditions may worsen;
• you are predisposed to high levels of calcium in the blood (hypercalcemia), for example if you suffer from severe kidney problems (chronic renal failure), have severe fluid loss (dehydration), or an imbalance of salts and other substances in the blood (electrolyte imbalance).

Due to the presence of magnesium, this medicine must be administered with caution if:

• you suffer from a severe muscle disease (myasthenia gravis);
• you suffer from kidney problems (renal failure);
• you suffer from heart problems (heart failure);
• you are taking medicines for the treatment of certain heart disorders (digitalized patients);
• you are being treated with medicines that reduce brain activity (central nervous system depressants) or reduce muscle contraction (neuromuscular blockers).

Due to the presence of acetate, this medicine must be administered with caution if:

• you have an increase in basic substances in the blood (metabolic and respiratory alkalosis).

During treatment with Electrolyte Rehydration Monico, your doctor must monitor:

• heart activity through specific tests (serial electrocardiograms);
• fluid levels (fluid balance), salts (electrolytes), and other substances (plasma osmolarity, acid-base balance) in the body;
• blood pressure (arterial pressure);
• your muscle reflexes (osteotendinous reflexes), as respiratory blockade (respiratory paralysis) may occur;
• calcium and magnesium levels in the blood;
• calcium levels in the urine, to prevent high calcium levels in the urine (hypercalciuria), which may lead to high calcium levels in the blood (hypercalcemia).

Children
There are insufficient data to establish the safety and efficacy of this medicine in children.
Other medicines and Electrolyte Rehydration Monico
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicine.
Use caution and inform your doctor, who should carefully monitor your blood potassium levels, if you are taking:

• medicines that promote urine elimination and reduce potassium loss (potassium-sparing diuretics); these medicines, when taken together with Electrolyte Rehydration Monico, especially if you have kidney problems (renal dysfunction), may cause increased blood potassium levels (hyperkalemia);
• medicines used to lower blood pressure (ACE inhibitors), as they may reduce potassium elimination.

Additionally, use extreme caution and inform your doctor if you are being treated with:

• corticosteroids, used for allergies and inflammation, as swelling due to fluid accumulation (edema) and increased blood pressure (hypertension) may occur;
• thiazide diuretics, which promote fluid elimination, as excessive increase in blood calcium levels (hypercalcemia) may occur;
• cardiac glycosides (digoxin and digitoxin), used to treat heart problems, as the risk of heart rhythm disturbances (arrhythmias) is higher (see section "Do not use Electrolyte Rehydration Monico");
• calcium channel blockers (verapamil), used to treat high blood pressure, because Electrolyte Rehydration Monico may reduce their effectiveness;
• medicines containing magnesium, as increased levels of calcium (hypercalcemia) and magnesium (hypermagnesemia) in the blood may occur, especially if you have kidney problems (renal disorders);
• neuromuscular blockers (tubocurarine), used to reduce muscle contractions, as Electrolyte Rehydration Monico may increase or reduce their effectiveness;
• medicines that reduce brain activity (barbiturates, narcotics, hypnotics, and systemic anesthetics), because Electrolyte Rehydration Monico may alter their effectiveness;
• aminoglycoside antibiotics, used to treat bacterial infections, as marked reduction in voluntary muscle contraction (neuromuscular blockade) may occur;
• eltrombopag, used for circulation disorders, as Electrolyte Rehydration Monico may reduce its effectiveness;
• rocuronium, used for anesthesia during surgical procedures, as excessive reduction in voluntary muscle contraction (neuromuscular blockade) and severe breathing problems (respiratory depression, apnea) may occur;
• labetalol, used for heart rhythm disorders, as reduced heart activity (cardiac output), shortness of breath, dizziness, and temporary loss of consciousness (fainting) may occur;
• calcium antagonists (isradipine, felodipine, nicardipina, and nifedipine), used to treat high blood pressure, as excessive lowering of blood pressure (hypotension) may occur;
• ceftriaxone (an antibiotic) due to the risk of particle formation.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor, pharmacist, or nurse before using this medicine, as it may only be used if your doctor considers it truly necessary.
This medicine must not be administered within 2 hours before delivery.
If you are pregnant and suffer from a condition called gestational toxemia, characterized by high blood pressure, swelling due to fluid accumulation, presence of proteins in the urine, and seizures, administration of this medicine may cause serious harm to your baby (neuromuscular, respiratory depression).
Driving and using machines
This medicine does not affect the ability to drive or use machinery.

3. How to use Elettrolitica reidratante monico

This medicine must be administered exactly as directed by your doctor,
pharmacist, or nurse. If you have any doubts, consult your doctor,
pharmacist, or nurse.
Elettrolitica reidratante monico will be prepared by a doctor, pharmacist, or nurse and must not be
mixed with, nor administered simultaneously to, injections containing ceftriaxone.
The medicine must be shaken well before administration.
Elettrolitica reidratante monico must be administered directly into the vein by infusion
(intravenous infusion), and not by any other route of administration (intramuscular, subcutaneous, or into perivascular tissues). This medicine must be administered at a controlled rate (not exceeding 10 mEq potassium/hour) and with great caution (see section “Warnings and precautions”).
The dose will be determined by your doctor based on your age, weight, and overall health condition.
The usual recommended dose for adults is 3 litres per day, administered at a rate of 1 litre per hour.
After receiving this medicine, remain lying down.
Inform your doctor or nurse immediately if you experience pain or redness at the injection site, as leakage of the infused solution from the vein (extravasation) may occur (see section “Possible side effects”).

Use in patients with kidney problems
If you have kidney problems, the use of this medicine is not recommended for you.

If you use more Elettrolitica reidratante monico than you should
Following administration of an excessive dose of this medicine, the following may occur:

• increased levels of sodium in the blood (hypernatraemia) and/or circulatory disturbances (hypervolaemia), which may cause dehydration of certain internal organs, particularly the brain, and swelling due to fluid accumulation (oedema), which may affect the lungs (pulmonary oedema), cerebral circulation, or legs and ankles (peripheral oedema);

• increased levels of potassium in the blood (hyperkalaemia), which may lead to death due to reduced heart function (cardiac depression), disturbances in heart rhythm (arrhythmias), and loss of heart activity (cardiac arrest);

• increased levels of magnesium in the blood (hypermagnesaemia), with symptoms such as sudden sensation of warmth (flushing), sweating, low blood pressure (hypotension), loss of voluntary movement (flaccid paralysis), reduced body temperature (hypothermia), severe
  disturbances of the heart, circulation, and brain (circulatory collapse, cardiac and central nervous system depression), and, in the most severe cases, respiratory paralysis (respiratory arrest);

• increased levels of calcium (hypercalcaemia), particularly in patients with kidney problems (renal disorders), with symptoms such as thirst, nausea, vomiting, constipation, excessive need to urinate (polyuria), abdominal pain, muscle weakness, mental disturbances, and, in severe cases, disturbances in heart rhythm (cardiac arrhythmia) and profound unconsciousness (coma).

If you have taken or received an excessive amount of this medicine, stop treatment immediately and contact your doctor or go to the nearest hospital.

If you forget to use Elettrolitica reidratante monico
Do not use a double dose to make up for the forgotten dose.
If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.
The adverse effects that may occur are listed below.
Frequency not known (frequency cannot be estimated from available data):

• gastrointestinal disorders, thirst, reduced salivation, nausea, vomiting, diarrhoea, abdominal pain, constipation (stipsis, delayed intestinal transit, paralytic ileus), taste disturbances (metallic taste, chalky taste);

• neuromuscular disorders, muscle stiffness, altered sensation in arms and legs (paraesthesiae), loss of muscle tone (flaccid paralysis), weakness, confusion, headache (cephalaea), dizziness, restlessness, irritability, seizures, coma, death;

• drowsiness, confusion, mental disorders;

• severe heart problems (arrhythmias, tachycardia, bradycardia, conduction disorders, disappearance of the P wave, widening of the QRS complex on the electrocardiogram, ventricular fibrillation, cardiac arrest);

• fainting associated with loss of consciousness (syncope);

• decreased or increased blood pressure (hypotension, hypertension), swelling due to fluid accumulation affecting legs and ankles (peripheral oedema), dilation of veins and arteries (vasodilatation), sudden sensation of heat (hot flushes), sweating, severe circulatory problems (shock);

• increased levels of sodium (hypernatraemia), chloride (hyperchloraemia), and blood volume (hypervolaemia);

• severe breathing problems (dyspnoea, pneumothorax), respiratory arrest, swelling due to fluid accumulation around the lungs (pulmonary oedema);

• reduced tear production;

• kidney problems (renal failure), increased need to urinate (polyuria);

• increased levels of calcium and/or increased blood acidity (hypercalcaemia, Burnett's syndrome, metabolic acidosis);

• muscle weakness;

• fever, redness, skin irritations (rash), pain and infection at the infusion site, calcium deposits in tissues (cutaneous calcification), inflammation due to pus accumulation (abscesses), formation of blood clots in veins (venous thrombosis), inflammation of veins (venous phlebitis), even in areas near the infusion site, leakage of infused solution from the vein (extravasation), tissue damage and death (tissue necrosis);

• kidney problems caused by calcium-ceftriaxone deposits. Pain during urination or reduced urine output may occur.

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

5. How to store Electrolyte Rehydration Monico

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after “Exp.”. The expiry date refers to the last day of that month.
Store the medicine in the original packaging and in a tightly closed container. Do not refrigerate or freeze.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What elettrolitica reidratante monico - solution for infusion III contains

• The active substances are: sodium chloride, potassium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate, sodium acetate trihydrate, sodium citrate.
  1 litre of solution (1000 ml) contains: 5.0 g of sodium chloride, 0.75 g of potassium chloride, 0.35 g of calcium chloride dihydrate, 0.31 g of magnesium chloride hexahydrate, 6.4 g of sodium acetate trihydrate and 0.75 g of sodium citrate.
  1000 ml of solution contain: 140 mEq of sodium, 10 mEq of potassium, 5 mEq of calcium, 3 mEq of magnesium, 103 mEq of chloride, 47 mEq of acetate and 8 mEq of citrate.
  pH: 5.0 ÷ 7.0.
• The other component is water for injections.

Description of the appearance of elettrolitica reidratante monico and contents of the pack
Glass vials of 50, 100, 250, 500 and 1000 ml.
Plastic bags of 50, 100, 250, 500 and 1000 ml.

Marketing Authorisation Holder and Manufacturer
Monico spa
Via Ponte di Pietra 7, 30173 Venezia Mestre - Italy