Sodium phosphate Nova Argentia

Package leaflet: Information for the user

SODIO FOSFATO NOVA ARGENTIA 16% / 6% rectal solution

Monobasic sodium phosphate monohydrate and dibasic sodium phosphate heptahydrate
Read this leaflet carefully before using this medicine because it contains important information for you.

• Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed.
• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice improvement or if you notice worsening of symptoms after a few days.

Contents of this leaflet:

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

1. What SODIO FOSFATO NOVA ARGENTIA is and what it is used for

SODIO FOSFATO NOVA ARGENTIA contains the active substances monobasic sodium phosphate and
dibasic sodium phosphate, which belong to the group of laxative medicines used to
soften and lubricate the stools, facilitating their passage through the intestine and evacuation. This
medicinal product is indicated for the treatment of constipation and for emptying the bowel prior to
surgical procedures or certain clinical examinations, such as radiological examinations or intestinal investigations.
Consult your doctor if you do not notice any improvement or if you experience worsening of symptoms after a few days.

2. What you need to know before using SODIUM PHOSPHATE NOVA ARGENTIA

Do not use SODIUM PHOSPHATE NOVA ARGENTIA

• if you are allergic to monobasic sodium phosphate, dibasic sodium phosphate, or any of the other ingredients of this medicine (listed in section 6);
• if you have severe abdominal pain or any pain of unknown origin;
• if you have nausea or vomiting;
• if you suffer from intestinal blockage or narrowing of the intestine or anorectal area (subocclusion or intestinal stenosis or anorectal stenosis);
• if you suffer from a stoppage in the movement of intestinal contents (paralytic ileus), especially if caused by a physical obstruction (mechanical ileus);
• if you have extensive dilation of the colon, either congenital or acquired (megacolon);
• if you suffer from a congenital colon disorder causing severe difficulty in bowel evacuation (Hirschsprung's disease);
• if you suffer from intestinal inflammation or other conditions that may increase absorption of the medicine;

if you experience problems in the lower part of the intestine such as rectal bleeding, hemorrhoids
in acute phase with pain and bleeding, or anal perforation;

• if you are severely dehydrated;
• if the person to be treated is a child under 12 years of age;
• if you suffer from heart and/or kidney problems (severe renal insufficiency);
• if you have elevated blood phosphate levels (hyperphosphatemia);
• if you are already taking other sodium phosphate preparations, such as oral phosphate solutions or sodium phosphate tablets.

Warnings and precautions
Talk to your doctor or pharmacist before using SODIUM PHOSPHATE NOVA ARGENTIA.
If you use this medicine excessively, frequently, or incorrectly, you may develop persistent diarrhea, resulting in loss of water, minerals (especially potassium), and other essential nutrients. In more severe cases, you may experience dehydration and low blood potassium levels (hypokalemia), which may cause problems with the heart, nerves, and muscles, particularly if you are also taking medicines to stimulate heart function (cardiac glycosides), medicines to increase urine production (diuretics), or medicines known as corticosteroids.
Drink fluids to prevent dehydration, especially if you are in conditions that may promote fluid loss, or if you are taking medicines that affect the kidneys, such as diuretics, angiotensin-converting enzyme inhibitors (ACE inhibitors), angiotensin receptor blockers (ARBs), or non-steroidal anti-inflammatory drugs (NSAIDs).
Since SODIUM PHOSPHATE NOVA ARGENTIA contains sodium phosphates, there may be an increase in sodium and phosphate levels in the blood (hypernatremia, hyperphosphatemia) and a decrease in calcium and potassium levels in the blood (hypocalcemia and hypokalemia), which may lead to involuntary muscle contractions (tetany) and kidney problems (renal failure).
If you use this medicine excessively or incorrectly, you may develop dependence (requiring progressively higher doses), chronic constipation, and loss of normal intestinal function (intestinal atony). Repeated use may lead to tolerance or damage.
Prolonged use of laxatives is not recommended for constipation. If you have had constipation for more than 2 weeks, if you notice changes in your usual bowel habits or stool characteristics, or if you do not experience improvement after using this medicine, consult your doctor.
Use this medicine with caution and only after consulting your doctor if you are elderly, in poor general health, or if you suffer from cardiovascular problems (uncontrolled blood pressure, heart disease), ascites, or disorders of the rectal mucosa (ulcers, fissures).
If you encounter resistance when using the medicine, stop immediately, as forced administration may cause injury.
For constipation, first correct your dietary habits by consuming an adequate amount of fiber and fluids (6–8 glasses per day) and engaging in physical activity. In most cases, a balanced diet rich in water and fiber (bran, vegetables, and fruit) can permanently resolve constipation. Many people mistakenly believe they are constipated if they do not have a bowel movement every day; however, this is often perfectly normal. True constipation occurs when bowel movements are less frequent than usual and are associated with hard stools. If episodes of constipation recur frequently, consult your doctor.

Children
This medicine must not be used in children under 12 years of age.

Elderly
If you are elderly, consult your doctor before using this medicine.

Other medicines and SODIUM PHOSPHATE NOVA ARGENTIA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
This medicine is only minimally absorbed in the intestine and therefore rarely interacts with other medicines.
Use caution if you are taking the following medicines:

• medicines that may alter electrolyte levels in the body, such as diuretics, corticosteroids, calcium antagonists, and lithium, as they may increase blood levels of phosphates, calcium, and sodium (hyperphosphatemia, hypercalcemia, hypernatremia). Increased sodium levels may reduce lithium levels in the blood, thereby decreasing the effectiveness of lithium;
• angiotensin-converting enzyme inhibitors (ACE inhibitors) and angiotensin receptor blockers (ARBs) used to lower blood pressure, or non-steroidal anti-inflammatory drugs (NSAIDs) used as painkillers or antipyretics, as these medicines may reduce the glomerular filtration rate in the kidneys;
• medicines that may affect certain heart parameters (such as QT interval), since sodium phosphate could increase their toxicity;
• medicines containing calcium, as they may increase the risk of calcium accumulation (ectopic calcification). Medicines containing sodium phosphates, such as oral solutions or sodium phosphate tablets, must not be taken concurrently with SODIUM PHOSPHATE NOVA ARGENTIA (see section

2. What you need to know before using SODIUM PHOSPHATE NOVA ARGENTIA).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
If you are pregnant or breastfeeding, use this medicine only if absolutely necessary and under direct medical supervision.

Driving and using machines
SODIUM PHOSPHATE NOVA ARGENTIA does not impair the ability to drive vehicles or operate machinery.
However, adverse effects may occur during treatment; therefore, it is advisable to understand your individual response to the medicine before driving or operating machinery.

SODIUM PHOSPHATE NOVA ARGENTIA contains methyl parahydroxybenzoate and propyl parahydroxybenzoate
Methyl parahydroxybenzoate and propyl parahydroxybenzoate may cause allergic reactions (including delayed reactions).

3. How to use SODIO FOSFATO NOVA ARGENTIA

Use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Use in adults and adolescents over 12 years of age
The recommended dose is 1 bottle of 120 ml per day.
Do not exceed this dose, and use each bottle for a single administration only, discarding any remaining solution.
Use this medicine at room temperature. If you prefer the medicine to be lukewarm, you can immerse the closed bottle in warm water or hold it under running tap water.
For optimal effect, administer the medicine while lying on your left side. To enhance the cleansing action, lie on the floor with your knees bent, your buttocks raised, and your chest resting on the floor for a few minutes immediately after administration.
For best results, follow these instructions for use:

1. Open the bottle, remove the cannula from its packaging, and screw it completely onto the neck of the bottle.
2. Hold the bottle, lubricate the cannula with a few drops of the solution, lie on your left side, gently insert the cannula into the rectum, then squeeze the bottle completely until all the solution has been expelled. A small amount of solution may remain in the bottle.
3. Remove the cannula while keeping pressure on the bottle after administration.
4. Remain lying down for a few minutes, preferably on your stomach or with your knees drawn toward your chest, before sitting up. Go to the toilet as soon as you feel the urge to defecate, which usually occurs within 5 minutes. In any case, do not retain the solution for more than 10–15 minutes.

Stop the administration immediately if you encounter resistance, as forced administration of the enema may cause injury.

If you use more SODIO FOSFATO NOVA ARGENTIA than you should
If you use an excessive dose of this medicine, either by accidental ingestion or rectal administration, the following may occur:

• irritation of the stomach and intestines, abdominal pain, nausea, vomiting, and diarrhea, leading to loss of water, electrolytes (especially potassium), and nutrients. In such cases, drink plenty of fluids to replace those lost;
• increased thirst, vomiting, weakness, fluid accumulation in various parts of the body (edema), bone pain (osteomalacia), and reduced levels of albumin in the blood (hypoalbuminemia);
• severe dehydration and low blood potassium levels (hypokalemia), causing problems to the heart, nerves, and muscles, especially if you are concurrently taking medicines to stimulate heart function (cardiac glycosides), those that increase urine production (diuretics), or medicines known as corticosteroids;
• increased levels of phosphates in the blood (hyperphosphatemia) and decreased calcium levels (hypocalcemia), leading to uncontrolled muscle contractions (tetany), seizures, and heart problems such as bradycardia, QT interval prolongation, arrhythmia, coma, and cardiac arrest;
• increased sodium levels in the blood (hypernatremia) and decreased magnesium levels (hypomagnesemia);
• low blood pressure (hypotension), rapid heartbeat (tachycardia), and increased acidity of the body (metabolic acidosis).

If you are elderly, a child, or suffer from reduced kidney function (renal insufficiency), you are more likely to experience the symptoms listed above. In case of accidental ingestion or overdose of SODIO FOSFATO NOVA ARGENTIA, contact your doctor immediately or go to the nearest hospital. Also refer to section 2, Warnings and Precautions, regarding laxative abuse.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The following side effects may occur.
Frequency not known (frequency cannot be estimated from the available data):

• allergic reactions (e.g. urticaria)
• blisters, itching, burning of the skin
• abdominal pain such as cramps and colic
• diarrhoea with loss of salts and water
• irritation of the lower part of the intestine (rectal irritation)
• nausea, vomiting
• decrease in blood potassium levels (hypokalaemia)
• increase in blood sodium levels (hypernatraemia)
• increase in blood phosphate levels (hyperphosphataemia)
• decrease in blood calcium levels (hypocalcaemia)
• accumulation of calcium in various internal parts of the body (calcification). Following the instructions contained in this leaflet reduces the risk of side effects. Reporting of side effects If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store SODIO FOSFATO NOVA ARGENTIA

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 medicine in its original, unopened packaging, stored correctly.
This medicine does not require any special storage conditions.
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 SODIO FOSFATO NOVA ARGENTIA contains

• The active substances are monobasic sodium phosphate and dibasic sodium phosphate. 100 ml of solution contain 16 g of monobasic sodium phosphate monohydrate (equivalent to 18 g of monobasic sodium phosphate dihydrate) and 6 g of dibasic sodium phosphate heptahydrate (equivalent to 8 g of dibasic sodium phosphate dodecahydrate).
• The other components are: methyl parahydroxybenzoate, propyl parahydroxybenzoate and purified water. Description of the appearance of SODIO FOSFATO NOVA ARGENTIA and package contents 120 ml vial of rectal solution. Marketing Authorization Holder Industria Farmaceutica NOVA ARGENTIA S.p.A. - Via Lovanio, 5 - Milan Manufacturers Industria Farmaceutica NOVA ARGENTIA S.p.A. - Via G. Pascoli, 1 - Gorgonzola - Milan AEFFE FARMACEUTICI s.r.l. - Via Torino, 448 - Brandizzo - Turin