Sodium phosphate Zeta

Package leaflet: Information for the user

SODIO FOSFATO ZETA 16% / 6% rectal solution

Monosodium phosphate monohydrate and disodium phosphate heptahydrate
Please read this leaflet carefully before you use 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 you.
• 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, consult your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement or if you notice worsening of symptoms after a few days.

Contents of this leaflet:

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

1. What SODIO FOSFATO ZETA is and what it is used for

SODIO FOSFATO ZETA contains the active substances sodium phosphate monobasic monohydrate and sodium phosphate dibasic heptahydrate, which belong to the group of laxative medicines used to soften and lubricate stools, thereby facilitating their passage through the intestine and evacuation. This medicine is indicated for the treatment of constipation and for emptying the bowel prior to surgical procedures or certain clinical examinations, such as radiological investigations or endoscopic intestinal explorations.
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 SODIO FOSFATO ZETA

Do not use SODIO FOSFATO ZETA

• if you are allergic to monobasic monohydrate sodium phosphate, dibasic heptahydrate sodium phosphate, or to any of the other ingredients of this medicine (listed in section 6);
• if you have severe abdominal pain or any pain of unknown origin, nausea or vomiting;
• if you suffer from intestinal blockage or narrowing of the intestine or anorectum (subocclusion or intestinal stenosis or anorectal stenosis);
• if you suffer from a stoppage of intestinal content movement (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 defecation (Hirschsprung's disease);
• if you suffer from intestinal inflammation or other conditions that may increase absorption of the medicine;
• if you have problems in the terminal part of the intestine such as rectal bleeding, acute hemorrhoids with pain and bleeding, or anal perforation;
• if you are in a state of severe dehydration;
• if the person to take the medicine is a child under 12 years of age;
• if you suffer from heart and/or kidney problems (severe renal insufficiency);
• if you have elevated levels of phosphates in the blood (hyperphosphatemia);
• if you are already taking other sodium phosphate preparations, such as oral solutions or sodium phosphate tablets.

Warnings and precautions
Talk to your doctor or pharmacist before using SODIO FOSFATO ZETA.
If you use this medicine excessively, frequently or incorrectly, you may experience prolonged diarrhea, resulting in loss of water, minerals (especially potassium), and other essential nutrients. In more severe cases, you may develop dehydration and low potassium levels in the blood (hypokalemia), which may cause problems affecting the heart, nerves, and muscles, especially if you are concurrently taking medicines to stimulate heart function (cardiac glycosides), 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 (sartans), or non-steroidal anti-inflammatory drugs (NSAIDs).
Since SODIO FOSFATO ZETA 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 for constipation is not recommended. In case of constipation, first correct your dietary habits by consuming adequate amounts of fiber and water (6–8 glasses per day) and by engaging in physical activity. If you have had constipation for more than 2 weeks, notice changes in your usual bowel habits or stool characteristics, or 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 suffer from cardiovascular problems (uncontrolled blood pressure, heart disease), ascites, or rectal mucosal disorders (ulcers, fissures).
If you encounter resistance when using the medicine, stop immediately, as forced administration may cause injury.

Health education notes
First of all, keep in mind that in most cases, a balanced diet rich in water and fiber (bran, vegetables, and fruit) can permanently resolve constipation.
Many people believe they suffer from constipation if they cannot defecate every day.
This is a mistaken belief, as this condition is perfectly normal for many individuals. Instead, consider constipation to be present when bowel movements are reduced compared to your usual habits 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 SODIO FOSFATO ZETA
Tell 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 levels of phosphates, calcium, and sodium in the blood (hyperphosphatemia, hypercalcemia, hypernatremia). Increased sodium levels may reduce lithium levels in the blood, thereby decreasing its effectiveness;
• angiotensin-converting enzyme inhibitors (ACE inhibitors) and angiotensin receptor blockers (sartans) used to lower blood pressure, or non-steroidal anti-inflammatory drugs (NSAIDs) used as painkillers or antipyretics, as these medicines reduce the glomerular filtration rate in the kidneys;
• medicines that may alter certain heart parameters (such as QT interval), as sodium phosphate may 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 at the same time as SODIO FOSFATO ZETA (see section 2. What you need to know before using SODIO FOSFATO ZETA).

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

Driving and using machines
SODIO FOSFATO ZETA does not impair the ability to drive or operate machinery. However, it may cause side effects that could affect such abilities. If this occurs, avoid driving or operating machinery.

SODIO FOSFATO ZETA contains bronopol
Bronopol may cause local skin reactions (e.g., contact dermatitis).

3. How to use SODIO FOSFATO ZETA

Use this medicine exactly as stated 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 application only, discarding any unused portion.
Use this medicine at room temperature. If you prefer the medicine to be warm, you may immerse the closed bottle in warm water or hold it under running tap water.
For optimal effect, administer while lying on your left side. For enhanced 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.
To achieve the best effect, follow these instructions for use:

1. Before using the product, push the cap cover downward until the safety seal on the bottle breaks.
2. Remove the protective cap from the rectal cannula.
3. Hold the bottle, lubricate the cannula with a few drops of the solution, lie on your side, and gently insert the cannula into the rectum. Then squeeze the bottle completely to empty all the solution. A small residue of solution remaining in the bottle is expected.
4. Remove the cannula while keeping pressure on the bottle after administration.
5. Remain lying down for a few minutes, then 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 longer than 10–15 minutes.

If you use more SODIO FOSFATO ZETA than you should
If you use an excessive dose of this medicine, the following may occur:

• Irritation of the stomach and intestines, abdominal pain, nausea, vomiting, and diarrhea, leading to loss of water, minerals (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 reduced blood potassium levels (hypokalemia), causing heart, nerve, and muscle problems, especially if you are concurrently taking medicines that stimulate heart function (cardiac glycosides), increase urine production (diuretics), or corticosteroids;
• Increased blood phosphate levels (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 levels of sodium and phosphate in the blood (hypernatremia, hyperphosphatemia) and decreased levels of magnesium and potassium (hypomagnesemia, hypokalemia);
• Low blood pressure (hypotension), increased heart rate (tachycardia), and increased body acidity (metabolic acidosis).

These symptoms are more likely to occur in elderly individuals, children, or patients with reduced kidney function (renal insufficiency).
In case of accidental ingestion or overdose of SODIO FOSFATO ZETA, 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 doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The following side effects may occur:
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;
• increased levels of phosphates in the blood (hyperphosphataemia);
• decreased levels of potassium in the blood (hypokalaemia);
• increased levels of sodium in the blood (hypernatraemia);
• decreased levels of calcium in the blood (hypocalcaemia);
• accumulation of calcium in various internal parts of the body (calcification).

Following the instructions 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, consult your doctor or pharmacist. You can also report side effects directly via
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store SODIO FOSFATO ZETA

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 medicine in its original packaging, correctly stored.
Store in the original packaging to protect the medicine from light.
Do not dispose of medicines 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 ZETA contains

• The active substances are sodium phosphate monobasic dihydrate and sodium phosphate dibasic dodecahydrate. 100 ml of solution contain 18.088 g of sodium phosphate monobasic dihydrate (equivalent to 16 g of sodium phosphate monobasic monohydrate) and 8.016 g of sodium phosphate dibasic dodecahydrate (equivalent to 6 g of sodium phosphate dibasic heptahydrate).
• The other components are: purified water, bronopol.

Description of the appearance of SODIO FOSFATO ZETA and package contents
120 ml bottle with catheter and catheter cap.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Zeta Farmaceutici S.p.A. - Via Mentana, 38 - 36100 Vicenza
Manufacturer
Zeta Farmaceutici S.p.A. - Via Galvani, 10 - 36066 Sandrigo (VI)