Sodium phosphate Marco Viti

Package leaflet: Information for the user

SODIUM PHOSPHATE MARCO VITI 16% / 6% rectal solution

Monobasic sodium phosphate monohydrate and dibasic sodium phosphate heptahydrate
Please 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, consult your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice improvement or if your symptoms worsen after a few days.

Contents of this leaflet:

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

1. What SODIO FOSFATO MARCO VITI is and what it is used for

SODIO FOSFATO MARCO VITI contains the active substances monobasic sodium phosphate monohydrate and dibasic sodium phosphate heptahydrate, which belong to the group of laxative medicines. This medicine is indicated for the treatment of constipation and for emptying the bowel before and after surgical procedures or certain clinical examinations, such as radiological examinations 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 MARCO VITI

Do not use SODIO FOSFATO MARCO VITI

• if you are allergic to monobasic sodium phosphate monohydrate, dibasic sodium phosphate heptahydrate, or any of the other ingredients of this medicine (listed in section 6);
• if you have acute abdominal pain or pain of unknown origin;
• if you experience nausea or vomiting;
• if you suffer from intestinal or rectal blockage or narrowing (subocclusion or intestinal stenosis or anorectal stenosis);
• if you have specific intestinal disorders such as mechanical ileus, paralytic ileus, congenital or acquired megacolon, Hirschsprung's disease, inflammations, or other conditions that may increase absorption of the medicine;
• if you experience terminal intestinal problems such as rectal bleeding, acute hemorrhoids with pain and bleeding, or anal perforation;
• if you are severely dehydrated;
• if the person taking 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 increased 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 MARCO VITI.
If you use this medicine excessively, frequently, or incorrectly, you may develop persistent diarrhea, resulting in loss of water, electrolytes (especially potassium), and other essential nutrients. In more severe cases, you may experience dehydration and low levels of potassium in the blood (hypokalemia), which may lead to heart, nerve, and muscle problems, especially if you are simultaneously taking medicines for heart conditions (cardiac glycosides), diuretics, or corticosteroids.
Drink fluids to prevent dehydration, especially if you have 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 MARCO VITI 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 (leading to a progressive need to increase the dose), chronic constipation, and loss of normal intestinal function (intestinal atony).
Avoid prolonged use of this medicine. If you have constipation lasting 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 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.
Laxative use should be considered supportive therapy. In case of constipation, first correct your dietary habits by consuming adequate fiber and water and engaging in physical activity. When using laxatives, it is advisable to drink at least 6–8 glasses of water or other fluids daily to help soften stools.
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, although this is often completely normal. True constipation occurs when bowel movements are less frequent than usual and are associated with hard stools.
If constipation recurs frequently or becomes chronic, consult your doctor for diagnosis, prescription of appropriate medication, and monitoring during treatment.

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 MARCO VITI
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, but under certain conditions it may interact 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, and 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 (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 affect certain heart parameters (such as QT interval), as sodium phosphate may increase their toxicity;
• calcium supplements or calcium-containing antacids, as they may increase the risk of calcium accumulation (ectopic calcification);
• medicines containing sodium phosphates, such as oral solutions or sodium phosphate tablets.

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

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

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

3. How to use SODIO FOSFATO MARCO VITI

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 may immerse the closed bottle in warm water or hold it under a warm tap.
To achieve the best effect, follow these instructions for use:

1. Before using the product, press the cannula cap downwards 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. A small amount 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 (preferably in the knee-chest position, with elbows and knees resting on the ground) and 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 MARCO VITI than you should
If you accidentally swallow or take too much SODIO FOSFATO MARCO VITI, inform your doctor immediately or go to the nearest hospital.
If you use an excessive dose of this medicine, the following may occur:

• irritation of the stomach and intestines, abdominal pain, nausea, vomiting, and diarrhoea, leading to loss of water, electrolytes (especially potassium), and nutrients. In this case, drink plenty of fluids to replace those lost;
• increased thirst, 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 levels of potassium in the blood (hypokalaemia), causing problems with the heart, nerves, and muscles, especially if you are concurrently taking medicines for the heart (cardiac glycosides), diuretics, or corticosteroids;
• increased levels of phosphate in the blood (hyperphosphataemia) and reduced levels of calcium in the blood (hypocalcaemia), 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 (hypernatraemia, hyperphosphataemia) and reduced levels of magnesium and potassium in the blood (hypomagnesaemia, hypokalaemia);
• low blood pressure (hypotension), increased heart rate (tachycardia), and increased acidity in the body (metabolic acidosis).

The symptoms listed above are more likely to occur in elderly people, children, or if you suffer from reduced kidney function (renal insufficiency).
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 gets 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)
• calcium accumulation 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 can 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 MARCO VITI

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. The expiry date applies to the medicine in its original, unopened packaging, properly stored.
Keep this medicine tightly closed in its original packaging to protect it from light.
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 MARCO VITI contains

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

Description of the appearance of SODIO FOSFATO MARCO VITI and contents of the pack
Packs of 1 or 4 plastic bottles of 120 ml with catheter and catheter cap.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Marco Viti Farmaceutici S.p.A. - Via Mentana, 38 - 36100 Vicenza
Manufacturer
Zeta Farmaceutici S.p.A. - Via Galvani, 10 - 36066 Sandrigo (VI)