Sodium phosphate Sella

Package leaflet: Information for the user

SODIUM PHOSPHATE SELLA 16% / 6% rectal solution

Monobasic dihydrate sodium phosphate and dibasic dodecahydrate sodium phosphate
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 you.
• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If any side effects occur, 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 you notice worsening of symptoms after a short period of treatment.

Contents of this leaflet:

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

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

SODIO FOSFATO SELLA contains the active substances sodium dihydrogen phosphate dihydrate and disodium hydrogen phosphate dodecahydrate, which belong to the group of laxative medicines used to soften and lubricate the stools, 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 exams or intestinal explorations.
Consult your doctor if you do not notice any improvement or if you observe a worsening of symptoms after a short period of treatment.

2. What you need to know before using SODIO FOSFATO SELLA

Do not use SODIO FOSFATO SELLA

• if you are allergic to monobasic sodium phosphate dihydrate, dibasic sodium phosphate dodecahydrate, or to any of the other ingredients of this medicine (listed in section 6);
• if you have sudden severe abdominal or other body pain (pain of unknown origin);
• if you have nausea or vomiting;
• if you suffer from intestinal blockage or narrowing (intestinal obstruction, intestinal stenosis, or anorectal stenosis);
• if you have partial intestinal blockage (sub-occlusion);
• if you have specific intestinal problems such as mechanical ileus, paralytic ileus, inflammation, or other conditions that may increase absorption of the medicine;
• if you suffer from anal perforation, congenital or acquired megacolon, or Hirschsprung's disease;
• if you have problems in the lower part of the intestine such as rectal bleeding, pain, or haemorrhoids;
• 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 increased levels of phosphates in the blood (hyperphosphataemia);
• if you are simultaneously taking other sodium phosphate preparations, including oral sodium phosphate solutions or tablets (see section "Other medicines and SODIO FOSFATO SELLA").

Warnings and precautions
Talk to your doctor or pharmacist before using SODIO FOSFATO SELLA.
During treatment with SODIO FOSFATO SELLA, it is advisable to drink plenty of water, which helps
prevent dehydration, especially if you have conditions that may predispose you to
dehydration or if you are taking medicines such as diuretics, ACE inhibitors, sartans, or non-steroidal anti-inflammatory drugs (NSAIDs).
If you use this medicine excessively, frequently, or incorrectly, you may experience prolonged
diarrhoea, resulting in loss of water, minerals (especially potassium), and other essential nutrients. In more severe cases, you may develop dehydration and low levels of potassium in the blood (hypokalaemia), which may cause problems with the heart, nerves, and muscles, especially if you are also taking medicines to stimulate heart function (cardiac glycosides), to increase urine production (diuretics), or medicines called corticosteroids.
SODIO FOSFATO SELLA contains sodium phosphates; therefore, there is a risk of elevated levels of sodium and phosphate and decreased levels of calcium and potassium in the blood (hypernatraemia, hyperphosphataemia, hypocalcaemia, and hypokalaemia), which may occur with clinical signs such as tetany and 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).
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 in the characteristics of your stools, 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 or in poor general health, particularly if you have uncontrolled arterial hypertension, ascites, heart disease, or changes in the rectal mucosa such as ulcers or fissures.
In case of constipation, first correct your dietary habits by consuming an adequate amount of fibre and water (6–8 glasses per day) and by engaging in physical activity. In most cases, a balanced diet rich in water and fibre (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; in fact, this condition is often completely normal. True constipation occurs when bowel movements are reduced compared to your usual pattern and are associated with the passage of hard stools. If episodes of constipation recur frequently, consult your doctor.
If you encounter resistance during administration, stop immediately: forced administration may cause injury.

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 SELLA
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 channel blockers, or lithium, as they may increase levels of phosphates, calcium, and sodium in the blood (hyperphosphataemia, hypercalcaemia, and hypernatraemia);
• medicines that may affect certain heart parameters (such as QT interval), as sodium phosphate may increase their toxicity;
• lithium-containing medicines, as concomitant use of SODIO FOSFATO SELLA and lithium may reduce lithium blood levels, leading to decreased effectiveness;
• calcium-containing medicines, as they may increase the risk of calcium accumulation (ectopic calcification);
• preparations containing sodium phosphates, including oral solutions and tablets (see section
  2. What you need to know before using SODIO FOSFATO SELLA).

Pregnancy and breastfeeding
If you are pregnant, think 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 if absolutely necessary and under direct medical supervision.

Driving and using machines
SODIO FOSFATO SELLA does not impair the ability to drive or operate machinery.
However, undesirable effects may occur during treatment; therefore, it is advisable to be aware of your individual response to the medicine before driving or operating machinery.

SODIO FOSFATO SELLA contains methyl parahydroxybenzoate and propyl parahydroxybenzoate
Methyl parahydroxybenzoate and propyl parahydroxybenzoate may cause allergic reactions (including delayed reactions).

3. How to use SODIO FOSFATO SELLA

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. Use each bottle for a single administration only, and discard any remaining solution.
Use this medicine at room temperature. If you prefer the medicine to be warm, you may immerse the closed bottle in warm water. It is advisable to administer the medicine while lying on your left side.

To achieve the best effect, follow these instructions for use:

1. Unscrew the bottle cap, remove the nozzle from the packaging and screw it completely onto the neck of the bottle.
2. Hold the bottle, lubricate the nozzle with a few drops of the solution, then lie down on your side and gently insert the nozzle into the rectum. Squeeze the bottle completely until all the solution has been expelled.
3. Remove the nozzle while keeping pressure on the bottle after administration.
4. Remain lying down for a few minutes, preferably face down or with knees drawn up to the chest (knee-chest position), before sitting up. Go to the bathroom 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.

If you use more SODIO FOSFATO SELLA 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 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 (oedema), bone pain (osteomalacia), and reduced levels of albumin in the blood (hypoalbuminaemia);
• Severe dehydration and low blood potassium levels (hypokalaemia), causing problems to the heart, nerves, and muscles, especially if you are also taking medicines that stimulate heart function (cardiac glycosides), increase urine production (diuretics), or medicines known as corticosteroids;
• Increased levels of phosphates in the blood (hyperphosphataemia) and decreased calcium levels (hypocalcaemia), 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 (hypernatraemia) and decreased magnesium levels (hypomagnesaemia);
• Low blood pressure (hypotension), rapid heartbeat (tachycardia), and increased body acidity (metabolic acidosis).

See also the information provided in section 2 under “Warnings and precautions” regarding laxative abuse.

If you are elderly, a child, or have reduced kidney function (renal insufficiency), you may be more likely to experience the symptoms listed above.
In case of accidental ingestion/overdose of SODIO FOSFATO SELLA, contact your doctor immediately or go to the nearest hospital.
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)

• hypersensitivity reactions (e.g. urticaria);
• blisters, itching, burning;
• abdominal pain, such as cramps and colic;
• diarrhoea with loss of salts and water, more frequent in cases of severe constipation;
• irritation of the final part of the intestine (rectal irritation);
• nausea, vomiting;
• increased levels of phosphate or sodium in the blood (hyperphosphataemia, hypernatraemia);
• decreased levels of calcium or potassium in the blood (hypocalcaemia, hypokalaemia);
• accumulation of calcium in various internal parts of the body (calcification).

Following the instructions provided 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, please consult your doctor or pharmacist. You may also report side effects directly through the national reporting system at the following website:
http://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 SODIUM PHOSPHATE SELLA

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.
The expiry date applies to the medicine in its original, unopened packaging, correctly stored.
Store this medicine tightly closed in the 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 no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What SODIO FOSFATO SELLA contains

• The active substances are sodium phosphate monobasic dihydrate and sodium phosphate dibasic dodecahydrate. 100 ml of product contain 18.08 g of sodium phosphate monobasic dihydrate (equivalent to 16 g of monobasic sodium phosphate monohydrate) and 8.03 g of sodium phosphate dibasic dodecahydrate (equivalent to 6 g of dibasic sodium phosphate heptahydrate).
• The other components are: methyl parahydroxybenzoate, propyl parahydroxybenzoate and purified water.

Description of the appearance of SODIO FOSFATO SELLA and contents of the pack
Packs containing 1, 4 or 20 vials of 120 ml each.
Marketing Authorization Holder and Manufacturer
LABORATORIO CHIMICO FARMACEUTICO A. SELLA S.r.l.
Via Vicenza, 67
36015, Schio (VI)
Italy

Package leaflet: Information for the patient
SODIO FOSFATO SELLA 16%/6% rectal solution
Sodium phosphate monobasic dihydrate and sodium phosphate dibasic dodecahydrate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Always take 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.
• Ask your pharmacist if you need more information or advice.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
• You must consult a doctor if you do not feel better or if you feel worse after a short period of treatment.

What is in this leaflet

1. What Sodio fosfato Sella is and what it is used for
2. What you need to know before you take Sodio fosfato Sella
3. How to take Sodio fosfato Sella
4. Possible side effects
5. How to store Sodio fosfato Sella
6. Contents of the pack and other information

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

Sodio fosfato Sella contains the active substances sodium phosphate monobasic dihydrate and
sodium phosphate dibasic dodecahydrate, which belong to the category of laxatives, used to
soften and lubricate the faeces, facilitating bowel transit and evacuation. This
medicine is used for the treatment of constipation and to empty the bowel in preparation for surgery
and certain clinical examinations, such as radiological and endoscopic examinations.
Talk to a doctor if you do not feel better or if you feel worse after a short period of treatment.

2. What you need to know before you take SODIO FOSFATO SELLA

Do not take SODIO FOSFATO SELLA:

• if you are allergic to sodium phosphate monobasic dihydrate, sodium phosphate dibasic dodecahydrate or any of the other ingredients of this medicine (listed in section 6);
• if you have acute abdominal pain or acute pain elsewhere in the body (of unknown origin);
• if you are experiencing nausea or vomiting;
• if you have intestinal obstruction or narrowing (stenosis) or anorectal stenosis;
• if you have partial intestinal obstruction;
• if you have an intestinal disorder such as mechanical ileus, paralytic ileus, intestinal inflammatory diseases, or other conditions that may increase the absorption of the medicine;
• if you have anal perforation, congenital or acquired megacolon, or Hirschsprung's disease;
• if you have rectal bleeding, pain, or haemorrhoids;
• if you are severely dehydrated;
• if the patient is a child under 12 years of age;
• if you have severe heart or kidney disease;
• if you have elevated levels of phosphates in the blood (hyperphosphatemia);
• if you are using other medicinal products containing sodium phosphates, including oral solutions and tablets (see section “Other medicines and SODIO FOSFATO SELLA”).

Warnings and precautions
Talk to your doctor or pharmacist before using SODIO FOSFATO SELLA.
During treatment with SODIO FOSFATO SELLA, it is advisable to drink plenty of water, which helps prevent dehydration, particularly if you have conditions that may predispose to dehydration or if you are taking medicines such as diuretics, ACE inhibitors, sartans, or nonsteroidal anti-inflammatory drugs.
If you use this medicinal product excessively, too frequently, or incorrectly, you may experience persistent diarrhoea, resulting in loss of water, electrolytes (especially potassium), and other essential nutrients. In more severe cases, excessive fluid loss (dehydration) or low blood potassium levels (hypokalemia) may occur, which can lead to cardiac or neuromuscular dysfunction, especially if you are also taking cardiac glycosides, diuretics, or corticosteroids.
SODIO FOSFATO SELLA contains sodium phosphates; therefore, there is a risk of high levels of sodium and phosphates and low levels of calcium and potassium in the blood (hypernatremia, hyperphosphatemia, hypocalcemia, and hypokalemia), which may lead to tetany and renal insufficiency.
Excessive or inappropriate use of this medicine may lead to dependence (requiring progressively higher doses), chronic constipation, and loss of normal bowel function (intestinal atony).
Avoid prolonged use of this medicine. If you have constipation lasting more than 2 weeks, notice changes in your usual bowel habits or in the characteristics of your stools, or do not feel better after using this medicine, consult your doctor.
If you are elderly and/or in poor general health, especially if you have uncontrolled arterial hypertension, ascites, heart disease, or changes in the rectal mucosa such as ulcers or fissures, use this medicine with caution and only after consulting your doctor.
In cases of constipation, first correct your dietary habits by increasing your daily intake of fibre and water (6–8 glasses per day) and engaging in regular physical activity. In many cases, a balanced diet rich in water and fibre (such as bran, fruit, and vegetables) can resolve constipation. Many people believe they are constipated if they do not have a bowel movement every day. This is incorrect, as such a pattern is normal for many individuals. Constipation should instead be considered when bowel movements are less frequent than your usual pattern and are associated with the passage of hard stools. If you frequently experience episodes of constipation, please consult your doctor.
If you feel resistance during administration of the medicine, stop treatment immediately: forced administration may cause injury.

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 SELLA
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
This medicine is poorly absorbed in the intestine and therefore has minimal interaction with other medicines.
Use caution if you are taking the following medicines:

• medicines that may alter electrolyte levels in the body, such as diuretics, calcium antagonists, lithium, or corticosteroids, as they may increase blood levels of phosphates, calcium, and sodium (hyperphosphatemia, hypercalcemia, hypernatremia);
• medicines that may affect cardiac parameters (e.g., QT interval), as sodium phosphate may increase their toxicity;
• lithium-containing medicines, because concomitant use of SODIO FOSFATO SELLA and lithium may reduce lithium blood levels, leading to reduced efficacy;
• calcium-containing medicines, which may increase the risk of calcium accumulation (ectopic calcification);
• preparations containing sodium phosphates, including oral solutions and tablets (see section
  2. What you need to know before you take SODIO FOSFATO SELLA).

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
If you are pregnant or breast-feeding, take this medicine only if necessary and under direct medical supervision.

Driving and using machines
SODIO FOSFATO SELLA has no effect on the ability to drive or operate machinery. Nevertheless, side effects may occur during treatment. Therefore, it is advisable to assess your individual response to the medicine before driving or operating machinery.

SODIO FOSFATO SELLA contains methyl parahydroxybenzoate and propyl parahydroxybenzoate
Methyl parahydroxybenzoate and propyl parahydroxybenzoate may cause allergic reactions (possibly delayed).

3. How to take SODIO FOSFATO SELLA

Always take this medicine exactly as your doctor or pharmacist has told you. Consult your doctor
or pharmacist if you are not sure.
Use in adults and adolescents over 12 years old
The recommended dose is 1 bottle of 120 ml per day. Do not exceed the recommended dose.
Each bottle is for single use only; any remaining solution must be discarded. Use
this medicinal product at room temperature; if you prefer it lukewarm, place the closed bottle in
warm water. It is advisable to lie on your left side when administering the product.
To achieve the best effect, follow these instructions for use:

1. Unscrew the cap from the bottle seal, remove the cannula from the package and screw it securely onto the neck of the bottle.
2. Holding the bottle, lubricate the tip of the tube with a few drops of the solution, lie down on your side, gently insert the tube into the rectum, then squeeze the bottle completely until all the solution has been expelled. Some residual liquid may remain in the bottle.
3. After administration, remove the cannula while holding the bottle.
4. Remain lying down for a few minutes, preferably on your stomach or with your knees drawn up toward your chest (genupectoral position), 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, it is not necessary to retain the solution for more than 10–15 minutes.

If you take more SODIO FOSFATO SELLA 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, mineral salts (mainly potassium), and nutrients. In this case, drink plenty of fluids to replace losses;
• increased thirst, weakness, fluid accumulation in certain areas (edema), bone pain (osteomalacia), and reduced blood albumin levels (hypoalbuminemia);
• severe dehydration and low potassium levels in the blood (hypokalemia), resulting in impaired function of the heart, nerves, and muscles—especially if you are taking medications that stimulate heart function (cardiac glycosides), increase urine output (diuretics), or corticosteroids;
• elevated phosphate levels (hyperphosphatemia) or reduced calcium levels (hypocalcemia) in the blood, leading to uncontrolled muscle contractions (tetany), convulsions, and heart problems such as bradycardia, QT prolongation, arrhythmias, coma, and cardiac arrest;
• increased sodium levels (hypernatremia) and reduced magnesium levels (hypomagnesemia) in the blood;
• low blood pressure (hypotension), rapid pulse (tachycardia), and increased acidity in the body (metabolic acidosis). See also section 2 “Warnings and precautions” regarding laxative abuse.

These symptoms are more likely if you are elderly, a child, or have impaired kidney function (renal insufficiency).
In case of accidental ingestion or overdose of Sodio fosfato Sella, contact your doctor immediately or go to the nearest hospital.
If you have any further questions about the use of this medicine, ask 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 have been reported:
Not known (frequency cannot be estimated from the available data)

• hypersensitivity reactions (for example, urticaria);
• vesicles, itching, burning;
• cramp-like pain or abdominal colic;
• diarrhoea, with loss of fluids and electrolytes, more frequent in case of severe constipation;
• irritation of the lower bowel tract (rectal irritation);
• nausea, vomiting;
• increase of phosphate or sodium levels in blood (hyperphosphataemia, hypernatraemia);
• decrease of calcium or potassium levels in blood (hypocalcaemia, hypokalaemia);
• accumulation of calcium in some internal areas of the body (calcification). Following the instructions provided with this leaflet reduces the risk of side effects.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly via the national reporting system
at the website: http://agenziafarmaco.gov.it/responsabili. By reporting side effects you can help
provide more information on the safety of this medicine.

5. How to store SODIO FOSFATO SELLA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after “Exp”.
The expiry date refers to the last day of the month.
The expiry date refers to the medicine in its intact and correctly stored packaging.
Store this medicine in its original container to protect it from light.
Do not throw away any medicines via wastewater. Ask your pharmacist how to dispose of
medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What SODIO FOSFATO SELLA contains
The active substances are sodium phosphate monobasic dihydrate and sodium phosphate dibasic dodecahydrate. 100 ml of product contains 18.08 g of sodium phosphate monobasic dihydrate (corresponding to 16 g of sodium phosphate monobasic monohydrate) and 8.03 g of sodium phosphate dibasic dodecahydrate (corresponding to 6 g of sodium phosphate dibasic heptahydrate).
The other ingredients are: methyl parahydroxybenzoate, propyl parahydroxybenzoate and purified water.
What SODIO FOSFATO SELLA looks like and contents of the pack
Pack with 1, 4 or 20 bottles of 120 ml.
Marketing Authorisation Holder and manufacturer
Laboratorio Chimico Farmaceutico A.Sella srl
via Vicenza 67 – 36015 Schio (VI)
This leaflet was last revised in