SODIUM PHOSPHATE ALFASIGMA

Patient Information Leaflet

SODIO FOSFATO ALFASIGMA rectal solution

Monobasic sodium phosphate monohydrate / Dibasic sodium phosphate heptahydrate
Please read all of this leaflet carefully before using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you to.

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

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

SODIO FOSFATO ALFASIGMA contains the active substances monobasic sodium phosphate monohydrate and dibasic sodium phosphate heptahydrate, which belong to the class of drugs known as laxatives and are used to facilitate the elimination of feces.
SODIO FOSFATO ALFASIGMA is used for:

• the treatment of constipation
• clinical conditions requiring complete bowel evacuation (for example, preparation before surgery, after surgery, diagnostic examinations such as endoscopic or radiological investigations, etc.)

Consult your 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 using SODIUM PHOSPHATE ALFASIGMA

Do not use SODIUM PHOSPHATE ALFASIGMA

• if you are allergic to sodium phosphate or to any of the other ingredients of this medicine (listed in section 6)
• if you have acute abdominal pain or any pain of unknown origin
• if you have nausea or vomiting
• if you have intestinal obstruction or narrowing (stenosis) of the intestine or anorectal area
• if you have a bowel blockage caused by a physical obstruction (mechanical ileus) or a partial blockage (sub-occlusion)
• if you have intestinal blockage or impaired normal intestinal emptying (paralytic ileus)
• if you suffer from inflammatory intestinal disorders or other conditions that may increase absorption of the medicine
• if you have perforation of the anal wall
• if you suffer from specific intestinal problems (colon abnormalities such as Hirschsprung's disease or congenital or acquired megacolon)
• if you have unexplained rectal bleeding
• if you are experiencing an acute hemorrhoidal crisis with pain and bleeding
• if you are severely dehydrated
• if you suffer from heart disorders or problems
• if you have severe kidney problems (severe renal insufficiency) or elevated levels of phosphate in the blood (hyperphosphatemia)
• in children under 12 years of age
• if you are taking other medicines containing sodium phosphate (such as oral solutions or tablets)

Warnings and precautions
Talk to your doctor before using SODIUM PHOSPHATE ALFASIGMA:

• if the need for a laxative arises from a sudden change in previous bowel habits (frequency and characteristics of bowel movements) lasting more than two weeks, or when use of the laxative fails to produce an effect
• if you are elderly or in poor general health
• if you suffer from high blood pressure, heart problems, increased volume of abdominal fluid (ascites), or ulcers and fissures in the rectal mucosa
• if you frequently have difficulty passing stools or suffer from chronic constipation.

Please keep in mind that:

• prolonged use of a laxative for the treatment of constipation is not recommended
• to treat constipation, medicines should only be an adjunct to lifestyle and dietary measures (e.g. increasing dietary fiber and fluid intake, regular physical activity, etc.)
• you should drink at least 6–8 glasses of water or other fluids during treatment with laxatives to help soften the stools
• it is advisable to correct dietary habits by increasing fiber and water intake during episodes of constipation. Abuse of laxatives (frequent or prolonged use, or excessive doses) may cause:
• persistent diarrhea leading to loss of water, electrolytes, and other essential substances
• in more severe cases, dehydration or a severe drop in blood potassium levels may occur, which can lead to heart, nerve, or muscle dysfunction, especially if you are also taking heart medications (digitalis), medications that increase urine production (diuretics), or corticosteroids (anti-inflammatory drugs)
• a state of dehydration, particularly if you are also taking medications that affect kidney filtration such as diuretics, ACE inhibitors, sartans (antihypertensive drugs acting on angiotensin), or NSAIDs (anti-inflammatory drugs)
• disturbances in blood levels of certain electrolytes, which may result in serious kidney problems (renal failure) or muscle stiffness (tetany)
• the need to progressively increase the dosage (dependence)
• chronic constipation
• loss of normal intestinal function (decreased intestinal tone).

Health education notes
A balanced diet rich in water and fiber (bran, vegetables, and fruit) can provide a lasting solution to constipation. Many people believe they suffer from constipation if they do not have a bowel movement every day: this is a misconception, as this pattern is perfectly normal for many individuals.
Constipation may be considered when bowel movements are less frequent than your usual pattern and are associated with hard stools.
Consult your doctor if episodes of constipation occur repeatedly.

Children
Do not use SODIUM PHOSPHATE ALFASIGMA in children under 12 years of age.

Other medicines and SODIUM PHOSPHATE ALFASIGMA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor before using SODIUM PHOSPHATE ALFASIGMA if you are taking:

• medications that increase urine output (diuretics), corticosteroid medications (corticosteroids), certain medications that lower blood pressure (calcium channel blockers), or lithium-containing medications
• medications that affect heart rhythm (prolongation of QT interval)
• calcium supplements and calcium-containing antacids
• other medications containing sodium phosphate (such as oral solutions or tablets)

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
During pregnancy and breastfeeding, SODIUM PHOSPHATE ALFASIGMA should only be used if necessary and under direct medical supervision, after careful evaluation of the expected benefit to the mother against the potential risk to the fetus or nursing infant.

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

SODIUM PHOSPHATE ALFASIGMA contains sodium benzoate and methyl parahydroxybenzoate
This medicine contains 120 mg per dose of sodium benzoate, which may cause local irritation.
This medicine contains methyl parahydroxybenzoate, which may cause allergic reactions (including delayed reactions).

3. How to use SODIO FOSFATO ALFASIGMA

Use this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Use in adults and adolescents (12 – 18 years)
The recommended dose is 1 bottle of 120 ml per day.
Please note the following:

• Do not use more than one bottle per day.
• Each bottle is intended for single use only: discard any unused medicine.
• Discontinue administration if resistance is encountered during cannula insertion to avoid causing injury.

Instructions for use and administration
The product may be administered at room temperature or, if preferred, slightly warmed by placing the bottle in contact with warm water (by immersion or under running tap water).

1. For optimal effect, administer while lying on your left side (as shown in figure 1).

2. For enhanced cleansing action, assume the knee-chest position for a few minutes immediately after administration (as shown in figure 2).

3. Remove the protective cap from the rectal cannula (see fig. 3).
4. Hold the bottle and gently insert the cannula into the rectum, directing it towards the navel (see fig. 4), then squeeze the bottle completely. A small amount of solution may remain in the bottle.

5. After administration, remove the cannula and dispose of the empty bottle in its original packaging (see fig. 5).
6. Remain lying down until a strong urge to defecate occurs, usually within 5 minutes. In any case, there is no need to retain the enema for longer than 10–15 minutes.

If you use more SODIO FOSFATO ALFASIGMA than you should
Inform your doctor immediately or go to the nearest hospital if you have accidentally taken an excessive dose of SODIO FOSFATO ALFASIGMA.
Adverse effects that may occur following oral ingestion or rectal administration include:

• abdominal pain
• nausea
• vomiting
• persistent diarrhoea leading to loss of water, electrolytes (especially potassium), and other essential nutrients. These losses should be replenished by drinking water or other fluids. Excessive absorption of phosphate from the enema may cause:
• high levels of phosphate in the blood (hyperphosphataemia)
• low levels of calcium in the blood (hypocalcaemia)
• low levels of magnesium in the blood (hypomagnesaemia)
  See also the information provided in section 2, Warnings and precautions, regarding laxative abuse.

If you stop treatment with SODIO FOSFATO ALFASIGMA
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 everybody will experience them.
The side effects that may occur with the use of SODIO FOSFATO ALFASIGMA are:

• isolated cramp-like abdominal pains
• intermittent abdominal pain (abdominal colic)
• diarrhoea with loss of fluids and salts, more frequent in cases of constipation (difficulty in defecation) that is severe
• redness with burning or pain (irritation) at the rectal level
• nausea and vomiting
• hypersensitivity reactions (e.g. urticaria)
• blisters, itching and burning of the skin

The following side effects occur rarely:

• increased levels of phosphate in the blood (hyperphosphataemia)
• increased levels of sodium in the blood (hypernatraemia)
• low levels of calcium in the blood (hypocalcaemia)
• low levels of potassium in the blood (hypokalaemia)
• calcium accumulation (calcification) in tissues

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 the following address: 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 SODIUM PHOSPHATE ALFASIGMA

Keep this medicine out of the sight and reach of children.
This medicine requires no special storage conditions.
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.
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 SODIO FOSFATO ALFASIGMA contains

• The active substances are monobasic sodium phosphate monohydrate and dibasic sodium phosphate heptahydrate. Each 100 ml of solution contains: 16 g of monobasic sodium phosphate monohydrate and 6 g of dibasic sodium phosphate heptahydrate.
• The other components are: sodium benzoate, methyl parahydroxybenzoate, purified water.

Description of the appearance of SODIO FOSFATO ALFASIGMA and contents of the pack

• Each pack of SODIO FOSFATO ALFASIGMA 16 % / 6 % rectal solution contains 1, 4 or 20 vials with 120 ml of rectal solution.

Marketing Authorization Holder and Manufacturer