Sodium phosphate Polifarma Benessere

Patient Information Leaflet: Information for the User

SODIO FOSFATO Polifarma Benessere 16% 6% Rectal Solution

Monobasic sodium phosphate monohydrate / 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 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, 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 Polifarma Benessere is and what it is used for
2. What you need to know before using Sodio Fosfato Polifarma Benessere
3. How to use Sodio Fosfato Polifarma Benessere
4. Possible side effects
5. How to store Sodio Fosfato Polifarma Benessere
6. Contents of the pack and other information

1. What Sodio Fosfato Polifarma Benessere is and what it is used for

Sodio Fosfato Polifarma Benessere contains the active substances monosodium phosphate monohydrate and
disodium phosphate heptahydrate, which belong to
a group of medicines called laxatives.
These act by stimulating intestinal movements, accelerating the passage of intestinal contents.
Sodio Fosfato Polifarma Benessere is used in adults and adolescents from 12 years of age and older for:

• the treatment of constipation;
• emptying the bowel before and after surgery or in preparation for a bowel examination.
  If you do not feel better or feel worse after a short period of treatment, consult your doctor.

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 provide a lasting solution to constipation.
Many people believe they suffer from constipation if they cannot defecate every day.
This is a mistaken belief, as this situation is completely normal for many
individuals. Instead, consider that constipation occurs when bowel movements are reduced compared to your usual habits and are associated with the passage of hard stools.
If episodes of constipation occur repeatedly, consult your doctor.

2. What you should know before using Sodio Fosfato Polifarma Benessere

Do not use Sodio Fosfato Polifarma Benessere

• 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 cause,
• if you have nausea or vomiting,
• if you suffer from intestinal or anal obstruction or narrowing (intestinal stenosis, anorectal stenosis),
• if you suffer from difficult intestinal transit (intestinal subocclusion),
• if you suffer from a complete stoppage of intestinal contents (paralytic ileus), especially if due to a physical obstruction (mechanical ileus),
• if you suffer from inflammation of the intestine or other conditions that may increase absorption of the medicine;
• if you have a perforation of the anal wall,
• if you have significant colon dilation, either congenital or acquired (megacolon),
• if you suffer from a congenital colon disorder causing severe difficulty in defecation (Hirschsprung's disease), if you are bleeding from the rectum and do not know the cause,
• if you have haemorrhoids that bleed,
• if you are severely dehydrated,
• if you suffer from heart problems,
• if you suffer from severe kidney disease (renal failure),
• if you have high levels of phosphate in the blood. Do not give Sodio Fosfato Polifarma Benessere to children under 12 years of age.

Do not use Sodio Fosfato Polifarma Benessere together with other medicines containing sodium phosphate
(oral solutions or tablets). See section “Other medicines and Sodio Fosfato Polifarma Benessere”.
Warnings and precautions
Talk to your doctor or pharmacist before using Sodio Fosfato Polifarma Benessere.
Like all laxatives, do not use Sodio Fosfato Polifarma Benessere daily or for prolonged periods
without prior medical evaluation of the cause of constipation. Chronic or recurrent constipation
requires medical supervision for diagnosis, prescription of medication, and monitoring during therapy.
Consult your doctor before using this medicine:

• when 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, or if you suffer from high blood pressure, heart disease, fluid in the abdomen (ascites), or rectal ulcers.

Since forced administration of an enema may cause injury, stop administration immediately if you encounter resistance.
Please keep in mind that:

• prolonged use of a laxative for treatment of constipation is not recommended.
• to treat constipation, medicines should only be an aid to hygienic-dietary measures (e.g. increasing dietary fibre 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 stools.
• it is advisable to correct dietary habits by increasing fibre and water intake during episodes of constipation.

If you abuse laxatives (frequent or prolonged use, or excessive doses), you may experience:

• persistent diarrhoea, leading to loss of water, electrolytes (especially potassium), and other essential nutrients.
• in more severe cases, dehydration or low blood potassium levels may occur, potentially causing heart, nerve, or muscle dysfunction, especially if you are also taking heart medications (digitalis), diuretics (medicines that increase urine production), or corticosteroids (anti-inflammatory drugs). Drink adequate fluids to prevent dehydration, particularly if you are predisposed to dehydration or are taking diuretics, or if you are being treated for high blood pressure (ACE inhibitors), heart failure, or are using anti-inflammatory, analgesic, or antipyretic medicines (NSAIDs).
• Sodio Fosfato Polifarma Benessere contains sodium phosphates, which may increase blood levels of sodium and phosphates and simultaneously decrease calcium and potassium levels, potentially causing muscle cramps (tetany) and kidney failure.
• dependence (and thus the need to increase the dose), chronic constipation, and loss of normal intestinal function (intestinal atony).
• it may lead to habituation or various types of damage.

Children
Do not use Sodio Fosfato Polifarma Benessere in children under 12 years of age.
Other medicines and Sodio Fosfato Polifarma Benessere
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, especially:

• diuretics (for treatment of high blood pressure),
• calcium-channel blockers (for treatment of high blood pressure),
• corticosteroids (for treatment of inflammation),
• lithium (for treatment of depression). If you take these medicines and excessive doses of Sodio Fosfato Polifarma Benessere, you may be at risk of imbalance in blood substances (phosphate, calcium, sodium),
• medicines that can alter the electrocardiogram (an examination to monitor the heart's electrical activity),
• antacids (for treatment of heartburn),
• calcium supplements.

Do not use Sodio Fosfato Polifarma Benessere together with other medicines containing sodium phosphate
(oral solutions or tablets).
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
If you are pregnant, use Sodio Fosfato Polifarma Benessere only if clearly needed and after consulting your doctor.
Breastfeeding
If you are breastfeeding, use Sodio Fosfato Polifarma Benessere only if clearly needed and after consulting your doctor.
Driving and using machines
Sodio Fosfato Polifarma Benessere does not affect the ability to drive or operate machinery.
However, adverse effects may occur. Please take this into account before driving or operating machinery.

3. How to use Sodio Fosfato Polifarma Benessere

Use this medicinal product exactly as described in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1 bottle of 120 ml per day.
Do not use more than 1 bottle per day. Each bottle is intended for single use only; any unused medicinal product must be discarded.

Administration
The bottle can be administered at room temperature. If you prefer it warm, place the bottle in contact with warm water (by immersion or under a running tap). For optimal effect, administer while lying on your left side. To enhance cleansing action, lie on the floor with knees bent, buttocks raised, and chest resting on the floor for a few minutes immediately after administration.

Instructions for use
Before using the medicinal product, press the cannula cap downward until the bottle seal breaks.

1. Remove the protective cap from the rectal cannula.
2. Hold the bottle and gently insert the cannula into the rectum. In adolescents, the cannula should not be inserted beyond half its length. Then squeeze the bottle completely. A small amount of solution remaining in the bottle is expected.
3. After administration, remove the cannula and dispose of the empty bottle in its original carton according to local regulations for disposal of medicinal products.
4. Remain lying down until you feel a strong urge to defecate, which usually occurs 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 Polifarma Benessere than you should
In case of accidental ingestion or overdose of Sodio Fosfato Polifarma Benessere, contact your doctor immediately or go to the nearest hospital.

Symptoms
If you use excessive doses, you may experience abdominal pain, nausea, vomiting, and diarrhea, as well as significant loss of water and substances present in the blood (potassium and other electrolytes). These losses may cause thirst, vomiting, weakness, swelling, bone pain (osteomalacia), and low levels of albumin in the blood (hypoalbuminemia).
In more severe cases, you may develop dehydration and low levels of potassium in the blood (hypokalaemia). This may lead to heart or muscle problems, especially if you are taking medicines for high blood pressure or inflammation (cardiac glycosides, diuretics, or corticosteroids).
You may also experience high levels of phosphate and low levels of calcium and magnesium, detectable through blood tests. In severe cases, you may develop uncontrolled body movements (tetany or convulsions) and heart disturbances (bradycardia, QT interval prolongation, arrhythmia, coma, and cardiac arrest). Additionally, you may develop severe fluid loss, high levels of sodium in the blood, low blood pressure, rapid heartbeat, and high levels of acids in the blood.
If you are elderly, an adolescent, or have kidney disease, you are at higher risk of toxic effects.
See also section 2, Warnings and precautions, regarding laxative abuse.

Treatment
Drink plenty of fluids, especially fruit juices.

If you forget to use Sodio Fosfato Polifarma Benessere
Do not use a double dose to make up for a forgotten dose.

If you stop using Sodio Fosfato Polifarma Benessere
If you have any questions about using this medicinal product, 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:

Effects related to stomach and intestine, more frequent in cases of severe constipation and rectal irritation.

• Pain and cramps
• Abdominal colic
• Diarrhoea with loss of salts and water
• Irritation of the lower part of the intestine (rectal irritation)
• Nausea
• Vomiting

Effects related to metabolism and nutrition

• High levels of phosphate in the blood (hyperphosphataemia)
• Low levels of calcium in the blood (hypocalcaemia)
• Tissue calcification
• Low levels of potassium in the blood (hypokalaemia)
• High levels of sodium in the blood (hypernatraemia)

Effects related to the immune system

• Allergic reactions, for example urticaria

Effects related to the skin and subcutaneous tissue

• Blisters
• Itching
• Burning sensation

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 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 Sodio Fosfato Polifarma Benessere

Keep the 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.
This medicine does not require any special storage temperature.
Keep the container tightly closed 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 Polifarma Benessere contains

• The active substances are monobasic sodium phosphate dihydrate 18.088 g, equivalent to monobasic sodium phosphate monohydrate 16 g; dibasic sodium phosphate dodecahydrate 8.016 g, equivalent to dibasic sodium phosphate heptahydrate 6 g.
• The other components are bronopol, purified water.

Description of the appearance of Sodio Fosfato Polifarma Benessere and package contents
Sodio Fosfato Polifarma Benessere is a rectal solution.
The package contains 1 bottle of 120 ml.

Marketing Authorization Holder
POLIFARMA BENESSERE S.r.l. Via Laurentina 289 – 00142 Roma
Manufacturer
Zeta Farmaceutici S.p.A. Via Galvani 10 - 36066 Sandrigo (VI)