PHOSPHO-SODA ORAL SOLUTION [SIN12230P]

Product Info

PHOSPHO-SODA ORAL SOLUTION

[SIN12230P]

1. WHAT PHOSPHO-SODA IS AND WHAT IT IS USED FOR

Phospho-Soda is a laxative. It is used in cases of severe constipation. You must also adapt your life style and your eating habits if you suffer from constipation.
Phospho-Soda is used to prepare the bowel for a surgical procedure or a bowel examination.
Phospho-Soda contains 10.8 g of Disodium phosphate dodecahydrate and 24.4 g of Sodium dihydrogen phosphate dihydrate per 45 mL bottle.
You must talk to a doctor if you do not feel better or if you feel worse.

3. HOW TO USE PHOSPHO-SODA

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

ATTENTION:

• Drink enough water or clear liquids to prevent dehydration or low blood volume.

• “Clear liquid” means water, clear soup (not thick), fruit juice without pulp, tea or black coffee, clear beverages not containing carbonic gas.

USE AS LAXATIVE:
It is recommended that you take this medicine 30 minutes before lunch or in the evening before bedtime. It is recommended that you first drink a glass of liquid before taking Phospho-Soda.
Always dilute the quantity indicated in a glass of cold water (± 120 mL).

• After administration of the solution it is recommended to drink an additional glass of water. In children in particular, it is recommended for them to drink additional liquid to prevent dehydration;

• If no intestinal transit is seen in the 6 hours following the use of the first or the second dose, discontinue the administration immediately and talk to a doctor.

• Habituation and intestinal problems may occur if you use this medicine frequently or on the long term.

• Unless directed by a physician Phospho-Soda should not be used for more than 3 consecutive days.

USE FOR BOWEL CLEANSING:
For use in adults only. Do not use in children under 18 years of age. Do not exceed the quantity prescribed. To prevent vomiting, it is recommended to drink a glass of clear liquid before taking Phospho-Soda.
Elderly patients: The same dose as in adults.
Start taking Phospho-Soda the day before your hospital appointment. For appointments BEFORE 12h00 pm, follow the recommendations applied to the MORNING. For appointments AFTER 12 noon, follow the recommendations for the afternoon.

MORNING appointments
The day BEFORE the examination:
7h00: As breakfast, drink a glass of clear liquid or water; if possible, it is recommended that you drink several glasses.
1^st dose: Immediately afterwards, dilute 45 mL of Phospho-Soda in half a glass of cold water (± 120 mL), and drink 1 or more large glasses (240 mL) of cold water. Drink all possible additional liquids to make up for the fluid loss occurring during intestinal transit.
13h00: Do not take food at lunch. Instead of food, drink at least 3 glasses (720 mL) of a clear liquid or water; you can drink more if you want.
19h00: Do not have dinner. Instead of food, drink 1 glass (240 mL) of a clear liquid or water; you can drink more if you want.
2^nd dose: Immediately after it, dilute 45 mL of Phospho-Soda in half a glass of cold water (± 120 mL), and drink 1 or more large glasses (240 mL) of cold water. Drink as much additional liquid as possible until midnight. Taking high amounts of clear liquid can cleanse the bowel before the procedure.

AFTERNOON appointment
The day BEFORE the examination:
13h00: Lunch: light meal, then do not take more solid food until after the examination.
19h00: Do not have dinner. Instead, drink 1 glass of a clear liquid or water; you can drink more if you want.
1^st dose: Immediately afterwards, dilute 45 mL in half a glass of cold water (± 120 mL), and drink 1 or more large glasses (240 mL) of cold water. Drink as much additional liquid as possible to replace the fluid loss occurring during intestinal transit. At night, drink at least 3 glasses (720 mL) of clear liquid or water in the evening; you can drink more if you want.

Day of examination:
7h00: As breakfast, drink a glass of clear liquid or water; if possible, it is recommended that you drink several glasses.
2^nd dose: Immediately afterwards, dilute 45 mL in half a glass of cold water (± 120 mL), and drink 1 or more large glasses (240 mL) of cold water. Drink all possible additional liquids to make up for the fluid loss occurring during intestinal transit. Taking high amounts of clear liquid can cleanse the bowel before the procedure. Continue taking all additional possible liquids until 8:00.

This product is effective in the bowel from half an hour to 6 hours after intake.
Your doctor will tell you how long to take Phospho-Soda.

If you take more Phospho-Soda than you should
High doses of Phospho-Soda are dangerous for children and patients with an intestinal obstruction. It can cause excess phosphate and sodium and deficit of calcium and potassium in blood. These disorders can cause body acidification, which can sometimes be fatal.
In case of overdosage or accidental intake, the following symptoms can occur: dehydration, hypotension, tachycardia, slowing down of pulse, cardiac arrest, shock, acceleration of breathing, respiratory problems, gasping, seizures, small bowel paralysis, anxiety, pain in the lower abdomen.
Cases of complete recovery after overdosage have been reported, both in children receiving Phospho-Soda accidentally and patients with obstruction.
In case of overdosage, it is essential to restore water balance.
Intravenous administration of 10% calcium gluconate may be sometimes necessary.
Hospitalisation is recommended.
If you have taken too much Phospho-Soda, contact your doctor, pharmacist, or the poison centre.

If you forget to take Phospho-Soda
If you must use Phospho-Soda as preparation for a bowel examination, tell your doctor so that further steps can be taken for the examination.
Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE PHOSPHO-SODA

Do not use Phospho-Soda

• If you are allergic to the active substances or any of the other ingredients of this medicine (listed in section 6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information);

• If you suffer from nausea, vomiting or stomach ache; in this case there is actually a risk of kidney failure;

• If you are younger than 18 years, you should not use Phospho-Soda for bowel cleansing (but you can use it as laxative; see Section 3. ‘How to use Phospho-Soda’);

• In case of:

  • kidney disease;

  • overactivity of the parotid glands (primary hyperparathyroidism) associated with high concentrations of calcium in blood;

  • symptomatic heart disease;

  • ascites (fluid accumulation in the abdominal cavity);

  • known or suspected occlusion in the stomach or the bowel;

  • colon hypertrophy (megacolon);

  • perforation in the gastrointestinal tract;

  • bowel occlusion (ileus);

  • active inflammatory bowel disease (such as Crohn’s disease or ulcerative colitis).

Phospho-Soda should not be used in combination with other laxatives containing sodium phosphate.