Sodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate.
Phospho-Soda contains 10.8 g of Disodium phosphate dodecahydrate and 24.4 g Sodium dihydrogen phosphate dihydrate per 45 mL bottle.
Excipients/Inactive Ingredients: glycerine, sodium saccharin, ginger-lemon flavour (ginger oil, alcohol, lemon oil, citric acid, water), sodium benzoate and purified water.
Phospho-Soda is a laxative. It is used in case of severe constipation. The patient must also adapt the eating habits if he/she suffers from constipation.
Phospho-Soda is used to prepare the bowel for a surgical procedure or a bowel examination.
The patient must talk to a doctor if he/she do not feel better or if the patient feels worse.
Always use this medicine exactly as the doctor or pharmacist has told. Check with the doctor or pharmacist if not sure.
Attention: Avoid exceeding the maximum recommended dose for both adults and children.
Drink enough water or clear liquids to prevent complete dehydration or too low volemia (volume of blood circulating in the body).
Clear liquid: means water, clear soup (not thick), fruit juice without pulp, tea or black coffee, clear beverages not containing carbonic gas.
Use as a laxative: It is recommended to use this medicine 30 minutes before lunch or in the evening before bedtime. It is recommended that the patient first drink a glass of liquid before taking Phospho-Soda.
Always dilute the quantity indicated in around 120 mL of cold water.
Adults and children older than 12 years: 4 tea-spoonfuls (20 mL).
Children aged 10 to 11 years: 2 tea-spoonfuls (10 mL).
Children aged 5 to 9 years: 1 tea-spoonfuls (5 mL).
The product should not be given to children 5 years and younger without instruction by doctor.
Taking more than one dose within 24 hours can be harmful: After administration of the solution it is recommended to drink an additional glass of water. In children in particular it is recommended to drink an additional liquid for the purpose of preventing complete dehydration.
If no intestinal transit is seen in the 6 hours following the use of the first or the second dose, discontinue immediately the administration and talk to a doctor.
Dependency and intestinal problems may occur if the patient uses this medicine frequently or on the long term.
Use as 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.
The doses of Phospho-Soda start the day before the hospital appointment. For appointments BEFORE 12 hours, follow the recommendations applied to the MORNING. For appointments fixed AFTER 12 hours, follow the recommendations applied to 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 the patient drinks several glasses.
1st dose: Immediately after it, dilute 3 soup-spoonfuls (45 mL) of Phospho-Soda in around 120 mL of cold water, 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; the patient can drink more if he/she wants.
19h00: Do not have dinner. Instead of food, drink 1 glass (240 mL) of a clear liquid or water, the patient can drink more if he/she wants.
2nd dose: Immediately after it, dilute 3 soup-spoonfuls (45 mL) of Phospho-Soda in around 120 mL of cold water, and drink 1 or more large glasses (240 mL) of cold water. Continue taking all additional possible liquid until midnight. Taking high amounts of clear liquid can cleanse the bowel before procedure.
AFTERNOON appointments: 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 of food, drink 1 glass of a clear liquid or water; the patient can drink more if he/she wants.
1st dose: Immediately after it, dilute 3 soup-spoonfuls (45 mL) in around 120 mL of cold water, 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. At night, drink at least 3 glasses (720 mL) of clear liquid or water in the evening; the patient can drink more if he/she wants.
Day OF the examination: 7h00: As breakfast, drink a glass of clear liquid or water; if possible, it is recommended that the patient drinks several glasses.
2nd dose: Immediately after it, dilute 3 soup-spoonfuls (45 mL) in around 120 mL of cold water, 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 medicine acts usually about half an hour to 6 hours following bowel administration.
The doctor will decide the time during which the patient will have to use Phospho-Soda.
If the patient forgets to take Phospho-Soda: If the patient must use Phospho-Soda as preparation for a bowel examination, tell the doctor so that new measures can be taken for the examination.
Do not take a double dose to make up for a forgotten dose.
If the patient stops taking Phospho-Soda: If the patient has any further questions on the use of this medicine, ask the doctor or pharmacist.
High doses of Phospho-Soda are dangerous for children and patients with constipation. These can cause excess phosphate and sodium in blood 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, large bowel paralysis, anxiety, pain in the lower abdomen.
Cases of complete recovery after overdosage have been reported, both in children receiving accidentally Phospho-Soda and patients with constipation.
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 the patient uses or takes more Phospho-Soda than he/she should, contact immediately the doctor.
Do not use Phospho-Soda: If the patient is allergic to the active substance or to any of the other ingredients of the medicine (listed in Description).
If the patient suffers from nausea or stomach ache; in this case there is actually a risk of kidney failure.
If the patient is younger than 18 years, he/she cannot use Phospho-Soda as bowel cleansing (but the patient can use it as a laxative; see Dosage & Administration).
In case of: renal problems; overactivity of the parotid glands (primary hyperparathyroidism) associated with high concentrations of calcium in blood; cardiac decompensation (heart failure); 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); progressing inflammatory bowel disease (such as Crohn's disease or bleeding rectal colitis).
Phospho-Soda cannot be used in combination with other laxatives containing sodium phosphate.
Talk to the doctor before using Phospho-Soda: If the patient is already taking other medicines, also see Interactions.
In patient older than 55 years or frail people, the fluid and electrolyte (water-salt) balance may be impaired with the use of Phospho-Soda. This disturbance may be fatal. Talk to the doctor before using Phopho-Soda.
During the use of Phospho-Soda, faeces will be abundant and more liquid. Also it is very important that the patient drinks as much water as possible. In fact, if the patient drinks too little, there is a risk of dehydration and too weak volemia (circulating blood volume).
If the patient suffers from any of the following: heart disease, such as myocardial infarction or angina pectoris (angor); hypotension; dehydration; hypovolemia (decreased intravascular volume); slowing down of gastric or intestinal activity, decreased bowel transit time, bowel obstruction or active colitis; colon inflammation; fluid and electrolyte imbalance.
If the patient do not absorb sufficient liquid.
If the patient is on a sodium-free (salt-free) diet.
After a gastrointestinal procedure, because gastrointestinal transit may be delayed.
If the patient has an artificial anus.
Children with congenital megacolon are exposed to a risk of dehydration caused by the sudden increase in sodium blood levels.
In case of use of diuretics, of some antihypertensives and anti-inflammatory analgaesics (of NSAID type), or other drugs which can affect renal perfusion or function.
This medicine takes usually about half an hour to 6 hours to act following administration. If no intestinal transit is seen within 6 hours following the use of the first or the second dose of Phospho-Soda, discontinue immediately the administration and talk to a doctor.
Dependency and intestinal problems may occur if the patient uses Phospho-Soda frequently or on the long term.
The patient can talk to the doctor if one of the warnings mentioned concerns him/her or has affected the patient in the past. Talk to the doctor before using Phospho-Soda.
Driving and using machines: Phospho-Soda can cause dizziness, probably as a result of dehydration. It can cause a mild to moderate effect on the ability to drive cars or use machines.
Phospho-Soda contains sodium: Each bottle contains 5.0 g of sodium per 45 mL. If the patient is on a sodium-free (salt-free) diet, he/she cannot use this medicine.
Phospho-Soda cannot be used during pregnancy, unless its use is completely necessary and it is administered under medical monitoring.
It is not known whether Phospho-Soda enters nursing milk. Since then, if the patient wants to use Phospho-Soda, collect the milk and dispose of it. Follow these steps from the last dose to 24 hours following the second dose (see Use as bowel cleansing under Dosage & Administration). Do not breastfeed within 24 hours following the second dose of Phospho-Soda.
If the patient is pregnant or breast-feeding, may be pregnant or is planning to have a baby, ask the doctor or pharmacist for advice before taking this medicine.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
In each frequency group, the side effects are classified by decreasing severity order as follows: Very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1000, <1/100); rare (≥1/10000, <1000); very rare (< 1/10000); not known (cannot be estimated from the available data).
Blood and lymphatic system disorders: Very rare: hypotension.
Immune system disorders: Very rare: hypersensitivity.
Metabolism and nutrition disorders: Uncommon: water deficit; Very rare: electrolyte balance disorders, mainly excess of phosphate and sodium and deficit of calcium and potassium in blood. These disorders can cause muscle cramps and acid intoxification.
Nervous system disorders: Very common: dizziness; Common: headache; Very rare: itching, fainting.
Cardiac disorders: Uncommon: acceleration of pulse and transient hypotension can occur; Very rare: heart rhythm disorders, caused by electrolyte balance changes. This disorder is mild.
Gastrointestinal disorders: Very common: nausea, abdominal pain, abdominal distension, diarrhoea; Common: vomiting. The combination of a fasting state and a laxative effect can cause nausea. To prevent these symptoms, it is recommended to drink all clear liquid possible; Uncommon: the doctor can see small aphthae during the bowel examination. These disorders are not clinically significant and are self-limited.
Skin and subcutaneous tissue disorders: Very rare: allergic skin rash.
Musculoskeletal and connective tissue disorders: Very rare: muscle cramps.
Renal and urinary disorders: Very rare: kidney failure, kidney stones and chronic kidney problems; Rare: formation of lime precipitates.
General disorders and administration site conditions: Very common: tremor, body weakness; Common: chest pain.
If the patient gets any side effects, talk to the doctor or pharmacist. This includes any possible side effects not listed.
Ask the doctor if the patient is taking the following medicines: medicines against hypertension; medicines against heart diseases; diuretics (tablets for increasing urine); parathormone (medicine for osteoporosis); lithium or other products susceptible of affecting electrolyte balance; medicines that modify heart rhythm.
The use of Phospho-Soda may delay or hinder completely intestinal absorption of medicines. This applies in particular to the following substances: contraceptives taken by oral route (by the mouth); medicines against epilepsy; medicines used for diabetes; antibiotics.
The concomitant use of other preparations based on sodium phosphate is not permitted.
Tell the doctor or pharmacist if the patient is using, have recently used or might use any other medicines.
Phospho-Soda with food and drink: This medicine contains 5.0 g sodium per 45 mL bottle. Take into account that patients must control their sodium diet supply.
This medicinal product need to keep in cool, dry & dark place below 25°C.
Keep this medicine out of the sight and reach of children.
Do not throw away any medicines via wastewater or household waste. Ask the pharmacist how to throw away medicines no longer use. These measures will help protect the environment.
A06AD10 - mineral salts in combination ; Belongs to the class of osmotically acting laxatives.
Phosphosoda oral soln
45 mL x 1's