24.4 g / 10.8 g oral solution
Sodium dihydrogen phosphate dihydrate/disodium phosphate dodecahydrate
What Phosphoral is and what it is used for
Phosphorous is an intestinal cleanser that works by increasing the amount of water in the stool. It is a solution that you drink and that is provided in cartons containing two 45 ml bottles. One bottle contains a dose to be diluted with water before use (see section 3).
You must take Phosphoral as a bowel cleanser before surgery and X-ray examination of the colon ( colon ) or examination of the bowel ( endoscopy ). The bowel must be empty so that doctors can see it.
Phosphorous is not a remedy for constipation.
Phosphoric should be used by adults.
What you need to know before using Phosphoral
Do not use Phosphoral
- if you are allergic to disodium phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate, or any of the other ingredients of this medicine (listed in section 6).
- if you are under 18 years of age.
- if you are nauseous, vomit, or have stomach pain.
- if you have kidney disease.
- if you suffer from symptomatic heart disease.
- if you have an abnormal accumulation of fluid in the abdominal cavity ( ascites ).
- if you have or suspect you have a blockage, broken wound, or paralysis of the intestines.
- if you have a congenital or acquired enlargement of the colon (megacolon).
- if you have active inflammatory bowel disease.
- if you have hyperactive parathyroid glands (hyperparathyroidism).
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before using Phosphoral.
Do not take Phosphoral with other laxatives that contain sodium phosphate.
Consult your doctor if you suspect that any of the above applies to you. Your doctor will then decide if Phosphoral is right for you.
Take special care with Phosphoral:
- if you are elderly or generally debilitated (65 years or older).
- if you have impaired heart or kidney function.
- if you have disturbances in the salinity of the body (electrolytic imbalance) or if you are at risk of having such disturbances, for example when you are dehydrated (dehydrated).
- if you have low blood pressure or reduced bowel movements in some or all of the intestines.
- if you have had surgery to remove a large bowel opening ( colostomy ) or small bowel opening ( ileostomy ).
- if you have had any other gastrointestinal surgery.
- if you are on a low-salt diet ( see also important information on some ingredients in Phosphoral at the end of section 2).
Talk to your doctor if you think any of these claims apply to you today or have ever happened to you before. Phosphoric may change the heart rhythm slightly as a result of disturbances in the electrolyte balance and consequently, you may need closer supervision during treatment.
After taking Phosphoral, you can expect frequent and fluid bowel movements. You should drink as much clear drink (see point 3) as possible so that you do not become dehydrated (dehydrated).
Phosphoric usually works within 30 minutes to 6 hours. If no bowel movement has been induced within 6 hours of taking either the first or second dose of Phosphoral, contact your doctor immediately as you may become dehydrated (dehydrated).
Other drugs and Phosphoral
Before you take Phosphoral, tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, in particular:
- medicines used to treat high blood pressure or chest pain ( angina pectoris ) (eg calcium channel blockers, ACE inhibitors (angiotensin converting enzyme inhibitors ), angiotensin receptor blockers (ARBs)).
- diuretics ( diuretics ).
- non-steroidal anti-inflammatory painkillers ( NSAIDs ) such as Aspirin.
- certain remedies for mental illness (which contain lithium).
- other medicines that can cause dehydration (dehydration) or affect different levels of salt ( potassium , sodium, phosphate or water) in your body (your electrolyte balance).
- drugs that change the rhythm of the heart.
- drugs with parathyroid hormone.
- medicines that are taken regularly by mouth e.g. birth control pills, antiepileptic drugs, or diabetes, and antibiotics such as Phosphoral can delay or completely prevent the uptake of these oral medications, reducing or destroying their effect.
Ask your doctor or pharmacist if you are unsure.
Phosphoric with food and drink
See section 3 of this leaflet.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding or think you may be pregnant or are planning to have a baby, ask your doctor for advice before using Phosphoral. You should not use this medicine during pregnancy unless your doctor considers it necessary. If you are breastfeeding, you should milk out and discard the breast milk from the first dose one to 24 hours after the second dose of the bowel cleansing solutions. You should not breastfeed your baby for 24 hours after taking the second dose of Phosphoral.
Weakened and elderly patients (65 years or older)
Carefully read the information given in the sections “Take special care with Phosphoral” and “Using other medicines” (above) and the instructions in section 3 (below). You may need closer supervision.
Driving and using machines
Do not drive or use machines or tools if you feel tired or dizzy or if you think you may be dehydrated (dehydrated) after taking Phosphoral. Also stay close to a toilet after taking this medicine.
You are always responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Phosphoric contains sodium
This medicine contains 5000 mg of sodium (the main ingredient in cooking/table salt) in each 45 ml dose. This corresponds to 250% of the recommended maximum daily intake of sodium for an adult. It should be noted that this may harm patients who require a low-sodium (low-salt) diet.
Phosphoric contains ethanol
This medicine contains small amounts of ethanol (alcohol), less than 100 mg per dose .
Phosphoric contains sodium benzoate
This medicine contains 15 mg of sodium benzoate (E 211) in each 45 ml dose.
How to use Phosphoral
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. Ask your doctor or pharmacist if you are unsure.
- From the time you start taking Phosphoral until the examination is done, you must drink only “clear drink”. Do not eat solid foods.
- “Clear beverage” includes water, broth, or soup that has been sieved to remove solids, sifted fruit juice without pulp (but no red or red-blue juice), tea, or coffee (without milk or cream), and clear carbonated or non-carbonated beverage t eg soft drinks.
- To prevent you from feeling unwell while taking this medicine, it is important that you drink as much clear drink as possible.
- Phosphorous can cause bowel movements similar to diarrhea. It often starts working within 30 minutes and can continue to work for up to 6 hours. Stay close to a toilet until bowel movements have stopped.
If bowel movements have not been induced within 6 hours after taking either the first or second dose of Phosphoral, you should contact your doctor immediately as you may become dehydrated (dehydrated).
Treatment with Phosphoral should be started THE DAY BEFORE the hospital visit.
How to take the first or second dose of one
Dilute the contents of a bottle (45 ml) of Phosphoral in half a glass (120 ml) of cold water and drink. Then drink at least one full glass (240 ml) of cold water. Drink as large amounts of clear drink as possible to replace the fluid lost during bowel movements.
When to take the first or second dose one
See one of the two boxes below, depending on what time you have for the hospital visit.
You must follow the instructions completely in order for the examination or operation to be performed.
| MORNING VISIT AT 8.00 – 12.00 | AFTERNOON VISIT AT 12.00 – 17.00 |
|---|---|
| THE DAY BEFORE THE EXAMINATION / OPERATION7 am – Instead of breakfast – drink at least one large glass (240 ml) clear drink, preferably more if desired. Immediately afterward take the first dose (see above). Kl. 13 – Instead of lunch – drink at least three large glasses (720 ml) of clear drink. In the afternoon you can continue to drink clear drink to quench your thirst. Kl. 19 – Instead of supper – drink at least one large glass (240 ml) clear drink, preferably more if desired. Immediately afterward take the second dose (see above). You can continue to drink clear drinks until midnight to quench your thirst. If you drink a clear drink after midnight, this can cause further toilet visits and result in lost sleep. | THE DAY BEFORE THE EXAMINATION / operational. 13 – A light lunch can be eaten, such as soup and a sandwich. After that, you must not eat any more solid food before the hospital visit. In the afternoon you can drink clear drink to quench your thirst. 19 – Instead of supper – drink at least one large glass (240 ml) clear drink, preferably more if desired. Immediately afterwards take the first dose (see above). During the evening, drink at least three full glasses (720 ml) of water or clear drink before going to bed. |
| EXAMINATION / OPERATION DAYKl. 7 – Instead of breakfast – drink at least a large glass of clear drink, preferably more if desired. Immediately afterwards take the second dose (see above). You can continue to drink clear drinks until 8 o’clock to quench your thirst. If you drink a clear drink after 8 o’clock, this can cause further toilet visits and result in you having difficulty getting to the hospital. |
Be sure to drink large amounts of fluid after the hospital visit to replace the fluid that was lost while you were taking Phosphoral.
If you take more Phosphoral than you should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine, contact a doctor or hospital for an assessment of the risk and advice. An excessive amount of the drug can cause dehydration (dehydration), problems with the heart and circulation, difficulty breathing, anxiety, and colic pain.
If you forget to take Phosphoral
Consult your doctor. Do not take a double dose to make up for a forgotten dose.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
In very rare cases, Phosphoral may cause severe allergic reactions with or without rash. Contact your doctor or emergency department at the nearest hospital immediately if your hands, face, lips, throat, or tongue begin to swell or if you have difficulty breathing or swallowing.
Other possible side effects are caused by Phosphoral:
Very common (may affect more than 1 user in 10):
nausea, abdominal pain, feeling of fullness in the stomach, diarrhea, chills, weakness, and dizziness.
Common (may affect up to 1 in 10 people):
vomiting, chest pain, and headache.
Uncommon (may affect up to 1 in 100 people):
dehydration (dehydration).
Rare (may affect up to 1 in 1,000 people):
deposition of calcium in the kidneys.
Very rare (may affect up to 1 in 10,000 people):
heart attack, palpitations, low blood pressure, change in the number of salts ( electrolytes ) in the blood (which can lead to muscle twitching and spasms ), muscle cramps, tingling, unconsciousness, and kidney failure.
Has been reported (occurs in an unknown number of users): Hyponatremia (low sodium concentration in the blood which can lead to neurological disorders, such as confusion, coma, or seizures.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
How to store Phosphoral
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 expiration date is the last day of the specified month.
Do not store above 25 ° C
Use immediately after opening. Discard any remaining solution.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the package and other information
Content declaration
- The active substance (s) are sodium dihydrogen phosphate dihydrate 24.4 g and disodium phosphate dodecahydrate 10.8 g each 45 ml dose.
- The other ingredients are sodium benzoate ( preservative E 211), saccharin sodium, glycerol, purified water and flavoring (ginger and lemon aroma) consisting of ginger balm, alcohol, lemon oil, terpene-reduced citric oil, citric acid and purified water.
What the medicine looks like and the contents of the pack
Phosphorous is a clear, colorless oral solution with the scent of ginger and lemon. Phosphorous is supplied in cartons containing 2 or 100 ml bottles with screw caps.
One bottle contains one dose.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder: Case Recordati SL, Autovía de Logroña, km. 13,300, 50180 Utebo, Zaragoza, Spain
Manufacturer: Casen Recordati SL, Autovia de Logrõno, km. 13,300, 50180 Utebo, Zaragoza, Spain.
This medicinal product is authorized under the European Economic Area under the names:
Denmark: Phosphoral oral solution
Finland: Phosphoral oraaliliuos
France: Recholan, buvable solution
Greece: Phospho soda
Ireland: Phospho-soda oral solution
Netherlands: Phosphoral, drink
Portugal: Phospho-Soda Oral Solution
Spain: Phosphosoda oral solution
United Kingdom: Phospho-soda oral solution
Sweden: Phosphoral oral solution
Germany: Phospho-soda solution for ingestion