Package Insert: Information for the Patient

FOSFOEVAC 10.8 g / 24.4 g Oral Solution

Dodecahydrate Disodium Phosphate

Dihydrate Monosodium Phosphate

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor.
• This medication has been prescribed only for you, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, even if they are not listed in this package insert.

FOSFOEVAC is a very strong laxative that acts by increasing the water content of its stools. Its action takes place between 30 minutes and 6 hours after taking it.

This medication is used to clean the intestines before surgical operations or as preparation of the colon before radiological or endoscopic examinations. FOSFOEVAC should not be used as a regular laxative.

Medications for intestinal evacuation should not be considered as a regular treatment for constipation.

Do not take FOSFOEVAC

• If you are allergic to the active ingredients or any of the other components of this medication.
• If you know or suspect you have intestinal obstruction or paralysis
• If you have colitis
• If you have congestive heart failure
• If you have uncontrolled high blood pressure
• If you have a dilated colon (megacolon)
• If you have inflammatory bowel disease
• If you have nausea, vomiting, or abdominal pain
• If you have severe or moderate kidney failure
• If you have conditions or diseases that may be associated with an increase in phosphorus absorption or a decrease in its excretion
• Children under 15 years old.

Inform your doctor if you have any of these symptoms. Your doctor will then decide if FOSFOEVAC is suitable for you.

Warnings and precautions

Consult your doctor before starting to take FOSFOEVAC.

Inform your doctor if you have any of the following problems:

• Mild kidney failure
• Heart disease
• Electrolyte imbalances (alteration of mineral salt levels in the blood) or a history of this
• If you have had a colon removal (colostomy)
• If you are following a low-sodium diet

If you may experience electrolyte imbalances due to FOSFOEVAC administration, you may need to be closely monitored during treatment. Follow your doctor's recommendations in this regard.

The administration of FOSFOEVAC may be a risk factor for the development of hyperphosphatemia (elevated phosphorus levels in the blood).

Children

Do not administer to children under 15 years old.

Use of FOSFOEVAC with other medications

Inform your doctor that you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription, homeopathic, herbal, and other health-related products, as taking other medications at the same time may be hazardous.

It is especially important for your doctor to know if you are taking medications for high blood pressure or angina (calcium channel blockers), medications for urinary emptying (diuretics), medications for certain psychiatric disorders (lithium), or other medications that may alter the balance of water or electrolytes. The effectiveness of contraceptive medications, or for the treatment of epilepsy (antiepileptics), or blood sugar regulators (antidiabetics), or medications for treating infections (antibiotics), may be reduced or completely eliminated.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medication.

Driving and operating machinery

Individual responses to intestinal evacuants vary. FOSFOEVAC may cause multiple bowel movements. It usually starts to be effective within 30 minutes and its effect may last more than 6 hours. We recommend that you remain near a restroom until the bowel movements cease.

FOSFOEVAC contains Sodium Benzoate and Sodium Saccharin

Patients with low-sodium diets should note that this medication contains 5,000 mg (217.4 mmol) of sodium per 45 ml bottle.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor again.

This medication is used to perform intestinal evacuation before surgical operations or as preparation of the colon before radiological or endoscopic examinations.

Phosphate enema intake will begin the DAY BEFORE your hospital appointment.

Check the time of your appointment. If your appointment is before 12:00 PM, you must follow the dosing instructions for a MORNING APPOINTMENT. If your appointment is after 12:00 PM, you will follow the instructions for an AFTERNOON APPOINTMENT.

It is essential that you do not eat any solid food during the treatment with Phosphate enema. Instead of solid food for breakfast, lunch, and dinner, you must drink a clear liquid or water. Clear liquids include broth (without solids), strained fruit juices (fruit juice cannot be red or purple), tea or coffee alone, and clear beverages, with or without bubbles (for example, lemonade).

Phosphate enema intake must begin the day before the hospital appointment.

Day before the appointment

7:00 AM:Instead of breakfast, drink at least one full glass of a clear liquid or water; you can drink more if desired.

First dose:Immediately after drinking at least one full glass of clear liquid or water. Dilute the contents of one bottle (45 ml) of Phosphate enema in half a glass (120 ml) of cold water. Drink this solution and then a full glass (240 ml) of cold water; you can drink more water or clear liquids if desired.

1:00 PM (13:00 hours): Instead of lunch, drink at least three full glasses (720 ml) of clear liquid or water; you can drink more if desired. In the afternoon, you can drink water or clear liquids if desired.

7:00 PM:Instead of dinner, drink at least one full glass of clear liquid or water; you can drink more if desired.

Second dose:Immediately after drinking at least one full glass of clear liquid or water. Dilute the contents of a second bottle (45 ml) of Phosphate enema in half a glass (120 ml) of cold water. Drink this solution and then a full glass (240 ml) of cold water; you can drink more if desired. If you deem it necessary, you can take more water or a clear liquid, but only until midnight. From this moment on, you must remain fasting.

Day before the appointment

1:00 PM (13:00 hours):You can take a light meal. For example: a sandwich and a salad. After lunch, you must not take any solid food until after your appointment at the hospital.

During the afternoon, you can drink water or a clear liquid.

7:00 PM:Instead of dinner, drink at least one full glass of clear liquid or water; you can drink more if desired.

First dose:Immediately after drinking at least one full glass of clear liquid or water. Dilute the contents of one bottle (45 ml) of Phosphate enema in half a glass (120 ml) of cold water. Drink this solution and then a full glass (240 ml) of cold water; you can drink more if desired, either water or clear liquids.

Before going to bed:Drink at least three full glasses of water or clear liquid.

Day of the appointment

7:00 AM:Instead of breakfast, drink at least one full glass of clear liquid or water; you can drink more if desired.

Second dose:Immediately after drinking at least one full glass of clear liquid or water. Dilute the contents of the second bottle (45 ml) of Phosphate enema in half a glass (120 ml) of cold water. Drink this solution and then a full glass (240 ml) of cold water. You can take more water or a clear liquid until 8:00 AM.

After 8:00 AM:You must not drink more water or clear liquids, as this could alter the results of the test you will be undergoing.

The Phosphate enema treatment must not be prolonged beyond the preparation program for the appointment with the doctor. Phosphate enema must not be used as a habitual laxative.

If you take more Phosphate enema than you should

If you take more Phosphate enema than you were told, or if someone has taken more Phosphate enema than recommended, immediately contact your doctor or go to the hospital.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Phosphate enema

Do not take a double dose to compensate for the missed doses.

As soon as you become aware of the oversight, contact your doctor, as you will not be able to attend the appointment with a proper intestinal cleansing.

Like all medications, FOSFOEVAC can produce adverse effects, although not everyone will experience them.

FOSFOEVAC's action may cause a certain sensation of cramping in the stomach or a feeling of gas in the abdomen. Additionally, the combination of fasting and the intestinal evacuant effect may cause nausea.

To help prevent these symptoms, you should drink as much clear liquid or water as possible.

Although very rare, cases of tetany with severe hypocalcemia and hyperphosphatemia may occur, presenting with irritability, hypotension (decreased blood pressure), muscle cramps, cyanosis (blue discoloration of the skin due to lack of oxygenation), tetany (rigidity of the muscles of the arms and hands), tachycardia, seizures, drowsiness, fatigue, weakness, and even comatose state (loss of consciousness). If you observe any of these symptoms, you should consult your doctor immediately.

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus.

You can also report them directly through the Spanish System of Pharmacovigilance for Human Use Medications: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Do not store in refrigerator or freeze. Keep in original packaging.

Keep this medication out of the sight and reach of children..

Do not use this medication after the expiration date that appears on the box after CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown down the drain or in the trash. Dispose of the containers and medications you no longer need at the Pharmacy Take-Back Point. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. This way, you will help protect the environment.

Composition of FOSFOEVAC

• The active principles are Disodium dodecahydrogenophosphate (DCI) and Monosodium dihydrogenophosphate (DCI). Each 45 ml bottle contains 10.8 g of Disodium dodecahydrogenophosphate (DCI) and 24.4 g of Monosodium dihydrogenophosphate (DCI)
• The other components are: Sodium saccharin, Sodium benzoate (E211), Glycerol (E422), Strawberry flavor, Orange flavor and Purified water.

Appearance of the product and contents of the packaging

FOSFOEVAC is an oral solution, presented in containers containing 2 bottles of 45 ml.

Holder of the marketing authorization and responsible for manufacturingLABORATORIOS BOHM, S.A.

C/Molinaseca, 23-25 Industrial Estate Cobo Calleja.28947 Fuenlabrada (Madrid)

91 642 18 18

Date of the last review of this leaflet:December 2011

The detailed and updated information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) htpp://www.aemps.gob.es/