Fosfoevac 10.8 g / 24.4 g oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

FOSFOEVAC 10.8 g / 24.4 g oral solution

Disodium phosphate dodecahydrate
Monosodium phosphate dihydrate

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor, even if they are adverse reactions not listed in this leaflet.

Contents of the leaflet:

1. What FOSFOEVAC is and what it is used for
2. What you need to know before taking FOSFOEVAC
3. How to take FOSFOEVAC
4. Possible adverse effects
5. How to store FOSFOEVAC
6. Contents of the pack and other information

1. What Fosfoevac is and what it is used for

FOSFOEVAC is a potent laxative that works by increasing the water content of your stools. Its effect occurs between 30 minutes and 6 hours after taking it.

This medicine is used to cleanse the bowel before surgical procedures or as preparation of the colon prior to radiological or endoscopic examinations. FOSFOEVAC must not be used as a regular laxative.

2. What you need to know before starting to take FOSFOEVAC

Intestinal evacuation drugs should not be considered as a routine treatment for constipation.

Do not take FOSFOEVAC

• If you are allergic to the active substances or to any of the other components of this medicine.
• If you know or suspect you have intestinal obstruction or intestinal paralysis
• If you have colitis
• If you suffer from 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 suffer from severe or moderate renal failure
• If you have diseases or conditions that may be associated with increased absorption of phosphorus or decreased excretion
• Children under 15 years of age.

Inform your doctor if you have any of these symptoms. Your doctor will then decide whether 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 conditions:

• mild renal failure
• heart disease
• electrolyte disturbances (alteration of mineral salt levels in the blood) or history thereof
• if you have undergone colon removal (colostomy)
• if you are on a low-salt diet

If you are at risk of developing electrolyte disturbances due to administration of FOSFOEVAC, you may need closer monitoring during treatment. Follow your doctor's recommendations in this regard.

Administration of FOSFOEVAC is a potential risk factor for the development of hyperphosphatemia (increased levels of phosphorus in the blood).

Children

Do not administer to children under 15 years of age.

Use of FOSFOEVAC with other medicines

Tell your doctor if you are taking, have recently taken, or might need to take any other medicines, including over-the-counter, homeopathic, herbal remedies, and other health-related products, as taking other medicines concurrently may be dangerous.

It is especially important that your doctor knows if you are taking medicines for high blood pressure or angina (calcium channel blockers), medicines to empty the bladder (diuretics), medicines for certain psychiatric disorders (lithium), or other drugs that could alter water or electrolyte balance. The effectiveness of contraceptive medicines, epilepsy treatments (antiepileptics), blood sugar regulators (antidiabetics), or drugs used to treat infections (antibiotics) may be reduced or completely eliminated.

Pregnancy, breastfeeding, and fertility

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

Driving and use of machines

Individual responses to bowel evacuants vary. FOSFOEVAC may cause multiple bowel movements. It generally starts to work within 30 minutes and its effect may last for more than 6 hours. It is recommended that you remain close to a toilet until bowel movements cease.

FOSFOEVAC contains Sodium benzoate and Sodium saccharin

Patients on low-sodium diets should be aware that this medicine contains 5,000 mg (217.4 mmol) of sodium per 45 ml bottle.

3. How to take Fosfoevac

Follow exactly the administration instructions for this medicine as indicated by your doctor. If in doubt, consult your doctor again.

This medicine is used to empty the bowel before surgical procedures or as preparation of the colon prior to radiological or endoscopic examinations.

The intake of FOSFOEVAC will begin the DAY BEFORE your hospital appointment.

Check the time of your appointment. If your appointment is before 12 noon, follow the dosing instructions for a MORNING APPOINTMENT. If your appointment is after 12 noon, follow the instructions for an AFTERNOON APPOINTMENT.

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

The intake of FOSPOEVAC should begin the day before your hospital appointment.

Day before the appointment

7:00 a.m.: Instead of breakfast, drink at least one full glass of clear liquid or water; you may 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 FOSFOEVAC in half a glass (120 ml) of cold water. Drink this solution, followed by one full glass (240 ml) of cold water; you may drink more water or clear liquids if desired.

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

7:00 p.m.: Instead of dinner, drink at least one full glass of clear liquid or water; you may 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 FOSFOEVAC in half a glass (120 ml) of cold water. Drink this solution, followed by one full glass (240 ml) of cold water; you may drink more if desired. If appropriate, you may drink additional water or other clear liquids, but only until midnight. After this time, you must remain fasting.

Day before the appointment

1:00 PM (13:00): You may have a light meal. For example: a sandwich and a salad. After lunch, no solid food should be consumed until after your hospital appointment.

During the afternoon, you may drink water or clear liquids.

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

First dose: Immediately after drinking at least one full glass of a clear liquid or water, dilute the contents of one bottle (45 ml) of FOSFOEVAC in half a glass (120 ml) of cold water. Drink this solution, followed by one full glass (240 ml) of cold water; you may drink more water or clear liquids if desired.

Before bedtime: You should drink at least three full glasses of water or clear liquids.

Day of the appointment

7:00 AM: Instead of breakfast, drink at least one full glass of a clear liquid or water; you may 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 FOSFOEVAC in half a glass (120 ml) of cold water. Drink this solution, followed by one full glass (240 ml) of cold water. You may continue drinking water or clear liquids until 8:00 AM.

After 8:00 AM: You must not drink any more water or clear liquids, as this could interfere with the test results.

The FOSFOEVAC treatment must not extend beyond the preparation schedule for your medical appointment. FOSFOEVAC must not be used as a habitual laxative.

If you take more FOSFOEVAC than you should

If you take more FOSFOEVAC than prescribed, or if someone else takes more than the recommended amount, contact your doctor immediately or go to the hospital.

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

If you forget to take FOSFOEVAC

Do not take a double dose to make up for missed doses.

As soon as you realize you have missed a dose, contact your doctor, as you will not be able to attend your appointment with adequate bowel cleansing.

4. Possible adverse effects

Like all medicines, FOSFOEVAC may cause adverse effects, although not everyone experiences them.

The action of FOSFOEVAC may cause you a cramping sensation in the stomach or a feeling of gas in the abdomen. In addition, the combination of fasting and the effect of the intestinal laxative 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 hypocalcemia and severe hyperphosphatemia may occur, manifesting as irritability, hypotension (decrease in blood pressure), muscle cramps, cyanosis (bluish discoloration of the skin due to lack of oxygenation), tetany (muscle rigidity in the arms and hands), tachycardia, seizures, obnubilation, fatigue, weakness, and even coma (loss of consciousness). If you notice any of these symptoms, you must consult your doctor immediately.

Reporting of 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 leaflet.

You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Fosfoevac

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

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

Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater drains or household waste. Return any unused medicines and their packaging to the Sigre collection point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of FOSFOEVAC

• The active substances are Disodium phosphate dodecahydrate (INN) and Monosodium phosphate dihydrate (INN). Each 45 ml vial contains 10.8 g of Disodium phosphate dodecahydrate (INN) and 24.4 g of Monosodium phosphate dihydrate (INN).
• 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 container

FOSFOEVAC is an oral solution, supplied in packages containing 2 vials of 45 ml each.

Marketing Authorization Holder and Manufacturer
LABORATORIOS BOHM, S.A.
C/Molinaseca, 23-25 Polígono Industrial Cobo Calleja.28947 Fuenlabrada (Madrid)
91 642 18 18

Date of the most recent review of this leaflet: December 2011

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/