FOSFOEVAC 10.8g / 24.4g ORAL SOLUTION

Introduction

Package Leaflet: Information for the Patient

FOSFOEVAC 10.8 g / 24.4 g Oral Solution

Disodium phosphate dodecahydrate

Monosodium phosphate dihydrate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack:

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

1. What is Fosfoevac and what is it used for

FOSFOEVAC is a very strong laxative that works by increasing the water content of your stools. Its action takes place between 30 minutes and 6 hours after administration.

This medicine is used to cleanse the intestine before surgical operations or as preparation of the colon before radiological or endoscopic examinations. FOSFOEVAC should not be used as a habitual laxative.

2. What you need to know before you take Fosfoevac

Intestinal evacuant drugs should not be considered as 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 that 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 diseases or situations that may be associated with increased absorption of phosphorus or decreased excretion
• Children under 15 years of age.

Tell 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.

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

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

In the event that you may have electrolyte disturbances due to the administration of FOSFOEVAC, you may need to be monitored more closely during treatment. Follow your doctor's recommendations in this regard.

The administration of FOSFOEVAC is a possible risk factor for the onset of hyperphosphatemia (elevated phosphorus levels in the blood).

Children

Do not administer in children under 15 years of age.

Use of FOSFOEVAC with other medicines

Tell your doctor that you are taking, have recently taken, or may take any other medicine, including those obtained without a prescription, homeopathic, herbal, and other health-related products, as taking other medicines at the same time can 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, or for the treatment of epilepsy (antiepileptics), or regulators of sugar levels (antidiabetics), or drugs to treat 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 medicine.

Driving and using machines

Individual responses to intestinal evacuants vary. FOSFOEVAC may cause multiple bowel movements. It usually starts to be effective within 30 minutes and its effect can last more than 6 hours. We recommend that until the bowel movements stop, you stay close to a bathroom.

FOSFOEVAC contains Sodium Benzoate and Sodium Saccharin

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

3. How to take Fosfoevac

Follow your doctor's instructions for taking this medicine exactly. If in doubt, consult your doctor again.

This medicine is used to cleanse the intestine before surgical operations or as preparation of the colon before radiological or endoscopic examinations.

Intake of FOSFOEVAC will begin the DAY BEFORE your hospital appointment.

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

It is essential that you do not eat any solid food during treatment with FOSFOEVAC. Instead of solid food for breakfast, lunch, and dinner, you should drink clear liquids or water. Clear liquids include broth (without particles), strained fruit juices (fruit juice cannot be red or purple), tea or coffee alone, and clear drinks, with or without bubbles (e.g., lemonade).

Intake of FOSFOEVAC should begin the day before the hospital appointment.

Day before the appointment

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

First dose:Immediately after drinking at least one full glass of clear liquid or water. Dilute the contents of one vial (45 ml) of FOSFOEVAC 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 you want.

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

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

Second dose:Immediately after drinking at least one full glass of clear liquid or water. Dilute the contents of a second vial (45 ml) of FOSFOEVAC 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 you want. If you think it's appropriate, you can take more water or clear liquids, but only until midnight. From this time on, you should fast.

Day before the appointment

1 pm (13 hours):You can have a light meal. For example: a sandwich and a salad. After lunch, you should not eat any solid food until after your hospital appointment.

In the afternoon, you can drink water or clear liquids.

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

First dose:Immediately after drinking at least one full glass of clear liquid or water. Dilute the contents of one vial (45 ml) of FOSFOEVAC 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 you want.

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

Day of the appointment

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

Second dose:Immediately after drinking at least one full glass of clear liquid or water. Dilute the contents of the second vial (45 ml) of FOSFOEVAC 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 until 8 am.

After 8 am:You should not drink more water or clear liquids, as this could alter the results of the test you are going to undergo.

Treatment with FOSFOEVAC should not be prolonged beyond the preparation program for the medical appointment. FOSFOEVAC should not be used as a habitual laxative.

If you take more FOSFOEVAC than you should

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

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

If you forget to take FOSFOEVAC

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

As soon as you realize you have forgotten, contact your doctor, as you will not be able to attend the appointment with adequate intestinal cleansing.

4. Possible side effects

Like all medicines, FOSFOEVAC can cause side effects, although not everybody gets them.

The action of FOSFOEVAC may cause you some stomach cramps or give you a feeling of having gas in your abdomen. Additionally, the combination of fasting and the effect of the intestinal evacuant may cause you nausea.

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

Although very rare, cases of tetany with severe hypocalcemia and hyperphosphatemia may occur, with symptoms such as irritability, hypotension (decreased blood pressure), muscle cramps, cyanosis (bluish skin discoloration due to lack of oxygen), tetany (stiffness of the muscles of the arms and hands), tachycardia, convulsions, confusion, fatigue, weakness, and even coma (loss of consciousness). If you notice any of these symptoms, you should consult your doctor immediately.

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet.

You can also report them directly through the Spanish Medicines and Health Products Agency (AEMPS) https://www.notificaram.es. By reporting side 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 package.

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 CAD. The expiry date is the last day of the month indicated.

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 protect the environment.

6. Contents of the pack and further information

Composition of FOSFOEVAC

• The active ingredients are Disodium phosphate dodecahydrate (DCI) and Monosodium phosphate dihydrate (DCI). Each 45 ml vial contains 10.8 g of Disodium phosphate dodecahydrate (DCI) and 24.4 g of Monosodium phosphate dihydrate (DCI)
• The other ingredients are: Sodium Saccharin, Sodium Benzoate (E211), Glycerol (E422), Strawberry flavor, Orange flavor, and Purified Water.

Appearance of the product and pack contents

FOSFOEVAC is an oral solution, presented in packs containing 2 vials of 45 ml.

Marketing authorization holder and manufacturerLABORATORIOS BOHM, S.A.

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

91 642 18 18

Date of last revision of this leaflet:December 2011

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/