FOSFOSODA 24.4g / 10.8g ORAL SOLUTION

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Fosfosoda24.4 g/10.8 goral solution

Monosodium phosphate dihydrate, Disodium phosphate dodecahydrate

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, pharmacist, or nurse.
• 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, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

1. What is Fosfosoda and what is it used for
2. What you need to know before you take Fosfosoda
3. How to take Fosfosoda
4. Possible side effects
5. Storage of Fosfosoda

Contents of the pack and other information

1. What is Fosfosoda and what is it used for

Fosfosoda is an intestinal evacuant that works by increasing the water content of your stools. It is a solution that you can drink and comes in packs with two 45 ml vials. Each vial contains a dose that must be diluted in water before use (see section 3).

You need to take Fosfosoda to clean your large intestine or colon before an endoscopy, intestinal surgery, or radiological examination. It is essential that your intestine is completely clean so that your doctor can see it clearly.

Fosfosoda is not a treatment for constipation.

Fosfosoda is indicated in adults

2. What you need to know before you take Fosfosoda

Do not take Fosfosoda if

• You are allergic to disodium phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate, or any of the other components of this medicine (listed in section 6).
• You are under 18 years old.
• You feel sick or are vomiting or have abdominal pain.
• You have kidney disease.
• You have symptomatic heart failure.
• You have an abnormal accumulation of fluid between the abdomen and abdominal organs (ascites).
• You know or suspect that you have an obstruction, perforation, or paralysis of the intestine.
• You have an inherited or acquired increase in the size of the large intestine (megacolon).
• You have active inflammatory bowel disease.
• You have an overactive thyroid gland (hyperparathyroidism)

Do not take Fosfosoda in combination with other laxative products containing sodium phosphate.

Consult your doctor if you think you are affected by any of the above points.

Your doctor will then decide if Fosfosoda is suitable for you.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Fosfosoda.

Be especially careful withFosfosoda

• If you are weak or elderly (65 years or older).
• If you have heart or kidney disease.
• If you have electrolyte disturbances or are at risk of these disturbances, for example, if you are dehydrated.
• If you have low blood pressure or reduced movement in part or all of your intestine.
• If you have had a colostomy or ileostomy (a surgical procedure in which a portion of the colon or ileum is exposed through an opening in the abdominal wall).
• If you have had other surgery or surgery on the stomach or intestine
• If you follow a low-salt diet (see also “important information about some of the components of Fosfosoda at the end of section 2”)

Consult your doctor, even if any of the above circumstances are currently occurring or have occurred in the past. Fosfosoda may slightly alter your heart rhythm due to electrolyte imbalances, so you may need direct medical supervision during treatment.

You should be aware that after taking Fosfosoda, you will have frequent liquid stools. You should drink as much "CLEAR LIQUID" as possible to avoid dehydration.

This product usually takes effect within 30 minutes and can last up to 6 hours. If you have not had a bowel movement 6 hours after taking the first or second dose, you should stop taking the product and consult a doctor immediately, as you may become dehydrated.

Other medicines and Fosfosoda

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, especially if you are taking medicines for:

• high blood pressure (hypertension) or angina (e.g., calcium channel blockers, angiotensin-converting enzyme inhibitors (ACEIs), and angiotensin receptor antagonists (ARAs)),
• diuretics (medicines that increase urine production),
• non-steroidal anti-inflammatory drugs (NSAIDs), such as aspirin,
• certain medicines for mental disorders (those containing lithium),
• other medicines that may dehydrate you or alter the levels of salts (potassium, sodium, phosphate, or water) in your body (electrolyte balance),
• medicines that alter heart rhythm,
• medicines that contain parathyroid hormone,
• medicines taken orally, such as oral contraceptives, antiepileptics, antidiabetics, or antibiotics, because Fosfosoda may reduce or even cancel the availability of these medicines in the body, making their effect smaller or even canceling their effect.

Consult your doctor or pharmacist if you have any doubts.

Taking Fosfosoda with food and drinks

See section 3 of this leaflet

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. You should not take this medicine during pregnancy unless your doctor considers it necessary. If you are breastfeeding, it is recommended to express and discard breast milk from the time of taking the first dose until 24 hours after taking the second dose of the intestinal evacuant. You should not breastfeed your child during the 24 hours after taking the second dose of Fosfosoda.

Weak and elderly patients (65 years and older)

Please pay special attention to the instructions in the sections "Be especially careful with Fosfosoda" and "If you are taking other medicines," as well as the instructions on how to take this medicine in section 3 (below). You may need special medical supervision.

Driving and using machines

Do not drive, use machinery, or tools if you feel tired, dizzy, or think you may be dehydrated after taking Fosfosoda. You should stay near a toilet after taking this medicine.

Fosfosoda contains sodium

This medicine contains 5000 mg of sodium (the main component of table salt) per 45 ml dose. This is equivalent to 250% of the maximum recommended daily intake of sodium for an adult. Patients on low-sodium diets should be aware of the potential harm it can cause.

Fosfosoda contains ethanol

This medicine contains 29 mg of alcohol (ethanol) per 45 ml dose. The amount in 45 ml of this medicine is equivalent to less than 0.73 ml of beer or 0.29 ml of wine. The small amount of alcohol in this medicine does not produce any noticeable effect.

Fosfosoda contains sodium benzoate

This medicine contains 15 mg of sodium benzoate (E 211) per 45 ml dose.

3. How to take Fosfosoda

Follow the instructions for administration of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

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• To prevent you from feeling nauseous while taking this medicine, you should drink as much "CLEAR LIQUID" as possible.
• Fosfosoda causes a series of intestinal movements similar to diarrhea. It usually starts to work within 30 minutes and its effect can last up to 6 hours. Please stay near a toilet until the intestinal movements stop.
• If you have not had a bowel movement 6 hours after taking both the first and second doses, you should consult a doctor immediately, as you may become dehydrated.

You should start taking Fosfosoda THE DAY BEFORE your hospital appointment.

How to take your first or second dose

Dilute the contents of onevial (45 ml) of Fosfosoda in half a glass (120 ml) of cold water. Drink it and continue with at least one full glass (240 ml) of cold water. Drink as much "CLEAR LIQUID" as possible to replace the fluids lost during bowel movements.

When to take your first or second dose

Please read the instructions below, depending on the time of your hospital appointment.

If you do not follow these instructions completely, it may not be possible to perform your examination or surgery.

MORNING APPOINTMENT. 8:00 – 12:00 HOURS

DAY BEFORE APPOINTMENT

At 7:00 am, drink at least one full glass (240 ml) of "CLEAR LIQUID" for breakfast. You can drink more if you want.

Immediately after, take yourfirst dose (see description above).

At 1:00 pm, drink at least three full glasses (720 ml) more of "CLEAR LIQUID" for lunch. During the afternoon, you can continue drinking "CLEAR LIQUID" when you are thirsty.

At 7:00 pm, drink at least one full glass (240 ml) of "CLEAR LIQUID". You can drink more if you want.

Immediately after, take yoursecond dose (see description above).

You can continue drinking "CLEAR LIQUID" until midnight when you are thirsty. If you drink "CLEAR LIQUID" after midnight, you may have to go to the bathroom several times, which may prevent you from sleeping.

AFTERNOON APPOINTMENTS. 12:00– 17:00 HOURS

DAY BEFORE APPOINTMENT

At 1:00 pm, have a light meal, such as broth and a sandwich. Do not take any more solid food until after your hospital appointment. During the afternoon, you can drink "CLEAR LIQUID" when you are thirsty.

At 7:00 pm, drink at least one full glass (240 ml) of "CLEAR LIQUID" for dinner. You can drink more if you want.

Immediately after, take yourfirst dose (see description above).

During the afternoon, you should drink at least three more full glasses (720 ml) of water or "CLEAR LIQUID" before bedtime.

DAY OF APPOINTMENT

At 7:00 am, drink at least one full glass of "CLEAR LIQUID" for breakfast. You can drink more if you want.

Immediately after, take yoursecond dose (see description above)

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After your hospital appointment, make sure you drink plenty of fluids to replace what you have lost while taking Fosfosoda.

If you take more Fosfosoda than you should

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.

You may become dehydrated, have heart and circulation problems, have breathing difficulties, feel anxious, or have colic-like pains.

If you forget to take Fosfosoda

Please consult your doctor. Do not take a double dose to make up for forgotten doses.

4. Possible side effects

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

Very rarely, Fosfosoda can cause severe allergic reactions with or without a rash. Tell your doctor immediately or contact the emergency department of your nearest hospital if your hands, face, lips, throat, or tongue start to swell or if you have difficulty breathing or swallowing.

Other possible side effects of Fosfosoda:

Very common(may affect more than 1 in 10 people)

Discomfort, abdominal pain, bloating, and 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

Rare(may affect up to 1 in 1,000 people)

Elevated calcium levels in the kidneys

Very rare(may affect up to 1 in 10,000 people)

Heart attack, palpitations, low blood pressure, electrolyte disturbances (which can cause muscle cramps and spasms), cramps, tingling, loss of consciousness, and kidney failure.

Not known(frequency cannot be estimated from the available data)

Hyponatremia (low sodium concentration in the blood, which can cause neurological disorders, such as confusion, coma, or convulsions).

If you think you are experiencing any of the side effects mentioned, or if you notice any side effects not mentioned in this leaflet, tell your doctor or pharmacist.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines Agency's website (www.notificaRAM.es). By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Fosfosoda

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

Do not use this medicine after the expiry date stated on the pack after EXP. The expiry date is the last day of the month shown.

Do not store above 25 °C.

Once the pack is opened, use immediately. Discard the unused solution.

Medicines should not be disposed of via wastewater or household waste. Return the packs and any unused medicines to a pharmacy for proper disposal. Ask your pharmacist how to dispose of packs and any unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Fosfosoda

• The active ingredients are monosodium phosphate dihydrate 24.4 g and disodium phosphate dodecahydrate 10.8 g per 45 ml dose.
• The other ingredients are: Sodium Benzoate (E211); Sodium Saccharin; Glycerol; Purified Water; Ginger and lemon flavor composed of ginger oleoresin; Alcohol; Lemon essence; Partially deterpenated lemon essence, Citric Acid, and Purified Water.

Appearance of the product and pack contents

Fosfosoda is a clear, colorless oral solution with a ginger and lemon odor, presented in packs containing two or one hundred 45 ml vials closed with screw caps. Each vial contains a dose. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Casen Recordati, S.L., Autovía de Logroño, km 13,300, 50180 Utebo, Zaragoza, Spain

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Denmark: Phosphoral oral opløsning

Finland: Phosphoral oraaliliuos

France: Recholan, solution buvable

Germany: Phospho-soda Lösung zum Einnehmen

Greece: Phospho-soda

Ireland: Phospho-soda oral solution

Netherlands: Phosphoral, drank

Portugal: Phospho-Soda Solução oral

Spain: Fosfosoda solución oral

Sweden: Phosphoral oral lösning

United Kingdom (Northern Ireland): Phospho-soda oral solution

Date of last revision of this leaflet: March 2022

Other sources of information

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