PATIENT INFORMATION LEAFLET

Fosfosoda24.4 g/10.8 goral solution

Monosodium phosphate dihydrate, Disodium phosphate dodecahydrate

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the pack and additional information

Fosfosoda is an intestinal evacuant that acts by increasing the water content of its stools. It is a solution that you can drink and comes in containers with two 45 ml bottles. Each bottle 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 for adults

Do not take Fosfosoda if

• You are allergic to sodium phosphate dodecahydrate, dihydrogen sodium phosphate dihydrate, or any of the other components of this medication (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 (ascitis).
• You know or suspect you have an intestinal obstruction, perforation, or paralysis.
• You have a hereditary or acquired megacolon.
• You have active inflammatory bowel disease.
• You have overactive thyroid glands (hyperparathyroidism).

Do not take Fosfosoda in combination with other laxatives 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 with Fosfosoda

• If you are weak or elderly (65 years or older).
• If you have heart or kidney disease.
• If you have electrolyte imbalances or are at risk of these imbalances, 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 (surgical procedure in which a portion of the colon or ileum is exposed through an opening in the abdominal wall).
• If you have had another type of surgery or operation in the stomach or intestine.
• If you are on a low-sodium 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 at any time. Fosfosoda may slightly alter your heart rhythm due to electrolyte imbalances, so you may need direct medical supervision during your treatment.

You should be aware that after taking Fosfosoda, you will have frequent liquid stools. You should drink as much of the "CLEAR LIQUID" (see Section 3) as possible to avoid dehydration.

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

Other medications and Fosfosoda

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, especially if you are taking medications for:

• Treating high blood pressure or angina (for example, calcium channel blockers, angiotensin-converting enzyme inhibitors (ACEIs), and angiotensin receptor blockers (ARBs)),
• Diuretics to increase urine excretion,
• Non-steroidal anti-inflammatory drugs (NSAIDs), such as aspirin,
• Certain medications for mental disorders (those containing lithium),
• Other medications that may dehydrate you or alter the levels of salts (potassium, sodium, phosphate, or water) in your body (electrolyte balance),
• Medications that affect heart rhythm,
• Medications containing parathyroid hormone,
• Medications taken orally: for example, oral contraceptives and antiepileptics, antidiabetics, or antibiotics, because Fosfosoda may reduce or even cancel the availability of these medications in your body, making their effect less or even canceling it.

Consult your doctor or pharmacist if you have any doubts.

Taking Fosfosoda with food and drinks

See section 3 of this prospectus

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medication.You should not take this medication 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 the first dose until 24 hours after taking the second dose of the intestinal evacuant solution. Do not breastfeed your child for 24 hours after taking the second dose of Fosfosoda.

People with weakened immune systems and the elderly (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 medications” as well as the instructions on how to take this medication in section 3 (below). You may need special medical supervision.

Driving and operating machinery

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

Fosfosoda contains sodium

This medication contains 5000 mg of sodium (main component of table salt/for cooking) in each 45 ml dose. This is equivalent to 250% of the recommended daily maximum sodium intake for an adult. Patients on low-sodium diets (low-sodium diets) should be aware of the potential harm.

Fosfosoda contains ethanol

This medication contains 29 mg of alcohol (ethanol) in each 45 ml dose. The amount in 45 ml of this medication is equivalent to less than0.73 mlof beer or0.29 mlof wine.The small amount of alcohol in this medication has no perceptible effect.

Fosfosoda contains sodium benzoate

This medication contains 15 mg of sodium benzoate (E 211) in each 45 ml dose.

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

?Before starting to take Fosfosoda until after your examination, it is essential that you only drink “CLEAR LIQUID”. Do not take any solid food. “CLEAR LIQUID” is water; clear broth or filtered broth to eliminate any solids; fruit juices without pulp (but not red or purple); black tea or coffee only and refreshing drinks with or without gas, for example, lemonade.

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

How to take your first or second dose

Dissolve the contents ofonebottle (45 ml) of Fosfosoda in half a glass (120 ml) of cold water. Drink it and continue with at least a full glass (240 ml) of cold water. Drink as much “CLEAR LIQUID” as possible to replenish the lost liquids 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.

HOSPITAL APPOINTMENT IN THE MORNING. 8.00 – 12.00 HOURS

DAY BEFORE THE APPOINTMENT

At7 in the morning,drink at least a full glass (240 ml) of a “CLEAR LIQUID” for breakfast. You can drink more if you want.

Immediately after take yourfirst dose (see previous description).

At1 in the afternoon,drink at least three full glasses (720ml) more of “CLEAR LIQUID” for lunch. During the afternoon, you can continue drinking “CLEAR LIQUID” when you feel thirsty.

At7 in the evening,drink at least a full glass (240ml) of “CLEAR LIQUID”. You can drink more if you want.

Immediately after take yoursecond dose (see previous description).

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

HOSPITAL APPOINTMENTS IN THE AFTERNOON. 12.00– 17.00 HOURS

DAY BEFORE THE APPOINTMENT

At1 in the afternoon,have a light meal, for example, broth and a sandwich. Do not take any more solid fooduntil after your hospital appointment. During the afternoon, you can drink “CLEAR LIQUID” if you feel thirsty.

At7 in the evening,drink at least a full glass (240ml) of “CLEAR LIQUID” for dinner. You can drink more if you want.

Immediately after take yourfirst dose (see previous description).

During the afternoon, you must drink at least three more full glasses (720ml) of water or “CLEAR LIQUID” before going to bed.

DAY OF THE APPOINTMENT

At7 in the morning,drink at least a full glass of a “CLEAR LIQUID” for breakfast. You can drink more if you want.

Immediately after take yoursecond dose (see previous description).

You can continue drinking “CLEAR LIQUID” until 8 in the morning when you feel thirsty. If you drink “CLEAR LIQUID” after 8 in the morning, you may have to go to the bathroom several times, which may cause you difficulties in attending your hospital appointment.

After your hospital appointment, make sure you drink a lot of liquid to replenish the one you 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

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

If you forgot to take Fosfosoda

Please consult your doctor.Do not take a double dose to compensate for the missed doses..

Like all medications, this medication may produce adverse effects, although not all people will experience them.

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

Other possible adverse effects of Fosfosoda:

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

Discomfort, abdominal pain, swelling, and diarrhea, chills, weakness, and dizziness.

Frequent(may affect up to 1 in 10 people)

Vomiting, chest pain, and headache

Infrequent(may affect up to 1 in 100 people)

Dehydration

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

Increased levels of calcium in the kidneys

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

Heart attack, palpitations, low blood pressure, alterations in the amount of salts (electrolytes) in the blood (which may cause muscle cramps and spasms), muscle cramps, numbness, loss of consciousness, and kidney failure.

Unknown(the frequency cannot be estimated from the available data)

Hypontremia (low sodium levels in the blood that may cause neurological disorders, such as confusion, coma, or seizures).

If you consider that any of the adverse effects you experience are severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use (www.notificaRAM.es). By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

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

Do not store at a temperature of more than25 °C.

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

Medications should not be disposed of through drains or in the trash. Deposit containers and medications that you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of containers and medications that you no longer need. In this way, you will help protect the environment.

Composition of Fosfosoda

• The active principles are monosodium dihydrogen phosphate24.4 gand disodium dodecahydrogen phosphate10.8 gper dose of 45 ml.
• The other components are: Sodium Benzoate (E211); Sodium Saccharin; Glycerol; Purified Water; Ginger and Lemon Aroma composed of ginger oleoresin; Alcohol; Lemon Essence; Partially de-esterified Lemon Essence, Citric Acid and Purified Water.

Appearance of the product and contents of the packaging

Fosfosoda is a clear and colorless oral solution with a ginger and lemon odor, presented in containers that contain two to one hundred 45 ml bottles closed with screw-top caps. Each bottle contains a dose.Only some sizes of packaging may be marketed.

Holder of the marketing authorization and responsible for manufacturing

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) with the following names:

Denmark: Phosphoral oral solution

Finland: Phosphoral oral solution

France: Recholan, oral solution

Germany: Phospho-soda solution for oral use

Greece: Phospho-soda

Ireland: Phospho-soda oral solution

Netherlands: Phosphoral, drink

Portugal: Phospho-Soda Oral Solution

Spain: Fosfosoda oral solution

Sweden: Phosphoral oral solution

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

Last review date of this leaflet:March 2022

Other sources of information

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