SORBISTERIT POWDER FOR ORAL/RECTAL SUSPENSION

2. What you need to know before starting to use Sorbisterit

Do not use Sorbisterit

• If your blood contains too little potassium, manifested bysevere muscle cramps or weakness and muscle fatigue
• If your blood contains too much calcium
• If you are allergic to resins containing calcium polystyrene sulfonate or any of the other componentsof this medication (listed in section 6).
• If you have constipation or complete intestinal obstruction
• If you are taking sorbitol (a laxative)
• In newborns by mouth
• In newborns with constipation

Warnings and precautions

Consult your doctor or pharmacist before starting to use Sorbisterit

• If you are going to use it orally, you must be seated to prevent inhalation of the liquid.
• If you have constipation, you must inform your doctor before using this medication.

Every day, your blood electrolyte levels should be checked.

Consult your doctor if any of the above points apply to you or have applied in the past.

Children

Special caution is necessary when using in children and newborns, as an overdose or incorrect dilution can cause the resin to have a too strong effect. Special caution is required in individuals with low body weight, especially in newborns, due to the risk of gastrointestinal bleeding and tissue death in the colon (necrosis).

Other medications and Sorbisterit

Tell your doctorif you are using, have recently used, or may need to use any other medication.

Concomitant administrationwith other orally administered medicationsshould be avoided. Sorbisterit should be taken at least three hours before or three hours after taking other oral medications. For patients with gastroparesis, a six-hour separation should be considered.

You should consult your doctor especially if you are using:

• Sorbitolshould not be used as a laxative, as there is a risk of colon damage (necrosis)
• Potassium-containing medications
• Medications for heartburn or laxatives, such as magnesium hydroxide, aluminum hydroxide, or calcium carbonate
• Medications that increase heart efficiency, such as digoxin (cardiac glycosides), as their action may be increased
• Lithium:an antidepressant, as its intake may be reduced by Sorbisterit.
• L-thyroxine:Sorbisterit reduces the intake and, consequently, the effect of this thyroid medication.
• Medications that interact with calcium:

• Ciprofloxacinoral, an antibiotic whose effect is reduced by Sorbisterit
• Tetracyclineoral, an antibiotic whose effect is reduced by Sorbisterit

• Medications that eliminate fluids from tissues, such as hydrochlorothiazide (thiazide diuretics) or furosemide or torasemide (loop diuretics)
• Certain types of medications that affect nerve cells or nerve fibers(anticholinergics) as there is an increased risk of Sorbisterit side effects in the stomach.

Using Sorbisterit with food and beverages

Sorbisterit should not be taken with fruit juices (e.g., pineapple, grapefruit, orange, tomato, or grape juice) rich in potassium, as this may negatively affect the action of Sorbisterit.

Pregnancy and breastfeeding

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

You should not use Sorbisterit during pregnancy or breastfeeding, unless your doctor considers it essential.

Driving and using machines

There are no known effects on the ability to drive or use machines.

Sorbisterit contains sucrose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to use Sorbisterit

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

The duration of treatment depends on daily measurements of blood potassium levels.

The recommended dose is:

Oral use

• Adults and elderly:

1 measuring spoon (20 g of powder) 1-3 times a day, suspended by shaking in about 150 ml of liquid.

• Children:

0.5 - 1 g of powder per kilogram of body weight per day, suspended by shaking in about 150 ml of liquid. This preparation is administered in at least three divided doses over a 24-hour period.

Possible liquids are water, tea, or soft drinks. Sorbisterit should be administered with the main meals and the upper body in an upright position.

Concomitant administrationwith other orally administered medicationsshould be avoided (see section 2).

Rectal use

• Adults and elderly:

After using an enema, 2 measuring spoons of Sorbisterit (40 g) are dispersed in 150 ml of 5% glucose solution and administered rectally, 1-3 times a day.

Retention time: 6 hours

• Children and newborns:

Rectal administration is performed if Sorbisterit cannot be swallowed. 0.5 - 1 g of powder per kilogram of body weight per day, dispersed in 150 ml of 5% glucose solution, and administered in at least three divided doses over a 24-hour period. Six hours after rectal administration, the colon should be irrigated to remove the resin.

If you notice that the effect of Sorbisterit is too strong or too weak, consult your doctor or pharmacist.

If you use more Sorbisterit than you should

If you have used too much Sorbisterit, inform your doctor or pharmacist immediately. In general, an overdose of Sorbisterit can cause a reduced potassium level in the blood (hypokalemia) with symptoms of cramps, leg discomfort while sitting, extreme body weakness, and occasionally paralysis. There may be an abnormal heartbeat. Other side effects of an overdose may include an elevated calcium level in the blood (hypercalcemia) with symptoms such as fatigue, muscle weakness, frequent urination, constipation, abnormal heartbeat, kidney failure, or coma. Additionally, an overdose can cause constipation, complete intestinal obstruction, and fluid accumulation.

If you forget to use Sorbisterit

Consult your doctor or pharmacist

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

If you stop treatment with Sorbisterit

This may cause an increase in blood potassium levels.

If you have any other questions about using this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Tell your doctor or nurse immediately if you notice any of the following serious side effects:

• Severe stomach pain, rectal pain
• Abdominal distension, severe constipation
• Severe nausea and vomiting
• Black, bloody, or tarry stools, coughing up blood or vomiting that looks like "coffee grounds"

The assessment of side effects was based on the following frequency of data:

Very common: may affect more than 1 in 10 people

Common: may affect up to 1 in 10 people

Uncommon: may affect up to 1 in 100 people

Rare: may affect up to 1 in 1,000 people

Very rare: may affect up to 1 in 10,000 people, including isolated reports.

Frequency not known: cannot be estimated from the available data

Common:

• too much calcium in the blood
• too little potassium in the blood, manifested in severe form by muscle cramps or weakness and muscle fatigue
• too little magnesium in the blood
• nausea
• vomiting

Uncommon:

• constipation
• diarrhea
• stomach ulcers
• colon damage, which can cause intestinal perforation (sometimes with fatal outcome)
• loss of appetite
• intestinal obstruction

Rare:

• complete intestinal obstruction, resulting in severe cases of
• • accumulation of the resin in the intestine
  • "thickening" of the stool after rectal use in children
  • formation of plugs after oral use in newborns
• anal bleeding has been observed after rectal use in premature and low-birth-weight newborns.

Very rare:

• acute inflammation of the respiratory tract, manifested by coughing and vomiting and sputum, and/or a particular type of pneumonia caused by inhalation of this medication.

Frequency not known:

• insufficient blood supply to the stomach or intestine
• severe stomach pain, rectal pain
• black, bloody, or tarry stools, coughing up blood or vomiting that looks like "coffee grounds"

When used orally, you may have difficulty swallowing the large amount of dissolved powder.

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are possible side effects not listed in this prospectus. You can also report them directly through the Spanish Medication Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Sorbisterit

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

Keep the container tightly closed to protect it from moisture.

Do not use this medication after the expiration date shown on the container after EXP. The expiration date is the last day of the month indicated.

Expiration after first opening: 3 months.

Medications should not be disposed of through wastewater or household waste. Deposit the containers and medications you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Sorbisterit composition:

• The active ingredient is calcium polystyrene sulfonate. 1 g of Sorbisterit contains 759 to 949 mg of calcium polystyrene sulfonate. 20 g of Sorbisterit contain 15.18 to 18.98 g of calcium polystyrene sulfonate
• The other ingredients are sugar and citric acid.

Appearance of the product and package contents

Sorbisterit is a fine, cream to light brown powder and is available in a 500 g bottle with a measuring spoon.

Marketing authorization holder and manufacturer

Marketing authorization holder

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Straße 1, 61352 Bad Homburg v.d.H., Germany

Manufacturer

Fresenius Medical Care Deutschland GmbH

Else-Kröner-Straße 1

61352 Bad Homburg v.d.H., Germany

Local representative

Vifor Fresenius Medical Care Renal Pharma España S.L.

Avenida Diagonal 613

Barcelona 08028 - Spain

Date of the last revision of this prospectus: 08/2023

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