Prospecto:Information for the User

Sorbisterit

Oral/Rectal Suspension Powder

Calcium Polystyrene Sulfonate

Read this prospect carefully before starting to use this medication, as it contains important information for you.

Sorbisterit is used in the treatment of hyperkalemia (elevated potassium levels in the blood), in patients with kidney problems and in patients undergoing dialysis (removal of waste products from the blood). Sorbisterit is a cation exchange resin (an insoluble structure that releases certain ions and exchanges them for others) that exchanges potassium for calcium in the intestine. As a result, it reduces the supply of potassium to the blood.

No use Sorbisterit

• If yourblood contains too little potassium, manifesting in aserious way bymuscle cramps or muscle weakness and fatigue
• If yourblood contains too much calcium
• If you areallergic to resins containing polystyrene sulfonate calcium or any of the other componentsof this medication (listed in section 6).
• If you haveconstipation or complete obstruction of the intestine
• If sorbitol (a laxative) is being administered
• Innewborns by oral route
• Innewborns 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.

Your blood electrolyte levels must be checked every day.

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

Children

Special caution is necessary when used in children and newborns, as a too high dose or incorrect dilution may cause the resin to have too strong an effect. Particular caution should be exercised in individuals with low body weight, especially in newborns, due to the appearance of gastrointestinal bleeding and the risk of colon tissue death (necrosis).

Other medications and Sorbisterit

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

You must avoidconcomitant administrationwith othermedications administered orally. Sorbisterit must be taken at least three hours before or three hours after taking other oral medications. For patients with gastroparesis, a separation of six hours 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)
• Medications containingpotassium
• Laxatives or antacids, 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:a antidepressant, as its intake may be reduced by Sorbisterit.
• L-thyroxine:Sorbisterit reduces 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 remove fluids from tissues, such as hydrochlorothiazide (thiazide diuretics) or furosemide or torsemide (loop diuretics)
• Certain typesof medications affecting nerve cells or nerve fibers(anticholinergics) as there is an increased risk of Sorbisterit side effects in the stomach.

Use of Sorbisterit with food and drinks

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

Pregnancy and lactation

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

You should not use Sorbisteritduring pregnancy or lactation, unless your doctor considers it essential.

Driving and operating machinery

No known effects on the ability to drive or operate machinery.

Sorbisterit contains saccharose

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

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

The duration of treatment depends on the daily measurements of the potassium level in the blood.

The recommended dose is:

Oral use

• Adults and elderly people:

1 teaspoonful (20 g of powder) 1-3 times a day, shaken well in about 150 ml of liquid.

• Children::

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

Possible liquids are water, tea, or refreshing drinks. Sorbisterit must be administered with the main meals with the upper part of the body in an upright position.

Administration with other oral medications should be avoided (see section 2).

Rectal use

• Adults and elderly people::

After using an enema, 2 teaspoonfuls 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 is dispersed in 150 ml of 5% glucose solution and administered, at least, in three divided doses over a period of 24 hours. Six hours after rectal administration, the colon must be irrigated to eliminate 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 may cause a reduced level of potassium in the blood (hypokalemia) with symptoms of cramps, discomfort in the legs while sitting, extreme body weakness, and in some cases paralysis. An abnormal heart rhythm may occur. Other adverse effects of an overdose may be an elevated level of calcium in the blood (hypercalcemia) with symptoms such as fatigue, muscle weakness, frequent urination, constipation, abnormal heart rhythm, kidney failure, or coma. Additionally, an overdose may cause constipation, complete intestinal blockage, and fluid accumulation.

If you forgot to use Sorbisterit

Consult your doctor or pharmacist

Do not take a double dose to compensate for the missed doses

If you interrupt the treatment with Sorbisterit

This may cause an increase in the potassium content in the blood.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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

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 available data

Common:

• Too much calcium in the blood
• Too little potassium in the blood, manifested in a severe form by muscle cramps or muscle weakness and fatigue
• Too little magnesium in the blood
• Nausea
• Vomiting

Uncommon:

• Constipation
• Dysentery
• Stomach ulcers
• Damage to the colon, which may cause a perforation of the intestine (sometimes with fatal outcome)
• Loss of appetite
• Intestinal blockage

Rare:

• Complete intestinal blockage, as a result in severe cases of
• • Accumulation of the resin in the intestine
  • “Thickening” of the stools after rectal use in children
  • Formation of plugs after oral use in newborns
• Bleeding from the anus after rectal use in premature and low-birth-weight infants has been observed.

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 medicine.

Frequency not known:

• Inadequate blood supply to the stomach or intestine
• Intense stomach pain, rectal pain
• Black, bloody, or tar-like stools, coughing up blood or vomiting that looks like “coffee grounds”

If you use it orally, you may have difficulty swallowing the large amount of dissolved powder.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse,even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSpanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Keep the container perfectly closed to protect it from moisture.

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

Expiration after first opening: 3 months.

Medicines should not be thrown into the drains or trash.Dispose of the containers and medicines you no longer need at the SIGRE collection point of the pharmacy.If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Composition of Sorbisterit:

• Theactive principle is calcium polystyrenesulfonate.1 gof Sorbisterit contains759 to949 mg of calcium polystyrenesulfonate. 20 g of Sorbisterit contain15.18 to18.98 gof calcium polystyrenesulfonate
• The other components are sugar and citric acid.

Appearance of the product and contents of the packaging

Sorbisterit is a fine powder of cream to light brown color and is available in a500 gcontainer with a measuring spoon.

Holder of the marketing authorizationand manufacturer

Holder of the marketing authorization

Fresenius Medical Care Nephrologica Deutschland GmbH

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

Manufacturer

Fresenius Medical Care Deutschland GmbH

Else-Kröner-Straße 1

61352 Bad Homburgv.d.H., Germany

Local representative

Vifor Fresenius Medical Care Renal Pharma España S.L.

Avenida Diagonal 613

Barcelona 08028 - Spain

Last review date of this leaflet: 08/2023

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.