Resincalcio is an ion-exchange resin that is recommended for the treatment of hyperkalaemia.

Posology
Resincalcio is for oral or rectal administration only.
The dosage recommendations detailed below are a guide only; the precise requirements should be decided on the basis of regular serum electrolyte determinations.
Adults, including the elderly:
Oral
The usual dose is 15 g three or four times a day. Each dose should be given as a suspension in a small amount of water or, for greater palatability, in syrup (but not fruit juices which contain potassium), in the ratio of 3 to 4 ml per gram of resin.
Administer Resincalcio at least 3 hours before or 3 hours after other oral medications. For patients with gastroparesis, a 6 hour separation should be considered (see sections 4.4 and 4.5).
Rectal
This route should be reserved for the patient who is vomiting or who has upper gastrointestinal tract problems, including paralytic ileus or it may be used simultaneously with the oral route for more rapid initial results. The resin may be given rectally as a suspension fo 30 g resin in 150 ml of water or 10% dextrose, as a daily retention enema. In the initial stages administration by this route as well as orally may help to achieve a rapid lowering of the serum potassium level.
The enema should, if possible, be retained for at least nine hours, then the colon should be irrigated to remove the resin. If both routes are used initially it is probably unnecessary to continue rectal administration once the oral resin has reached the rectum.

Paediatric population
Children:
OralIn smaller children and infants, correspondingly smaller doses should be employed by using as a guide a rate of 1mEq of potassium per gram of resin as the basis for calculation. An appropriate initial dose is 1 g/kg body weight daily in divided doses, in acute hyperkalaemia. Dosage may be reduced to 0.5 g/kg body weight daily in divided doses for maintenance therapy.
The resin is given orally, preferably with a drink (not a fruit squash because of the high potassium content) or a little jam or honey.
Rectal
When refused by mouth it should be given rectally using a dose at least as great as that which would have been given orally, diluted in the same ratio as described for adults. Following retention of the enema, the colon should be irrigated to ensure adequate removal of the resin.
Neonates:
Resincalcio should not be given by the oral route. With rectal administration, the minimum affective dosage within the range 0.5 g/kg to 1 g/kg should be employed, diluted as for adults with adequate irrigation to ensure recovery of the resin.

- In patients with plasma potassium levels below 5 mmol/litre. - Conditions associated with hypercalcaemia (e.g. hyperparathyroidism, multiple myeloma, sarcoidosis or metastatic carcinoma). - History of hypersensitivity to polystyrene sulfonate resins. - Obstructive bowel disease. - Resincalcio should not be administered orally to neonates and is contraindicated in neonates with reduced gut motility (post-operatively or drug induced). - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Binding to other orally administered medications: Resincalcio may bind to orally administered medications, which could decrease their gastrointestinal absorption and efficacy. Avoid co-administration of Resincalcio with other orally administered medications. Administer Resincalcio at least 3 hours before or 3 hours after other oral medications. For patients with gastroparesis, a 6-hour separation should be considered (see sections 4.2 and 4.5).
Sorbitol: Gastrointestinal stenosis, intestinal ischemia and its complications (necrosis and perforation) may occur in patients treated with polystyrene sulfonate, especially in patients using sorbitol. Therefore, concomitant use of Sorbitol with calcium polystyrene sulfonate is not recommended (see section 4.5 and section 4.8).
Hypokalaemia: The possibility of severe potassium depletion should be considered, and adequate clinical and biochemical control is essential during treatment, especially in patients on digitalis. Administration of the resin should be stopped when the serum potassium falls to 5 mmol/litre.
Other electrolyte disturbances: Like all cation-exchange resins, calcium polystyrene sulfonate is not totally selective for potassium. Hypomagnesaemia and/or hypercalcaemia may occur. Accordingly, patients should be monitored for all applicable electrolyte disturbances. Serum calcium levels should be estimated at weekly intervals to detect the early development of hypercalcaemia, and the dose of resin adjusted to levels at which hypercalcaemia and hypokalaemia are prevented.
Other risks: In the event of clinically significant constipation, treatment should be discontinued until normal bowel movement has resumed. Magnesium-containing laxatives should not be used (see section 4.5).

The patient should be positioned carefully when ingesting the resin, to avoid aspiration, which may lead to bronchopulmonary complications.
Children: In neonates, calcium polystyrene sulfonate should not be given by the oral route. In children and neonates, particular care is needed with rectal administration as excessive dosage or anadequate dilution could result in impaction of the resin. Due to the risk of digestive haemorrhage or colonic necrosis, particular care should be observed in premature infants or low birth weight infants.

Orally adminstered medications
Resincalcio has the potential to bind to other orally administered medications. Binding of Resincalcio to other oral medications could cause decrease in their gastrointestinal absorption and efficacy. Dosing separation of Resincalcio from other orally administered medications is recommended (see sections 4.2 and 4.4).
Concomitant use not recommended
Sorbitol (oral or rectal): Concomitant use of Sorbitol with calcium polystyrene sulfonate is not recommended due to cases of intestinal necrosis and other serious gastrointestinal adverse reactions, which may be fatal (see section 4.4 and section 4.8).
To be used with caution
Cation-donating agents: may reduce the potassium binding effectiveness of Resincalcio.
Non-absorbable cation-donating antacids and laxatives: There have been reports of systemic alkalosis following concurrent administration of cation-exchange resins and non-absorbable cation-donating antacids and laxatives such as magnesium hydroxide and aluminium carbonate.
Aluminium hydroxide: Intestinal obstruction due to concretions of aluminium hydroxide has been reported when aluminium hydroxide has been combined with the resin (sodium form).
Digitalis-like drugs: The toxic effects of digitalis on the heart, especially various ventricular arrhythmias and A-V nodal dissociation, are likely to be exaggerated if hypokalaemia and/or hypercalcaemia are allowed to develop (see section 4.4).
Lithium: Possible decrease of lithium absorption.
Levothyroxine: Possible decrease of levothyroxine absorption.

Pregnancy
There are no data from the use of calcium polystyrene sulfonate in pregnant women. Resincalcio should not be used during pregnancy unless the potential benefit outweighs any potential risk to the foetus.
Lactation
No data are available concerning the use of polystyrene sulfonate resins in humans during lactation. Resincalcio should not be used during breast-feeding unless the potential benefit outweighs any potential risk.
Fertility
There is no data available on fertility.

There is no specific warnings.

The undesirable effects are classified as follows:
Very common (≥1/10)
Common (≥1/100 to <1/10)
Uncommon (≥1/1,000 to <1/100)
Rare (≥1/10,000 to <1/1,000)
Very rare (<1/10,000)
Not known (cannot be estimated from the available data)
Table 1: Resincalcio Undesirable effects

Metabolism and nutrition disorders	Common	Hypokalaemia, hypercalcaemia, hypomagnesaemia
	Uncommon	Decreased appetite
Respiratory, thoracic and mediastinal disorders	Very rare	Acute bronchitis and/or bronchopneumonia associated with inhalation of particles of calcium polystyrene sulfonate
Gastrointestinal disorders	Common	Nausea, vomiting, constipation
	Uncommon	Diarrhoea, gastric irritation, gastrointestinal ulcer, intestinal obstruction
	Rare	Faecaloma (faecal impaction) following rectal administration particularly in children and gastrointestinal concretions (bezoars) following oral administration. Gastrointestinal necrosis (colon necrosis), which could lead to intestinal perforation which is sometimes fatal. The majority of cases have been reported with concomitant use of Sorbitol (see sections 4.4 and 4.5).

Saudi Arabia:
- The National Pharmacovigilance and Drug Safety Centre (NPC)
Fax: +966-11-205-7662
Call NPC at +966-11-2038222, Exts: 2317-2356-2353-2354-2334-2340
Toll free phone: 8002490000
E-mail: npc.drug@sfda.gov.sa
Website: www.sfda.gov.sa/npc
Other GCC States:
- Please contact the relevant competent authority.

Biochemical disturbances from overdosage may give rise to clinical signs or symptoms of hypokalaemia, including irritability, confusion, delayed thought processes, muscle weakness, hyporeflexia and eventual paralysis. Apnoea may be a serious consequence of this progression. Electrocardiographic changes may be consistent with hypokalaemia or hypercalcaemia; cardiac
CPS/400/B, sa-spc_v01.0 , Jun. 2019 Page 5 of 6
arrhythmia may occur. Appropriate measures should be taken to correct serum electrolytes and the resin should be removed from the alimentary tract by appropriate use of laxatives or enemas.

Pharmacotherapeutic group: All other therapeutic products; Drugs for treatment of hyperkalaemia and hyperphosphatemia, ATC code: V03AE01
Ion-exchange resin.

Not applicable as this product is not absorbed.

There is no preclinical data of relevance to the prescriber, which are additional to those already included in other sections of the SmPC.

Vanilla flavour.

Not applicable.

5 years. Shelf life after first opening the container: 1 month.

Do not store above 30ºC.
After first opening of the container, keep it tightly closed and do not store above 30ºC. Shelf life after first opening of the container is 1 month.

Resincalcio is packaged in:
• Polyethylene multidose container with 400 g of powder, fitted with a screw cap with a safety seal (operculum), and with a measuring spoon of 5 g inside.
• Paper/polyethylene/aluminium/polyethylene sachet containing 15 g of powder. Boxes of 26 sachets.
Not all pack sizes may be marketed.

No special requirements.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.