Package leaflet: Information for the patient

Nefrocitran, 1080 mg, modified-release tablets
Potassium citrate
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
If you have any questions, please consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

What Nefrocitran is and what it is used for
Important information before taking Nefrocitran
How to take Nefrocitran
Possible side effects
How to store Nefrocitran
Contents of the pack and other information

1. What Nefrocitran is and what it is used for

The active substance in Nefrocitran is potassium citrate. Potassium citrate is an alkalinizing agent which makes the urine less acidic, thereby reducing the likelihood of kidney stone formation.
Nefrocitran is used:

in the treatment and (or) prevention of kidney stones;
in the treatment of hypocitraturia (a metabolic disorder characterized by low urinary citrate excretion);
in the treatment of renal tubular acidosis (when kidneys fail to excrete acids from the blood into the urine as they should), associated with calcium-containing kidney stones.

2. Important information before using Nefrocitran

When not to use Nefrocitran

if the patient is allergic to potassium citrate or any of the other ingredients of this medicine (listed in section 6)
if the patient has severe kidney function disorders
if the patient has active or chronic urinary tract infections
if the patient has significant or complete obstruction of the urinary tract
if the patient has elevated blood potassium levels (hyperkaliemia)
if the patient has severe heart function disorders
if the patient has uncontrolled diabetes
if the patient has adrenal gland dysfunction
if the patient has disturbed acid-base balance in blood and body fluids (metabolic or respiratory alkalosis)
if the patient has a peptic ulcer
if the patient has a condition in which food remains in the stomach longer than normal (delayed gastric emptying)
if the patient has intestinal obstruction

Warnings and precautions
Before starting treatment with Nefrocitran, discuss this with your doctor or pharmacist,
especially if the patient has:

a condition in which potassium cannot be adequately excreted. Nefrocitran may cause excessive potassium levels in the blood (hyperkaliemia) and cardiac arrest, which may result in death. Your doctor will monitor your condition and perform blood tests every 4 months.
significantly reduced liver function.

Nefrocitran and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken,
as well as any medicines the patient plans to take.
Inform your doctor if the patient is taking:

medicines used to treat high blood pressure, such as aliskiren, candesartan, captopril, digoxin, irbesartan, heparin, indomethacin (NSAID), losartan, mecamylamine, propranolol, valsartan
antidepressants (e.g. amitriptyline, clomipramine, imipramine, nortriptyline, selegiline, rasagiline, safinamide)
stimulants that speed up body functions (amphetamines)
medicines that slow gastrointestinal motility (anticholinergic agents, e.g. biperiden, procyclidine, orphenadrine)
medicines helping kidneys remove excess sodium and water from the body (potassium-sparing diuretics, e.g. amiloride, spironolactone, triamterene, eplerenone)
medicines that neutralize stomach acid used to treat heartburn, indigestion, etc. (aluminum hydroxide)
a medicine used to treat symptoms of Parkinson's disease (amantadine)
hormonal contraceptives or medicines used in menopausal hormone therapy (drospirenone)
a medicine used to treat chronic kidney disease associated with type 2 diabetes (finerenone)
a medicine used to treat dementia (memantine)
a medicine used to treat angina pectoris (nicorandil)
medicines used to treat malaria, leg cramps, and similar conditions (quinine)

Nefrocitran and alcohol
Do not drink alcohol while taking Nefrocitran, as it may cause too rapid release of the medicine in the body.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child,
she should consult her doctor or pharmacist before using this medicine.
Pregnancy
The doctor will recommend this medicine to the patient only if absolutely necessary and under strict medical supervision.
Breastfeeding
Nefrocitran may be used during breastfeeding.
Driving and operating machinery
Nefrocitran does not affect the ability to drive or operate machinery.
Nefrocitran contains potassium
Nefrocitran contains 390 mg of potassium per tablet. This should be taken into account in patients with reduced kidney function or in patients controlling potassium intake in their diet.

3. How to use Nefrocitran

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
The tablets should be taken during a meal or within 30 minutes after a meal to avoid gastrointestinal
discomfort.
The tablets should be swallowed whole with an adequate amount of fluid. Do not take the tablets
with alcohol. The tablets must not be crushed, chewed or dissolved.
The tablets should be taken in combination with a diet low in foods high in salt. During treatment with
Nefrocitran, avoid using table salt in large amounts.
During treatment with Nefrocitran, fluid intake should be increased.
Your doctor will closely monitor your condition and will perform regular blood tests.
Recommended dose:
Severe hypocitraturia (urinary citrate < 150 mg/24 hours):
Initial dose: 6 tablets/day (60 mEq) in 3 divided daily doses.
Mild hypocitraturia (urinary citrate > 150 mg/24 hours):
Initial dose: 3 tablets/day (30 mEq) in 3 divided daily doses.
If necessary, the dose may be increased, provided that the maximum dose of 10 tablets/day (100 mEq)
is not exceeded.
Taking more Nefrocitran than recommended
Seek immediate medical help if you or someone else has taken more tablets of Nefrocitran than recommended,
even if there are no symptoms of discomfort or poisoning.
Symptoms of overdose include, among others: depression, confusion, paresthesia (e.g. tingling, numbness),
muscle weakness and sometimes paralysis of limbs, which may develop gradually or in stages, slow
heart rate (bradycardia), low blood pressure, which in some cases may be severe (leading to irregular
heartbeat, possible myocardial infarction and sudden death).
If you miss a dose of Nefrocitran
If you miss a dose, skip that dose completely. Take the next dose at the usual time. Do not take a double
dose to make up for a missed dose.
Stopping Nefrocitran treatment
Do not stop taking Nefrocitran unless your doctor advises you to do so.
Your doctor will decide when treatment with Nefrocitran should be discontinued.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of these potentially serious adverse reactions occur,
seek immediate medical advice:

Frequency unknown (frequency cannot be estimated from the available data)

Burning sensation and discomfort in the lower abdomen, mild nausea, vomiting, loss of appetite, and weakness due to damage to the gastric mucosa
Vomiting blood and (or) black stools due to gastrointestinal bleeding
Constipation, vomiting, inability to pass stools or gas, abdominal distension due to intestinal obstruction
Muscle weakness, confusion, speech difficulties due to high levels of potassium in the blood (hyperkalemia)
Reversible circulatory arrest

Other possible adverse reactions:
Very common (may affect more than 1 in 10 people)

Abdominal pain

Common (may affect up to 1 in 10 people)

Upper abdominal pain
Diarrhea
Indigestion
Nausea
Vomiting
Gas (bloating, belching, flatulence)

Patients may notice remnants of the tablet's wax matrix in the stool. This is normal and should not be a cause for concern.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store the medicine Nefrocitran

Keep the medicine out of the sight and reach of children.
There are no special storage temperature requirements for this medicine. Store in the original
packaging to protect from moisture.
Do not use this medicine after the expiry date stated on the carton and bottle label after "EXP". The expiry date refers to the last day of the stated month.
"Lot" means batch number.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Nefrocitran contains

The active substance is potassium citrate. Each tablet contains 1080 mg of potassium citrate (10 milliequivalents (mEq)), corresponding to 390 mg of potassium.
The other ingredients are carnauba wax and magnesium stearate.

What Nefrocitran looks like and contents of the pack
Oval, biconvex, uncoated, speckled tablets, of an uneven colour ranging from cream to yellow (length: 18.5 mm ± 0.2 mm, width: 8.5 mm ± 0.1 mm).
Pack size: 100 modified-release tablets.
The tablets are packed in a plastic bottle closed with a cap equipped with a tamper-evident ring and an inner plug. The bottle is placed in a cardboard box.
Marketing Authorisation Holder and Manufacturer:
Tarchomin Pharmaceutical Works ,,Polfa” Joint Stock Company
A. Fleminga Street 2
03-176 Warsaw
Telephone number: (22) 811-18-14
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Malta, Poland: Nefrocitran
Bulgaria: Nefromeltar
Hungary: Renocitar 1080 mg módosított hatóanyagleadású tabletta
Latvia: Potassium citrate TZF 1080 mg modificētās darbības tabletes
Lithuania: Potassium citrate TZF 1080 mg modifikuoto atpalaidavimo tabletės