Litocid

PATIENT INFORMATION LEAFLET: USER INFORMATION

LITOCID ®

(Potassium Citrate)
680 mg, tablets with modified release

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Litocid and what is it used for
• 2. Important information before taking Litocid
• 3. How to take Litocid
• 4. Possible side effects
• 5. How to store Litocid
• 6. Contents of the pack and other information

1. What is Litocid and what is it used for

The active substance in Litocid is potassium citrate. The form of the medicine causes slow release of the active substance. Citrates are known as a group of chemical compounds that act as inhibitors of kidney stone formation, which includes calcium. This is possible due to the reduction of urine saturation with calcium stone-forming salts. Citrates slow down the growth of calcium oxalate and calcium phosphate crystals and alkalize the urine. The medicine is absorbed from the gastrointestinal tract in 90% of the administered dose. Taking the medicine before or after meals does not have a significant effect on its bioavailability. When taken orally, citrates are largely metabolized, mainly in the intestinal wall. A small portion (from 1 to 10%) of the standard therapeutic dose of citrates administered passes into the bloodstream and is then excreted in the urine. The dicarboxylates produced by the metabolism of citrates are an alkalizing factor that causes the release of the rate of endogenous citrate utilization in the tricarboxylic acid cycle and increases their excretion by the kidneys. A single dose of potassium citrate in a slow-release form causes an increase in citrate excretion within 1 to 10 hours after its ingestion (there is, however, a large individual variability). The indication for the use of Litocid is:

• calcium kidney stones in patients with low citrate excretion in the urine,
• distal renal tubular acidosis, metabolic acidosis in chronic renal failure, without significant reduction of daily urine output and without hyperkalemia,
• potassium deficiency in the body,
• other pathological conditions requiring chronic urine alkalization.

2. Important information before taking Litocid

When not to take Litocid

Do not take Litocid in the following cases:

• hyperkalemia (elevated potassium levels in the blood),
• local and generalized hemostasis disorders (including blood coagulation disorders, vascular diseases),
• urinary tract infections,
• alkalosis, especially metabolic,
• phosphate-ammonium-magnesium stones and mixed forms of kidney stones with a predominance of phosphate-ammonium-magnesium, especially with concomitant urinary tract infection,
• chronic renal failure (glomerular filtration rate less than 0.7 ml/kg/min), especially in moderate to terminal stages,
• gastritis and duodenitis, as well as active peptic ulcer disease, gastrointestinal bleeding,
• diseases in which the passage of the tablet through the gastrointestinal tract is slowed down, such as delayed gastric emptying, esophageal compression, intestinal obstruction or narrowing, as well as in the case of anticholinergic treatment,
• planned surgical procedure within the next 2 days, especially those associated with a high risk of significant blood loss.

Warnings and precautions

Be particularly cautious when taking Litocid, as breaking or chewing the tablet accelerates the release of the medicine and may intensify its potential irritating effect on the stomach wall. Due to this, it is recommended to swallow the tablets whole and drink a large amount of fluid. During treatment, it is recommended to monitor the acidity of the urine. Measurements should be performed in freshly collected urine 3-4 times a day (the most important is the morning measurement) - it is recommended to maintain the urine pH in the range of 6.5-7.0. Based on the results obtained, the dose of the medicine should be adjusted in consultation with a doctor. At the same time, the presence of urinary tract infections, which may prevent a proper assessment of the effect of citrates on urine pH, should be excluded. One of the ways to control the need for the medicine may also be the measurement of daily citrate excretion in the urine, the recommended excretion value is above 500 mg/day (or concentration in urine higher than 350 mg/l - important when urine excretion is less than 1.5 l/day). Taking doses of the medicine that cause citrate excretion in the urine in an amount exceeding 1200 mg/day does not bring significant benefits. The most important thing for treatment and prevention of kidney stones is taking the medicine in the evening (before sleep) and in the morning (after waking up). Litocid should be one of the elements of the therapeutic scheme developed by the doctor, including care for the excretion of the appropriate amount of urine, dietary recommendations, cyclic urine and blood tests. It should be remembered that in most of the indicated cases, the medicine should be used for a long time, even many years. Uncontrolled, even short-term (1-2 days), interruption of treatment (without consulting a doctor) may cancel the positive effects of long-term therapy and cause a relapse or exacerbation of kidney stone symptoms. Do not take higher doses than recommended. Consult a doctor also if the above symptoms have occurred in the past.

Litocid with food, drinks, and alcohol

Taking the medicine immediately after a meal may alleviate potential gastrointestinal irritation. During the use of the medicine, do not drink alcoholic beverages.

Litocid in patients with renal or hepatic impairment

In patients with mild renal impairment or a tendency to higher potassium levels in the blood, treatment should be carried out under the supervision of a nephrologist. It is necessary to monitor the levels of creatinine and potassium in the blood and possibly limit the consumption of foods rich in potassium (tomatoes, oranges, fruit compotes).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before taking this medicine. The safety of using the medicine during pregnancy and breastfeeding has not been sufficiently documented. Treatment may be continued only under the control of a gynecologist and nephrologist. The daily dose should be determined anew based on tests.

Driving and using machines

The medicine, when used as recommended, does not affect the ability to drive vehicles and operate machines.

Litocid and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have recently taken, as well as any medicines you plan to take. Potassium citrate should not be administered with aluminum and magnesium hydroxide, eplerenone (selective aldosterone blocker), and methenamine. Consult a doctor when taking Litocid with potassium-sparing diuretics, opioids, ephedrine (a component of cough syrup), and pseudoephedrine (a component of tablets for colds and cough syrups), anticoagulants, macrolide antibiotics, tricyclic antidepressants, medicines that alkalize or acidify the urine (e.g., Phytolysin, Citropepsin, Alugastrin). Additionally, due to the increased risk of hyperkalemia, special caution should be exercised when taking Litocid with ACE inhibitors and angiotensin II receptor antagonists.

3. How to take Litocid

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist. In adults with average body weight, treatment should be started with oral administration 3 times a day, 2 tablets (50 mg/kg body weight) at regular intervals (on average every 8 hours). The maximum dose, individually for each patient, is determined based on urine pH and/or the amount of citrate excreted in the urine.

Use in children

There is no proper indication for the use of Litocid in children.

Taking a higher dose of Litocid than recommended

The minimum toxic dose has not been established. Potassium salts administered to patients with normally functioning kidneys usually show minimal toxicity. Nausea, vomiting, weakness, numbness of limbs, pallor, hypotension, muscle cramps, and arrhythmias (heart rhythm disorders) may occur. Low doses of potassium salts can be toxic to patients with renal failure. In these patients, metabolic alkalosis (alkalosis) may also occur. Overdose of potassium citrate may lead to hyperkalemia. Symptomatic treatment is recommended, depending on the disorders found by the doctor, as well as drinking more water than usual within the next 12-24 hours. If the medicine has been taken no more than half an hour ago, an attempt should be made to induce vomiting. In case of signs of bleeding, the administration of drugs that strengthen blood vessels and vitamin K is helpful. Symptoms of gastrointestinal irritation should be alleviated using drugs that create a protective barrier on the surface of the gastric mucosa (e.g., preparations containing sucralfate) or possibly drugs that block H receptors (e.g., preparations containing ranitidine). Great caution should be exercised when considering the use of other medicines that alkalize the stomach contents. Mild alkalosis can be treated (in outpatient settings) using vitamin C and/or cranberry juice, after consulting a nephrologist. If you have taken more than the recommended dose of the medicine, seek medical attention immediately.

Missing a dose of Litocid

Take the missed dose as soon as possible, unless it is already time for the next dose. Do not take a double dose to make up for the missed dose.

4. Possible side effects

Like all medicines, Litocid can cause side effects, although not everybody gets them. The frequency of possible side effects listed below is defined as follows:

• very common: (occurring in more than 1 in 10 people);
• common: (occurring in 1 to 10 people in 100);
• uncommon: (occurring in 1 to 10 people in 1,000);
• rare: (occurring in 1 to 10 people in 10,000);
• very rare: (occurring in less than 1 in 10,000 people);
• not known: (frequency cannot be estimated from the available data).

General disorders and administration site conditions
Very rare: upper gastrointestinal irritation (especially when taken on an empty stomach and without drinking water) - vomiting, nausea, heartburn, feeling of fullness in the right upper quadrant.
Vascular disorders
Worsening of venous insufficiency of the lower limbs, manifestation or worsening of symptoms of bleeding disorders.
Respiratory, thoracic, and mediastinal disorders
In people with a tendency to hyperventilation (most often expressed as rapid and deep breathing), it is possible to intensify the resulting clinical symptoms (e.g., dizziness, fainting). If the described symptoms occur during the use of the preparation, the medicine should be discontinued and medical attention should be sought immediately. In some people, during the use of Litocid, other side effects may occur.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49-21-301; fax: +48 22 49-21-309, e-mail: [email protected]. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Litocid

Keep the medicine out of the sight and reach of children. Store in a temperature below 25°C. Store in the original packaging to protect from moisture. Do not use this medicine after the expiry date stated on the carton and blister pack. The expiry date refers to the last day of the month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Litocid contains

The active substance is potassium citrate. The other ingredients are carbomer 974 P, carbomer 971 P, magnesium stearate, povidone, talc.

What Litocid looks like and contents of the pack

White, round, biconvex tablet. Available packaging: HDPE or LDPE container with a PE cap containing a desiccant, in a cardboard box, containing 100 tablets and a patient information leaflet.

Marketing authorization holder and manufacturer

LABOR Pharmaceutical-Chemical Company Ltd. ul. Długosza 49, 51-162 Wrocław, tel.: +48 71 325 30 85, fax: +48 71 326 14 57, e-mail: [email protected]

Date of leaflet approval: