URALYT-U dissolving uric acid stones and for metaphylaxis Granules

Pack size:

280g

Dosage form:

granules

Uralyt-U Granules. Active ingredient: potassium sodium hydrogen citrate (6:6:3:5). Indications: for dissolving uric acid stones and for metaphylaxis (prevention of re-formation) of calcium and uric acid stones, or mixed stones made of calcium oxalate/uric acid or calcium oxalate/calcium phosphate.

dissolving uric acid stones and for metaphylaxis

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Uralyt-U Granules for oral solution
Active ingredient: potassium sodium hydrogen citrate (6:6:3:5)

Read the entire package leaflet carefully before you start taking this medicine because it contains important information. Always take this medicine exactly as described in this leaflet or exactly as your doctor or pharmacist has told you.

• Keep this leaflet. You may want to read it again later.
• Ask your pharmacist if you need further information or advice.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
• If you do not feel better or if you feel worse, consult your doctor.

What is in this leaflet:

1. WHAT IS URALYT AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING URALYT?
3. HOW SHOULD URALYT&ndash%%%U BE TAKED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD URALYT&ndash%%%U BE STORED?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS URALYT-U AND WHAT IS IT USED FOR?

Uralyt-U is an alkali citrate anti-urolithiasis agent.

Indications:

• to dissolve uric acid stones.
• for the metaphylaxis (prevention of re-formation) of calcium and uric acid stones, or mixed stones made of calcium oxalate/uric acid or calcium oxalate/calcium phosphate.

Note:
This product should only be used as part of an overall metaphylactic program (e.g., diet, increased fluid intake, etc.).

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING URALYT-U?

Uralyt-U should not be used in cases of acute or chronic kidney failure, a low-salt diet prescribed by a doctor, severe acid-base disturbances (e.g., metabolic alkalosis, elevated blood potassium levels (hyperkalemia)), or urinary tract infections with urea-splitting bacteria. Uralyt-U should not be taken if you are hypersensitive (allergic) to potassium sodium hydrogen citrate, Sunset Yellow FCF (E 110), or any of the other ingredients of Uralyt-U.

Warnings and Precautions:

• Before starting therapy, conditions or diseases that may promote the occurrence of urinary stones and that are amenable to targeted treatment (e.g. adenomas of the parathyroid glands, malignancies in uric acid stones, etc.) should be excluded.
• Before first use, serum electrolytes should be determined and renal function should be monitored. If renal tubular acidosis (RTA) is suspected, the acid-base status should also be monitored.
• Particularly in elderly patients, or in patients with impaired renal function, or during concomitant therapy with certain drugs for high blood pressure (e.g., aldosterone antagonists, angiotensin receptor antagonists (sartans), potassium-sparing diuretics, ACE inhibitors) or for chronic pain (nonsteroidal anti-inflammatory drugs and peripheral analgesics), it should be taken into account that the maximum recommended daily dose is 11.25 g of granules (4.5 level measuring spoons). This corresponds to 1.86 g potassium and 1.09 g sodium, i.e., 47.5 mmol potassium and 47.5 mmol sodium. Interactions with the drugs mentioned here may lead to hyperkalaemia.
• Uralyt should be used with caution in patients with severe liver impairment.
• Sunset Yellow FCF (E 110) may cause allergic reactions. This medicine contains Sunset Yellow FCF (E 110), which may cause allergic reactions in people who are particularly sensitive to this substance.

Children and adolescents:
Treatment of children under 12 years of age is not recommended due to insufficient experience in this age group.

When taking Uralyt-U with other medicines:
An increase in the extracellular potassium concentration reduces the effect of cardiac glycosides; a decrease in it promotes the development of cardiac arrhythmias under cardiac glycosides. Some medicines for high blood pressure (e.g. aldosterone antagonists, angiotensin receptor antagonists (sartans), potassium-sparing diuretics, ACE inhibitors) or for chronic pain (nonsteroidal anti-inflammatory drugs and peripheral analgesics) reduce urinary potassium excretion. Please note that 10 g of Uralyt-U (average daily dose) contains 1.72 g, equivalent to 44 mmol of potassium. If a low-sodium diet is prescribed, please note that 10 g of Uralyt-U (average daily dose) contains 1 g, corresponding to 44 mmol sodium or 2.6 g table salt. Simultaneous administration of substances containing citrate and aluminum (e.g. for heartburn) can lead to increased aluminum absorption. Therefore, if such preparations are required, they should be administered at least 2 hours apart. Please note that this information may also apply to recently used medicines. Inform your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines.

Pregnancy and breastfeeding:
There is insufficient data on the use in pregnant or breastfeeding women. Animal studies have shown no evidence of teratogenic effects. If you are pregnant or breastfeeding, please consult your doctor before taking Uralyt-U.

Driving and operating machinery:
No special precautions are required.

Important information about certain other ingredients of Uralyt-U:
This medicine contains the dye Sunset Yellow FCF (E 110), which may cause allergic reactions, including asthma, in people who are particularly sensitive to this substance. This allergy occurs more frequently in people who are allergic to 2-acetoxybenzoic acid (acetylsalicylic acid).

3. HOW TO TAKE URALYT-U

Always take this medicine exactly as described in this leaflet or as your doctor has told you. Consult your doctor or pharmacist if you are unsure.

To dissolve and prevent the formation of new uric acid stones:
The recommended dose is: Take 4 level measuring spoons (= 10 g of granules) daily in 3 separate doses after meals. Take 1 level measuring spoon in the morning and at lunchtime and 2 level measuring spoons in the evening after meals. The pH of fresh urine should be within the following pH range: Uric acid stones: 6.2 - 6.8. If the pH is below the specified range, increase the daily dose by half a level measuring spoon in the evening. If the pH is above the specified range, decrease the daily dose by half a level measuring spoon in the evening. The correct dose is found when the pH of fresh urine is always within the specified range before taking Uralyt-U. For the metaphylaxis of uric acid stones, regular monitoring of the urine pH is recommended.

To prevent the formation of new calcium-containing kidney stones:
The recommended dose is: The daily dose is 2 - 3 level measuring spoons (= 5 - 7.5 g granules) and should be taken as a single evening dose. If the pH value is too low, 3 - 4.5 level measuring spoons (= 7.5 - 11.25 g granules) should be taken daily in 2 - 3 doses spread throughout the day after meals. A pH value of 7.0 should be aimed for. The pH value should not fall below 6.2 and not exceed 7.4. Citrate and/or urine pH values should be checked regularly, and the individual dose (see above) adjusted accordingly.

Method of administration:
The granules are dissolved in a glass of water and drunk.

Measuring the pH value in urine:
Immediately before each dose, moisten a test strip of the enclosed indicator paper with fresh urine using the enclosed clip. The color of the moist test strip is then compared with the color chart, and the corresponding pH value is read off the corresponding color. The pH value thus determined and the number of measuring spoons of granules taken should be recorded in the monitoring calendar. The monitoring calendar should be brought to every doctor's appointment.

Duration of use:
The treating physician will decide on the duration of use. If symptoms persist despite taking Uralyt-U, you should consult your doctor.

Please speak to your doctor or pharmacist if you feel that the effect of Uralyt-U is too strong or too weak.

If you have taken more Uralyt-U than you should:
An undesirable effect on metabolic physiological parameters is not to be expected, even at doses higher than recommended, provided kidney function is adequate. Overdose may lead to hyperkalemia (potassium plasma levels >5 mmol/l), particularly in the presence of concurrent acidosis or impaired kidney function. A possible overdose can be detected at any time by checking the urine pH range and corrected by reducing the dose. If necessary, medical advice should be sought.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Possible side effects:
Gastrointestinal disorders:
Common, mostly mild stomach or abdominal pain. Rarely, mild diarrhea or nausea occurs.

Other possible side effects:
Sunset Yellow FCF (E 110) may cause allergic reactions.

Reporting of side effects:
If you notice any side effects, contact your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Pharmacovigilance Department, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW SHOULD URALYT-U BE STORE?

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and can.

Storage conditions:
There are no special restrictions on shelf life after opening the container. The ready-to-use solution should be consumed immediately.

6. FURTHER INFORMATION

What Uralyt-U contains:
The active ingredient is: potassium sodium hydrogen citrate. 1 measuring spoon containing 2.5 g contains: Active ingredients: potassium sodium hydrogen citrate (6:6:3:5) 2.4 g. The other ingredients are: flavoring: lemon oil, color: sunset yellow FCF (E 110).

What Uralyt-U looks like and contents of the pack:
Original packs containing 280 g of light orange granules. The pack contains one measuring spoon and indicator paper.

Pharmaceutical entrepreneur:
MEDA Pharma GmbH & Co. KG
Benzstraße 1
61352 Bad Homburg


Manufacturer:
Madaus GmbH
51101 Cologne

This package leaflet was last revised in April 2025.

Source: Information from the package leaflet.
Version: 06/2025

Active ingredient: potassium sodium hydrogen citrate (6:6:3:5). Indications: for the dissolution of uric acid stones and for the metaphylaxis (prevention of recurrence) of calcium and uric acid stones, or mixed stones consisting of calcium oxalate/uric acid or calcium oxalate/calcium phosphate.

dissolving uric acid stones and for metaphylaxis