URALYT-U 2.4g / 2.5g x 280g gr
Potassium sodium hydrogen citrate
Read this leaflet carefully because it contains important information for you.
This medicinal product is available without a prescription. Nevertheless, you should take Uralit-U carefully to get better results.
Keep this leaflet. You may need to read it again.
If you need further information or advice, ask your pharmacist.
You should see a doctor if your symptoms worsen or do not improve.
If any of the side effects become serious or if you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
Contents of the leaflet:
1. What Uralit-U is and what it is used for
2. Before using Uralit-U
3. How to use Uralit-U
4. Possible side effects
5. How to store Uralit-U
6. Additional information
1. What Uralit-U is and what it is used for
Uralit-U is an alkaline citrate for the treatment of kidney stones.
Composition: potassium sodium hydrogen citrate (6:6:3:5) 2.4 g/2.5 g
Indications:
for breaking up urate stones;
for metaphylaxis (prevention of recurrence) of calcium stones and urate stones, as well as mixed forms of stones of calcium oxalate / uric acid or calcium oxalate / calcium phosphate.
Note:
Administration of the product should be part of a general metaphylaxis concept (eg diet, increased fluid intake, etc.).
2. Before using Uralit-U
You should not use Uralit-U if you suffer from acute or chronic renal failure, following a low-sodium diet, if you suffer from metabolic alkalosis or chronic urinary tract infections with urea-splitting bacteria.
Do not use Uralit-U
if you are hypersensitive to any of its ingredients.
Pay special attention
Before starting the treatment, all circumstances and adverse conditions that may contribute to the formation of kidney stones should be excluded. This also applies to cases in which specific therapy is applied (adenoma of the parathyroid glands, malignancy with formation of uric acid stones, etc.).
Before the first dose, serum electrolytes should be determined and renal function should be monitored. In addition, acid-base status should be checked if renal tubular acidosis is suspected.
Be careful with the use of Uralit-U in patients with severe impairment of function.
In children.
Treatment of children under 12 years of age is not recommended because there is insufficient clinical experience with this age group.
If you are taking other medicines:
Any increase in the extracellular concentration of potassium can weaken the action of cardiac glycosides, while its decrease will enhance their arrhythmogenic action. Aldosterone antagonists, potassium-sparing diuretics, ACE-inhibitors, nonsteroidal anti-inflammatory drugs, and peripheral analgesics reduce potassium excretion by the kidneys. Remember that 10 g of Uralit-U (the average daily dose) contains 1.72 g or 40 mmol of potassium.
If you have been recommended a low-sodium diet, please remember that 10 g of Uralit-U (the average daily dose) contains 1.0 g or 40 mmol of sodium (which is equivalent to 2.6 g of salt).
Medicines containing citrate that are given at the same time as those containing aluminum can cause an increase in the absorption of aluminum. If such drugs must be taken, there should be an interval of at least 2 hours between taking them.
Please note that this data also applies to recently used drugs.
Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those without a prescription.
Pregnancy and breastfeeding
There is insufficient data on the use of Uralit-U by pregnant or lactating women. Experimental studies in animals have not shown any mutagenic or fetal harm effect.
If you are pregnant or nursing, consult your doctor before taking it.
Driving and using machines
There are no limits.
Important information about some of the ingredients of Uralit-U:
This medicinal product contains the coloring agent orange yellow S (E110), which may cause allergic reactions, including asthma, in susceptible individuals. Allergies are more common in people who react to acetylsalicylic acid (aspirin).
3. How to use Uralit-U
If the doctor has not prescribed otherwise, follow the instructions below, otherwise Uralit-U will not work as it should!
a) To dissolve and prevent recurrence of urate stones:
How much and how often should you take Uralit-U?
Take 4 measuring spoons (= 10 g granules) daily, divided into 3 doses, after meals: Drink 1 measuring spoon every morning, 1 at lunch and 2 every evening after eating. The pH of fresh urine should be between 6.2 - 6.8.
If the pH level is lower, the daily dose should be increased by half a measuring spoon in the evening. If the pH is above the recommended limit, the daily dose should be reduced by half a measuring spoon in the evening. The exact dose should be found at which the pH of fresh urine before taking the dose of Uralit-U is within the permissible limits.
Regular monitoring of urine pH is recommended for metaphylaxis of urate stones.
b) To prevent recurrence of calcium stones:
How much and how often should you take Uralit-U?
The daily dose should be 2-3 measuring spoons (= 5 - 7.5 g granules), to be taken once in the evening. If the pH is very low, take 3 - 4.5 measuring spoons (= 7.5 - 11.25 g granules), divided into 2-3 doses during the day, after eating. You should aim for a urine pH of 7.0. The pH should not fall below 6.2 and rise above 7.4.
Urinary citrate and/or pH levels should be checked regularly and individual dosing adjusted accordingly.
Application method
The granules should be dissolved in a glass of water and then drunk.
Urine pH measurement:
Immediately before taking each dose, take a strip of the indicator paper provided in the package, grasp it with the clip (also included) and wet it with fresh urine. Then compare the color of the wet strip to the color chart and read what pH is printed under the corresponding color. Thus, the pH reading and the number of measuring spoons of the granules you drank are recorded in the control calendar. You must carry the control calendar with you whenever you visit the doctor.
Duration of use
Your doctor will determine the duration of treatment. If the complaints persist, you should visit your doctor.
If you have the feeling that the action of Uralit-U is too strong or too weak, talk to your doctor or pharmacist.
If you have taken more Uralit-U than you should
Provided that renal function is normal, no adverse effects on metabolic or physiological parameters should be expected, even when doses greater than recommended have been taken.
Any overdose can be recognized at any time by checking the pH of the urine and can be corrected by reducing the dosage. If necessary, consult a doctor.
If you have any further questions about the use of this product, ask your doctor or pharmacist.
4. Possible adverse drug reactions
Like all other drugs, Uralit-U can have side effects.
The following terms are used to determine the frequency of these reactions:
Very common: more than 1 in 10 patients;
Common: 1 to 10 in 100 patients;
Uncommon: 1 to 10 in 1,000 patients;
Rare: 1 to 10 in 10,000 patients;
Very rare: less than 1 in 10,000 patients;
Unknown: cannot be estimated from the available data.
Possible side effects:
Mild stomach or abdominal pain is common. Rarely, mild diarrhea or nausea may occur.
Other possible side effects
Orange yellow S (E110) can cause allergic reactions.
If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
5. How to store Uralit-U
Keep out of the reach of children.
The expiry date is printed on the carton and the vial. Do not use after this date.
Storage conditions:
No special storage conditions are required.
After preparing the solution, it should be drunk immediately.
6. Additional information
What Uralit-U contains:
The active substance is: potassium sodium hydrogen citrate
1 measuring spoon of 2.5 g granules contains:
potassium sodium hydrogen citrate (6:6:3:5) - 2.4 g.
Auxiliary substances are: flavoring - lemon oil, coloring - orange yellow S (E110).
What Uralit-U looks like and what the package contains:
Original packaging: polypropylene vials with polypropylene screw caps with 280 g of pale orange granules in a cardboard box.
Clinical packs of 10 x 280 g.
Not all packages are on the market.
The package also contains a measuring spoon, indicator paper and a control calendar.
