Uralyt U

Package leaflet: Information for the patient

URALYT-U 99.8 g granules for oral solution
kalnacitrato
Read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What URALYT-U is and what it is used for
2. What you need to know before taking URALYT-U
3. How to take URALYT-U
4. Possible side effects
5. How to store URALYT-U
6. Contents of the pack and other information

1. What URALYT-U is and what it is used for

URALYT-U contains the active substance kalnacitrato, which belongs to a group of medicines that facilitate the dissolution of uric acid stones forming in the urinary tract by making the urine more alkaline.
URALYT-U is indicated for the treatment and prevention (prophylaxis) of uric acid stone formation.

2. What you should know before taking URALYT-U

Do not take URALYT-U

• if you are allergic to kalnacitrato or to any of the other ingredients of this medicine (listed in section 6);
• if you have severe kidney problems (acute or chronic renal failure);
• if you are being treated with medicines used for heart conditions called digitalics;
• if you suffer from a disease characterized by the formation of a specific type of stone, called calcium magnesium ammonium calculosis, because in this case you should take a medicine that makes the urine more acidic;
• if you have high levels of potassium in the blood (hyperkalaemia);
• if you suffer from metabolic alkalosis;
• if you have chronic urinary tract infections caused by bacteria capable of splitting urea;
• if you are following a low-sodium diet as advised by your doctor.

Warnings and precautions
Talk to your doctor or pharmacist before taking URALYT-U.

Before starting treatment with URALYT-U, your serum electrolyte levels should be determined and your kidney function should be checked.
If renal tubular acidosis (RTA) is suspected, an assessment of acid-base status should also be performed.
Avoid taking this medicine if you have severe heart problems, as it may increase potassium levels in the blood (hyperkalaemia). This risk is greater if you have severe kidney problems (acute or chronic renal failure) or if you experience a sudden increase in blood acidity (acidosis). In such cases, your doctor must carefully monitor your blood potassium levels through specific tests (blood tests, ECG).
Before starting treatment with URALYT-U, your doctor will help you eliminate all risk factors for the formation of new stones.
Take this medicine with great caution and inform your doctor in the following cases:

• if your kidneys are poorly functioning (impaired renal function);
• if you suffer from high blood pressure (hypertension);
• if you experience swelling due to fluid retention (oedema);
• if you suffer from gout or if stone formation is severe (severe lithiasis). In these cases, a low-protein diet (hypoproteic diet) is required. In milder cases, it is sufficient to avoid a high-protein diet (excessive protein intake);
• if you have severe liver problems (severe hepatic dysfunction).

Drink at least 2 to 2.5 litres of water per day (taking into account also the water contained in food), preferably low-mineral and slightly alkaline (alkaline) water. If you sweat heavily (excessive perspiration), drink more to compensate for this loss.
If you have heart problems (cardiopathy), drink 1.5 litres of water per day.
If you have a urinary tract infection and need to take URALYT-U, do not stop the treatment with the medicines (antibacterial therapy) prescribed by your doctor to treat the infection.

Other medicines and URALYT-U
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Avoid taking this medicine if you are taking the following medicines:

• tetracyclines, oral antibiotics used to treat infections, as URALYT-U may reduce their effectiveness;
• antacids, used for indigestion and heartburn;
• digitalics, used to treat heart disorders.

Take this medicine with caution and inform your doctor if you are taking the following medicines, as they may lead to increased potassium levels in the blood (hyperkalaemia) (see section "Warnings and precautions"):

• potassium-sparing diuretics such as amiloride, triamterene, and aldosterone antagonists such as spironolactone, which promote urine elimination and retain potassium;
• ACE inhibitors, used to treat high blood pressure;
• angiotensin receptor antagonists, medicines used to treat high blood pressure, diabetic kidney disease, and heart failure;
• anticholinergics, used to treat irritable bowel syndrome, asthma, or incontinence;
• non-steroidal anti-inflammatory drugs, used to relieve pain and inflammation, as they may be toxic to the kidneys (nephrotoxic). Use with caution and inform your doctor also if you are taking potassium supplements, as this may lead to increased potassium levels in the blood.
  Take other medicines only after at least 2 hours have passed since taking URALYT-U.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
If you are pregnant or breastfeeding, take URALYT-U only when strictly necessary and under direct medical supervision.

Driving and using machines
URALYT-U does not affect the ability to drive vehicles or operate machinery.

URALYT-U contains potassium, sodium, and the colouring agent sunset yellow (E110)
This medicine contains 43 mmol (1.7 g) of potassium per recommended daily dose (10 g of granules). This should be taken into account in patients with reduced kidney function or those on a low-potassium diet.
This medicine contains 1000 mg of sodium (the main component of table salt) per recommended daily dose (10 g of granules). This corresponds to 50% of the maximum recommended daily dietary intake for an adult. Talk to your doctor or pharmacist if you need to take 2 or more doses per day for a prolonged period, especially if you have been advised to follow a low-sodium diet.
This medicine contains the colouring agent sunset yellow. It may cause allergic reactions.

3. How to take URALYT-U

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

The recommended dose is 10 g of granules (4 measuring spoons) per day, divided as follows:

• 1 measuring spoon (2.5 g of granules) in the morning (between 7 and 8 a.m.);
• 1 measuring spoon in the afternoon (after lunch, between 2 and 3 p.m.);
• 2 measuring spoons in the evening (around 10 p.m.). Dissolve the dose in a glass of water and drink the contents.

To determine the most appropriate dose for you, carefully follow the instructions below:

• Tear off a test strip from the booklet located inside the package;
• Dip the test strip into a container with your recently collected urine for a few seconds;
• Remove excess liquid by gently tapping the strip;
• Compare the color appearing on the test strip with the color scale (chromatic scale) provided inside the package: each color corresponds to a number (urine pH value);
• Record on a control calendar:
  • the number (urine pH value) corresponding to the color obtained on the test strip;
  • the amount of URALYT-U taken;
  • the date;
  • the time of day (morning, afternoon, evening) when the medicine was taken;
• Repeat this procedure 3 times daily, before taking URALYT-U. If you obtain a pH value between 6.4 and 7, this means the dose you are taking is appropriate for you. If the value is higher or lower, your doctor will decide whether to reduce or increase the dose to achieve the maximum effect.

Use in children and adolescents
Based on available data, no dosage recommendations can be established for neonates, children, and adolescents.

If you take more URALYT-U than you should
Cases of overdose with this medicine are not known.
However, after taking an excessive dose of URALYT-U, an increase in blood potassium levels (hyperkalemia) may occur, particularly in patients with concomitant acidosis or renal insufficiency.
If you have taken too much of this medicine, contact your doctor or the nearest hospital immediately.

If you forget to take URALYT-U
Do not take a double dose to make up for the missed dose.

If you stop taking URALYT-U
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The following side effects may occur:
Frequency not known (frequency cannot be estimated from the available data)

• increased levels of potassium in the blood (hyperkaliemia);
• nausea;
• diarrhea;
• abdominal pain.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You may also report side effects directly via the national reporting system at http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store URALYT-U

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.".
The expiry date refers to the last day of that month and applies to the product in its original unopened packaging,
properly stored.
URALYT-U 99.8 g granules for oral solution: store this medicine below 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What URALYT-U contains
URALYT-U 99.8 g granules for oral solution

• The active substance is kalnacitrato. 100 g of granules contain 99.8 g of hydrated hexapotassium hexasodium pentacitrate complex.
• The other components are: lemon flavour, sunset yellow (E110).

Description of the appearance of URALYT-U and contents of the pack
URALYT-U 99.8 g granules for oral solution
Granules for oral solution. 100 g bottle with dosing spoon and a booklet of indicator paper strips for measuring urinary pH.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Viatris Italia S.r.l. - Via Vittor Pisani 20 - 20124 Milan, Italy
Manufacturer
MADAUS GMBH - Lutticher Strasse, 5 - 53842 Troisdorf - Germany