URALYT-U

URALYT-U Granules

Important notes (mandatory information)

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

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


INSTRUCTIONS FOR USE: INFORMATION FOR THE USER

Uralyt-U Granules for preparing a solution to be taken orally
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 package leaflet or exactly as directed by your doctor or pharmacist.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you notice any side effects, contact your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.
• If you do not feel better or even worse, contact your doctor.

What this package leaflet contains

1. WHAT IS URALYT-U AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING URALYT-U?
3. HOW SHOULD URALYT-U BE TAKEN?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD URALYT-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, urolithiasis agent.

Areas of application:

• for dissolving uric acid stones.
• for metaphylaxis (prevention of renewed formation) of calcium and uric acid stones, or mixed stones made of calcium oxalate/uric acid or calcium oxalate/calcium phosphate.

Note

The preparation should only be used as part of an overall metaphylaxis concept (e.g. diet, increased fluid intake, etc.).

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

Uralyt-U should not be used in the case of acute or chronic kidney failure, a low-salt diet ordered by a doctor, severe disorders of the acid-base balance (e.g. metabolic alkalosis, excessive blood potassium levels (hyperkalemia)) and in the case of urinary tract infections with urea-splitting bacteria. Uralyt-U must not be taken if you are hypersensitive (allergic) to potassium sodium hydrogen citrate, yellow orange S (E 110) or any of the other ingredients of Uralyt-U.

Warnings and precautions:

• Before starting therapy, conditions or diseases that can promote the occurrence of urinary stones and that are accessible to targeted treatment (e.g. adenomas of the parathyroid glands, malignancies in the case of uric acid stones, etc.) should be ruled out.
• Before the first use, the electrolytes in the serum should be determined and the kidney function should be checked. If renal tubular acidosis (RTA) is suspected, the acid-base status should also be checked.
• Particularly in elderly patients, or in patients with impaired kidney function or with simultaneous therapy with certain medicines for high blood pressure (e.g. aldosterone antagonists, angiotensin receptor antagonists (sartans), potassium-sparing diuretics, ACE inhibitors) or for chronic pain (non-steroidal anti-inflammatory drugs and peripheral analgesics), it should be taken into account that the maximum recommended daily dose is 11.25 g 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. Interaction with the medicines mentioned here can lead to hyperkalemia.
• Uralyt-U should only be used with caution in patients with severe liver dysfunction.
• Yellow orange S (E 110) can cause allergic reactions. This medicine contains yellow orange S (E 110), which can cause allergic-type reactions in people who are particularly sensitive to this substance.

Children and adolescents

Treatment of children under 12 years of age is not recommended, as there is insufficient experience for 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 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 (non-steroidal anti-inflammatory drugs and peripheral analgesics) reduce the excretion of potassium in the urine. It should be noted that 10 g Uralyt-U (average daily dose) contains 1.72 g, corresponding to 44 mmol potassium. When prescribing a low-sodium diet, it should be noted that 10 g Uralyt-U (average daily dose) contains 1 g, corresponding to 44 mmol sodium or 2.6 g table salt. Simultaneous administration of citrate and aluminum-containing substances (e.g. for heartburn) can lead to increased aluminum absorption; therefore, if such preparations are required, they should be taken at least 2 hours apart. Please note that this information may also apply to medicines that have been used recently. Inform your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines.

Pregnancy and breast-feeding

There are no sufficient data on the use in pregnant or breast-feeding women. Animal studies have shown no evidence of a harmful effect on the fetus. If you are pregnant or breast-feeding, 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 colorant yellow orange S (E 110), which can cause allergic-type reactions, including asthma, in people who are particularly sensitive to this substance. The allergy is more common in people who are allergic to 2-acetoxybenzoic acid (acetylsalicylic acid).

3. HOW SHOULD URALYT-U BE TAKEN?

Always take this medicine exactly as described in this package leaflet or exactly as agreed with your doctor. Check with your doctor or pharmacist if you are not sure.

To dissolve and prevent the formation of uric acid stones

The recommended dose is: Take 4 level measuring spoons (= 10 g granules) daily in 3 single doses after meals. Take 1 level measuring spoon each in the morning and at noon and 2 level measuring spoons in the evening after meals. The pH value of fresh urine should be in the following pH range: Uric acid stones: 6.2 - 6.8. If the pH values are below the specified range, the daily dose should be increased by half a level measuring spoon in the evening. If the pH values are above the specified range, the daily dose should be reduced by half a level measuring spoon in the evening. The correct dose has been found when the pH value of fresh urine is always within the specified range before taking Uralyt-U. Regular monitoring of the urine pH value is recommended for metaphylaxis of uric acid stones.

To prevent the formation of 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 over the day after meals. A pH value of 7.0 should be aimed for. The pH value should not fall below 6.2 or exceed 7.4. The 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 intake, a test strip of the enclosed indicator paper is moistened 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 under the matching color. The pH value found in this way and the number of measuring spoons of granules taken each time are to be entered in the control calendar. The control calendar must be brought to every doctor's visit.

Duration of use

The duration of use is determined by the attending physician. If the symptoms persist despite taking Uralyt-U, a doctor should be consulted.

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

If you have taken more Uralyt-U than you should

An undesirable influence on metabolic physiological parameters is not to be expected even with a higher than the recommended dosage with sufficient kidney function. In case of overdose, hyperkalemia (potassium plasma level >5 mmol/l) may occur, especially in the case of simultaneous 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 the medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

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

The following frequency information is used to evaluate side effects:
Very common:	more than 1 in 10 treated persons
Common:	1 to 10 in 100 treated persons
Uncommon:	1 to 10 in 1,000 treated persons
Rare:	1 to 10 in 10,000 treated persons
Very rare:	less than 1 in 10,000 treated persons
Not known:	frequency cannot be estimated from the available data.

Possible side effects

Gastrointestinal disorders

Mild stomach or abdominal pain is common. Mild diarrhea or nausea occurs rarely.

Other possible side effects

Yellow orange S (E 110) can cause allergic reactions.

Reporting of side effects

If you get any side effects, talk to 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, Department of Pharmacovigilance, 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 STORED?

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

Storage conditions

There are no special storage conditions for the shelf life after opening the container. The ready-to-use solution should be drunk immediately.

6. FURTHER INFORMATION

What Uralyt-U contains

The active ingredient is: Potassium sodium hydrogen citrate. 1 measuring spoon with 2.5 g contains: Active pharmaceutical ingredients: Potassium sodium hydrogen citrate (6:6:3:5) 2.4 g. The other ingredients are: Flavoring: Lemon oil, Colorant: Yellow orange S (E 110).

What Uralyt-U looks like and contents of the pack

Original packs with 280 g light orange granules. The pack contains a measuring spoon and indicator paper.

Pharmaceutical entrepreneur

MEDA Pharma GmbH & Co. KG
Benzstraße 1
61352 Bad Homburg
Telephone: (06172) 888-01
Telefax: (06172) 888-27 40
E-mail: medinfo@medapharma.de

Manufacturer

Madaus GmbH
51101 Cologne

This leaflet was last revised in April 2015.

Source: Information from the package leaflet
Status: 06/2020
Active ingredient: Potassium sodium hydrogen citrate (6:6:3:5). Areas of application: for dissolving uric acid stones and for metaphylaxis (prevention of renewed formation) of calcium and uric acid stones, or mixed stones made of calcium oxalate/uric acid or calcium oxalate/calcium phosphate.