Blanel

BLANEL effervescent tablets

Important notes (mandatory information)

Blanel effervescent tablets. Areas of application: for the metaphylaxis of calcium stones, predominantly calcium oxalate stones (prevention of recurrence or increase in size of remaining fragments) and/or for alkalinisation of urine in the case of uric acid stones, also in the case of simultaneous presence of calcium stones. Warning: Contains sorbitol and sodium.

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


PACKAGE LEAFLET: INFORMATION FOR USERS

Blanel effervescent tablets

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 your doctor or pharmacist has told you.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects, talk to 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 if you feel worse, contact your doctor.

What this package leaflet contains

1. WHAT IS BLANEL AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING BLANEL?
3. HOW TO TAKE BLANEL?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE BLANEL?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS BLANEL AND WHAT IS IT USED FOR?

Blanel is a medicine for the treatment of urinary stone disease. Blanel is used for the metaphylaxis of calcium stones, predominantly calcium oxalate stones (prevention of recurrence or increase in size of remaining fragments) and/or for alkalinisation of urine in the case of uric acid stones, also in the case of simultaneous presence of calcium stones. To support the effect of the medicine, patients should be advised to reduce their salt intake during treatment and to increase their daily fluid intake.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING BLANEL?

Blanel must not be taken:

• if you are allergic to citric acid, potassium citrate, sodium hydrogen carbonate, sodium carbonate or any of the other ingredients of this medicine listed in section 6.
• in case of impaired renal function.
• in case of severe hepatic impairment.
• in case of metabolic alkalosis.
• in case of chronic urinary tract infections with urea-splitting bacteria (risk of struvite stone formation).
• in case of severe high blood pressure.
• in case of a low-salt diet.
• as well as in case of adynamia episodica hereditaria (periodic hyperkalaemic paralysis; rare hereditary disease with paralysis symptoms).

Warnings and precautions

Please talk to your doctor or pharmacist before taking Blanel. You should inform your doctor about your previous illnesses, if it is known that these can contribute to the formation of urinary stones (kidney diseases, parathyroid diseases and malignant diseases). Your doctor may carry out additional examinations to rule out such conditions and may also check certain blood and urine values or carry out X-ray examinations during therapy. Please observe the information in the dosage instructions on adjusting the so-called pH of the urine. You should definitely avoid exceeding the recommended urine pH for several days, as this could have adverse consequences.

Children

Do not give Blanel to children, as there is insufficient data on this.

Taking Blanel with other medicines

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines. In particular, tell your doctor if you are taking any of the following medicines:

• So-called cardiac glycosides to strengthen heart performance or combat cardiac arrhythmias (active ingredient digoxin or digitoxin).
• Medicines to lower blood pressure (so-called diuretics such as triamterene, spironolactone, amiloride; so-called ACE inhibitors such as captopril or enalapril).
• Pain or anti-inflammatory drugs (so-called non-steroidal anti-inflammatory drugs or antirheumatics such as ibuprofen, diclofenac).
• Citrate or aluminium-containing medicines (e.g. in so-called antacids, which are taken for acid-related complaints). Please note that you should take these medicines at different times - with an interval of at least 2 hours.

If you are taking cardiac glycosides or have to follow a low-salt diet, you should note that a daily dose of 3 Blanel effervescent tablets (= 9.9 g potassium sodium hydrogen citrate) provides 1.10 g sodium and 1.72 g potassium.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before taking this medicine. There is no experience with the use of Blanel in pregnant women. If you are pregnant or breast-feeding, you should only take Blanel if your doctor considers it absolutely necessary.

Driving and using machines

No special precautions are required.

Blanel contains sorbitol

Sorbitol is a source of fructose. Talk to your doctor before taking or receiving this medicine if your doctor has told you that you have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI) - a rare, inherited condition in which a person cannot break down fructose. This medicine contains 100 mg sorbitol per effervescent tablet.

This medicine contains 366.3 mg sodium (main component of cooking salt/table salt) per effervescent tablet

This corresponds to approx. 19% of the maximum recommended daily intake of sodium with food for an adult of 2 g. Talk to your doctor or pharmacist if you need to take 4 effervescent tablets daily over a longer period of time, especially if you are on a low-salt (low-sodium) diet.

3. HOW TO TAKE BLANEL?

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

The recommended dose is

The daily dosage should be individually adjusted for the patient so that a pH value of 6.0 - 7.0 of the freshly collected urine is reached before the next medication (ideally a pH of 6.2 - 6.8 in the case of pure uric acid stones and preferably a pH of 6.4 - 7.0 in the case of calcium stones). The following dosage recommendations are given for adults:

• 3 - 4 Blanel effervescent tablets per day divided into 3 individual doses - corresponding to 9.9 - 13.2 g potassium sodium hydrogen citrate per day (i.e. 90 - 120 mmol alkali or 36 -48.8 mmol citrate): 1 effervescent tablet each in the morning and at noon and 1-2 effervescent tablets in the evening.
• In the case of calcium stones, 1 - 2 effervescent tablets can alternatively be taken as a single dose in the evening - corresponding to 3.3 - 6.6 g potassium sodium hydrogen citrate (i.e. 30 - 60 mmol alkali and 12 - 24 mmol citrate).

To check whether the dosage is adequate, it is recommended to measure the amount of citrate excreted over 24 hours and the pH value of the urine at the start of therapy and with each dose adjustment. If the specified pH range is undershot or exceeded, the daily dose should be increased or decreased. Such a correction should preferably be made in the evening. For further information on dose adjustment and on how to measure the pH value of urine, please refer to the enclosed information brochure including pH test strips.

Method of administration

Please dissolve the effervescent tablets in a glass of drinking water after each meal according to the prescribed dosage and drink the contents of the glass completely.

Duration of use

The duration of use depends on the individual requirements of the patient and is determined by the attending physician.

If you have taken more Blanel than you should

Cases of overdosage of potassium sodium hydrogen citrate have not been described to date. In the case of adequate renal function, an undesirable influence on metabolic parameters - even if the recommended dosages are exceeded - is not to be expected, since the excretion of an excess of bases by the kidneys is a normal regulation process for maintaining the acid-base balance. A pH range of the urine that is too high should not be exceeded for several days, as this increases the risk of calcium phosphate crystallisation on the one hand and a longer-term metabolic alkalosis should be avoided on the other hand. Any overdose can be corrected at any time by reducing the dose. If necessary, measures to treat a metabolic alkalosis should be considered.

If you forget to take Blanel

Do not take double the dose to make up for a forgotten dose, but continue taking the medicine as described in the dosage instructions or as prescribed by your doctor.

If you stop taking Blanel

Please do not interrupt or stop treatment with Blanel without first talking to your doctor.

If you have any further questions on the use of this 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.

Common - may affect up to 1 in 10 people

Mild gastrointestinal disorders (stomach upset, nausea, vomiting and mild diarrhoea).

Very rare - may affect up to 1 in 10,000 people

Hypersensitivity 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, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help to provide more information on the safety of this medicine.

5. HOW TO STORE BLANEL?

Keep out of reach of children! Do not use the medicine after the expiry date which is stated on the carton and the blister pack. The expiry date refers to the last day of the month.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What one Blanel effervescent tablet contains

The active ingredients are: 1409.0 mg citric acid, 1586.0 mg potassium citrate 1 H2O, 980.0 mg sodium hydrogen carbonate, 159.0 mg sodium carbonate, corresponding to 3266.3 mg potassium sodium hydrogen citrate (6:6:3:5). The other ingredients are: flavourings, sodium cyclamate, povidone K30, sorbitol (Ph. Eur.).

What Blanel looks like and contents of the pack

White, flat, round effervescent tablet; packs of 48 and 96 effervescent tablets.

Pharmaceutical entrepreneur and manufacturer

Dr. Pfleger Arzneimittel GmbH
Dr.-Robert-Pfleger-Str. 12
96052 Bamberg
Telephone: 0951/6043-0
Telefax: 0951/604329.
E-mail: info@dr-ptleger.de

This package leaflet was last revised in August 2018.

Source: Information from the package leaflet
Status: 03/2023
Areas of application: for the metaphylaxis of calcium stones, predominantly calcium oxalate stones (prevention of recurrence or increase in size of remaining fragments) and/or for alkalinisation of urine in the case of uric acid stones, also in the case of simultaneous presence of calcium stones. Warning: Contains sorbitol and sodium.