Package Leaflet: Information for the User

Acalka 1080 mg

prolonged-release tablets

Potassium citrate

1. What Acalka is and what it is used for

2. What you need to know before taking Acalka

3. How to take Acalka

4. Possible side effects

5. Storage of Acalka

6. Contents of the pack and other information

Acalka belongs to the group of medications known as urinary stone solvents that serve to dissolve stones (calculi) in the urinary system.

Acalka reduces the formation of calcium oxalate crystals and the precipitation of uric acid. It increases the pH of urine, aiming to restore normal levels without causing any alteration in the body.

It is indicated for the prevention and treatment of kidney stones (calculi formation in the kidney) due to calcium oxalate and/or calcium phosphate, uric acid alone or accompanied by calcium lithiasis and hypocitraturia (decrease in citrate in the urine).

Do not take Acalka

- If you are allergic (hypersensitive) to potassium citrate or to any of the other components of this medication (listed in section 6).

- If you have kidney insufficiency (kidney disease) since the use of Acalka could produce hyperkalemia (elevated potassium levels in the blood).

- If you have a permanent alkaline urinary tract infection.

- If you have an obstruction in the urinary system (partial or total blockage of the urinary system that produces an interruption of the passage of urine through it).

- If you have hyperkalemia (elevated potassium levels in the blood).

- If you have adrenal insufficiency (disease of the adrenal glands that leads to hormonal deficiency).

- If you have respiratory alkalosis (decreased carbon dioxide levels in the blood) or metabolic alkalosis (increased bicarbonate levels in the blood).

- If you have an active peptic ulcer (stomach or duodenal ulcer).

- If you have an obstruction in the intestine (partial or total blockage of the intestine that produces an interruption of the passage of intestinal content through it).

- If you have slow gastric emptying.

- If you are taking anticholinergic medications.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Acalka.

- If you have liver insufficiency (liver disease) or a decrease in potassium excretion (elimination by the body) since the use of Acalka could produce hyperkalemia (elevated potassium levels in the blood).

- Potassium citrate is included in cera matrix tablets that allow for slow release of potassium citrate. It is likely that once the cera matrix is empty, it will be eliminated intact through the feces in a still visible form.

Use of Acalka with other medications

Inform your doctor or pharmacist that you are using, have used recently, or may need to use any other medication.

Acalka should not be taken with potassium-sparing diuretics (medications used to increase urine production without increasing potassium excretion) such as Triamtereno, Espironolactona, or Amiloride.

Use of Acalka with food and beverages

While taking Acalka, it is recommended to follow a low-sodium diet and significantly increase daily liquid consumption.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

If you are pregnant, take Acalka only if your doctor has instructed you to.

Do not take Acalka if you are breastfeeding unless your doctor has instructed you to.

Driving and operating machines

The influence on the ability to drive or operate machines is zero.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

Mild or moderate hypocitraturia (decrease of citrates in the urine):

The usual dose of Acalka is 1 tablet (10 mEq of potassium citrate) 3 times a day, 30 minutes after the 3 main meals.

Severe hypocitraturia:

The usual dose of Acalka is 2 tablets (20 mEq of potassium citrate) 3 times a day, 30 minutes after the 3 main meals.

Do not exceed, even in very severe cases of hypocitraturia, 10 tablets.

Acalka tablets are for oral administration.

Swallow the tablets whole with sufficient liquid, do not chew, break, or dissolve in a liquid, 30 minutes after the 3 main meals to prevent mild gastrointestinal disturbances (of the stomach and intestine).

Open the bottle following the instructions indicated below:

If you take more Acalka than you should

If you have taken more Acalka than you should, consult your doctor or pharmacist immediately. In case of overdose or accidental ingestion, also contact the Toxicological Information Service, telephone (91) 562.04.20.

In case of hyperkalemia (increase of potassium levels in the blood) the treatment consists of administering an intravenous solution of 10% dextrose with 10-12 U of insulin/1000 ml. If acidosis also occurs, the treatment consists of administering intravenous sodium bicarbonate and hemodialysis or peritoneal dialysis.

If you forgot to take Acalka

Do not take a double dose to compensate for the missed doses.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, Acalka may have adverse effects, although not everyone will experience them.

Acalka may cause mild gastrointestinal disturbances (stomach and intestine) that decrease if taken with food.

If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus.

Keep this medication out of the sight and reach of children.

Keep the bottle perfectly closed to protect it from light and moisture.

Do not use this medication after the expiration date that appears on the packaging and on the label after CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown down the drains or in the trash. Dispose of the containers and the

medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and the medications you no longer need. By doing so, you will help protect the environment.

Composition of Acalka

- The active principle is potassium citrate. Each tablet contains 1080 mg of potassium citrate (10 milliequivalents) corresponding to 390 mg of potassium.

- The other components (excipients) are: Carnauba wax (E-903) and Magnesium stearate.

Appearance of the product and content of the packaging

Acalka are prolonged-release tablets. They are presented in packs of 100 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder:

Ferrer Internacional, S.A.

Gran Vía Carlos III, 94

08028-Barcelona

Responsible for manufacturing:

Ferrer Internacional, S.A.

Joan Buscallà, 1-9

08173 Sant Cugat del Vallès (Barcelona)

Date of the last review of this leaflet:July 2012

“Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/”