KALIUM VERLA

KALIUM VERLA Granules Btl.

Important notes (mandatory information)

Kalium Verla 20 mmol Granulate. Active ingredient: Potassium citrate. Areas of application: o for potassium replacement: in the case of pronounced potassium deficiency (hypokalaemia) (serum potassium below 3.2 mmol/l), especially in the case of simultaneously existing metabolic acidosis, in the case of neuromuscular disorders or cardiac arrhythmias in the case of potassium deficiency, in the case of potassium deficiency during simultaneous treatment with digitalis. To prevent potassium deficiency of the body (hypokalaemia) (serum potassium below 3.5 mmol/l) in the case of metabolic acidosis caused by ketone bodies (ketoacidosis).

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Kalium Verla 20 mmol Granulate for the preparation of a solution for oral administration
Active ingredient: Potassium citrate
Mineral supplement

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 doctor or 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 after 2 – 3 weeks, contact your doctor.

What this package leaflet contains

1. WHAT IS KALIUM VERLA AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING KALIUM VERLA?
3. HOW SHOULD KALIUM VERLA BE TAKEN?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD KALIUM VERLA BE STORED?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS KALIUM VERLA AND WHAT IS IT USED FOR?

Kalium Verla is a mineral supplement. Kalium Verla is used:

• for potassium replacement:
  • in the case of pronounced potassium deficiency (hypokalaemia) (serum potassium below 3.2 mmol/l), especially in the case of simultaneously existing metabolic acidosis.
  • in the case of neuromuscular disorders or cardiac arrhythmias in the case of potassium deficiency.
  • in the case of potassium deficiency during simultaneous treatment with digitalis.
• to prevent potassium deficiency of the body (hypokalaemia) (serum potassium below 3.5 mmol/l) in the case of metabolic acidosis caused by ketone bodies (ketoacidosis).

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING KALIUM VERLA?

Kalium Verla must not be taken:

• if you are allergic to potassium citrate or any of the other ingredients of this medicine listed in section 6.
• if you suffer from diseases that are often associated with an increased potassium content in the blood:
  • dehydration,
  • impaired excretory function of the kidneys,
  • adrenal insufficiency (Morbus Addison),
  • congenital episodic muscle weakness (Adynamia episodica heredltarla).

Warnings and precautions

Please talk to your doctor or pharmacist before taking Kalium Verla.

Special care must be taken when taking Kalium Verla:

• in the case of sickle cell anaemia,
• in the case of simultaneous treatment with potassium-sparing diuretics (diuretics), aldosterone antagonists, ACE inhibitors, anticholinergics or potentially kidney-damaging medicines (non-steroidal anti-inflammatory drugs – anti-inflammatories – etc.). Due to interaction with these medicines, due to sudden onset of acidosis, acute impairment of kidney function or other conditions, an excessively high potassium content in the blood (hyperkalaemia) may occur. Before use, the electrolyte and acid-base status, the heart rhythm and, especially in elderly patients, the kidney function must be checked. These parameters must be monitored at first at shorter intervals and later at longer intervals during treatment.

Taking Kalium Verla together with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken or intend to take any other medicines. The effect of the following active substances or groups of preparations may be influenced in the case of simultaneous treatment with Kalium Verla.

• Cardiac glycosides, e.g. digitalis: an increase in the potassium concentration in the blood and body water (extracellular) reduces their effect, a decrease intensifies the effect of cardiac glycosides that promotes cardiac arrhythmias.
• Aldosterone antagonists, potassium-sparing diuretics (diuretics), ACE inhibitors, non-steroidal anti-inflammatory drugs (anti-inflammatories) and peripherally acting analgesics (painkillers) reduce the excretion of potassium via the kidneys.
• Anticholinergics inhibit bowel movements and therefore increase the risk of side effects in the gastrointestinal tract in the case of simultaneous use.
• The citric acid contained in Kalium Verla increases the absorption of aluminium and bismuth salts and thus intensifies their side effects.

Pregnancy and breast-feeding

There are no known indications of harmful effects during pregnancy and breast-feeding.

Driving and operating machinery

No special precautions are required.

Important information about certain other ingredients of Kalium Verla

This medicine contains sucrose. Please only take Kalium Verla after consulting your doctor if you know that you suffer from an intolerance to certain sugars. 1 sachet of Kalium Verla contains 1.64 g of sucrose (sugar). If you have to follow a diabetic diet, you should take this into account. Frequent and continuous use of Kalium Verla can be harmful to the teeth (caries) due to the sugar content.

3. HOW SHOULD KALIUM VERLA BE TAKEN?

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

The recommended dose is

The dosage depends on the deficiency to be replaced. In general, 1 - 2 sachets (corresponding to 20 - 40 mmol of potassium) 2-3 times a day are sufficient. No more than 2 sachets (corresponding to 40 mmol of potassium) should be taken at once and no more than 7 sachets (corresponding to 140 mmol of potassium) per day. One sachet of Kalium Verla contains 1.64 g of sucrose. If the dosage instructions are followed, between 1.64 g and 3.28 g of sucrose are administered with each use.

Method of administration

Please stir the contents of one sachet in a glass of water, mineral water, tea or fruit juice and drink the contents of the glass completely. Kalium Verla should be taken during or after a meal. The intake should be spread over 10 - 15 minutes and should not be taken lying down.

If you have taken more Kalium Verla than you should

In the case of an overdose, life-threatening cardiac arrhythmias may occur. Signs of an overdose may also include paraesthesia, paralysis and confusion. Therefore, if you suspect an overdose, contact a doctor immediately!

If you forget to take Kalium Verla Do not take twice the amount if you have forgotten to take the previous dose.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them. Rarely (in up to 1 in 1,000 patients treated), nausea and vomiting may occur in predisposed patients. Rarely, belching, heartburn, flatulence, abdominal pain and diarrhoea have also been reported.

Reporting of side effects

If you notice any side effects, contact 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 about the safety of this medicine.

5. HOW SHOULD KALIUM VERLA BE STORED?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the folding box and the sachet. This medicine does not require any special storage conditions.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Kalium Verla contains

The active ingredient is: Potassium citrate. 1 sachet with 5.4 g of granulate for the preparation of a solution for oral administration contains 2157.8 mg of potassium citrate 1 H20 corresponding to 20 mmol = 780 mg of potassium. The other ingredients are: Sucrose 1.64 g, citric acid, sodium cyclamate, orange flavour. Kalium Verla contains no gluten and no lactose.

What Kalium Verla looks like and contents of the pack

It is an almost white granulate packed in sachets. Kalium Verla is available in packs of 20, 50 and 100 sachets with 5.4 g of granulate for the preparation of a solution for oral administration.

Pharmaceutical entrepreneur and manufacturer
Verla-Pharm Arzneimittel GmbH & Co. KG
82324 Tutzing
www.verla.de

This package leaflet was last revised in February 2017.

Source: Information from the package leaflet
Status: 05/2018
Active ingredient: Potassium citrate. Areas of application: o for potassium replacement: in the case of pronounced potassium deficiency (hypokalaemia) (serum potassium below 3.2 mmol/l), especially in the case of simultaneously existing metabolic acidosis, in the case of neuromuscular disorders or cardiac arrhythmias in the case of potassium deficiency, in the case of potassium deficiency during simultaneous treatment with digitalis. To prevent potassium deficiency of the body (hypokalaemia) (serum potassium below 3.5 mmol/l) in the case of metabolic acidosis caused by ketone bodies (ketoacidosis).