KALINOR

KALINOR retard P 600 mg hard capsules

Important notes (mandatory information)

Kalinor-retard P, 600 mg hard capsules, retarded. Active ingredient: 600 mg potassium chloride. Areas of application: Treatment of potassium deficiency, preventive use with diuretics that lead to increased potassium excretion (kaliuresis).

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Kalinor-retard P, 600 mg hard capsules, retarded for use in adults
Active ingredient: 600 mg potassium chloride

Read the entire package leaflet carefully because it contains important information for you. This medicine is available without a prescription. However, to achieve the best possible treatment results, Kalinor-retard P 600 mg must be used as directed.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If your symptoms worsen or do not improve, you must see a doctor in any case.
• If any of the listed side effects affect you significantly or if you notice side effects that are not listed in this package leaflet, please inform your doctor or pharmacist.

This package leaflet contains

1. WHAT IS KALINOR-RETARD P 600 MG AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING/USING KALINOR-RETARD P 600 MG?
3. HOW SHOULD KALINOR-RETARD P 600 MG BE TAKEN/USED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD KALINOR-RETARD P 600 MG BE STORED?
6. FURTHER INFORMATION.

1. WHAT IS KALINOR-RETARD P 600 MG AND WHAT IS IT USED FOR?

Kalinor-retard P 600 mg is a mineral/potassium preparation for normalising the potassium balance. Areas of application: Treatment of potassium deficiency. Preventive use with diuretics that lead to increased potassium excretion (kaliuresis).

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING/USING KALINOR-RETARD P 600 MG?

Kalinor-retard P 600 mg must not be taken/used:

• if you are hypersensitive (allergic) to potassium chloride or any of the other ingredients of Kalinor-retard P 600 mg.
• in diseases that are often associated with an increase in the blood potassium level above normal (hyperkalaemia):
  • impaired excretory renal function (reduced excretion capacity of the kidneys)
  • dehydration (lack of body water as a result of a disturbance in the water and salt balance)
  • Addison's disease ("bronze skin disease", insufficient performance of the adrenal cortex)
  • Adynamia episodica hereditaria (GAMSTORP syndrome, a rare hereditary disease with episodic flaccid paralysis with increased blood potassium concentration)
  • sickle cell anaemia (a disorder of the formation of the red blood pigment)
  • metabolic disorders in the acidic range, e.g. diabetic acidosis (acidification of the blood in diabetes)
• as well as in the case of elevated blood potassium levels due to potassium shifts from the intracellular to the extracellular space, i.e. from the cells into the blood.

Special care should be taken when taking/using Kalinor-retard P 600 mg

The prescription of a solid potassium chloride preparation such as Kalinor-retard P 600 mg must be carefully considered by your doctor if you have a known impairment of the oesophageal or gastrointestinal passage. It may be more favourable to prescribe a liquid potassium preparation (e.g. as an effervescent tablet) if, for example, there is a narrowing in the oesophagus, stomach or intestine. Other possible causes of difficulty swallowing can also be diseases that result in the taking of certain medicines (such as anticholinergics, which have an effect comparable to atropine from deadly nightshade). These medications can slow down the transport of food and medicines through the stomach and intestines. Before use, the condition of the mineral and acid-base balance (electrolyte-acid-base status), the heart rhythm and, especially in elderly patients, the kidney function must be checked. These values should be monitored at shorter intervals initially and at longer intervals later during treatment.

When taking/using Kalinor-retard P 600 mg with other medicines

Please inform your doctor or pharmacist if you are taking/using or have recently taken/used any other medicines, even if they are non-prescription medicines.

Kalinor-retard P 600 mg should only be used with caution if taken at the same time as:

• medicines that have an effect comparable to "atropine" (from deadly nightshade) (anticholinergics)
• potassium-sparing diuretics
• substances that counteract the effect of adrenal cortex hormones (aldosterone antagonists)
• certain blood pressure lowering medicines (ACE inhibitors, angiotensin II receptor blockers)
• possibly kidney-damaging medicines such as certain painkillers and anti-rheumatic medicines (non-steroidal anti-inflammatory drugs, etc.).

By interaction with these latter medicines, by a sudden onset of acidosis (acidification of the blood), sudden impairment of kidney function or other conditions, a random increase in the blood potassium concentration above normal (hyperkalaemia) can occur. An increase in the blood potassium concentration above normal reduces the effect of cardiac glycosides. When used at the same time as certain blood pressure lowering medicines {angiotensin-converting enzyme inhibitors/ACE inhibitors, angiotensin-II receptor blockers), aldosterone antagonists (substances that counteract the effect of adrenal cortex hormones), potassium-sparing diuretics (potassium-sparing diuretics) or certain painkillers and anti-rheumatic medicines (non-steroidal anti-inflammatory drugs and peripheral analgesics), such as indomethacin, special monitoring of the blood potassium concentration is indicated, as the aforementioned medicines can lead to a reduction in potassium excretion via the kidneys and thus to an increase in the blood potassium concentration above normal. Anticholinergics (medicines that have an effect comparable to atropine from deadly nightshade) inhibit the movement processes in the intestine (intestinal motility) and therefore increase the (low) probability of side effects in the stomach and intestines when used at the same time. Please note that this information may also apply to medicines that have been used recently!

When taking/using Kalinor-retard P 600 mg with food and drink

Interactions between taking Kalinor-retard P 600 mg and stimulants, food or drinks are not to be expected.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking/using any medicine. There is no evidence of harmful effects during pregnancy and breast-feeding.

Driving and operating machinery

Taking Kalinor-retard P has no harmful effects on your ability to drive, your reaction time or your general ability to act, even when operating machinery or working without a secure hold.

3. HOW SHOULD KALINOR-RETARD P 600 MG BE TAKEN/USED?

Always take/use Kalinor-retard P 600 mg exactly as described in this package leaflet. Please ask your doctor or pharmacist if you are not sure. The dosage depends on the potassium loss to be compensated and is adjusted by the doctor for you personally. Unless otherwise prescribed by your doctor, the usual dose is: To prevent potassium deficiency, generally 2 - 3 capsules of Kalinor-retard P 600 mg daily (corresponding to 16 - 24 mmol of potassium ions). You can start with a dosage of 3x1 capsule daily. The dosage can then be adjusted to your personal potassium requirement if necessary. To treat potassium deficiency, 5 - 12 capsules of Kalinor-retard P 600 mg daily (corresponding to 40 - 96 mmol of potassium ions). You can start with a dosage of 3 x 2 capsules daily. The dosage can then be adjusted to your personal potassium requirement if necessary.

Method of administration

The capsules should be taken whole with plenty of liquid (at least one glass of water) during meals. If you have difficulty swallowing capsules, you can pull the two halves of the capsule apart and take the contents on a spoon. Do not forget to drink plenty of liquid (at least one glass of water) with it. A daily dose of more than 2 capsules should be taken throughout the day (e.g. morning, noon, evening), i.e. divided into 2 or more individual doses.

Duration of use

As long as the cause of the potassium deficiency persists, continuous administration of Kalinor-retard P 600 mg is recommended. In other cases, days to weeks are often sufficient to compensate for the potassium deficiency.

Please talk to your doctor or pharmacist if you have the impression that the effect of Kalinor-retard P 600 mg is too strong or too weak.

If you have taken/used more Kalinor-retard P 600 mg than you should

Excess potassium is rapidly excreted by normally functioning kidneys. A threatening elevation of the blood potassium concentration is therefore to be expected only in the case of considerable overdose. Since the normal function of the heart is impaired at greatly elevated blood potassium concentrations, a doctor should be consulted immediately in the event of a considerable overdose. A laboratory test can be used by the doctor to determine the blood potassium concentration and/or the heart rhythm can be checked by means of an ECG. If necessary, the doctor can then normalise the heart function and the blood potassium concentration by means of appropriate measures. In the case of only slightly elevated blood potassium concentration, normalisation can also occur without further treatment due to the normal excretion of potassium via the kidneys.

If you forget to take/use Kalinor-retard P 600 mg

If you have forgotten to take Kalinor-retard P 600 mg once, you can make up for this at a later time. However, you should not take more than 2 capsules at once.

If you stop taking/using Kalinor-retard P 600 mg

If you are supposed to take Kalinor-retard P 600 mg to correct a potassium deficiency or to prevent a potassium deficiency from developing, then this potassium supply through Kalinor-retard P 600 mg is necessary to keep your potassium balance in equilibrium. Without this additional potassium supply, your potassium intake with food is not sufficient to cover your current potassium requirement. If you interrupt or prematurely discontinue taking Kalinor-retard P 600 mg, you may therefore develop a potassium deficiency, which has unfavourable effects on the heart and on the function of nerves and muscles.

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, Kalinor-retard P 600 mg can have 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

Upper abdominal and intestinal complaints, nausea, vomiting and diarrhoea are occasionally observed. The occurrence of severe damage to the mucous membrane in the oesophagus and gastrointestinal tract, which can manifest itself, for example, through severe vomiting, severe abdominal pain and gastrointestinal bleeding, has not been observed for Kalinor-retard P 600 mg to date. Even if you observe side effects that are not listed in this package leaflet, please inform your doctor or pharmacist.

What countermeasures should be taken in the event of side effects?
Nausea and the other gastrointestinal complaints mentioned above do not require any special treatment, provided that they are actually related to taking Kalinor-retard P 600 mg. To avoid this, you should always make sure to take Kalinor-retard P 600 mg with sufficient liquid and never on an empty stomach. Please follow the instructions given in the section "Dosage instructions". In the case of severe vomiting, severe abdominal pain and gastrointestinal bleeding, you must inform your doctor immediately and must not take Kalinor-retard P 600 mg any further. Your doctor will then decide what to do next.

Please inform your doctor or pharmacist if any of the listed side effects affect you significantly or if you notice side effects that are not listed in this package leaflet.

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 provide more information on the safety of this medicine.

5. HOW SHOULD KALINOR-RETARD P 600 MG BE STORED?

Keep out of reach of children. Do not use this medicine after the expiry date which is stated on the folding box (see closure flap) after "Use by". The expiry date refers to the last day of the month. Storage conditions: Keep the container tightly closed. Note on shelf life after opening or preparation: Shelf life after opening 6 months. Do not dispose of the medicine in waste water or household waste. Ask your pharmacist how to dispose of the medicine when you no longer need it. This measure helps to protect the environment.

6. FURTHER INFORMATION

What Kalinor-retard P 600 mg contains

The active ingredient is: Potassium chloride. 1 hard capsule, retarded contains: 600 mg potassium chloride (potassium content 315 mg corresponding to 8 mmol = 8 mval potassium ions). The other ingredients are: Quinoline yellow, erythrosine, ethylcellulose, gelatine, magnesium stearate (Ph.Eur.), sodium dodecyl sulphate, titanium dioxide.

What Kalinor-retard P 600 mg looks like and contents of the pack

Kalinor-retard P 600 mg is a hard gelatine capsule (capsule top yellow-opaque, capsule bottom white-opaque) with practically odourless, white free-flowing pellets. Original packs of 20, 50 and 100 hard capsules retarded.

Pharmaceutical entrepreneur

Desma GmbH
Peter-Sander-Str. 41b
55252 Mainz-Kastel
Tel.: 06134 21079 0
Fax.: 06134 21079 24
e-mail: info@desma-pharma.com

Manufacturer

Nordmark Arzneimittel GmbH & Co.KG
Pinnauallee 4
25436 Uetersen

This package leaflet was last revised in December 2013.

Source: Information from the package leaflet
Status: 12/2017
Active ingredient: 600 mg potassium chloride. Areas of application: Treatment of potassium deficiency, preventive use with diuretics that lead to increased potassium excretion (kaliuresis).