Plenish-K Tablets

PLENISH - K 600 SR belongs to a group of medicines called potassium supplements. PLENISH-K 600 SR is used as an oral potassium supplementation to treat or prevent low levels of potassium in your body. Potassium supplements may be needed by patients using certain medicines, such as diuretics or digoxin.

Do not take PLENISH-K 600 SR :

• If you are hypersensitive (allergic) to potassium chloride or any of the other ingredients of PLENISH-K 600 SR tablets.
• If you have ulcers in your bowel or gut.
• If you have been told by your doctor you have kidney failure.
• If you have Addison’s disease (which is a condition where your adrenal gland is not producing enough steroids).
• If you have recently suffered from trauma, severe burns, anaemia and muscle cramps and metabolic complications occurring after cancer treatment.
• If you suffer from digestive problems or have difficulty swallowing (due to a narrowing or blockage of your gullet (food pipe) or intestines).
• If you have been told you have metabolic acidosis (a condition caused by increased acid levels in the blood).
• If you are dehydrated (you may feel thirsty with a dry mouth).
• If you have high blood potassium levels (which can cause an abnormal heartbeat).
• If you suffer from a condition called hyporeninaemic hypoaldosteronism (where your body is low on an enzyme called renin and a hormone called aldosterone which normally helps to control your blood pressure).

Warnings and precautions

Take special care with PLENISH-K 600 SR:

• If you experience severe nausea and vomiting, severe stomach pain or experience gas in your stomach, increased urgency to empty your bowels (diarrhoea) or any bleeding in your stomach or intestines, contact your doctor immediately.
• If you have undergone any surgery of the intestine or bowel (e.g. colostomy (an operation to remove part of your bowels or colon)).
• If you suffer from any condition which affects your bowel movements ( intestinal ischaemia).
• If you suffer from heart disease (which may cause chest pain, shortness of breath or ankle swelling).
• If you suffer from kidney problems or if you were told by your doctor that your body has difficulty eliminating potassium (e.g. because of kidney problems). If you suffer from severe kidney impairment. Your dose may need to be adjusted.
• If you suffer from abnormal slowing or pooling of food and liquid within the oesophagus (oesophageal stasis).
• If you have or have ever had a stomach ulcer.
• If you are elderly, your doctor may need to monitor your renal function.
• If you suffer from cirrhosis, a condition where your liver gets scarred and damaged over time.
• If you suffer from renal impairment, a condition where your kidneys aren’t working as well as they should, your doctor may need to monitor your renal function more regularly.

Children

There is no experience with PLENISH-K 600 SR in children. PLENISH-K 600 SR is therefore not recommended for use in children.

Other medicines and PLENISH - K 600 SR

Always tell your healthcare provider if you are taking any other medicine (this includes complementary or traditional medicines). Tell your doctor if you are taking any of the following:

• Potassium-sparing diuretics (e.g. triamterene, amiloride): used in the treatment of high blood pressure or certain heart diseases (see Do not take PLENISH-K 600 SR).
• Aldosterone antagonists (e.g. spironolactone, eplerenone): used in the treatment of high blood pressure or certain heart diseases (see Do not take PLENISH-K 600 SR).
• ACE inhibitors (e.g. lisinopril, captopril, enalapril and other): used in the treatment of high blood pressure (see Do not take PLENISH-K 600 SR).
• Angiotensin-II-receptor-blockers (e.g. valsartan, losartan and others): used in the treatment of high blood pressure.
• Non - steroidal anti - inflammatory medicines (e.g. indomethacin and others): used to relieve pain and inflammation.
• Beta - blockers (e.g. atenolol, propranolol and others): used in the treatment of high blood pressure.
• Direct renin inhibitors (e.g. aliskerin): used in the treatment of high blood pressure.
• Anticholinergics (e.g. atropine): medicines used for a variety of disorders such as stomach cramps, bladder spasms, asthma, motion sickness, muscle spasms, poisoning with certain toxic compounds and as an aid to anaesthesia and after heart attacks.
• Heparin: medicine used to prevent blood clotting.
• Digoxin: medicine used in the treatment of certain heart diseases to help the heartbeat.
• Ciclosporin: Medicine used to control your body’s immune system in to order to prevent rejection of a transplanted organ.
• Potassium containing salt substitutes for flavouring food.

Do not share medicines prescribed for you with any other person. Always take PLENISH - K 600 SR exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure.

Swallow the tablets whole with a full glass of water of liquid during meals while sitting upright. Do not crush, chew or suck the tablet. PLENISH-K 600 SR should not be taken on an empty stomach because of its potential to cause irritation in your digestive tract.

The usual dose for adults is 6 to 12 tablets daily. Not more than 2 tablets should be taken at once. Your doctor or pharmacist will tell you exactly how many tablets of PLENISH-K 600 SR to take. Your doctor will tell you how long your treatment with PLENISH-K 600 SR will last. Depending on how you respond to the treatment, your doctor may suggest a higher or lower dose.

If you have the impression that the effect of PLENISH-K 600 SR is too strong or too weak, tell your doctor or pharmacist.

If you take more PLENISH - K 600 SR than you should In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre.

If you forget to take PLENISH - K 600 SR Take your missed dose as soon as you remember, if within a few hours after missing a dose. Do not take a double dose to make up for forgotten individual doses.

PLENISH-K 600 SR can have side effects. Not all side effects reported for PLENISH-K 600 SR are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking PLENISH-K 600 SR, please consult your healthcare provider for advice.

If any of the following happens, stop taking PLENISH - K 600 SR and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing,
• rash or itching,
• fainting.

These are all very serious side effects. If you have them, you may have had a serious reaction to PLENISH-K 600 SR. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• Bleeding from your intestines or stomach (gastrointestinal haemorrhage);
• obstruction in the stomach or intestines which may result in cramping in your stomach (gastrointestinal obstruction), loss of appetite, constipation, vomiting swelling of the stomach and the inability to pass gas.

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent side effects:

• Feeling or being sick (nausea and vomiting);
• buildup of gas in the digestive system (flatulence);
• pain and cramps in the stomach;
• diarrhoea.

Side effects with an unknown frequency:

• High potassium levels in your blood (hyperkalaemia);
• ulcer in the stomach or intestines (gastrointestinal ulcer);
• skin rash;
• itchy skin (urticaria, pruritus).

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website.

Aspen Pharmacare: E-mail: [email protected] Tel: 0800 118 088 By reporting side effects, you can help provide more information on the safety of PLENISH- K 600 SR.

Store all medicines out of reach of children. Store at or below 25 °C. Protect from moisture. Keep in original packaging until required for use.

Do not store in a bathroom. Do not use after the expiry date stated on the label. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).