Renodyra 1080 mg Modified-release tablets

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Renodyra is and what it is used for
2. What you need to know before you take Renodyra
3. How to take Renodyra
4. Possible side effects
5. How to store Renodyra
6. Contents of the pack and other information

• if you are allergic to potassium citrate, or any of the other ingredients of this medicine listed in section 6;
• if you have severely impaired kidney function;
• if you have active or persistent urinary tract infection;
• if you have significant or complete obstruction of the urinary tract;
• if you have excessive potassium in your blood (hyperkalaemia);
• if you have severely impaired heart function;
• if you have uncontrolled diabetes;
• if your adrenal glands are not working properly;
• if your blood and body fluids acid-base balance is disrupted (metabolic or respiratory alkalosis;
• if you have a peptic ulcer;
• if you have a condition in which food stays in your stomach for longer than it should (delayed gastric emptying);
• if you suffer from bowel obstruction.

Talk to your doctor or pharmacist before taking Renodyra if you have:

• a condition, where you cannot excrete potassium. Renodyra may cause excessive potassium in your blood (hyperkalaemia) and cardiac arrest which may be fatal. Your doctor will monitor you and take blood tests every 4 months;
• severely reduced liver function.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Some medicines may affect how Renodyra works and vice versa. Concomitant use with the below medicines:

• may increase the level of potassium in your blood:
  • potassium-sparing diuretics (to treat reduce blood pressure, fluid build-up in tissue (oedema), heart conditions), e.g., amiloride, eplerenone, spironolactone, triamterene;
  • finerenone (to treat chronic kidney disease in connection with type 2-diabetes);
  • angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers, aliskiren, beta-blockers (to reduce high blood pressure);
  • digoxin (to treat different heart conditions);
  • drospirenone (oral contraceptive, hormone replacement therapy);
  • heparin (blood thinner);
  • nicorandil (to treat angina);
  • nonsteroidal anti-inflammatory drugs (NSAIDs) (to reduce pain, fever, inflammation), e.g., indomethacin.
• may increase the effect of the below medicines:
  • Alpha-/beta-agonists (indirect-acting) (to treat ADHD, narcolepsy, nasal congestion, asthma);
  • amantadine (to treat symptoms of Parkinson's disease);
  • mecamylamine (to reduce high blood pressure);
  • memantine (to treat dementia);
  • quinine (to treat malaria, leg cramps and similar conditions);
  • amphetamines (stimulants that speed up the body's system);
  • aluminium hydroxide (to treat heartburn, acid indigestion).
• may increase the risk of abdominal pain (stomach ulcers):
  • anticholinergics (medicine that delays gastrointestinal motility).

You should not drink alcohol when taking Renodyra as this may result in the medicine being released too quickly in your body.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Your doctor will only treat you with this medicine if strictly necessary and under strict medical surveillance.

Breast-feeding

Renodyra can be used during breast-feeding.

Renodyra does not affect your ability to drive and use machines.

Renodyra contains 390 mg of potassium per tablet. To be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet.

Severe hypocitraturia (urinary citrate < 150 mg/day)

Initial dose: 6 tablets/day (60 mEq/6480 mg) in 3 divided daily doses.

Mild hypocitraturia (urinary citrate > 150 mg/day)

Initial dose: 3 tablets/day (30 mEq/3240 mg) in 3 divided daily doses.

If necessary, the dose may be increased as long as the maximum dose of 10 tablets/day (100 mEq/10800 mg) is not exceeded.

Your kidney function will be monitored regularly.

Renodyra should be used with caution.

You should immediately seek medical attention if you think that you or anyone else may have taken too many Renodyra tablets even if there are no signs of discomfort or poisoning.

Signs of overdose include depression, mental confusion, paraesthesia (e.g., tingling sensation, numbness); muscle weakness and sometimes paralysis of the extremities, which can develop gradually or in stages; slow heartbeat (bradycardia); low blood pressure which may in some cases be serious (leading to irregular heart beat, possibly heart attack and sudden death).

If you forget to take a tablet, leave out that dose completely. Take your next dose at the normal time it is due. Do not take a double dose to make up for a forgotten dose.

Do not stop taking Renodyra tablets unless your doctor tells you to.

Your doctor will decide when treatment with Renodyra should be stopped.

Not known (frequency cannot be estimated from the available data)

• burning and heavy feeling in the pit of the stomach, mild nausea, vomiting, loss of appetite and weakness caused by damage to the mucosal lining in your stomach;
• bloody vomit and/or black stools due to bleeding in the stomach and intestines;
• constipation, vomiting, inability to pass stool or gas, swelling of the abdomen due to intestinal obstruction;
• muscle weakness, confusion, difficulty speaking due to too much potassium in your blood (hyperkalaemia).

Very common (may affect more than 1 in 10 people)

• stomach pain;
• nausea.

Common (may affect up to 1 in 10 people)

• upper stomach pain;
• diarrhoea;
• dyspepsia;
• difficulty swallowing;
• inflammation of the oesophagus;
• vomiting;
• gaseousness (bloating, belching, flatulence);
• rash.

You may notice the remnants of the tablet wax matrix in your faeces. This is normal. Do not be concerned.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme (website: www.mhra.gov.uk/yellowcard) or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects, you can help provide more information on the safety of this medicine.

• The active substance is potassium citrate.
  Each tablet contains 1080 mg (10 mEq) of potassium citrate, equivalent to 390 mg of potassium.
• The other ingredients are carnauba wax and magnesium stearate.

Cream coloured to yellow, oval, biconvex, uncoated tablets. Tablet size: approx. 18.5 mm.

Pack size: 100 modified-release tablets.

The tablets are packed in a plastic bottle and closed with a tamper evident cap. The bottle is packed in a box.