Pharmacotherapeutic group: Drugs for treatment of hyperkalemia and hyperphosphataemia.

Veltassa is a medicine that contains the active substance patiromer.

Veltassa is used to treat adults with high levels of potassium in their blood.

Too much potassium in the blood can affect how your nerves control your muscles. This can lead to weakness or even paralysis. High potassium levels can also result in an abnormal heartbeat, which can cause serious effects on your heart rhythm.

Veltassa works by attaching to potassium in your gut. This prevents potassium from entering your bloodstream and lowers potassium levels in your blood back to normal.

a. Do not take Veltassa

if you are allergic to patiromer or any of the other ingredients of this medicine (listed in section 6).

b. Take special care with Veltassa.

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

•  problems swallowing
•  severe stomach or bowel problems
• had major surgery on your stomach or bowel.

Low blood magnesium can occur when taking Veltassa. Your doctor will check the magnesium level during treatment with Veltassa for at least 1 month and may prescribe a magnesium supplement if required.

Veltassa contains sorbitol. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. The sorbitol content is approximately 4 g (10.4 kcal) per 8.4 g of patiromer.

c. Children and adolescents

Do not give Veltassa to children under 18 years, as it has not been studied in this age group.

d. Using other medicines, herbal or dietary supplements

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

Veltassa may affect certain medicines if they are taken by mouth and at the same time, such as:

•  ciprofloxacin: a medicine to treat bacterial infections
• levothyroxine: a medicine to treat thyroid hormone deficiency
•  metformin: a medicine to treat diabetes
• quinidine: a medicine to treat irregular heart rhythm.

Take all medicines taken by mouth at least 3 hours before or after you take Veltassa unless your doctor or pharmacist gives you different advice. Ask your doctor or pharmacist if you are not sure.

e. Pregnancy and breast‑feeding

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.

Use Veltassa during pregnancy and breast‑feeding only if your doctor considers it necessary.

f. Driving and using machines

Veltassa has no or negligible influence on your ability to drive and use machines.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is:

•  starting dose: 8.4 g patiromer (the content of one 8.4 g sachet) once daily
•  maximum dose: 25.2 g patiromer (the content of one 25.2 g sachet) once daily

Your doctor may adjust the dose depending on the potassium level in your blood.

Take Veltassa at least 3 hours before or after other medicines taken by mouth unless your doctor or pharmacist gives you different advice.

Method of administration

Mix Veltassa with water and stir until it is thoroughly mixed, as follows:

•  Prepare about 40 ml (3 tablespoons) of water in a glass.
•  Add the required number of Veltassa sachets and stir.
•  Add about 40 ml (3 tablespoons) of additional water and stir thoroughly. The powder does not dissolve but forms a suspension.
•  You may add more water to the mixture to help you swallow the medicine.
•  Drink the mixture immediately after preparation. If powder remains in the glass after drinking, add more water, stir and drink immediately. You may need to do this again to make sure that you have taken all the powder.

You can use apple juice or cranberry juice instead of water. Other liquids cannot be used as they may contain high amounts of potassium. You should drink only moderate amounts (less than 400 ml per day) of cranberry juice as it can affect other medicines.

Take the prepared Veltassa suspension with food, preferably at the same time each day. Never heat Veltassa or add it to heated foods or liquids.

Do not take Veltassa as a dry powder.

If you take more Veltassa than you should

Stop taking Veltassa and talk to your doctor or pharmacist immediately.

If you forget to take Veltassa

If you have missed a dose, take it as soon as possible on the same day. Do not take a double dose to make up for a forgotten dose. If you miss more than one dose, contact your doctor.

If you stop taking Veltassa

Do not stop taking the medicine without your doctor’s approval, as your potassium blood level may increase.

Like all medicines, Veltassa can cause side effects, although not everybody gets them.

The following side effects have been reported:

Common, may affect up to 1 in 10 people:

•  constipation
•  diarrhea
• abdominal pain
•  wind
•  low blood magnesium seen in tests

Uncommon, may affect up to 1 in 100 people:

• nausea
•  vomiting

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

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

Do not use this medicine after the expiry date which is stated on the carton or sachet after “EXP”. The expiry date refers to the last day of that month.

Store and transport refrigerated (2°C – 8°C).

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.