Patient leaflet - Veltassa
B. PACKAGE LEAFLET
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
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1. What Veltassa is and what it is used for
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2. What you need to know before you take Veltassa
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3. How to take Veltassa
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4. Possible side effects
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5. How to store Veltassa
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6. Contents of the pack and other information
1. What Veltassa is and what it is used for
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.
2. What you need to know before you take Veltassa
Do not take Veltassa
- if you are allergic to patiromer or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
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.
Children and adolescents
Do not give Veltassa to children under 18 years, as it has not been studied in this age group.
Other medicines and Veltassa
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.
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.
Driving and using machines
Veltassa has no or negligible influence on your ability to drive and use machines.
3. How to take Veltassa
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 the liquids or soft foods listed below and stir until it is thoroughly mixed, as follows:
- Prepare about 40 mL (3 tablespoons) of the liquid or soft food in a glass/bowl.
- Add the required number of Veltassa sachets and stir.
- Add about 40 mL (3 tablespoons) of additional liquid or soft food and stir thoroughly. The powder does not dissolve but forms a suspension, which might feel grainy.
- You may add more the liquid or soft food to the mixture to help you swallow the medicine.
- Drink or eat the mixture within 1 hour after preparation. If powder remains in the glass/bowl
after drinking/eating, add more liquid or soft food, stir and drink/eat immediately. You may need to do this again to make sure that you have taken all the powder.
You can use water or the following liquids or soft foods to prepare the mixture by following the same steps as described above: apple juice, cranberry juice, pineapple juice, orange juice, grape juice, pear juice, apricot nectar, peach nectar, yoghurt, milk, thickener, apple sauce, vanilla and chocolate pudding.
When using such liquids and soft foods, follow your dietary recommendations on potassium intake. Check with your doctor or pharmacist if you are not sure.
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 or without 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.
4. Possible side effects
Like all medicines, this medicine 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
- diarrhoea
- abdominal pain
- wind
- low blood magnesium seen in tests
Uncommon, may affect up to 1 in 100 people:
- nausea
- vomiting
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Veltassa
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).
Once you have received Veltassa, it can be stored below 25°C for up to 6 months.
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.
6. Contents of the pack and other information
What Veltassa contains
The active substance is patiromer (as patiromer sorbitex calcium).
- Veltassa 8.4 g powder for oral suspension: each sachet contains 8.4 g of patiromer
- Veltassa 16.8 g powder for oral suspension: each sachet contains 16.8 g of patiromer.
- Veltassa 25.2 g powder for oral suspension: each sachet contains 25.2 g of patiromer.
What Veltassa looks like and contents of the pack
The powder for oral suspension is off white to light brown, with occasional white particles.
Veltassa is available in packs containing 30, 60 or 90 sachets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Vifor Fresenius Medical Care Renal Pharma France
100–101 Terrasse Boieldieu
Tour Franklin La Défense 8
92042 Paris La Défense Cedex
France
Manufacturer
Vifor France
100–101 Terrasse Boieldieu
Tour Franklin La Défense 8
92042 Paris La Défense Cedex
France
OM Pharma S.A.
R. da Industria, 2
Quinta Grande
Amadora, 2610–088
Portugal
For any information about this medicine, please contact the Marketing Authorisation Holder.
This leaflet was last revised in
Detailed information on this medicine is available on the European Medicines Agency web site: http : // .
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