8.4 g; 16.8 g; 25.2 g powder for oral suspension,
patiromer (as patiromer sorbitex calcium)
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 elevated levels of potassium in the blood.
Increased potassium in the blood can affect how the nerves control the muscles. This can lead to weakness or even paralysis. Elevated levels of potassium can also result in heart rhythm disturbances, which can have serious effects on heart rhythm.
Veltassa works by binding to potassium in the gut. This prevents potassium from entering your bloodstream and thus lowers the level of potassium in your blood to a normal level.
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:
- trouble swallowing
- severe stomach or intestinal problems
- underwent major stomach or intestinal surgery
Low levels of magnesium in the blood can occur while taking Veltassa. Your doctor will monitor your magnesium levels during your treatment with Veltassa for at least 1 month and may prescribe magnesium supplements if necessary.
Children and young people
Do not give Veltassa to children under 18 years of age 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 can affect certain medicines if taken by mouth and at the same time, such as:
- ciprofloxacin: a medicine used to treat bacterial infections
- levothyroxine: a medicine to treat thyroid hormone deficiency
- metformin: a medicine used to treat diabetes
- quinidine: a medicine used to treat irregular heart rhythms.
Take all medicines to be taken by mouth at least 3 hours before or after you take Veltassa unless otherwise advised by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Use Veltassa during pregnancy and breastfeeding only if your doctor considers it necessary.
It is unlikely that the drug is transferred into breast milk.
Driving ability and use of machinery
Veltassa has no or negligible effect on your ability to drive and use machines.
Veltassa contains sorbitol and calcium
Veltassa contains sorbitol
The sorbitol content is approximately 4 g (10.4 kcal) per 8.4 g patirome. Sorbitol is a source of fructose. If you have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare, inherited disease that makes it impossible to break down fructose, consult a doctor before using this medicine.
Veltassa contains calcium
If your doctor has told you to reduce the amount of calcium in your diet, talk to your doctor before taking or receiving this medicine.
How to take Veltassa
Always take this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
The recommended dose is:
- starting dose: 8.4 g patiromer (the contents of an 8.4 g sachet ) once daily
- maximum dose: 25.2 g patiromer (the contents of a 25.2 g sachet ) once daily
Your doctor may adjust the dose during the treatment period depending on the potassium levels in your blood.
Take Veltassa at least 3 hours before or after other medicines to be taken by mouth, unless otherwise advised by a doctor or pharmacist.
Mode of administration
Mix Veltassa with the liquids or soft foods listed below and stir until well mixed, as follows:
- Prepare about 40 ml (3 tablespoons) of the liquid or soft food in a glass/bowl.
- Add the number of Veltassa sachets needed and stir.
- Add another 40 ml (3 tablespoons) of liquid or soft food and stir well. The powder does not dissolve but forms a suspension that can feel grainy.
- You can add more liquid or soft food to the mixture to make the medicine easier to swallow.
- Drink or eat the mixture within 1 hour of preparation. If there is powder left 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 you have taken all the powder.
You can use water or the following liquids or soft foods to prepare a 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, yogurt, milk, thickeners (eg. cornstarch), applesauce, vanilla, and chocolate pudding.
When using such liquids or soft foods, follow the dietary recommendation for potassium intake. Ask your doctor or pharmacist if you are unsure.
You should only drink moderate amounts of cranberry juice (less than 400ml per day) 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 food or liquid.
Do not take Veltassa as a dry powder.
If you have taken too much Veltassa
Stop taking Veltassa and consult a doctor or pharmacist immediately
If you forget to take Veltassa
If you forget to take a dose, take it as soon as possible on the same day. Do not take a double dose to make up for a missed dose. If you forget more than one dose, contact your doctor.
If you stop taking Veltassa
Do not stop taking the medicine without a doctor’s approval because the level of potassium in the blood may increase.
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 users:
- constipation
- diarrhea
- abdominal pain
- gas formation
- low levels of magnesium in the blood have been observed in tests
Uncommon, may affect up to 1 in 100 users:
- nausea
- vomiting
How to store Veltassa
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the carton or sachet after “EXP”. The expiration date is the last day of the specified month.
Store and transport cold (2°C – 8°C).
Once you have received Veltassa, it can be stored at room temperature (below 25°C) for up to 6 months.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
The active substance is patiromer (as patiromer sorbitex calcium).
- Veltassa 8.4 g powder for oral suspension: each sachet contains 8.4 g patiromer.
- Veltassa 16.8 g powder for oral suspension: each sachet contains 16.8 g patiromer.
- Veltassa 25.2 g powder for oral suspension: each sachet contains 25.2 g patiromer.
Another ingredient is xanthan gum.
Appearance and package sizes of the medicine
The powder for oral suspension is off-white to light brown, with occasional white particles.
Veltassa 8.4 g is available in packs of 30, 60, or 90 sachets and multiple packs consisting of 3 cartons, each containing 30 sachets.
Veltassa 16, 8 g, and 25.2 g are available in packs of 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
For France
100–101 Terrasse Boieldieu
Tour Franklin La Défense 8
92042 Paris La Défense Cedex
France
ABOUT Pharma SA
R. da Indústria, 2
Quinta Grande
Amadora, 2610-088
Portugal