Veltassa 8.4 g powder for oral suspension
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Veltassa 1 g powder for oral suspension
Veltassa 8.4 g powder for oral suspension
Veltassa 16.8 g powder for oral suspension
Veltassa 25.2 g powder for oral suspension
Patiromer (as patiromer calcium-sorbitex)
Read all of this leaflet carefully before you or your child starts taking this medicine, because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you or your child only. Do not give it to other people, even if they have the same symptoms as you, because it may harm them.
- If you or your child experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Contents of this leaflet
- What Veltassa is and what it is used for
- What you need to know before taking Veltassa
- How to take Veltassa
- Possible side effects
- How to store Veltassa
- Contents of the pack and other information
1. What Veltassa is and what it is used for
Veltassa is a medicine containing patiromer as the active substance.
This medicine is used to treat adults and adolescents aged 12 to 17 years with high levels of potassium in the blood.
Too much potassium in the blood can affect the way nerves control muscles, which may cause weakness or even paralysis. High potassium levels may also cause an abnormal heartbeat, which can lead to serious disturbances in your or your child's heart rhythm.
This medicine works by binding potassium in the intestine, thereby preventing potassium from entering the bloodstream and reducing blood potassium levels to restore normal levels.
2. What you need to know before taking Veltassa
Do not take Veltassa
- If you or your child are allergic to patiromer or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Consult your doctor or pharmacist before starting to use Veltassa if you or your child:
- have difficulty swallowing. If you cannot swallow the medicine, it will not work.
- have serious stomach or intestinal problems. This medicine may cause constipation or diarrhea in some patients.
- have had major surgery on the stomach or intestines. This medicine acts through the intestine, so major surgery in this area could reduce its effectiveness.
The level of magnesium in the blood may decrease when taking this medicine. Your doctor will monitor your magnesium levels during treatment with this medicine for at least 1 month and may prescribe a magnesium supplement if necessary.
Children and adolescents
Do not give this medicine to children under 12 years of age, as it has not been studied in this age group.
Other medicines and Veltassa
Inform your doctor or pharmacist if you or your child are taking, have recently taken, or might need to take any other medicines.
This medicine may reduce the absorption of certain medicines or interact with them if taken orally at the same time, for example:
- ciprofloxacin: a medicine used to treat bacterial infections
- levothyroxine: a medicine used to treat thyroid hormone deficiency
- metformin: a medicine used to treat diabetes
- mycophenolate mofetil: a medicine used to prevent the body from rejecting a transplanted organ
- quinidine: a medicine used to treat irregular heart rhythm
- telmisartan, bisoprolol, carvedilol, nebivolol: medicines used to treat high blood pressure and heart problems.
Take all oral medicines at least 3 hours before or after taking Veltassa. Some medicines are not affected by the use of Veltassa, so your doctor or pharmacist may give you different instructions depending on the medicines you or your child are taking. Consult 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 become pregnant, consult your doctor or pharmacist before using this medicine.
Use this medicine during pregnancy and breastfeeding only if your doctor considers it necessary.
Driving and using machines
The effect of this medicine on the ability to drive and operate machinery is none or negligible.
Veltassa contains sorbitol
The sorbitol content is approximately 4 g (10.4 kcal) per 8.4 g of patiromer and 0.5 g (1.2 kcal) per 1 g of patiromer. Sorbitol is a source of fructose. If your doctor has told you or your child that you have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which patients cannot break down fructose, consult your doctor before using this medicine. Sorbitol may cause gastrointestinal discomfort and a mild laxative effect.
Veltassa contains calcium
If your doctor has advised you or your child to limit calcium intake in your diet, consult your doctor before using this medicine. Your doctor will monitor calcium levels during treatment with this medicine for at least 1 month.
3. How to take Veltassa
Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
This medicine is administered once daily. The recommended starting dose varies by age. Several sachets may be used to achieve the desired dose. Your doctor may adjust the daily dose based on your or your child's blood potassium level, up to a maximum dose of 25.2 g daily.
Adults
Starting dose: 8.4 g of patiromer (the contents of one 8.4 g sachet) once daily.
Adolescents aged 12 to 17 years
- Starting dose: 4 g of patiromer (the contents of four 1 g sachets) once daily. Switch to 8.4 g patiromer sachets if doses greater than 7 g are required.
Your doctor will determine the duration of treatment based on your blood potassium level.
Use this medicine at least 3 hours before or after taking other oral medications, unless your doctor or pharmacist advises otherwise.
Method of administration
Before taking this medicine, it must be mixed with water as described below. The volume of water depends on your dose:
- 1 g of patiromer: 10 ml (2 teaspoons)
- 2 g of patiromer: 20 ml (4 teaspoons)
- 3 g of patiromer: 30 ml (6 teaspoons)
- 4 g of patiromer: 40 ml (3 tablespoons)
- More than 4 g of patiromer: 80 ml (6 tablespoons)
Prepare the mixture following these steps:
- Pour half of the water into a glass, add the required number of Veltassa sachets and mix.
- Add the remaining half of water and mix thoroughly. The powder does not dissolve but forms a suspension that may feel granular.
- You may add more water to the mixture to help you swallow the medicine. Note that with a larger volume, the powder may settle more quickly.
- Drink the mixture within one hour of preparation. If powder remains in the glass after drinking, add more water, mix and drink immediately. You may need to repeat this to ensure you have taken all the powder.
If preferred, you may use the following liquids or soft foods instead of water to prepare the mixture, following the same steps described above: apple juice, cranberry juice, pineapple juice, orange juice, grape juice, or pear juice; apricot or peach nectar; yogurt; milk; thickening agent (e.g. cornstarch); apple puree; chocolate or vanilla pudding.
If you use these liquids or soft foods, you or your child should continue to follow the dietary recommendations regarding potassium intake. If in doubt, ask your doctor or pharmacist.
Drink cranberry juice only in small amounts (less than 400 ml per day), as it may affect other medicines.
Take the prepared Veltassa suspension with or without food, preferably at the same time each day. Never heat this medicine or add it to hot food or liquids.
Do not take this medicine as dry powder.
If using a nasogastric tube or a percutaneous endoscopic gastrostomy (PEG) tube, follow the steps described above to prepare the oral suspension. For doses up to 8.4 g of patiromer, use the volume described above. For doses greater than 8.4 g up to 16.8 g of patiromer, use a total volume of 160 ml (12 tablespoons). For doses greater than 16.8 g up to 25.2 g of patiromer, use a total volume of 240 ml (18 tablespoons). These volumes ensure the suspension flows easily through the tubes.
Polyurethane, silicone, and polyvinyl chloride tubes may be used. The recommended tube diameter is 2.17 mm (6.5 Fr) or larger. After administration of the suspension, flush the tube with water. Follow the manufacturer's instructions for the tube.
If you take more Veltassa than you should
Stop using this medicine and contact your doctor or pharmacist immediately.
If you forget to take Veltassa
If you or your child 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 forgotten doses. If you miss more than one dose, contact your doctor.
If you stop taking Veltassa
Do not stop using this medicine without your doctor's approval, as blood potassium levels may increase.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Stop taking the medicine and contact your doctor urgently if you notice any of the following adverse effects:
Frequency not known, cannot be estimated from available data:
allergic reactions: symptoms include skin rash, hives, swelling of lips, tongue or throat
The following additional adverse effects have been reported:
Common, may affect up to 1 in 10 people:
- constipation
- diarrhea
- abdominal pain
- nausea
- gas
- low blood magnesium levels (observed in blood tests)
Uncommon, may affect up to 1 in 100 people:
- vomiting
Cases of constipation, diarrhea, and gas have also been reported in children and adolescents aged 6 to 17 years.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Veltassa
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or sachet after "EXP". The expiry date refers to the last day of the month indicated.
Store and transport refrigerated (between 2°C and 8°C).
After receiving this medicine, it may be stored below 25°C for up to 6 months.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This helps protect the environment.
6. Contents of the pack and other information
Composition of Veltassa
- The active substance is patiromer (as patiromer calcium sorbitex).
- Veltassa 1 g oral suspension powder: each sachet contains 1 g of patiromer.
- Veltassa 8.4 g oral suspension powder: each sachet contains 8.4 g of patiromer.
- Veltassa 16.8 g oral suspension powder: each sachet contains 16.8 g of patiromer.
- Veltassa 25.2 g oral suspension powder: each sachet contains 25.2 g of patiromer.
The other component (excipient) is xanthan gum (for more information on sorbitol, see section 2).
Appearance of Veltassa and contents of the pack
The colour of the oral suspension powder ranges from off-white to light brown, with isolated white particles.
Veltassa 1 g is available in packs of 60 sachets.
Veltassa 8.4 g is available in packs of 30, 60 or 90 sachets and in multiple packs containing 3 boxes of 30 sachets each.
Veltassa 16.8 g and 25.2 g are available in packs of 30, 60 or 90 sachets.
Only certain pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
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
Date of the most recent review of this leaflet: 06/2024
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.