Package Insert: Information for the Patient

Veltassa 1 g Powder for Oral SuspensionVeltassa 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 of sorbitex)

Read the entire package insert carefully before you or your child start taking this medication, because it contains important information for you.Read the entire package insert carefully before you or your child start taking this medication, because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you or your child, and should not be given to others even if they have the same symptoms as you, as it may harm them.
• If you or your child experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Veltassa is a medication that contains patiromer as its active ingredient.

This medication is used to treat adults and adolescents between 12 and 17 years of age with high levels of potassium in the blood.

High levels of potassium in the blood can affect how nerves control muscles; which can cause weakness or even paralysis. Elevated potassium levels can also produce an abnormal heart rhythm, which can cause severe effects on your or your child's heart rhythm.

This medication acts by binding to potassium in the intestine, preventing potassium from entering the bloodstream and reducing potassium levels in the blood to recover normal levels.

Do not take Veltassa

• If you or your child are allergic to patiromer or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Veltassa if you or your child:

The level of magnesium in the blood may decrease when takingthis medication. Your doctor will monitor the magnesium level during treatment withthis medicationfor at least 1 month and may prescribe a magnesium supplement if necessary.

Children and adolescents

Do not administerthis medicationto children under 12 years old, as it has not been studied in this age group.

Other medications and Veltassa

Inform your doctor or pharmacist if you or your child are taking, have taken recently, or may need to take any other medication.

This medication may reduce the absorption of certain medications or interact with them if taken orally at the same time, for example:

Use all oral medications at least 3hours before or after using Veltassa. Some medications are not affected by the use of Veltassa, so your doctor or pharmacist may give you different instructions depending on the medications 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 plan to become pregnant, consult your doctor or pharmacist before using this medication.

Usethis medicationduring pregnancy and breastfeeding only if your doctor considers it necessary.

Driving and operating machinery

The effect ofthis medicationon the ability to drive and operate machinery is negligible or insignificant.

Veltassa contains sorbitol

The sorbitol content is approximately 4g (10.4kcal) per 8.4g of patiromer and 0.5g (1.2kcal) per 1g of patiromer. Sorbitol is a source of fructose.If your doctor has indicated that you or your child have an intolerance to certain sugars, or have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the patient cannot break down fructose, consult your doctor before using this medication.Sorbitol may cause gastrointestinal discomfort and a mild laxative effect.

Veltassa contains calcium

If your doctor has indicated that you or your child should limit calcium in your diet, consult your doctor before using this medication. Your doctor will monitor the calcium level during treatment with this medication for at least 1month.

Follow exactly the usage instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

This medication is administered once a day. The initial recommended dose of this medication varies with age. Several packets 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 daily dose of 25.2g.

Adults

Initial dose:8.4g of patiromer (the contents of an 8.4g packet) once a day.

Adolescents aged 12 to 17 years

• Initial dose:4g of patiromer (the contents of four 1g packets) once a day. Switch to 8.4g patiromer packets if higher doses are needed.

Your doctor will determine the duration of treatment based on your blood potassium level.

Use this medication at least 3 hours before or after taking other oral medications, unless your doctor or pharmacist tells you otherwise.

Administration form

Before taking this medication, it is necessary to mix it with water, as described below. The volume of water depends on your dose:

• 1g of patiromer: 10ml (2 teaspoons)
• 2g of patiromer: 20ml (4 teaspoons)
• 3g of patiromer: 30ml (6 teaspoons)
• 4g of patiromer: 40ml (3tablespoons)
• More than 4g of patiromer: 80ml (6tablespoons)

Prepare the mixture by following these steps:

• Mix half the water in a glass, add the required number of Veltassa packets and mix.
• Add the remaining half of water and mix well. The powder does not dissolve but forms a suspension that may be noticed as granular.
• You can add more water to the mixture to help you swallow the medication. Note that with a larger volume, the powder may settle more quickly.
• Drink the mixture within the hour following preparation.If there is powder left in the glass after drinking the contents, add more water, mix, and drink immediately. You may need to do this again to ensure you have taken all the powder.

You can use the following liquids or soft foods instead of water to prepare the mixture, following the same steps as above: apple juice, blackberry juice, pineapple juice, orange juice, grape juice, or pear juice, apricot nectar or peach nectar, yogurt, milk, thickener (such as cornstarch), apple sauce, chocolate and vanilla pudding.

If you use these liquids and soft foods, you or your child should follow the potassium intake recommendations for your diet. If in doubt, ask your doctor or pharmacist.

Only use blackberry juice in small amounts (less than 400ml per day), as it may affect other medications.

Use the prepared Veltassa suspension with or without food, preferably at the same time every day.Neverheat this medication or add it to hot foods or liquids.

Do not takethis medication as dry powder.

If you use a nasogastric tube or a percutaneous endoscopic gastrostomy tube, follow the steps described above to prepare the suspension for oral administration. For doses up to 8.4g of patiromer, use the volume described above. For doses greater than 8.4g and up to 16.8g of patiromer, use a total volume of 160ml (12tablespoons), and for doses greater than 16.8g and up to 25.2g of patiromer, use a total volume of 240ml (18tablespoons). These volumes ensure that the suspension flows easily through the tubes.

You can use polyurethane, silicone, or PVC tubes. The recommended tube diameter is 2.17mm (6.5Fr) or larger. After administering the suspension, the tube should be washed with water. Follow the manufacturer's instructions for the tube.

If you take more Veltassa than you should

Stop using this medication and consult 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 the missed dose. If you forget more than one dose, contact your doctor.

If you interrupt Veltassa treatment

Do not stop usingthe medication without your doctor's approval, as your blood potassium level may increase.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Stop taking the medication and seek urgent medical attention if you notice any of the following adverse effects:

Unknown frequency,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:

Frequent,may affect up to 1 in 10 people:

Rare, may affect up to 1 in 100 people:

There have also been cases of constipation, dysentery, and flatulence reported in children and adolescents aged 6 to 17 years.

Reporting 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 prospectus. You can also report them directly through the national notification system included in theAppendix V. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not use this medication after the expiration date that appears on the box or on the blister pack after “CAD”. The expiration date is the last day of the month indicated.

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

Once you have received this medication, it can be stored below 25°C for up to 6 months.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. In this way, you will help protect the environment.

Composition of Veltassa

The other component (excipient) is xanthan gum (for more information on sorbitol, see section2).

Appearance of Veltassa and contents of the container

The color of the oral powder is between off-white and light brown, with isolated white particles.

Veltassa 1g is available in packs of 60 sachets.

Veltassa 8.4g is available in packs of 30, 60 or 90 sachets and in multiple packs containing 3boxes, each containing 30sachets.

Veltassa 16.8g and 25.2g are available in packs of 30, 60 or 90 sachets.

Only some pack sizes may be marketed.

Marketing authorization holder and responsible person for manufacturing

Marketing authorization holder

Vifor Fresenius Medical Care Renal Pharma France

100–101 Terrasse Boieldieu

Tour Franklin La Défense 8

92042 Paris La Défense Cedex

France

Responsible person for manufacturing

Vifor France

100–101 Terrasse Boieldieu

Tour Franklin La Défense 8

92042 Paris La Défense Cedex

France

Last review date 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.