VELTASSA 1 G ORAL SUSPENSION POWDER

Introduction

Package Leaflet: Information for the Patient

Veltassa 1g oral powder for suspension

Veltassa 8.4g oral powder for suspension

Veltassa 16.8g oral powder for suspension

Veltassa 25.2g oral powder for suspension

patiromer (as patiromer calcium sorbitex)

Read the entire package leaflet carefully before you or your child start taking this medicine, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you or your child only. Do not give it to others, as it may harm them, even if they have the same symptoms as you.
• If you or your child experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the package leaflet

1. What is Veltassa and what is it used for
2. What you need to know before taking Veltassa
3. How to take Veltassa
4. Possible side effects
5. Storage of Veltassa
6. Package contents and further information

1. What is Veltassa and what is it used for

Veltassa is a medicine that contains patiromer as the active substance.

This medicine is used to treat adults and adolescents from 12 to 17 years of age with high levels of potassiumin the blood.

Too much potassium in the blood can affect the way nerves control muscles, which can cause weakness or even paralysis. High levels of potassium can also cause an abnormal heartbeat, which can have serious effects on your or your child's heart rhythm.

This medicine works by binding to potassium in the intestine, which prevents potassium from entering the bloodstream and reduces potassium levels in the blood 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 any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

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

• have problems swallowing. If you cannot swallow the medicine, it will not work.
• have severe stomach or intestinal problems. This medicine may cause constipation or diarrhea in some patients.
• have had major stomach or intestinal surgery. This medicine works through the intestine, so major surgery in this area may reduce its effect.

The level of magnesium in the blood may decrease when taking this medicine.Your doctor will monitor the magnesium level 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

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

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

• ciprofloxacin: a medicine for treating bacterial infections
• levothyroxine: a medicine for treating thyroid hormone deficiency
• metformin: a medicine for treating diabetes
• mycophenolate mofetil: a medicine for preventing the body from rejecting a transplanted organ
• quinidine: a medicine for treating irregular heartbeat
• telmisartan, bisoprolol, carvedilol, nebivolol: medicines for treating high blood pressure and heart problems.

Use all oral medicines at least 3 hours before or after using 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. Talk to 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, talk to your doctor or pharmacist before using this medicine.

Use this medicine during pregnancy and breastfeeding only if your doctor considers itnecessary.

Driving and using machines

The influence of this medicine on the ability to drive and use machines is negligible or non-existent.

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 you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the patient cannot break down fructose, talk to your doctor before using this medicine. Sorbitol may cause gastrointestinal upset and a mild laxative effect.

Veltassa contains calcium

If your doctor has told you or your child to limit calcium in your diet, talk to your doctor before using this medicine. Your doctor will monitor the calcium level during treatment with this medicine for at least 1 month.

3. How to take Veltassa

Follow the instructions for use of this medicine exactly as indicated by your doctor or pharmacist. If you are unsure, talk to your doctor or pharmacist again.

This medicine is given once a day. The recommended initial dose of this medicine varies with 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 per day.

Adults

Initial dose:8.4 g of patiromer (the contents of one 8.4 g sachet) once a day.

Adolescents from 12 to 17 years of age

Initial dose:4 g of patiromer (the contents of four 1 g sachets) once a day. Switch to 8.4 g patiromer sachets if doses above 7 g are needed.

Your doctor will determine the duration of treatment based on your or your child's blood potassium level.

Use this medicine at least 3 hours before or after taking other oral medicines, unless your doctor or pharmacist tells you 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 by 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 the water and mix well. The powder does not dissolve but forms a suspension that can be felt as granular.
• You can 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 1 hour of preparation. If powder remains 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.

If you prefer, you can use the following liquids or soft foods instead of water to prepare the mixture, following the same steps as above: apple juice, cranberry juice, pineapple juice, orange juice, grape juice, or pear juice, apricot or peach nectar, yogurt, milk, thickener (e.g., cornstarch), applesauce, chocolate or vanilla pudding.

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

Only drink cranberry juice in small amounts (less than 400 ml per day), as it may affect other medicines.

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

Do not takethis medicine as dry powder.

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

Polyurethane, silicone, and polyvinyl chloride tubes can be used. The recommended tube diameter is 2.17 mm (6.5 Fr) or larger. After administration of the suspension, the tube should be flushed with water. Follow the manufacturer's instructions for the tube.

If you take more Veltassa than you should

Stop using this medicine and talk to 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 forget more than one dose, contact your doctor.

If you stop treatment with Veltassa

Do not stop using the medicine without your doctor's approval, as the potassium level in the blood may increase.

4. Possible side effects

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

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

Frequency not known,cannot be estimated from the available data:

allergic reactions: symptoms include skin rash, hives, swelling of lips, tongue, or throat.

The following additional side effects have been reported:

Common,may affect up to 1 in 10 people:

• constipation
• diarrhea
• abdominal pain
• nausea
• gas
• low magnesium level in the blood (observed in laboratory tests)

Uncommon,may affect up to 1 in 100 people:

• vomiting

There have also been reports of constipation, diarrhea, and gas in children and adolescents from 6 to 17 years of age.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report side effects directly through the national reporting system listed in Appendix V. By reporting side 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 which is stated on the carton or sachet after "EXP". The expiry date is the last day of the month stated.

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

Once you have received this medicine, it can 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 no longer required. This will help protect the environment.

6. Package contents and further information

Composition of Veltassa

The active substance is patiromer (as patiromer calcium sorbitex).

• Veltassa 1 g oral powder for suspension: each sachet contains 1 g of patiromer.
• Veltassa 8.4 g oral powder for suspension: each sachet contains 8.4 g of patiromer.
• Veltassa 16.8 g oral powder for suspension: each sachet contains 16.8 g of patiromer.
• Veltassa 25.2 g oral powder for suspension: each sachet contains 25.2 g of patiromer.

The other ingredient (excipient) is xanthan gum (for more information on sorbitol, see section 2).

Appearance of Veltassa and package contents

The powder for oral suspension is white to light brown in color, 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 multipacks containing 3 packs of 30 sachets each.

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

Vifor France

100–101 Terrasse Boieldieu

Tour Franklin La Défense 8

92042 Paris La Défense Cedex

France

Date of last revision of this package leaflet:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.