LOKELMA 10 G ORAL SUSPENSION POWDER

Introduction

Package Leaflet: Information for the Patient

Lokelma 5g oral powder for suspension

Lokelma 10g oral powder for suspension

sodium zirconium cyclosilicate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet

1. What is Lokelma and what is it used for
2. What you need to know before you take Lokelma
3. How to take Lokelma
4. Possible side effects
5. Storage of Lokelma
6. Contents of the pack and other information

1. What is Lokelma and what is it used for

Lokelma contains the active substance sodium zirconium cyclosilicate.

Lokelma is used to treat high levels of potassium in the blood in adults. Having high levels of potassium in the blood means that there is too much potassium in the blood.

Lokelma reduces high levels of potassium in your body and helps to maintain a normal level. As it passes through your stomach and intestines, Lokelma binds to potassium and both are eliminated from the body with the feces, reducing the amount of potassium in the body.

2. What you need to know before you take Lokelma

Do not take Lokelma:

• If you are allergic to the active substance.

Warnings and precautions

Monitoring

Your doctor or nurse will check your potassium levels in your blood when you start taking this medicine:

• They will make sure you are receiving the correct dose. The dose may be increased or decreased depending on your potassium levels in the blood.
• Treatment may be stopped if your potassium levels in the blood are too low.
• Tell your doctor or nurse if you are taking any medicines that may change your potassium levels in the blood, as it may be necessary to change your dose of Lokelma. These include diuretics (medicines that increase urine production), angiotensin-converting enzyme inhibitors (ACE inhibitors) such as enalapril, angiotensin receptor blockers such as valsartan (medicines for high blood pressure and heart problems), and renin inhibitors such as aliskiren (for high blood pressure).

While you are taking Lokelma, talk to your doctor or nurse if

• you have a heart signaling disorder (prolonged QT interval), as Lokelma reduces potassium levels in the blood, which can affect heart signaling.
• you need to have an X-ray, as Lokelma may affect the interpretation of the results.
• you have sudden or severe abdominal pain, as this may be a sign of a problem that occurs with medicines that work in the gastrointestinal tract.

Children and adolescents

Do not give this medicine to children or adolescents under 18 years old, as the effects of Lokelma in children or adolescents are not known.

Other medicines and Lokelma

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

Lokelma may affect how certain medicines are absorbed in your digestive tract. If you are taking any of the following medicines, they should be taken 2 hours before or after taking Lokelma, otherwise, they may not work properly.

• tacrolimus (a medicine used to suppress your immune system to prevent organ transplant rejection)
• ketoconazole, itraconazole, and posaconazole (used to treat fungal infections)
• atazanavir, nelfinavir, indinavir, ritonavir, saquinavir, raltegravir, ledipasvir, and rilpivirine (used to treat HIV infection)
• tyrosine kinase inhibitors such as erlotinib, dasatinib, and nilotinib (used to treat cancer)

If any of the above applies to you (or if you are unsure), talk to your doctor, pharmacist, or nurse before taking this medicine.

Pregnancy and breastfeeding

Pregnancy

Do not use this medicine during pregnancy, as there is no information on its use during pregnancy.

Breastfeeding

No effects on newborns/infants are expected since systemic exposure to Lokelma in breastfeeding women is negligible. Lokelma can be used during breastfeeding.

Driving and using machines

The ability to drive and use machines is not affected or is negligible.

Lokelma contains sodium

This medicine contains approximately 400 mg of sodium (the main component of table salt/cooking salt) per 5 g dose. This is equivalent to 20% of the maximum recommended daily intake of sodium for an adult.

Talk to your pharmacist or doctor if you need to take Lokelma 5 g or more per day for a prolonged period, especially if you have been advised to follow a low-salt diet (sodium).

3. How to take Lokelma

Follow the instructions for administration of this medicine exactly as told by your doctor. If you are unsure, talk to your doctor again.

How much to take

Initial dose - to reduce high potassium levels to normal:

• The recommended dose is 10 g taken three times a day.
• The medicine takes one or two days to work.
• Do not take this initial dose for more than three days.

Maintenance dose - to keep potassium levels within the normal range once they have decreased:

• The recommended dose is 5 g taken once a day.
• Your doctor will decide if you need a higher dose (10 g once a day) or a lower dose (5 g every other day).
• Do not take a maintenance dose of more than 10 g once a day.

If you are on hemodialysis:

• Take Lokelma only on non-dialysis days.
• The recommended initial dose is 5 g once a day.
• Your doctor may decide that you need more (up to 15 g once a day).
• Do not take more than 15 g once a day.

How to take this medicine

• Try to take Lokelma at the same time every day.
• You can take this medicine with or without food.

Method of administration

• Open the sachet(s) and pour the powder into a glass with about 45 ml of non-carbonated water.
• Stir well and drink the tasteless liquid immediately.
• The powder does not dissolve and the liquid has a cloudy appearance. The powder will settle quickly to the bottom of the glass. In this case, stir the liquid again and drink it.
• If necessary, rinse the glass with a small amount of water and drink it to take all of the medicine.

If you take more Lokelma than you should

If you take more of this medicine than you should, talk to a doctor as soon as possible. Do not take it again until you have talked to a doctor.

If you forget to take Lokelma

• If you forget to take a dose of this medicine, skip the missed dose.
• Take the next dose as usual at the usual time.
• Do not take a double dose to make up for missed doses.

If you stop taking Lokelma

Do not reduce the dose of this medicine or stop taking it without talking to the doctor who prescribed it. If you do, your potassium levels in the blood may increase again.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

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

Tell your doctor or nurse if you get any of the following side effects:

Common (may affect up to 1 in 10 people):

• you feel tired, or have muscle weakness or muscle cramps; these could be signs that your potassium levels in the blood have decreased too much. Talk to your doctor immediately if these symptoms get worse.
• you notice swelling in the tissues, which causes unusual or unexpected swelling in some parts of the body (usually the feet and ankles).
• constipation.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. 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 Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Lokelma

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 and sachet after EXP. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Lokelma contains

The active substance is sodium zirconium cyclosilicate.

Lokelma 5 g oral powder for suspension

Each sachet contains 5 g of sodium zirconium cyclosilicate.

Lokelma 10 g oral powder for suspension

Each sachet contains 10 g of sodium zirconium cyclosilicate.

This medicine does not contain any other ingredients.

Appearance and packaging

The oral powder for suspension is a white to grey powder. It is available in a sachet.

Lokelma 5 g oral powder for suspension

Each sachet contains 5 g of powder.

Lokelma 10 g oral powder for suspension

Each sachet contains 10 g of powder.

The sachets are available in a carton with 3 or 30 sachets.

Not all pack sizes may be marketed.

Marketing authorisation holder

AstraZeneca AB

SE-151 85 Södertälje

Sweden

Manufacturer

AstraZeneca AB

Gärtunavägen

SE-152 57 Södertälje

Sweden

You can get more information on this medicine by contacting the local representative of the marketing authorisation holder:

Date of last revision of this leaflet:

Other sources of information

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