Lokelma 10 g powder for oral suspension

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

Lokelma 5g oral suspension powder

Lokelma 10g oral suspension powder

sodium zirconium cyclosilicate

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

• Keep this leaflet, as you may need to read it again.

• If you have any questions, ask your doctor, pharmacist, or nurse.

• This medicine has been prescribed for you only, and must not be given to other people, even if they have the same symptoms as you, because it could harm them.

• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are possible side effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Lokelma is and what it is used for

Lokelma contains the active substance sodium zirconium cyclosilicate.

Lokelma is used to treat hyperkalaemia in adults. Having hyperkalaemia means that you have high levels of potassium in the blood.

Lokelma reduces high potassium levels in your body and helps maintain normal levels. As it passes through the stomach and intestine, Lokelma binds to potassium, and both are removed together from the body in the faeces, thereby reducing the amount of potassium in the body.

2. What you need to know before starting Lokelma

Do not take Lokelma:

• If you are allergic to the active substance.

Warnings and precautions

Follow-up

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

• This ensures you are receiving the correct dose. The dose may be increased or decreased depending on your blood potassium level.
• Treatment may be interrupted if your blood potassium level is too low.
• Inform your doctor or nurse if you are taking any medicine that may affect your blood potassium levels, as your dose of Lokelma may need to be adjusted. These include diuretics (medicines that increase urine production), angiotensin-converting enzyme (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, consult your doctor or nurse if:

• You have a heart conduction disorder (QT interval prolongation), as Lokelma reduces blood potassium levels, which may affect heart conduction.
• You need to undergo an X-ray examination, as Lokelma may interfere with the interpretation of results.
• You experience sudden or severe abdominal pain, as this may be a sign of a condition associated with medicines acting in the gastrointestinal tract.
• You have pre-existing heart failure. In some patients, this medicine may worsen this condition. Signs and symptoms of worsening heart failure may include: worsening shortness of breath; swelling of the legs or ankles; sudden weight gain. If you experience any of these signs or symptoms, contact your doctor immediately.

Children and adolescents

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

Other medicines and Lokelma

Tell your doctor or nurse if you are taking, have recently taken, or might need to 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 body's 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 situations apply to you (or if you have any doubts), speak with 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 available on its use during pregnancy.

Breastfeeding

Effects on newborns/infants are not expected, as systemic exposure to Lokelma in breastfeeding mothers is negligible. Lokelma may be used during breastfeeding.

Driving and using machines

The effect of this medicine on the ability to drive and use machines is none or negligible.

Lokelma contains sodium

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

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

3. How to take Lokelma

Follow exactly the administration instructions for this medicine as given by your doctor. If you are unsure, please consult your doctor again.

What dose to take

Initial dose – to reduce elevated potassium levels to normal:

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

Maintenance dose – to maintain potassium levels within the normal range once they have decreased:

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

If you are undergoing hemodialysis therapy:

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

How to take this medicine

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

Instructions for use

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

If you take more Lokelma than you should

If you take more of this medicine than you should, consult a doctor as soon as possible. Do not take any further doses until you have spoken with a doctor.

If you forget to take Lokelma

• If you forget to take a dose of this medicine, skip the missed dose.
• Take your next dose 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 or stop taking this medicine without speaking to your prescribing doctor. If you do, your blood potassium levels may rise again.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Inform your doctor or nurse if you experience any of the following adverse effects:

Very common (may affect more than 1 in 10 people):

• Worsening of pre-existing heart failure

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 blood potassium has decreased too much. Contact your doctor immediately if these symptoms worsen.
• You notice a build-up of fluid in the tissues, causing unusual or unexpected swelling in any part of the body (usually the feet and ankles).
• Constipation.

Reporting of adverse effects

If you experience any kind of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system detailed in Appendix V. By reporting adverse 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 stated on the carton and sachet after “CAD/EXP”. The expiry date is the last day of the month indicated.

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 and packaging that you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Lokelma

The active substance is sodium zirconium cyclosilicate.

Lokelma 5 g oral suspension powder

Each sachet contains 5 g of sodium zirconium cyclosilicate.

Lokelma 10 g oral suspension powder

Each sachet contains 10 g of sodium zirconium cyclosilicate.

This medicine does not contain any other ingredients.

Appearance of the product and contents of the pack

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

Lokelma 5 g oral suspension powder

Each sachet contains 5 g of powder.

Lokelma 10 g oral suspension powder

Each sachet contains 10 g of powder.

Sachets are packed in a carton containing 3 or 30 sachets.

Some pack sizes may not be marketed.

Marketing Authorisation Holder

AstraZeneca AB

SE‑151 85 Södertälje

Sweden

Manufacturer

AstraZeneca AB

Gärtunavägen

SE‑152 57 Södertälje

Sweden

For more information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Date of the most recent review of this leaflet:

Other sources of information

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