Lokelma 5 g polvo para suspension oral

Prospect: information for the patient

Lokelma 5g powder for oral suspension

Lokelma 10g powder for oral suspension

sodium and zirconium silicate

Read this prospect carefully before starting to take this medication, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only to you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.

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

1.What is Lokelma and what it is used for

2.What you need to know before starting to take Lokelma

3.How to take Lokelma

4.Adverse effects

5.Storage of Lokelma

6.Contents of the package and additional information

Lokelma contains the active ingredient sodium zirconium cyclosilicate.

Lokelma is used to treat hyperkalemia in adults. Having hyperkalemia means that there is a high level of potassium in the blood.

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

Do not take Lokelma:

• If you are allergic to the active ingredient.

Warnings and precautions

Follow-up

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

• They will ensure that you are receiving the correct dose. The dose may be increased or decreased depending on your blood potassium level.
• Treatment may be stopped if your blood potassium level is too low.
• Inform your doctor or nurse if you are taking any medication that may affect your blood potassium levels, as your dose of Lokelma may need to be changed. These include diuretics (medicines that increase urine production), angiotensin-converting enzyme inhibitors (ACE inhibitors), such as enalapril, angiotensin receptor blockers (ARBs), 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 signal disorder (prolonged QT interval), as Lokelma reduces blood potassium levels, 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 associated with medications that affect the gastrointestinal tract.

Children and adolescents

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

Other medicines and Lokelma

Inform your doctor or nurse if you are taking, have taken recently, or may need to take any other medicine.

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

• tacrolimus (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 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

No adverse effects are expected in newborns/breastfed infants, as systemic exposure to Lokelma in lactating mothers is insignificant. Lokelma may be used during breastfeeding.

Driving and operating machinery

The influence of this medicine on your ability to drive and operate machinery is negligible or insignificant.

Lokelma contains sodium

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

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

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor again.

How much to take

Initial dose‑to reduce elevated potassium levels to normal:

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

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

• The recommended dose is 5 g administered 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 therapy:

• 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 medication

• Make sure to take Lokelma at the same time every day.
• You can take this medication with or without food.

Form of use

• Open the(the)packets(s)and pour the powder into a glass with about 45ml of water without gas (not carbonated).
• Stir well and drink the tasteless liquid immediately.
• The powder does not dissolve and the liquid has a turbid appearance. The powder will settle quickly at the bottom of the glass. In this case, stir the liquid again and drink it.
• If necessary, rinse the glass witha small amount ofwater and drink it to take the entire medication.

If you take more Lokelma than you should

If you take more of this medication than you should, consult a doctor as soon as possible. Do not take it again until you have spoken with a doctor.

If you forget to take Lokelma

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

If you interrupt treatment with Lokelma

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

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

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

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

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

• You feel tired, or have muscle weakness or muscle cramps; they could be signs that your blood potassium has decreased too much. Consult your doctor immediately if these symptoms worsen.
• You notice a buildup of fluid in the tissues, causing unusual or unexpected swelling in some part of the body (usually the feet and ankles).
• Constipation.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through thenational 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 and on the blister pack after “CAD/EXP”. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

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

Composition of Lokelma

The active ingredient is sodium and zirconium cyclamate.

Lokelma 5g powder for oral suspension

Each sachet contains 5g ofsodium and zirconium cyclamate.

Lokelma 10g powder for oral suspension

Each sachet contains 10g ofsodium and zirconium cyclamate.

This medicine does not contain any other components.

Appearance of the product and contents of the pack

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

Lokelma 5g powder for oral suspension

Each sachet contains 5g of powder.

Lokelma 10g powder for oral suspension

Each sachet contains 10g of powder.

The sachets are presented in a box with 3 or 30sachets.

Only some pack sizes may be marketed.

Marketing Authorisation Holder

AstraZeneca AB

SE‑151 85 Södertälje

Sweden

Responsible for manufacturing

AstraZeneca AB

Gärtunavägen

SE‑152 57 Södertälje

Sweden

For more information about this medicine, please contact the local representative of the marketing authorisation holder:

Last update of this leaflet:

Other sources of information

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