Lokelma

Patient Information Leaflet

Lokelma 5 g oral suspension powder, 10 g oral suspension powder

sodium zirconium cyclosilicate
Please read this leaflet carefully before taking this medicine as it contains important information for you.

• Keep this leaflet. 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. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

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 for the treatment of hyperkalaemia in adults.
Hyperkalaemia means a high level of potassium in the blood.
Lokelma reduces elevated potassium levels in the body and helps maintain them within the normal range. Lokelma passes through the stomach and intestine and captures potassium. Lokelma and the bound potassium are then eliminated from the body in the faeces, thereby reducing the amount of potassium in the body.

2. What you need to know before taking Lokelma

Do not take Lokelma

• If you are allergic to the active substance.

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

• To ensure you are taking the correct dose. The dose may be increased or decreased depending on your blood potassium levels.
• Treatment may be stopped if your blood potassium level becomes too low.
• Inform your doctor or nurse if you are taking medicines that can affect potassium levels in the blood, 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 taking Lokelma, inform your doctor or nurse if

• You have a heart conduction disorder (prolonged QT interval), since Lokelma lowers blood potassium levels, which may affect heart conduction.
• You are scheduled for X-rays, 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 on the gastrointestinal tract.

Children and adolescents
Do not give this medicine to children and adolescents under 18 years of age, as the effects of Lokelma in these populations are unknown.
Other medicines and Lokelma
Inform your doctor or nurse if you are taking, have recently taken, or might take any other medicines.
Lokelma may affect the way certain medicines are absorbed from the gastrointestinal 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 (medicines used to suppress the 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 you are in any of the above situations (or if you have any doubts), consult your doctor, pharmacist, or nurse before using this medicine.
Pregnancy and breastfeeding
Pregnancy
Do not use this medicine during pregnancy, as there is no available information on the use of this medicine in pregnant women.
Breastfeeding
Sodium zirconium cyclosilicate is not expected to cause effects in newborns/infants, as systemic exposure to Lokelma in breastfeeding women is negligible. Lokelma may be used during breastfeeding.
Driving and use of machines
This medicine does not affect or has a negligible effect on the ability to drive vehicles or operate machinery.
Lokelma contains sodium
This medicine contains approximately 400 mg of sodium (the main component of table salt) in each 5 g dose. This is equivalent to 20% of the maximum recommended daily dietary intake of sodium 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 (low-sodium) diet.

3. How to take Lokelna

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.

Dosage

Initial dose – to reduce high potassium levels and bring them back to normal:

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

Maintenance dose – to maintain normal potassium levels once achieved:

• The recommended dose is 5 g taken once daily.
• Your doctor may prescribe 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 on haemodialysis:

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

How to take this medicine

• Take Lokelma at the same time each day.
• This medicine can be taken with or without food.

How to take the medicine

• Open the sachet(s) and pour the powder into a glass containing about 45 ml of plain (non-carbonated) water.
• Stir well and drink the tasteless liquid immediately.
• The powder does not dissolve and the liquid will appear cloudy. The powder will settle quickly at the bottom of the glass. In this case, stir again and drink the entire mixture.
• If needed, rinse the glass with a small amount of water and drink it to ensure the full dose is taken.

If you take more Lokelma than you should
If you take more medicine than recommended, speak to a doctor immediately. Do not take any further dose until you have spoken with a doctor.

If you forget to take Lokelma

• If you forget to take a dose, do not take the missed dose.
• Take your next dose at the usual time.
• Do not take a double dose to make up for a forgotten dose.

If you stop taking Lokelma
Do not reduce the dose or stop taking this medicine without consulting your doctor, as blood potassium levels may rise again.
If you have any questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

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

Inform your doctor or nurse if you experience any of the following common side effects (may affect up to 1 in 10 people):

• you start to feel tired, have muscle weakness or muscle cramps, as this could be a sign of excessively low potassium levels in the blood. Contact your doctor immediately if these symptoms become severe.
• you start to retain fluid in the tissues, causing swelling in any part of the body (usually in the feet and ankles).
• constipation.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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, following
Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Lokelma contains
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 medicinal product contains no other ingredients.

Description of the appearance of Lokelma and contents of the pack
The oral suspension powder is a white to grey powder. It is contained 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 supplied in a box containing 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

For further information about this medicinal product, contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
AstraZeneca S.A./N.V. UAB AstraZeneca Lietuva
Tel: +32 2 370 48 11 Tel: +370 5 2660550

България Luxembourg/Luxemburg
АстраЗенека България ЕООД AstraZeneca S.A./N.V.
Тел.: +359 24455000 Tél/Tel: +32 2 370 48 11

Česká republika Magyarország
AstraZeneca Czech Republic s.r.o. AstraZeneca Kft.
Tel: +420 222 807 111 Tel.: +36 1 883 6500

Danmark Malta
AstraZeneca A/S Associated Drug Co. Ltd
Tlf: +45 43 66 64 62 Tel: +356 2277 8000

Deutschland Nederland
AstraZeneca GmbH AstraZeneca BV
Tel: +49 40 809034100 Tel: +31 85 808 9900

Eesti Norge
AstraZeneca AstraZeneca AS
Tel: +372 6549 600 Tlf: +47 21 00 64 00

Ελλάδα Österreich
AstraZeneca A.E. AstraZeneca Österreich GmbH
Τηλ: +30 210 6871500 Tel: +43 1 711 31 0

España Polska
AstraZeneca Farmacéutica Spain, S.A. AstraZeneca Pharma Poland Sp. z o.o.
Tel: +34 91 301 91 00 Tel.: +48 22 245 73 00

France Portugal
AstraZeneca AstraZeneca Produtos Farmacêuticos, Lda.
Tél: +33 1 41 29 40 00 Tel: +351 21 434 61 00

Hrvatska România
AstraZeneca d.o.o. AstraZeneca Pharma SRL
Tel: +385 1 4628 000 Tel: +40 21 317 60 41

Ireland Slovenija
AstraZeneca Pharmaceuticals (Ireland) Ltd AstraZeneca UK Limited
Tel: +353 1609 7100 Tel: +386 1 51 35 600

Ísland Slovenská republika
Vistor hf. AstraZeneca AB, o.z.
Sími: +354 535 7000 Tel: +421 2 5737 7777

Italia Suomi/Finland
AstraZeneca S.p.A. AstraZeneca Oy
Tel: +39 02 00704500 Puh/Tel: +358 10 23 010

Κύπρος Sverige
Αλέκτωρ Φαρµακευτική Λτδ AstraZeneca AB
Τηλ: +357 22490305 Tel: +46 8 553 26 000

Latvija United Kingdom (Northern Ireland)
SIA AstraZeneca Latvija AstraZeneca UK Ltd
Tel: +371 67377100 Tel: +44 1582 836 836

Other sources of information
More detailed information about this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.