Lokelma - patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

Package Leaflet: Information for the patient

Lokelma 5 g powder for oral suspension

Lokelma 10 g powder for oral suspension sodium zirconium cyclosilicate

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

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 get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible

side effects not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What Lokelma is and what it is used for

• 2. What you need to know before you take 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. Hyperkalaemia means that there is a high level of potassium in the blood.

Lokelma lowers the high levels of potassium in your body and helps to keep it at a normal level. As Lokelma passes through your stomach and gut it attaches to potassium and the two are carried together out of the body in your stools, lowering 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 blood potassium level when you start taking this medicine:

• This is to make sure you are getting the correct dose. The dose may be raised or lowered based

on your blood potassium level.

• Treatment may be stopped if your blood potassium level becomes too low.

While you are taking Lokelma, tell your doctor or nurse if

• you need to have an X-ray, as Lokelma may affect the interpretation of the results.
• you have sudden or severe pain in your abdomen as this may be a sign of a problem that is

observed with other medications that work in the gastrointesti­nal tract.

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

Children and adolescents

Do not give this medicine to children and adolescents under 18 years of age. This is because the effects of Lokelma in children and 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.

In particular, tell them about any medicines which can change your blood potassium levels because your dose of Lokelma may need to be changed. These include:

• diuretics (medicines that increase urine production)
• angiotensin converting enzyme (ACE) inhibitors such as enalapril, and angiotensin receptor

blockers which name ends with sartan (medicines for high blood pressure and for heart problems)

• renin inhibitors such as aliskiren (for high blood pressure)

Also, tell your doctor or nurse if you are taking any of the following:

• ketoconazole, itraconazole and posaconazole (used to treat fungal infections)
• atazanavir, nelfinavir, indinavir, ritonavir, saquinavir, raltegravir, ledipasvir and rilpivirine

(used to treat HIV infection)

• tyrosin kinase inhibitors such as erlotinib, dasatinib and nilotinib (used to treat cancer)

If any of the above apply to you (or you are not sure), tell your doctor, pharmacist or nurse before taking this medicine.

Pregnancy and breast feeding

Pregnancy

Do not use this medicine during pregnancy because there is no information on its use in pregnancy.

Breast-feeding

No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breastfeeding woman to Lokelma is negligible. Lokelma can be used during breast-feeding.

Driving and using machines

This medicine has no or negligible influence on your ability to drive or to use machines.

Lokelma contains sodium

This medicine contains approximately 400 mg sodium (main component of cooking/table salt) in each

• 5 g dose. This is equivalent to 20% of the recommended maximum daily dietary intake of sodium for an adult.

3. How to take Lokelma

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

How much to take

Starting dose – to lower your high potassium level 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 starting dose for more than three days.

Maintenance dose – to keep your potassium level within the normal range after it has been lowered :

• The recommended dose is 5 g taken once a day.
• Your doctor may decide that you need more (10 g once a day) or less than this (5 g every other

day).

• Do not take a maintenance dose of more than 10 g once a day.

If you are on haemodialysis therapy:

• Take Lokelma only on non-dialysis days.
• The recommended starting dose is 5 g taken 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.

Taking this medicine

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

How to take

• Open the sachet and pour the powder into a drinking glass with approximately 45 ml of still

(non-carbonated) water.

• Stir well and drink the tasteless liquid straight away.
• The powder does not dissolve and the liquid appears cloudy. The powder will settle in the glass

quickly. If this happens, stir the liquid again and drink it all up.

• Rinse the glass with more water and drink it all up to take all the medicine.

If you take more Lokelma than you should :

If you take more of this medicine than you should, talk to a doctor straight away. Do not take any more until you have spoken to a doctor.

If you forget to take Lokelma

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

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. This is because you may get high potassium levels in your blood 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 experience any of the following:

Common side effects (may affect up to 1 in 10 people).

• you start to feel tired, or have muscle weakness or cramps, this may be a sign that your blood

potassium has become too low. Talk to your doctor immediately if these symptoms become severe.

• you start to have a build up of fluid in the tissues, leading to swelling anywhere in your body

(usually in the feet and ankles).

Not known (frequency cannot be estimated from the available data).

• you start to have abdominal pain or discomfort, nausea, vomiting, diarrhoea or constipation.
• you start to have itching of the skin or recognise redness or scaling of your skin.

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 which is stated on the carton and the sachet after ‘EXP’. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. 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 powder for oral suspension

Each sachet contains 5 g of sodium zirconium cyclosilicate.

Lokelma 10 g powder for oral suspension

Each sachet contains 10 g of sodium zirconium cyclosilicate.

There are no other ingredients in this medicine.

What Lokelma looks like and contents of the pack

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

Lokelma 5 g powder for oral suspension

Each sachet contains 5 g of powder.

Lokelma 10 g powder for oral suspension

Each sachet contains 10 g of powder.

The sachets are supplied in a carton containing 3, 28 or 30 sachets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

AstraZeneca AB

SE-151 85 Sodertalje

Sweden

Manufacturer

AstraZeneca AB

Gärtunavägen

SE-151 85 Södertälje

Sweden

For any information about this medicine, please

Authorisation Holder:

Belgie/Belgiqu­e/Belgien

AstraZeneca S.A./N.V.

Tel: +32 2 370 48 11

Efc^rapufl

Acmpa3eHeKa Etnrapua EOOfl

Tea.: +359 24455000

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AstraZeneca Czech Republic s.r.o.

Tel: +420 222 807 111

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AstraZeneca A/S

Tlf: +45 43 66 64 62

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AstraZeneca GmbH

Tel: +49 41 03 7080

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Tel: +372 6549 600

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AstraZeneca A.E.

Tql: +30 210 6871500

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AstraZeneca Farmacéutica Spain, S.A.

Tel: +34 91 301 91 00

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Tél: +33 1 41 29 40 00

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AstraZeneca d.o.o.

Tel: +385 1 4628 000

Ireland

AstraZeneca Pharmaceuticals (Ireland) Ltd

Tel: +353 1609 7100

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Sími: +354 535 7000

Italia

contact the local representative of the Marketing

Lietuva

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Tel: +370 5 2660550

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Tel: +43 1 711 31 0

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Tel.: +48 22 245 73 00

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Tel: +351 21 434 61 00

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Kûnpoç

AXéKTœp Oap^aKeuTiKrç At5

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Latvija

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United Kingdom

AstraZeneca UK Ltd

Tel: +44 1582 836 836

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is also available on the European Medicines Agency web site:

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