Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - lokelma

Document Subject

Generated Narrative: MedicinalProductDefinition mp37704f8130504ea382184950ae8a2cfe

identifier: http://ema.europa.eu/identifier/EU/1/17/1173/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Lokelma 5 g powder for oral suspension

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-37704f8130504ea382184950ae8a2cfe

identifier: http://ema.europa.eu/identifier/EU/1/17/1173/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - lokelma

Attesters

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

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.

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.

Tell your doctor or nurse if you are taking 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, angiotensin receptor blockers such as valsartan (medicines for high blood pressure and for heart problems), and renin inhibitors such as aliskiren (for high blood pressure). While you are taking Lokelma, tell your doctor or nurse if

you have a heart signaling disorder (QT prolongation) since Lokelma lowers your blood potassium levels which may affect heart signaling.

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 medicines that work in the gastrointestinal tract. 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. Lokelma may affect how certain medicines are absorbed from 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 (medicines 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 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 breast- feeding 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. 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.

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(s) 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.

If needed, rinse the glass with a small amount of 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.

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).

constipation. Reporting of side effects If you get 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.

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.

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 or 30 sachets. Not all pack sizes may be marketed. Marketing Authorisation Holder AstraZeneca AB SE-151 85 S dert lje Sweden Manufacturer AstraZeneca AB G rtunav gen SE-152 57 S dert lje Sweden For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Belgi /Belgique/Belgien AstraZeneca S.A./N.V. Tel: +32 2 370 48 Lietuva UAB AstraZeneca Lietuva Tel: +370 5 2660

.: +359 24455Luxembourg/Luxemburg AstraZeneca S.A./N.V. T l/Tel: +32 2 370 48 esk republika AstraZeneca Czech Republic s.r.o. Tel: +420 222 807 Magyarorsz g AstraZeneca Kft. Tel.: +36 1 883 6Danmark AstraZeneca A/S Tlf: +45 43 66 64 Malta Associated Drug Co. Ltd Tel: +356 2277 8Deutschland AstraZeneca GmbH Tel: +49 40 809034Nederland AstraZeneca BV Tel: +31 85 808 9Eesti AstraZeneca Tel: +372 6549 Norge AstraZeneca AS Tlf: +47 21 00 64
AstraZeneca A.E. : +30 210 6871 sterreich AstraZeneca sterreich GmbH Tel: +43 1 711 31 0 Espa a AstraZeneca Farmac utica Spain, S.A. Tel: +34 91 301 91 Polska AstraZeneca Pharma Poland Sp. z o.o. Tel.: +48 22 245 73 France AstraZeneca T l: +33 1 41 29 40 Portugal AstraZeneca Produtos Farmac uticos, Lda. Tel: +351 21 434 61 Hrvatska AstraZeneca d.o.o. Tel: +385 1 4628 Rom nia AstraZeneca Pharma SRL Tel: +40 21 317 60 Ireland AstraZeneca Pharmaceuticals (Ireland) Ltd Tel: +353 1609 7Slovenija AstraZeneca UK Limited Tel: +386 1 51 35 sland Vistor hf. S mi: +354 535 7Slovensk republika AstraZeneca AB, o.z. Tel: +421 2 5737 7Italia AstraZeneca S.p.A. Tel: +39 02 00704Suomi/Finland AstraZeneca Oy Puh/Tel: +358 10 23

: +357 22490Sverige AstraZeneca AB Tel: +46 8 553 26 Latvija SIA AstraZeneca Latvija Tel: +371 67377United Kingdom (Northern Ireland) AstraZeneca UK Ltd Tel: +44 1582 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: http://www.ema.europa.eu