Інструкція із застосування LOKELMA
Зміст інструкції
Lokelma 5 g powder for oral suspension, 10 g powder for oral suspension
sodium zirconium cyclosilicate
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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
- If you get any side effects, even those not listed in this leaflet, tell 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 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 is Lokelma and what is it used for
Lokelma contains the active ingredient sodium zirconium cyclosilicate.
Lokelma is used for the treatment of hyperkalemia in adults.
Hyperkalemia indicates a high level of potassium in the blood.
Lokelma reduces high levels of potassium in the body and helps to maintain them within the normal range. Lokelma
passes through the stomach and intestines and traps potassium. Lokelma and potassium are eliminated
from the body through the stool, thereby decreasing 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 ingredient.
Warnings and precautions
Monitoring
Your doctor or nurse will check your blood potassium level when you start taking
this medicine:
- To make sure you are taking the correct dose. The dose may be increased or decreased based on your blood potassium level.
- Treatment may be stopped if your blood potassium level drops too low.
- Tell your doctor or nurse if you are taking medicines that can change your blood potassium levels because the 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, tell your doctor or nurse if
- you have a heart conduction disorder (prolonged QT interval) as Lokelma lowers blood potassium levels which can affect heart conduction.
- you need to have an X-ray, as Lokelma may affect the interpretation of the results.
- you experience sudden or severe abdominal pain as this may be a sign of a problem that is observed with medicines that act 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 subjects are not known.
Other medicines and Lokelma
Tell your doctor or nurse if you are taking, have recently taken or might take
any other medicine.
Lokelma can affect the mechanism through which some medicines are absorbed from the
digestive tract. If you are taking any of the following medicines, they must 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 for the treatment of HIV infection)
- tyrosine kinase inhibitors such as erlotinib, dasatinib and nilotinib (used to treat cancer)
If you fall into any of the above cases (or if you have 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 information available
on the use of this medicine during pregnancy.
Breastfeeding
Sodium zirconium cyclosilicate is not believed to cause effects on newborns/infants, as
systemic exposure to Lokelma in breastfeeding women is negligible. Lokelma can be used
during breastfeeding.
Driving and using machines
This medicine does not or negligibly alters the ability to drive vehicles or use
machinery.
Lokelma contains sodium
This medicine contains approximately 400 mg of sodium (the main component of table/cooking salt)
in each 5 g dose. This is equivalent to 20% of the maximum recommended daily intake
of sodium for an adult.
Talk to your pharmacist or doctor if you need Lokelma 5 g or more per day for a prolonged
period, especially if you have been advised to follow a low-salt (sodium) diet.
3. How to take Lokelma
Take this medicine following the instructions of your doctor exactly. If you have any doubts, ask your
doctor or pharmacist.
How much to take
Initial dose – to reduce high potassium levels and return them to normal:
- The recommended dose is 10 g to be taken three times a day.
- The medicine takes one to two days to work.
- Do not take this initial dose for more than three days.
Maintenance dose – to maintain the normal potassium level achieved:
- The recommended dose is 5 g to be taken once a day.
- The doctor may establish a higher dose (10 g once a day) or a lower dose (5 g every other day).
- Do not take a maintenance dose higher than 10 g once a day.
If you are on hemodialysis:
- Take Lokelma only on non-dialysis days.
- The recommended initial dose is 5 g to be taken once a day.
- The doctor may establish a higher dose (up to 15 g once a day).
- Do not take a dose higher than 15 g once a day.
Taking 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 approximately 45 ml of still (non-carbonated) water.
- Mix 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. If this happens, stir the liquid again and drink everything.
- If necessary, rinse the glass with a small amount of water and drink everything to take the complete dose of the medicine.
If you take more Lokelma than you should
If you take more medicine than recommended, talk to a doctor immediately. 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, do not take the missed dose.
- Take the next usual dose at the usual time.
- Do not take a double dose to make up for a missed dose.
If you stop taking Lokelma
Do not reduce the dose of this medicine or stop taking it without consulting the doctor
who prescribed it, as potassium levels in the blood may rise again.
If you have any questions about 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.
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 experience fatigue, muscle weakness or muscle cramps, as this could be a sign of a too low level of potassium in the blood. See your doctor immediately if these symptoms become severe.
- you start to accumulate fluid in the tissues, resulting in swelling in any part of the 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. You can also report side effects directly
through the national reporting system detailed in Annex V. By reporting side effects you can help to 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 which is stated on the box and on the sachet after
Exp. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What Lokelma contains
The active ingredient 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.
This medicine does not contain any other components.
Description of the appearance of Lokelma and contents of the pack
The powder for oral suspension is a powder from white to grey. It is contained 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 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 on this medicine, contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien
AstraZeneca S.A./N.V.
Tel: +32 2 370 48 11
Lietuva
UAB AstraZeneca Lietuva
Tel: +370 5 2660550
България
АстраЗенека България ЕООД
Тел.: +359 24455000
Luxembourg/Luxemburg
AstraZeneca S.A./N.V.
Tél/Tel: +32 2 370 48 11
Česká republika
AstraZeneca Czech Republic s.r.o.
Tel: +420 222 807 111
Magyarország
AstraZeneca Kft.
Tel.: +36 1 883 6500
Danmark
AstraZeneca A/S
Tlf: +45 43 66 64 62
Malta
Associated Drug Co. Ltd
Tel: +356 2277 8000
Deutschland
AstraZeneca GmbH
Tel: +49 40 809034100
Nederland
AstraZeneca BV
Tel: +31 85 808 9900
Eesti
AstraZeneca
Tel: +372 6549 600
Norge
AstraZeneca AS
Tlf: +47 21 00 64 00
Ελλάδα
AstraZeneca A.E.
Τηλ: +30 210 6871500
Österreich
AstraZeneca Österreich GmbH
Tel: +43 1 711 31 0
España
AstraZeneca Farmacéutica Spain, S.A.
Tel: +34 91 301 91 00
Polska
AstraZeneca Pharma Poland Sp. z o.o.
Tel.: +48 22 245 73 00
France
AstraZeneca
Tél: +33 1 41 29 40 00
Portugal
AstraZeneca Produtos Farmacêuticos, Lda.
Tel: +351 21 434 61 00
Hrvatska
AstraZeneca d.o.o.
Tel: +385 1 4628 000
România
AstraZeneca Pharma SRL
Tel: +40 21 317 60 41
Ireland
AstraZeneca Pharmaceuticals (Ireland) Ltd
Tel: +353 1609 7100
Slovenija
AstraZeneca UK Limited
Tel: +386 1 51 35 600
Slovenská republika
AstraZeneca AB, o.z.
Tel: +421 2 5737 7777
Ísland
Vistor hf.
Sími: +354 535 7000
Italia
AstraZeneca S.p.A.
Tel: +39 02 00704500
Suomi/Finland
AstraZeneca Oy
Puh/Tel: +358 10 23 010
Sverige
AstraZeneca AB
Tel: +46 8 553 26 000
Κύπρος
Αλέκτωρ Φαρµακευτική Λτδ
Τηλ: +357 22490305
Latvija
SIA AstraZeneca Latvija
Tel: +371 67377100
United Kingdom (Northern Ireland)
AstraZeneca UK Ltd
Tel: +44 1582 836 836
Other sources of information
More detailed information on this medicine is available on the website of the European Medicines Agency, http://www.ema.europa.eu.

- Країна реєстрації
- Лікарська формаOral suspension powder, 5 G
- Код АТХV03AE10
- Діюча речовина
- Потрібен рецептНі
- Виробник
- Ця інформація надана лише для ознайомлення і не є медичною порадою. Рішення щодо лікування завжди приймає лікар.
- Альтернативи до LOKELMAЛікарська форма: Chewable tablet, 250 MGДіюча речовина: lanthanum carbonateПотрібен рецептЛікарська форма: Oral suspension powder, 454 GДіюча речовина: polystyrene sulfonateВиробник: SANOFI S.R.L.Рецепт не потрібенЛікарська форма: Film-coated tablet, 435 MG/235 MGДіюча речовина: calcium acetate and magnesium carbonateПотрібен рецепт
Аналоги LOKELMA в інших країнах
Препарати з тією самою діючою речовиною, доступні в інших країнах.
Аналог LOKELMA у Іспанія
Лікарі онлайн щодо LOKELMA
Застосування, безпека та можливість призначення рецепта — за результатами медичної оцінки.
Отримайте рецепт на LOKELMA онлайн
Заповніть форму за 2 хвилини
Розкажіть про симптоми, історію хвороби та потрібний препарат.
Оберіть лікаря або ми призначимо
Оберіть спеціаліста або ми підберемо найближчого доступного лікаря.
Лікар розглядає ваш випадок
Зазвичай протягом 30 хвилин. Може ставити уточнювальні запитання в чаті.
Отримайте в будь-якій аптеці
Електронний рецепт надсилається на вашу пошту — дійсний по всій Польщі.
Часті запитання
LOKELMA не потребує рецепта в Італія. Ви можете обговорити з лікарем онлайн, чи підходить цей лікарський засіб для вашої ситуації.
Діюча речовина у LOKELMA — sodium zirconium cyclosilicate. Це допомагає визначити препарати з тим самим складом, але під іншими торговими назвами.
LOKELMA виробляється компанією ASTRAZENECA AB. Назва бренду та упаковка можуть відрізнятися залежно від дистрибʼютора.
Лікарі, зокрема Сімейні лікарі, Психіатри, Дерматологи, Кардіологи, Ендокринологи, Гастроентерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Інфекціоністи, Алергологи, Геріатри, Педіатри, Онкологи, можуть оцінити доцільність застосування LOKELMA з урахуванням вашого стану та місцевих правил. Ви можете записатися на онлайн-консультацію, щоб обговорити симптоми та можливі подальші кроки.
Польща має добре розвинену систему охорони здоров'я у великих містах, таких як Варшава, Краків, Вроцлав і Гданськ. Аптеки широко доступні та працюють відповідно до чинного законодавства, забезпечуючи доступ до рецептурних препаратів.
Ви можете придбати LOKELMA у Варшаві, Кракові, Вроцлаві або Гданську в будь-якій аптеці за наявності дійсного рецепта.
Щоб отримати рецепт, ви можете скористатися Oladoctor:
Інші препарати з тією самою діючою речовиною (sodium zirconium cyclosilicate) включають FOTSNOL, KAYEXALATE, OSVAREN. Вони можуть відрізнятися торговою назвою або формою випуску, але містять той самий терапевтичний компонент. Перед зміною або початком прийому нового препарату варто проконсультуватися з лікарем.
















