5 g, 10 g powder for oral suspension
sodium zirconium cyclosilicate
What Lokelma is and what it is used for
Lokelma contains the active substance sodium ‑zirconium ‑ cyclosilicate.
Lokelma is used to treat hyperkalemia in adults. Hyperkalaemia means that there is a high content of potassium in the blood.
Lokelma lowers high levels of potassium in the body and helps keep it at a normal level. When Lokelma passes through the stomach and intestines, potassium binds to the medicine and leaves the body via the stool, and this lowers the amount of potassium in the body.
What you need to know before taking Lokelma
Do not take Lokelma
- If you are allergic to the active substance.
Warnings and cautions
Monitoring
Your doctor or nurse will check the level of potassium in your blood when you start taking this medicine:
- This is done to ensure that you receive the correct dose . Dose one can be increased or decreased depending on the potassium content in the blood.
- The treatment can be stopped if the level of potassium in the blood becomes too low.
While taking Lokelma, tell your doctor or nurse
- you should undergo an X-ray examination, as Lokelma can influence the interpretation of the results.
- you get sudden or severe pain in the abdomen as this may be a sign of a problem observed with other drugs acting on the gastrointestinal tract.
Consult a doctor or pharmacist if you need Lokelma 5 grams or more daily for an extended period, especially if you have been prescribed a low-salt (sodium-poor) diet.
Children and young people
Do not give this medicine to children and adolescents under 18 years of age. The reason is that 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 us about medicines that may alter your blood potassium levels, as your dose of Lokelma may need to be changed. This applies to the following medicines:
- diuretics (drugs that increase urine production)
- angiotensin converting enzyme (ACE) inhibitors such as enalapril , and angiotensin receptor blockers whose names end in sartan (medicines for high blood pressure and 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 medicines:
- 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), talk to 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 on its use during pregnancy.
Breast-feeding
No effects are expected on breastfed newborns/infants as the uptake of Lokelma into the blood of the breastfeeding woman is negligible.
Lokelma can be used during breastfeeding.
Driving and using machines
This medicine has no or negligible effect on the ability to drive or use machines.
How to take Lokelma
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
How much to take
Starting dose – to lower high potassium levels to normal:
- The recommended dose is 10 g – three times daily.
- It takes one to two days before the drug takes effect.
- Do not take this starting dose for more than three days.
Maintenance dose – to keep your potassium level within the normal range once it has been lowered:
- The recommended dose is 5 g – once a day.
- Your doctor may decide to increase or decrease your dose .
- Do not take a maintenance dose higher than 10 g once daily.
If you are receiving treatment with hemodialysis:
- Take Lokelma only on days when you do not receive hemodialysis .
- The recommended starting dose is 5 g once daily.
- Your doctor may decide that you need more (up to 15 g once daily).
- Do not take more than 15 g once daily.
Take Lokelma as follows:
- Try to take Lokelma at the same time each day.
- You can take this medicine with or without food.
How to take the medicine:
- Open the sachet and pour the powder into a drinking glass with about 45 ml of water, not carbonated.
- Stir well and drink the tasteless liquid immediately.
- The powder does not dissolve and the liquid looks cloudy. The white powder sinks rapidly into the glass. If this happens, stir the liquid again and drink everything.
- Rinse the glass with more water and drink everything so that you get all the medicine in you.
If you take more Lokelma than you should
Talk to your doctor immediately if you have taken too much of this medicine. Do not take more until you have talked 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 the usual time.
- Do not take a double dose to make up for a forgotten dose .
If you stop taking Lokelma
You should not reduce the dose of one of these medicines or stop taking it without talking to the doctor who prescribed it, you may then have high potassium levels in your blood again.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor or nurse immediately if any of the following occur:
Common side effects (may affect up to 1 in 10 people).
- you start to feel tired or have muscle weakness or cramps – it may be a sign that the level of potassium in the blood has become too low. Talk to your doctor immediately if these symptoms become severe.
- you begin to accumulate fluid in the tissues , which leads to swelling somewhere in the body (usually in the feet and ankles).
No known frequency (can not be calculated from the available data).
- you begin to experience abdominal pain or discomfort, nausea, vomiting, diarrhea or constipation.
- you begin to get itchy skin or see redness or peeling of the skin.
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 or sachet after “EXP”. The expiration date is the last day of the specified month.
This medicine does not require any special storage instructions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
The active substance is sodium ‑zirconium ‑ cyclosilicate.
Lokelma 5 g powder for oral suspension
1 sachet contains 5 g sodium ‑zirconium ‑ cyclosilicate.
Lokelma 10 g powder for oral suspension
1 sachet contains 10 g sodium ‑zirconium ‑ cyclosilicate.
There are no other ingredients in this medicine.
What the medicine looks like and contents of the pack
The powder for oral suspension is a white, free-flowing powder, substantially free of dust and particles. It is delivered in a sachet.
Lokelma 5 g powder for oral suspension
1 sachet contains 5 g of powder.
Lokelma 10 g powder for oral suspension
1 sachet contains 10 g of powder.
The sachets are delivered in a carton containing 3, 28, or 30 sachets.
Marketing Authorisation Holder
AstraZeneca AB
SE-151 85 Södertälje
Sweden
Manufacturer
AstraZeneca AB
Gärtunavägen
SE-151 85 Södertälje
Sweden
Contact the representative of the marketing authorization holder to find out more about this medicine:
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