8 mEq and 24 mEq depot granules potassium
citrate / potassium bicarbonate
What Sibnayal is and what it is used for
Sibnayal contains two active substances, potassium citrate and potassium bicarbonate (also called potassium bicarbonate).
Sibnayal is an alkalizing drug (which makes the blood more alkaline) that is used to treat acidity (acidity) in the blood caused by a kidney disease called renal tubular acidosis (RTA).
Sibnayal helps reduce the impact of data on your daily life.
Sibnayal can be given to adults, adolescents, and children over 1 year of age.
What you need to know before using Sibnayal
Do not take Sibnayal
- if you are allergic to potassium citrate or potassium bicarbonate or any of the other ingredients of this medicine (listed in section 6),
- if you have severe kidney disease or kidney failure,
- if you have high potassium levels in your blood ( hyperkalemia )
Warnings and cautions
Talk to your doctor before taking Sibnayal
- if you have a disease or are taking a medicine that can increase the level of potassium in your blood (see below “Other medicines and Sibnayal”),
- if you often have gastrointestinal symptoms such as bloating, diarrhea, nausea, vomiting,
- if you have chronic kidney disease.
Sibnayal prolonged-release granules are designed to provide a slow release of the active substances after you have ingested granules. You may see remnants of granules in your stool. This is normal and does not reduce the effect of the medicine.
If you vomit within two hours of taking the medicine, take another dose.
You will need to see your doctor regularly. From time to time, your doctor will need to take blood and urine samples or test your heart to adjust the dose of Sibnayal. Your doctor will check your kidney function regularly if you are elderly and/or if you have impaired kidney function.
Children
Do not give this medicine to children under 1 year of age as they may choke and suffocate.
Other medicines and Sibnayal
Tell your doctor or pharmacist if you have recently taken, or might take any other medicines.
Some medicines may affect the way Sibnayal works or make you more likely to get side effects. This includes the following:
- Drugs that increase the level of potassium in the blood such as
- ACE inhibitors (used to treat high blood pressure, heart disease, and kidney disease in patients with type 1 diabetes ),
- potassium-sparing diuretics (used to treat high blood pressure, fluid retention in the tissues ( edema ), and heart disease),
- potassium supplements (used to prevent or treat low levels of potassium in the blood), – cyclosporine (used to prevent or treat transplant rejection ),
- heparin sodium (used to prevent or delay blood clotting),
- non-steroidal anti-inflammatory drugs ( NSAIDs ) (used to reduce fever, pain, and inflammation ).
- Drugs that can be affected by a change in the level of potassium in the blood such as
- digitalis glycosides (eg digoxin, used to treat heart failure and certain heart rhythm disorders),
- corticosteroids (used to treat inflammation ),
- other drugs that can cause heart rhythm disorders such as
- amiodarone and quinidine (used to control heart rhythm),
- chlorpromazine (used to treat certain mental illnesses),
- cisapride (used to treat heartburn),
- sparfloxacin (used to treat certain bacterial infections).
Some medicines may be affected by elevated urinary pH in connection with treatment with Sibnayal such as
- salicylates (used to treat pain and inflammation
- acetylsalicylic acid-like drugs),
- tetracyclines (used to treat certain bacterial infections),
- barbiturates (sleeping pills).
Sibnayal with food, drink, and alcohol
Do not mix Sibnayal with hot food or hot drinks. Do not drink alcohol while taking Sibnayal.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Sibnayal is not expected to affect the ability to drive or use machines.
Sibnayal contains potassium
Sibnayal 8 mEq contains 308 mg of potassium per sachet . This should be considered if you have impaired kidney function or if you have been prescribed a low-potassium diet.
Sibnayal 24 mEq contains 924 mg of potassium per sachet . This should be considered if you have impaired kidney function or if you have been prescribed a low-potassium diet.
How to use Sibnayal
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
The amount of Sibnayal you should take depends on your age, weight, and condition. Your doctor will tell you exactly what dose of Sibnayal to take. This will always be one or more whole sachets.
Your doctor may need to adjust the dose of Sibnayal.
The use of this drug requires medical supervision.
Dosage
Dose one is adjusted by your doctor according to the level of bicarbonate in your blood.
How to use Sibnayal
Sibnayal is for oral use (should be swallowed). If you are not sure how to take Sibnayal, talk to a doctor or pharmacist.
1. Hold the sachet vertically (upright) with your fingers over the dashed line. Shake it from side to side so that the contents move to the bottom of the sachet. 2. Cut the sachet along the dotted line, using scissors if necessary.
3. Place all or part of the contents of the sachet directly in the mouth of the tongue. 4. Swallow granules immediately with a large glass of water. Granules must not be chewed or crushed. Repeat steps 1 to 4 as needed until you have taken the full dose one.
For patients who cannot swallow granules
Mix Sibnayal with small amounts of soft and cold foods (eg fruit puree or yogurt) directly on the spoon. You must swallow the soft food mixture immediately. Do not save the mixture for later use.
2. Place the mixture directly in your mouth and swallow it without chewing. Make sure that Sibnayal is not left in the mouth. Repeat steps 1 and 2 as needed until the full dose is taken.
Do not mix granules with liquid before taking them.
When to take Sibnayal
Take Sibnayal in the morning and the evening, during a meal. You must allow approximately 12 hours between each dose to cover the entire 24-hour period.
Dose increases and dose reductions should be done gradually and over a few weeks. Your doctor will adjust the dose according to your condition. The usual recommended dose is 4 to 6 whole sachets of 24 mEq per day.
You should consult your doctor if you experience any side effects as he or she may need to adjust the dose of the medicine.
Switching from another alkalizing drug
If you are switching from another alkalizing drug to Sibnayal, your doctor should closely monitor the change.
If you use more Sibnayal than you should
Talk to your doctor or pharmacist if you have taken too much Sibnayal. You may feel nauseous, vomit, and have diarrhea. If you have taken a large amount of Sibnayal, you may feel weak or have inexplicably stiff muscles, cramps (muscle contractions), abnormal stinging or burning sensation, crawling or numbness, and mental confusion, or abnormal heart rate.
If you forget to use Sibnayal
Do not take a double dose to make up for a forgotten dose. Take a dose as soon as you remember it. However, if your next dose is to be taken in less than six hours, skip the dose you forgot to take. Do not take more than two doses per day. Talk to your doctor if you forget to take one or more doses
If you stop using Sibnayal
This medicine is intended for long-term use. It will only work as long as you use it. You should not stop taking it unless your doctor tells you to, even if you feel better, as your illness may get worse. If you want to stop treatment, talk to your doctor first. If you have any further questions on the use of this product, ask your doctor.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common side effects (may affect more than 1 in 10 people)
– abdominal pain (stomach pain)
Common side effects (may affect up to 1 in 10 people)
– upper abdominal pain (pain in the upper abdomen)
– gastrointestinal pains and diseases (gastrointestinal pain and diseases),
– dyspepsia (digestive problems),
– vomiting,
– diarrhea
nausea at the start of treatment.
How to store Sibnayal
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 label and carton after “EXP” or “EXP”. The expiration date is the last day of the specified month.
Do not store above 30 ° C.
After opening a sachet, discard all unused contents.
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 packaging and other information
Content declaration
The active substances are potassium citrate and potassium bicarbonate (also called potassium bicarbonate).
Each sachet of Sibnayal 8 mEq contains 282 mg of potassium citrate and 527 mg of potassium bicarbonate.
Each sachet of Sibnayal 24 mEq contains 847 mg of potassium citrate and 1,582 mg of potassium bicarbonate.
The other ingredients are hypromellose (E464), microcrystalline cellulose (E460 (i)), glycerol behenate, magnesium stearate (E470b), colloidal anhydrous silica, heavy magnesium oxide (E530), ethylcellulose (E462), chlorophyllin (E140 (ii)).
What the medicine looks like and the contents of the pack
Sibnayal is a mixture of green and white depot granules that are delivered in sachets. The cartons contain 60 sachets.
Sibnayal is available in multiple packs of 2, 3, 4, 5, and 6 cartons, each containing 60 sachets. Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
ADVICE
262 rue du Faubourg Saint Honoré
75008 Paris
France
infomed@advicenne.com
Manufacturer
ELAIAPHARM
2881 route des Crêtes
ZI les Bouillides Sophia Antipolis
06560 Valbonne
France