1 g tablets of
sodium bicarbonate
What Sodium Bicarbonate Evolan is and what it is used for
Sodium bicarbonate Evolan is used to treat metabolic acidosis (increased acidity of the blood due to the kidneys not being able to remove enough acid from the body) in adults and adolescents over 14 years of age with chronic kidney disease.
Sodium bicarbonate contained in Sodium Bicarbonate Evolan may also be approved for the treatment of other diseases not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you use Sodium Bicarbonate Evolan
Do not use Sodium Bicarbonate Evolan
- is hypersensitive to sodium bicarbonate or any of the other ingredients of this medicine (listed in section 6).
- has alkalosis (excess of bases in blood and body fluids, with elevated pH )
- have respiratory acidosis (abnormally high acidity in blood and body fluids due to breathing problems)
- have hypokalaemia (too little potassium in the blood)
- have hypernatremia (too much sodium in the blood)
- stands on a low-sodium diet.
Warnings and cautions
Talk to your doctor or pharmacist before taking Evolan Sodium Bicarbonate:
- if you suffer from heart failure
- if you have impaired kidney function
- if you have abnormally slow breathing (hypoventilation)
- if you have an abnormally low concentration of calcium in your blood ( hypocalcaemia )
- if you have an abnormal increase in solutes in the blood (hyperosmolar diseases).
Regular laboratory checks are necessary for long-term treatment.
Children and young people under 14 years
The safety and efficacy of Sodium Bicarbonate Evolan in children under 14 years of age have not been established.
Other medicines and Sodium Bicarbonate Evolan
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In general, changes in the pH of the gastrointestinal tract or the urine may affect the effectiveness of other medicines taken at the same time. This can apply to:
- ferrous sulphate (used in anemia )
- non-steroidal anti-inflammatory drugs ( NSAIDs ) (used eg for inflammation , pain and fever)
- tetracycline and ciprofloxacin (used in bacterial infections)
- digoxin (used for heart problems)
- ketoconazole (used in Cushing’s syndrome)
- itraconazole (used for fungal infections)
- sympathomimetics (used in eg asthma , severe allergic reactions, sinusitis or ADHD )
- anticholinergics (used in eg asthma , Parkinson’s disease , motion sickness, stomach cramps and diseases of the urinary tract)
- tricyclic antidepressants (used for depression)
- barbiturates (used in epilepsy )
- H2 blocker (used for stomach ulcers and heartburn)
- salicylates (used as blood thinners)
- captopril ( ACE inhibitor used in high blood pressure and heart failure )
- quinidine (used for irregular heartbeat)
- lithium (used in bipolar disorder ).
The amount of potassium in the blood may decrease if Sodium Bicarbonate Evolan is used at the same time as certain medicines:
- glucocorticoids (cortisone preparations used for inflammation or allergy )
- mineral corticoid er (cortisone preparations used for eg high blood pressure )
- androgen er (male sex hormones used in hormone replacement therapy)
- diuretics ( diuretics for high blood pressure , heart failure and edema )
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.
Pregnancy
Sodium bicarbonate Evolan should only be used during pregnancy if your doctor thinks it is necessary.
Breast-feeding
Sodium bicarbonate is excreted in human milk. There are no known effects on newborns after low dose use and short-term use. The use of high doses and long-term use of Sodium Bicarbonate Evolan is not recommended during breastfeeding. Talk to your doctor if you are breastfeeding.
Driving and using machines
Sodium bicarbonate Evolan has no or negligible effect on the ability to drive and use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Sodium bicarbonate Evolan contains lactose and sodium
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains 273 mg of sodium (the main ingredient in table salt/table salt) per tablet. This corresponds to 14% of the highest recommended daily intake of sodium for adults. Talk to your doctor or pharmacist if you need to take one or more tablets daily for a long period, especially if you have been prescribed a low-salt (sodium-poor) diet.
How to use Sodium Bicarbonate Evolan
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Dose one is adjusted according to the severity of your symptoms and after checking your blood tests. The recommended dose for adults and adolescents over 14 years is:
Treatment of metabolic acidosis in chronic kidney disease
Starting dose: 2-3 tablets daily, taken in divided doses
Maintenance dose: up to 8 tablets daily, taken in divided doses
Treatment of metabolic acidosis in renal tubular acidosis
Distal renal tubular acidosis
Starting dose: 4-6 tablets daily, taken in divided doses
Maintenance dose: determined by your doctor after checking your blood tests
Proximal renal tubular acidosis
Dose one is determined by a doctor after checking your blood samples and adjusted according to your body weight.
How to take Evolan Sodium Bicarbonate
The tablets should be taken in divided doses several times a day. The tablets should be swallowed. The notch is for you to be able to divide the tablet if you have difficulty swallowing it whole.
Your doctor may ask you to take urine and/or blood samples at regular intervals, for example weekly or less frequently, to adjust the dose of Sodium Bicarbonate Evolan.
If you use more sodium bicarbonate Evolan than you should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
Overdose can cause dizziness, muscle weakness, fatigue, bluish discoloration of the skin and mucous membranes (cyanosis), shortness of breath, involuntary muscle contractions, and heavy gas formation. Later, apathy, confusion, intestinal upset, and circulatory shock may occur. Overdose is treated by restoring fluid – electrolyte and acid-base balance and, if necessary, gastric pumping.
If you forget to use Sodium Bicarbonate Evolan
Do not take a double dose to make up for a forgotten dose.
If you stop using Sodium Bicarbonate Evolan
If you stop taking Sodium Bicarbonate Evolan, your symptoms will return. Do not stop your treatment without talking to your doctor first.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Rare (may affect up to 1 in 1,000 people) :
- alkalosis (excess of bases in blood and body fluids, with elevated pH ) with long-term use in high doses .
Has been reported (occurs in an unknown number of users):
- gas formation, abdominal pain
- muscle cramps with excessive dosing which may be exacerbated by pre-existing diseases of the gastrointestinal tract (eg diarrhea)
- formation of kidney stones during prolonged use
How to store Sodium Bicarbonate Evolan
Keep this medicine out of the sight and reach of children.
Used before the expiry date which is stated on the carton. The expiration date is the last day of the specified month.
No 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 bicarbonate (sodium bicarbonate) 1 g per tablet.
- The other ingredients are maize starch, lactose monohydrate , povidone, croscarmellose sodium, talc (E 553b), magnesium stearate.
What the medicine looks like and contents of the pack
Sodium bicarbonate The Evolan tablet is a white, capsule-shaped tablet, 19 x 8 mm, with a scoreline. The notch is for you to be able to divide the tablet if you have difficulty swallowing it whole.
Pack size: 90, 100, 105, 3 x 100, 5 x 100 tablets in a plastic jar.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Evolan Pharma AB
Box 120
182 12 Danderyd
Manufacturer:
SC Laropharm SRL, 145 A Alexandriei street, Bragadiru, Ilfov, 077025, Romania