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MEDICE Arzneimittel Pütter GmbH&Co.KG

NEPHROTRANS, sodium hydrogen carbonate, metabolic acidosis, sodium bicarbonate

NEPHROTRANS, sodium hydrogen carbonate, metabolic acidosis, sodium bicarbonate

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NEPHROTRANS gastro-resistant, sodium hydrogen carbonate capsules, metabolic acidosis, sodium bicarbonate

Nephrotrans Capsules, sodium hydrogen carbonate, metabolic acidosis, sodium bicarbonate


Active ingredient: sodium hydrogen carbonate

Areas of application:
For the treatment of metabolic acidification of the blood (metabolic acidosis) and maintenance treatment against recurrence of metabolic acidification of the blood in chronic underperformance of the kidneys (chronic renal insufficiency)
Note:
Patients with a blood pH below 7.2 need to correct the hyperacidity (acidosis) by infusion.

For the treatment of metabolism-related hyperacidity of the blood.

application:
- Metabolic acidification of the blood (metabolic acidosis), in chronic kidney dysfunction

Application notes:
The total dose should not be exceeded without consulting a doctor or pharmacist.

Type of application?
Take the medicine with liquid (e.g. 1 glass of water).

Duration of use?
The duration of use depends on the type of symptoms and/or the course of the disease. It should therefore be determined in consultation with your doctor.

overdose?
There are currently no known signs of overdose. If in doubt consult your doctor.

In general, pay attention to a conscientious dosage, especially for infants, small children and the elderly. If in doubt, ask your doctor or pharmacist about any effects or precautions.

A dosage prescribed by the doctor may deviate from the information on the package leaflet. Therefore, since the doctor adjusts them individually, you should use the medicine according to his instructions.

Mode of action:
How does the ingredient in the drug work?

The active ingredient is a salt that the body needs to maintain the neutral blood environment. If the pH value shifts into the acidic range, for example as a result of pulmonary or kidney dysfunction, a life-threatening situation can arise for the patient. The salt brings the disturbed balance back into balance. If severe diarrhea has deprived the body of the necessary salts, a solution that contains sodium bicarbonate, among other things, for example, will replenish the stores.


Contraindications:
What speaks against an application?

Always:
- Hypersensitivity to the ingredients
- Shift of the acid-base balance in the blood to the alkaline side (alkalosis)
- Potassium deficiency
- Elevated sodium levels

Under certain circumstances - talk to your doctor or pharmacist about this:
- Shortness of breath
- Calcium deficiency
- Hyperosmolar conditions (increased water inflow from the tissue into the bloodstream)
- Low-sodium diet, eg if table salt has to be avoided

What about pregnancy and breastfeeding?
- Pregnancy: consult your doctor. Various considerations play a role in whether and how the drug can be used during pregnancy.
- Breast-feeding: consult your doctor or pharmacist. He will examine your particular starting position and advise you accordingly as to whether and how you can continue breastfeeding.

If you have been prescribed the drug despite a contraindication, talk to your doctor or pharmacist. The therapeutic benefit can be higher than the risk that the use involves in the event of a contraindication.

Side effects:
What side effects can occur?

- Flatulence
- Abdominal pain

If you notice any changes in your condition or changes during treatment, contact your doctor or pharmacist.

For the information at this point, side effects are primarily taken into account that occur in at least one in 1,000 patients treated.

Important information:
What should you consider?
- Beware of allergies to cinnamon, birch, poplar buds, propolis, valerian, turmeric and rosin!
- Be careful with allergies to peanuts, soy and legumes, possibly also to lupines (as flour in ready-made dough for pizza and rolls)!
- Be careful if you are allergic to emulsifiers (e.g. sorbitan fat esters with E numbers E 493 and E 494)!
- Be careful if you are allergic to the solvent propylene glycol (E number E 477)!
- Be careful if you are allergic to talc!
- Be careful if you are allergic to the solvent polyethylene glycol (E number E 431)!
- Caution is advised if you have a known hypersensitivity to fructose (fruit sugar). Gastrointestinal problems can be triggered.
- There may be medicines with which interactions occur. You should therefore generally tell your doctor or pharmacist about any other medicine you are already using before starting treatment with a new medicine. This also applies to medicines that you buy yourself, use only occasionally or have been using for some time.

For the treatment of metabolism-related hyperacidity of the blood.

active NEPHROTRANS, sodium hydrogen carbonate, metabolic acidosis, sodium bicarbonate ingredients

  • 500 mg sodium bicarbonate

NEPHROTRANS, sodium hydrogen carbonate, metabolic acidosis, sodium bicarbonate excipients

  • wax, yellow
  • Soybean oil, hydrogenated
  • Soybean oil, partially hydrogenated
  • Lecithin (soybean)
  • Rapeseed oil, refined
  • Iron(II,III) oxide
  • titanium dioxide
  • Glycerol 85%
  • gelatin
  • sorbitol
  • sorbitan
  • mannitol
  • polyols
  • hypromellose
  • hyprolose
  • talc
  • macrogol
  • Methacrylic acid ethyl acrylate copolymer (1:1)
  • Polysorbate 80
  • Sodium Lauryl Sulfate
  • propylene glycol
  • glycerol monostearate
  • Hydrochloric acid for pH adjustment
  • water, purified
  • 137 mg sodium ion

NEPHROTRANS, sodium hydrogen carbonate, metabolic acidosis, sodium bicarbonate indication

  • The preparation is an acidosis therapeutic for the correction of metabolic acidosis.
  • application areas
    • For the treatment of metabolically-caused hyperacidity of the blood (metabolic acidosis) and for maintenance treatment against recurrence of metabolically-caused hyperacidity of the blood in the case of chronic underperformance of the kidneys (chronic renal insufficiency).
  • Note: Patients with a blood pH below 7.2 require correction of hyperacidity (acidosis) by infusion.

NEPHROTRANS, sodium hydrogen carbonate, metabolic acidosis, sodium bicarbonate dosage

  • Always take the medicine exactly as directed. Please check with your doctor or pharmacist if you are not sure.
  • The dosage always depends on the severity of the metabolic acidification of the blood (metabolic acidosis).
  • Unless otherwise prescribed by the doctor, the usual dose is:
    • 6 - 9 soft capsules per day, corresponding to 3 - 4.5 g sodium bicarbonate per day.

 

  • duration of use
    • As long as an existing metabolic acidosis requires a prescription of Nephrotrans by a doctor. The preparation must not be taken uncontrolled over a longer period of time.
    • Please talk to your doctor or pharmacist if you have the impression that the effect of the medicine is too strong or too weak.

 

  • If you take more than you should
    • Overdose of sodium bicarbonate can lead to alkalosis of the blood with symptoms such as muscle weakness, exhaustion, shallow breathing. Please contact your doctor immediately to initiate countermeasures and dose adjustment.

 

  • If you forget to take a dose
    • Do not take a double dose to make up for a forgotten dose, in this case continue with the prescribed dose. However, please inform your doctor about this.

 

  • If you stop taking it
    • Please inform your doctor about this.

 

  • If you have any further questions on the use of the medicine, ask your doctor or pharmacist.

NEPHROTRANS, sodium hydrogen carbonate, metabolic acidosis, sodium bicarbonate way

  • The soft capsules should be taken unchewed, possibly with a little liquid throughout the day with meals.

side effects

  • Like all medicines, the preparation can have side effects, although not everyone gets them.
  • The frequency of side effects is based on the following categories:
    • Very common: affects more than 1 in 10 people
    • Common: affects 1 to 10 users in 100
    • Uncommon: affects 1 to 10 users in 1,000
    • Rare: affects 1 to 10 users in 10,000
    • Very rare: affects less than 1 in 10,000 people
    • Not known: frequency cannot be estimated from the available data.
  • possible side effects
    • Gastrointestinal symptoms such as bloating and abdominal pain may occur.
    • Prolonged use of the drug can promote the formation of calcium or magnesium phosphate stones in the kidneys.
    • If the dose is exceeded, muscular hyperexcitability due to reduced calcium (hypocalcaemic tetany) is possible. In the case of pre-existing disorders of the gastrointestinal tract, such as diarrhea, these disorders may be aggravated.
  • Please tell your doctor or pharmacist if any of the side effects gets serious, or if you notice any side effects that are not listed.

NEPHROTRANS, sodium hydrogen carbonate, metabolic acidosis, sodium bicarbonate interactions

  • When taking the preparation with other medicines
    • Please inform your doctor or pharmacist if you are taking/using or have recently taken/used other medicines, even if they are non-prescription medicines.
    • The absorption and excretion of weak acids and bases can be influenced by increasing the pH value in the stomach and intestines. This applies, for example, to sympathomimetics, anticholinergics, tricyclic antidepressants, barbiturates, H2 antagonists, captopril, quinidine.
    • Functional interactions are possible with gluco- and mineralocorticoids, androgens and diuretics that increase potassium excretion. Attention must be paid to a possible influence on the solubility of drugs that are eliminated with the urine (eg ciprofloxacin).
  • Taking the drug with food and drink
    • No food and drink interaction studies have been performed.

Contraindications

  • The medicine must not be taken
    • if you are allergic (hypersensitive) to sodium bicarbonate or any of the other ingredients of the preparation.
    • in the case of a metabolic base excess (metabolic alkalosis).
    • with reduced serum potassium (hypokalemia).
    • with increased serum sodium (hypernatraemia).
    • on a low-sodium diet.
    • by children under the age of 14.

pregnancy and breast feeding period

  • Ask your doctor or pharmacist for advice before taking/using any medicine.
  • There is no experience with taking the preparation. Although there are no objections to the use of sodium bicarbonate (the active ingredient in the preparation) if indicated, the drug should only be taken during pregnancy and breastfeeding after consultation with the doctor treating you.

patient NEPHROTRANS, sodium hydrogen carbonate, metabolic acidosis, sodium bicarbonate notes

  • Special care is required when taking the drug
    • with weakened breathing (hypoventilation).
    • if you have low levels of calcium in your blood (hypocalcaemia).
    • with increased salt content of the blood (hyperosmolar conditions).
  • The sodium content (137 mg sodium = 6 mEq per soft capsule) should be taken into account, especially in long-term treatment; if necessary, a low-salt or strictly low-salt diet should be observed in order to counteract the further increase in existing high blood pressure.
  • The effect of the drug should be checked at least 1-2 weeks apart (e.g. pH measurement, standard bicarbonate, alkali reserve) initially and especially with higher doses. The plasma electrolytes, especially sodium, potassium and calcium, must also be checked regularly. Depending on the result of these checks, the respective further dosage is to be determined. These checks must also be carried out regularly under long-term medication. Depending on the result of these checks, the respective further dosage is to be determined. Any overbasing can be corrected by reducing the dose.

 

  • Driving and using machines:
    • The preparation has no influence on the ability to drive and use machines.

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