• 235 mg magnesium carbonate, heavy, basic
• 435 mg calcium diacetate

• magnesium stearate
• Croscarmellose sodium
• Castor Oil, Refined
• hypromellose
• Corn starch, pregelatinized
• gelatin
• 50 mg sucrose
• cornstarch

Hemodialysis, peritoneal dialysis at home, Kidney failure itching, OSVAREN film tablets  indication

• The medicine is used to treat high phosphate levels in patients with chronic kidney failure who are undergoing dialysis (blood washing) (hemodialysis, peritoneal dialysis).
• It belongs to a group of drugs known as phosphate binders. Phosphate is a mineral that affects bone health. In the case of impaired kidney function, there are generally also high phosphate levels in the blood. This can lead to bone problems.
• The preparation binds phosphate and thus balances your phosphate levels.

Hemodialysis, peritoneal dialysis at home, Kidney failure itching, OSVAREN film tablets  dosage

• Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
• The prescribed dose should be taken exactly as directed and should be checked by your doctor according to the level of phosphate in your blood.
• The recommended dose is:
  • 3 to 10 film-coated tablets
• Maximum daily dose:
  • 12 film-coated tablets
• The recommended starting dose is 3 tablets per day. The dose is then gradually increased until the desired blood phosphate levels are reached, unless you have high calcium levels.
• Use in children and adolescents:
  • Safety and effectiveness in children and adolescents have not been established. For this reason, use in children and adolescents under the age of 18 is not recommended.

• duration of use
  • The medicine can be taken for a long period of time, although it is up to your doctor to determine the exact length of time.
  • Please talk to your doctor or pharmacist if you feel that the effect is either too strong or too weak.

• If you take more than you should
  • Please ask your doctor for advice, as in this case the calcium and magnesium levels increase and can lead to serious side effects.
  • The typical symptoms of high levels of calcium and magnesium in the blood are stomach dysfunction, muscle weakness, low blood pressure, nausea, loss of appetite, sluggish bowel (constipation), cardiac arrhythmia and sleepiness. The typical signs of extremely high calcium levels are loss of energy, fainting and even coma. The typical characteristics of extremely high magnesium levels are low blood pressure and even coma.

• If you forget to take a dose
  • If you miss a dose, you should continue with the next dose. Do not take a double dose to make up for a forgotten dose.

• If you stop taking it
  • Do not interrupt or stop taking it without first consulting your doctor.

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

Hemodialysis, peritoneal dialysis at home, Kidney failure itching, OSVAREN film tablets way

• Always take this medicine with meals.
• Do not crush or chew the tablets.
• No other oral medicines mentioned in the package leaflet should be taken within a period of 2 hours before and 3 hours after dosing.
• See package leaflet for more information.

side effects

• Like all medicines, this medicine can cause side effects, although not everybody gets them.
  • Common (may affect up to 1 in 10 people)
    • Gastrointestinal disorders such as
      • soft stool
      • nausea
      • loss of appetite
      • bloating
      • burping
      • constipation
      • Diarrhea
    • Increase in the level of calcium in the blood, which can occur without symptoms or together with the following symptoms
      • constipation
      • loss of appetite
      • nausea
      • Vomit
    • Increase in magnesium levels in the blood, usually without symptoms.
  • Uncommon (may affect up to 1 in 100 people)
    • Moderate to severe increase in blood calcium levels, which may be associated with the following symptoms
      • impaired consciousness such as B. disorientation, loss of consciousness (drowsiness) and even coma
      • weakness
      • confusion
      • increased calcium excretion in the urine
      • hypoacidity of the blood
      • cardiac arrhythmias
      • high blood pressure
      • Tissue hardening (deposits of calcium salts)
    • Moderate to severe increases in blood levels of magnesium which may be associated with the following conditions
      • fatigue
      • muscle weakness
      • Drowsiness to decreased consciousness
      • lower pulse
      • drop in blood pressure
  • Very rare (may affect up to 1 in 10,000 people)
    • Increased levels of potassium in the blood
    • Disturbed mineral balance of the bones
• If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects that are not specified.

Kidney failure itching, Hemodialysis, peritoneal dialysis at home, OSVAREN interactions

• Taking with other medicines
  • Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any other medicines.
    • The preparation can reduce the levels and thus the effect of the following medicines:
      • antibiotics such as B. tetracycline, doxycycline, norfloxacin ,, some cephalosporins, such as. B. cefpodoxime, cefuroxime, and some quinolones such. B. Ciprofloxacin
      • bisphosphonates such as B. alendronate and risedronate, medicines used to treat bone diseases
      • Fluorides to prevent and treat tooth decay and bone disease
      • Ketoconazole, a drug used to treat fungal diseases
      • estramustine, a drug used to treat prostate cancer
      • Anticholinergic agents used to treat Parkinson's disease and irritable bladder
      • zinc
      • Urso- and chenodeoxycholic acid, agents used to treat gallstones
      • Halofantrine, a drug used to treat malaria
      • iron supplements
      • Digoxin (cardiac glycoside), a drug used to increase cardiac output
      • Nitrofurantoin, a drug used to treat urinary tract infections
      • Penicillamine, a medicine used to treat chronic joint inflammation
    • The preparation can increase the values ​​and thus the effect of the following medicines:
      • levothyroxine, a drug used to treat thyroid disorders.
    • The calcium level in the blood must be monitored when taking the following medicines:
      • Vitamin D, as taking it increases the amount of calcium in your body
      • certain diuretics (water pills) such as B. hydrochlorothiazide, as the levels of calcium in your body may increase
    • Oestrogens, since female sex hormones increase the level of calcium in the body
    • The drug can increase calcium levels and thus the effect of the following medicines:
      • Digitalis glycosides (cardiac glycosides such as digoxin) as a means of increasing cardiac output
      • Adrenaline, a substance used to control allergic reactions and treat shock.
      • Possible consequence: severe cardiac arrhythmias.
    • The preparation can reduce the effect of the following medicines:
      • Calcium channel blockers, such as verapamil, a drug used to lower blood pressure.
  • None of the other oral medicines mentioned here should be taken 2 hours before and 3 hours after taking this medicine.
  • Even when taken properly, the drug can affect the effects of other medications through its effects on blood calcium levels.
• Use with food and drink
  • The medicine must be taken with a meal.

Contraindications

• The medicine must not be used
  • if you are allergic to calcium acetate, magnesium carbonate or any of the other ingredients of this medicine.
  • if your blood phosphate levels are too low.
  • if you have high levels of calcium in your blood.
    • This can be due to vitamin D overdose, tumors in the lungs, breast, kidneys or blood, bone metastases, certain lung diseases (sarcoidosis) or bone loss as a result of lack of exercise.
  • if you have increased levels of magnesium in your blood and/or signs of it.
  • if you have a heart rhythm disorder called AV block III (total AV block).
  • if you suffer from muscle fatigue, including that of the eyes and muscle weakness when chewing, swallowing and breathing (myasthenia gravis - severe muscle weakness).

pregnancy and breast feeding period

• If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
• So far, there is no or only very limited experience with use in pregnant and breastfeeding women. You should only take the medicine if your doctor decides that the potential benefit outweighs the risk. Your calcium and magnesium levels will be checked regularly.
• breastfeeding
  • If you are taking the medicine, breastfeeding is not recommended.

patient notes

• Warnings and Precautions
  • Please talk to your doctor before taking the preparation. Please talk to your doctor about changing your diet, as the medicine you take and the type of dialysis you have have an effect on your body's phosphate levels.
  • Caution should be exercised when taking this medicine with regard to the levels of calcium, magnesium and phosphate in the blood in the following cases:
    • with very high, non-treatable phosphate levels
    • with high potassium levels that are difficult to treat
    • if you have a slow heart rate or cardiac conduction defects associated with a slow heartbeat (second degree AV block).
  • Your doctor will regularly check your levels of phosphate, magnesium, calcium and the calcium phosphate product in your blood. If your blood levels of calcium and magnesium are too high, your doctor will reduce the dose of this medicine accordingly, or stop treatment. Calcium and magnesium levels in the dialysate may need to be adjusted.
  • Caution is advised:
    • if you are taking vitamin D supplements and certain diuretics (water tablets), such as hydrochlorothiazide, at the same time, as these increase the amount of calcium in the body
    • if you are taking high doses of this medicine for a long time, as the levels of magnesium in your blood may increase. Possible signs of high magnesium levels are stomach problems such as nausea, loss of appetite and constipation. Very high levels of magnesium can cause muscle weakness, low blood pressure, and fainting and coma.
    • if you are taking acid neutralizing medicines (e.g. to relieve heartburn) that contain calcium or magnesium. Talk to your doctor before taking acid-neutralizing medicines, as they may further increase the amount of calcium and magnesium in this medicine.
    • if you have chronic kidney disease, as taking this medicine can lead to high levels of calcium in the blood. Possible signs of high calcium levels are muscle weakness and stomach problems such as stomach pain, constipation, nausea and vomiting. Please speak to your doctor if you experience such symptoms.
    • Please pay attention to the possible symptoms of increased calcium levels in the blood as set out in the "Side effects" category.
    • if you take the preparation for a long time, as this can lead to calcium deposits in the tissues and thus tissue hardening.
    • if you take medicines such as B. digitalis glycosides (digoxin or digitoxin), your doctor will carry out an electrocardiogram (ECG) examination while you are taking them and check your calcium levels.
    • if you develop sluggish bowel movements (constipation).
    • if you have diarrhea. In this case, contact your doctor and take a lower dose of this medicine.

• Ability to drive and use machines
  • Not applicable.