Phosphonorm hard capsules, 200 pcs

Therapeutic indication

This medicinal product is used to bind phosphate in the intestine.It is used to reduce phosphate absorption from the intestine in patients with renal insufficiency and elevated serum phosphate levels, particularly in patients undergoing dialysis.No prescription is required for this product.

Active substances / ingredients / components

The active substance in this preparation is aluminium chloride hydroxide complex (9:8:19) 23-hydrate at a dosage of 300 mg per hard capsule.It also contains various excipients such as gelatin, macrogol 20000, magnesium stearate, sodium dodecyl sulfate, highly dispersed silicon dioxide, stearic acid, titanium dioxide, purified water, and sodium ions.The total amount of sodium ions per hard capsule is 23 mg.

Contraindications

Do not take this medicinal product if you are allergic to aluminium chloride hydroxide complex (9:8:19) 23 H2O or any of the other ingredients of this medicinal product.Use is also contraindicated in cases of hypophosphataemia, constipation, or stenosis of the large intestine, as well as in infants and children up to three years of age and during pregnancy.

Dosage

Always take this medicinal product exactly as described in the package leaflet or as advised by your doctor or pharmacist.The dosage depends on the serum phosphate level.The recommended dose is 3–6 hard capsules per day, corresponding to an amount of 900 mg to 1800 mg of aluminium chloride hydroxide complex (9:8:19) 23 H2O.For children aged 3 years and older, the dosage should be reduced according to body weight.Plasma phosphate levels should be monitored regularly to adjust the dosage.The hard capsules should be swallowed whole with sufficient liquid, taken with meals and distributed throughout the day.

Treatment continues for as long as elevated serum phosphate levels require your doctor to prescribe the product.Please speak to your doctor or pharmacist if you feel that the effect of the medicine is too strong or too weak.

If you have taken more than you should, constipation may occur.In this case, the use of laxatives may be necessary.Please discuss this with your treating physician.

If you miss a dose, do not take a double dose; simply continue with the prescribed regimen.However, please inform your doctor.

If you stop taking the medicine, please inform your doctor.

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

Administration

The hard capsules should be swallowed whole with sufficient liquid, taken with meals and distributed throughout the day.

Information for patients

Please speak to your doctor or pharmacist before taking the medicine.Regular monitoring of blood aluminium levels is required during treatment; levels should not exceed 40 µg/l.In addition, neurological examinations and potentially bone examinations should be performed at regular intervals to detect aluminium toxicity at an early stage.Phosphate levels should be monitored regularly to adjust the dosage.

No studies on the effects on the ability to drive and use machines have been conducted.

Pregnancy

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 or using this medicine.The product must not be taken during pregnancy, as there is no experience with its use in humans and animal studies involving aluminium compounds have shown harmful effects on offspring.The product should not be taken during breast-feeding, as aluminium passes into breast milk.

Information

For risks and side effects, read the package leaflet and consult your doctor or pharmacist.