Sodium phosphate 16 + 6% 120 ml

Product Description

Drug indicated for the treatment of constipation

Indications

• Treatment of constipation.
• Clinical conditions that require pre- and post-operative intestinal emptying, in preparation for radiological examinations and endoscopic investigations of the upper intestinal tract.

Composition

Active ingredients

100 ml of solution contain: active ingredients: sodium phosphate monobasic dihydrate 18.088 g equivalent to sodium phosphate monobasic monohydrate 16 g; sodium phosphate dibasic dodecahydrate 8.016 g equivalent to sodium phosphate dibasic heptahydrate 6 g For the full list of excipients, see section 6.1.

Excipients

Bronopol, Purified water.

Directions for use and Dosage

Adults and adolescents (12–18 years): 1 bottle of 120 ml. Do not use more than one bottle per day. Each bottle must be used for a single administration; any residual medicinal product must be discarded. Administration can be carried out at room temperature. If lukewarm water is preferred, simply place the bottle in contact with hot water (by immersion or under the tap). For best effect, it is advisable to administer the product lying on the left side. For greater cleansing action, assume the knee-chest position for a few minutes immediately after administration.

Instructions for use Before using the medicine, push the cannula cover down until the bottle seal breaks.

1. Remove the protective cap from the rectal cannula.
2. Hold the bottle and gently insert the cannula into the rectum, then squeeze the bottle thoroughly. Some solution residue is expected to remain in the bottle. In adolescents, the cannula should not penetrate more than half its length.
3. Once administration is complete, remove the cannula and dispose of the empty bottle in its box according to the rules for disposing of medicines.
4. Remain lying down until you feel the urgent need to evacuate, which usually occurs within 5 minutes.

In any case, it is not necessary to hold the enema for more than 10–15 minutes.

Warnings

Interactions

The systemic absorption of sodium phosphate rectal solution is limited; however, in some conditions it may be increased and predispose to possible interactions with other drugs. Concomitant use of drugs that can affect electrolyte balance (such as corticosteroid diuretics and calcium antagonists, lithium) may facilitate the onset of hyperphosphatemia, hypercalcemia, and hypernatremia. Patients taking drugs that can prolong the QT interval may be at greater risk of developing this adverse reaction if treated concomitantly with sodium phosphate. Since hypernatremia is associated with low lithium levels, concomitant use of Sodium Phosphate Polifarma Benessere and lithium may cause a reduction in serum lithium levels, with a decrease in efficacy. Concomitant use of calcium supplements or calcium-containing antacids may increase the risk of ectopic calcification. Other preparations containing sodium phosphates, including oral solutions or sodium phosphate tablets, should not be administered concomitantly (see section 4.3).

Pregnancy and breastfeeding

No adequate and well-controlled studies have been conducted on the use of the medicinal product during pregnancy or breastfeeding. Although there are no obvious contraindications to the use of the medicine during pregnancy and breastfeeding, it is recommended to take the medicine only when necessary and under medical supervision.

Storage

Store in the original packaging away from light.

Format

120 ml