100 ml of rectal solution contains: sodium dihydrogen phosphate monohydrate ( Natrii dihydrophosphas monohydricus ) 14 g; disodium phosphate dodecahydrate ( Dinatrii phosphas dodecahydricus ) 5 g.

For a full list of excipients, see section 6.1.

• Colon cleansing before diagnostic tests of the colon and before surgical procedures and childbirth

• Constipation occurring occasionally, e.g. after surgery and constipation after the use of contrast agents

Rectanal is indicated for use in adults and children and adolescents from 3 years of age.

• Hypersensitivity to the active substances or to any of the excipients listed in section 6.1

• Perforation of the large intestine

• Intestinal obstruction, anal atresia, ulcerative colitis

• Severe general condition, heart disease, congestive heart failure

• Suspected perforation, obstruction or ulcerative colitis

• Severe renal failure

• Hypertension

• Appendicitis

• Abdominal pain, nausea, vomiting of unknown cause

• Age under three years

• Dehydration

• Pregnancy

The frequency of adverse reactions is defined as follows: rare (≥1/10,000 to <1/1,000).

Rare: metabolic and nutritional disorders: transient hypocalcaemia and hyponatremia leading to dehydration Rare:

gastrointestinal disorders: large intestine dysfunction (if used frequently)

Electrolyte changes may occur in patients taking calcium channel blockers or diuretics.

Dosage

Adults

The medicinal product is administered rectally by squeezing approximately 120 to 150 ml of solution from the bottle in the evening before the examination or surgery and on the day of surgery. The rectal enema may be repeated on the day before surgery if complete cleansing is not achieved. Do not use more than once daily.

The solution introduced into the rectum should be at room temperature.

After taking the medicinal product, the patient should be given additional fluids orally.

Laxatives should not be used for longer than one week.

Before surgery, it is recommended to have your blood electrolyte levels checked.

Children and youth

For children aged 3 to 12 years, the medicinal product is administered rectally by squeezing 60 to 90 ml of solution from the container in the evening before the examination or surgery and on the day of surgery. The rectal enema may be repeated on the day before surgery if complete cleansing is not achieved. Do not use more than once daily.

The product should be used with particular caution in children, and in children aged 3 to 5 years only with a doctor's prescription and under his supervision.

The solution introduced into the rectum should be at room temperature.

After taking the medicinal product, the patient should be given additional fluids orally.

Laxatives should not be used for longer than one week.

Before surgery, it is recommended to test the concentration of electrolytes in the blood.

Rectanal should not be used in children under 3 years of age due to safety reasons.

Method of administration

Precautions to be taken before using or administering the medicinal product

Before using the product, remove the cap from the dispenser on the bottle (Fig. 1).

The tip of the dispenser should be lubricated with Vaseline or liquid paraffin for easier insertion into the rectum (Fig. 2).

If the patient is self-administering the medicinal product, he or she should lie on his or her side (preferably on the left) and bend both legs at the hips and knees (Fig. 3a).

If someone is administering a medicinal product, the patient should assume a position supported on their elbows and knees (Fig. 3b).

The dispenser tip should be carefully inserted into the rectum. Then, slowly squeezing the bottle, empty its contents into the rectum. The patient should try to contract the anal sphincter. The bottle contains excess solution, so it is not necessary to empty it completely. After instilling the solution into the intestine, the patient should remain in one of the described positions for 2-5 minutes until a feeling of urgency occurs, and then defecate. Positioning with the pelvis above head level is most effective. This can be achieved by placing a blanket or pillow under the pelvis.

In cases of anal stenosis or defects in the anal mucosa, the procedure can be performed by extending the rigid tip of the bottle with a soft catheter, such as a Foley catheter. A similar technique should be used for enema through an artificial anus. In this case, the best position is the supine position.