ІЗОФРА 8000 IU/ml Spray

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1. INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT GLYCERIN MICRO-ENEMAS FOR ADULTS ADYULAX
   1. Composition:
   2. Pharmaceutical form.
   3. Main physical and chemical properties:
   4. Pharmacotherapeutic group.
   5. Pharmacological properties.
   6. Clinical characteristics.
   7. Method of administration and dosage.
   8. Children.
   9. Overdose.
   10. Adverse reactions.
   11. Shelf life.
   12. Storage conditions.
   13. Packaging.
   14. Release category.
   15. Manufacturer.
   16. Location of the manufacturer and address of the place of its activities.

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT GLYCERIN MICRO-ENEMAS FOR ADULTS ADYULAX

Composition:

The active substance is glycerin; 1 applicator (7.5 ml) contains glycerin 6.14 ml; the auxiliary substance is purified water.

Pharmaceutical form.

Rectal solution.

Main physical and chemical properties:

A syrupy liquid, transparent, colorless with a characteristic odor, which does not contain foreign inclusions.

Pharmacotherapeutic group.

Laxatives. Glycerin.

ATC code A06A X01.

Pharmacological properties.

Pharmacodynamics.

The active substance of the medicinal product is glycerin, which, after rectal administration, causes a laxative effect due to its ability to lubricate fecal masses and promote the flow of fluid to them, stimulating intestinal contractions.

Pharmacokinetics.

Glycerin promotes bowel emptying within 15-30 minutes to 1 hour after administration of the micro-enema.

Clinical characteristics.

Indications.

For local relief of symptoms of short-term and episodic constipation.

Contraindications.

• Increased sensitivity to glycerin.
• Abdominal spasms, colic, nausea, vomiting, or other symptoms of appendicitis.
• Hemorrhagic rectocolitis.
• Diarrhea.
• Anorectal diseases.
• Ulcerative colitis and inflammatory hemorrhoidal conditions.
• Abdominal pain.
• Intestinal obstruction.
• Acute inflammatory bowel diseases.
• Children under 12 years of age.

Interaction with other medicinal products and other types of interactions.

No interactions have been reported.

If the patient is taking or has recently taken any medicinal product, it is recommended to consult a doctor.

Special instructions.

In case of blood in the stool, irritation, pain, or lack of improvement in bowel condition, treatment should be stopped and a doctor consulted regarding further use of the medicinal product.

Adyulax should not be used for more than one week, unless the doctor has prescribed otherwise.

Patients with severe diseases, including cardiovascular diseases, can use the medicinal product only under medical supervision.

Glycerin may exacerbate abdominal pain in patients with irritable bowel syndrome. Such patients are recommended to use the preparation with caution.

Prolonged use of the medicinal product should be avoided.

Use during pregnancy or breastfeeding.

Use is possible only when, in the doctor's opinion, the benefit to the woman outweighs the potential risk to the fetus/child.

Ability to affect reaction speed when driving vehicles or operating machinery.

Given the nature of the preparation and its action, no effect on reaction speed is expected.

Method of administration and dosage.

It is necessary to follow the recommendations below, unless the doctor has given other instructions.

This medicinal product is intended only for rectal administration.

Adults and children over 12 years: 1 rectal applicator per day.

Elderly patients: the recommended dose is the same as for adults.

Liver and/or kidney insufficiency: dose adjustment is not necessary.

It is recommended to consult a doctor if the effect of glycerin micro-enemas for adults Adyulax seems too strong or too weak.

Method of administration

At the chosen time of administration, remove the cap that covers the tip of the cannula and, holding the cannula vertically upwards, gently press to allow a few drops of the preparation to moisten the tip of the cannula to facilitate the introduction of the applicator into the rectum.

After introduction into the rectum, express the contents of the applicator and, when it is empty, remove it, continuing to squeeze the walls of the applicator.

Each applicator is filled with an excess of the product, which remains in the applicator after use.

Thus, the amount that enters the rectum during administration is the full dose, and there is no need to empty the applicator completely, which makes it easier to use.

Each applicator contains 1 dose of the medicinal product - it should be discarded after use.

If resistance is felt during administration, administration should be stopped, as it may cause harm.

Therefore, before continuing treatment, it is necessary to consult a doctor to determine the cause of the resistance.

Delay bowel movement as long as possible to allow the medicinal product to take effect.

Duration of treatment

The preparation should not be used for more than one week, unless the doctor has prescribed otherwise.

If symptoms worsen or persist after 7 days of use, a doctor should be consulted.

Children.

This medicinal product is not used in children under 12 years of age.

Overdose.

Misuse and prolonged use of the preparation may cause irritable bowel syndrome (diarrhea or constipation).

Therefore, in case of need for longer use, it is recommended to use it with caution under medical supervision.

In case of overdose or accidental ingestion, a doctor should be consulted.

Adverse reactions.

Local discomfort, irritation, and anal pain, itching may be observed.

Allergic reactions are possible.

A doctor should be consulted if any of these or other adverse reactions not mentioned in the instructions are noticed.

Shelf life.

3 years.

Do not use after the expiration date stated on the packaging.

Storage conditions.

Store at a temperature not exceeding 25 ºC.

Store in a place inaccessible to children.

Packaging.

Rectal solution, 6.14 ml/7.5 ml, 7.5 ml in applicators No. 4 in a cardboard box.

Release category.

Without a prescription.

Manufacturer.

Casen Recordati, S.L.

Location of the manufacturer and address of the place of its activities.

Autovia de Logrono km 13,300, 50180 Utebo, Zaragoza, Spain.