MICRALAX CITRATE/LAURIL SULFACETATE 450 MG/45 MG RECTAL SOLUTION

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

MICRALAX SODIUM CITRATE/SODIUM LAURYL SULFOACETATE 450mg/45mg rectal solution

Sodium citrate / Sodium lauryl sulfoacetate

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

Follow exactly the instructions for use of this medicine as described in this leaflet or as indicated by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or if you do not improve after 6 days of treatment.

Contents of the leaflet:

1. What Micralax Sodium Citrate/Sodium Lauryl Sulfoacetate is and what it is used for.
2. What you need to know before using Micralax Sodium Citrate/Sodium Lauryl Sulfoacetate.
3. How to use Micralax Sodium Citrate/Sodium Lauryl Sulfoacetate.
4. Possible side effects.
5. How to store Micralax Sodium Citrate/Sodium Lauryl Sulfoacetate.
6. Contents of the pack and other information.

1. What Micralax Sodium Citrate/Sodium Lauryl Sulfacetate is and what it is used for

Micralax Sodium Citrate/Sodium Lauryl Sulfacetate acts as an osmotic-type laxative, due to the combined action of Sodium Citrate, which retains fluid in the intestine and increases water volume in the stools, and Sodium Lauryl Sulfacetate, a wetting agent.

It is indicated for the local symptomatic relief of occasional constipation in adults and adolescents over 12 years of age.

You should consult a doctor if symptoms worsen or do not improve after 6 days of treatment.

2. What you need to know before using Micralax Sodium Citrate/Sodium Lauryl Sulfoacetate

Do not use Micralax Sodium Citrate/Sodium Lauryl Sulfoacetate:

• If you are allergic to sodium citrate/sodium lauryl sulfoacetate or any of the other ingredients of this medicine (listed in section 6).
• If you are suffering from hemorrhoids.
• If you have ulcerative colitis.

Warnings and precautions

If your symptoms do not improve, worsen, or if you notice blood in your stools, irritation, or pain, you must stop treatment and consult your doctor.

Do not use this medicine for more than 6 consecutive days unless otherwise directed by your doctor.

Children and adolescents

This medicine should not be used in children under 12 years of age unless considered necessary by your doctor.

Other medicines and Micralax Sodium Citrate/Sodium Lauryl Sulfoacetate

Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines.

If you are undergoing treatment to lower blood calcium levels with a medicine containing sodium polystyrene sulfonate, do not use Micralax, as intestinal necrosis may occur.

SODIUM POLYSTYRENE SULFONATE:

Isolated cases of ileocolic perforation and colonic necrosis have been reported in patients treated for hyperkalemia.

Patients taking sorbitol are advised to consult their doctor before using this medicine.

Use of Micralax Sodium Citrate/Sodium Lauryl Sulfoacetate with food and drink

Taking food or drink does not affect the effectiveness of this medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

This medicine does not affect your ability to drive or operate machinery.

Micralax contains sorbic acid

This medicine may cause local skin reactions (such as contact dermatitis) because it contains sorbic acid.

3. How to use Micralax Citrate/Lauryl Sulfacetate

Follow exactly the administration instructions provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

The recommended dose for adults and adolescents over 12 years of age is 1 applicator per day.

Do not use this medicine for more than 6 consecutive days.

Method of administration

This medicine is administered rectally.

At the chosen time for defecation, remove the cap covering the tip of the applicator. Hold the applicator vertically with the tip pointing upward and gently squeeze it until a few drops of Micralax moisten the tip, to facilitate insertion into the rectum. After insertion, press the sides of the applicator to completely empty its contents, then gently withdraw it while continuing to apply pressure.

Delay defecation as long as possible to allow the medicine to take effect.

Use in children

This medicine must not be used in children under 12 years of age, unless considered necessary by the physician.

If you use more Micralax Citrate/Lauryl Sulfacetate than you should

Due to the nature of this medicine, intoxication is unlikely.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91.562.04.20 (indicating the medicine and the amount ingested).

4. Possible adverse effects

Like all medicines, Micralax Citrate/Lauryl Sulfacetate may cause adverse effects, although not everyone will experience them.

Stop using Micralax and contact a doctor immediately if you notice any of the following adverse effects:

Frequency not known (cannot be estimated from available data):

• Sudden and severe allergic reaction with difficulty breathing, swelling, rapid heartbeat, sweating, dizziness, and loss of consciousness (anaphylactic reaction, including shock).

Very rare adverse effects (may affect up to 1 in 10,000 people): abdominal pain, anorectal discomfort, diarrheal stools, and allergic reactions (urticaria).

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Micralax Sodium Citrate/Lauryl Sulfacetate

Keep this medicine out of the sight and reach of children.

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the Sigre Point collection system at your pharmacy. If you are unsure, please ask your pharmacist how to properly dispose of unused medicines and packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Micralax Sodium Citrate/Sodium Lauryl Sulfacetate

The active substances are: Sodium citrate (450 mg per applicator) and Sodium lauryl sulfacetate (45 mg per applicator).

The other components (excipients) are: Sorbitol (E-420), Glycerol (E-422), Sorbic acid (E-200) and Purified water.

Appearance of the medicinal product and contents of the pack

Viscous rectal solution presented in 5 ml capacity applicators.

Available in packs containing 4 and 12 applicators.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder:

JNTL Consumer Health (Spain), S.L.

C/ Vía de los Poblados 1, Edificio E, planta 3

28033-Madrid

Spain

Manufacturer:

DELPHARM ORLEANS

5, Avenue de Concyr

45071 Orleans Cedex 2, (France)

OR

JNTL Consumer Health (France) S.A.S.

Domaine de Maigremont

F27100 Val de Reuil FRANCE

Date of the most recent revision of this leaflet: January 2026

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/