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

Introduction

Package Leaflet: Information for the User

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

Sodium citrate/ Sodium lauryl sulfoacetate

Read the package leaflet carefully before you start using this medicine because it contains important information for you.

Follow the administration instructions of the medicine contained in this package leaflet or as indicated by your doctor or pharmacist.

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

Contents of the package leaflet:

1. What Micralax Citrate/Lauryl sulfoacetate is and what it is used for.
2. What you need to know before you start using Micralax Citrate/Lauryl sulfoacetate.
3. How to use Micralax Citrate/Lauryl sulfoacetate
4. Possible side effects.
5. Storage of Micralax Citrate/Lauryl sulfoacetate
6. Package contents and additional information

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

Micralax Citrate/Lauryl sulfoacetate acts as an osmotic laxative due to the combined action of sodium citrate, which acts by retaining liquid in the intestine, increasing the water volume in the stool, and sodium lauryl sulfoacetate, a humectant 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 your condition worsens or does not improve after 6 days of treatment.

2. What you need to know before you start using Micralax Citrate/Lauryl sulfoacetate

Do not use Micralax Citrate/Lauryl sulfoacetate:

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

Warnings and precautions

In case of no improvement, worsening, or appearance of blood in stool, irritation, pain, you should interrupt treatment and consult your doctor.

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

Children and adolescents

It should not be used in children under 12 years of age, unless your doctor considers it necessary.

Other medicines and Micralax Citrate/Lauryl sulfoacetate

Inform your doctor or pharmacist that you are using, have recently used, or may need to use any other medicine.

If you are being treated to lower your blood calcium level with a medicine that contains sodium polystyrene sulfonate, do not use Micralax, as intestinal necrosis may occur.

SODIUM POLYSTYRENE SULFONATE:

Isolated cases of ileocecal perforation and colon necrosis have been reported in patients treated for hyperkalemia.

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

Using Micralax Citrate/Lauryl sulfoacetate with food and drinks

Taking food and drinks does not affect the efficacy of this medicine.

Pregnancy and breastfeeding

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

Driving and using machines

Using this medicine does not affect your ability to drive or use machines.

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 sulfoacetate

Follow the administration instructions of the medicine contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The recommended dose in 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 used rectally.

At the chosen time for bowel movement, and once the cap of the package that closes the end of the applicator is removed, place it in a vertical position with the tip upwards and press it slightly so that a few drops of Micralax moisten the end of the applicator, in order to facilitate its introduction into the rectum. Once introduced, squeeze the walls of the applicator until its contents are completely emptied and remove it gently without stopping the pressure.

Hold back the bowel movement for as long as possible so that the medicine can take effect.

Use in children

It should not be used in children under 12 years of age, unless your doctor considers it necessary.

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

Due to the type of medicine, it is unlikely that intoxication will occur.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91. 562.04.20 (indicating the medicine and the amount ingested).

4. Possible side effects

Like all medicines, Micralax Citrate/Lauryl sulfoacetate can cause side effects, although not everybody gets them.

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

Reporting side effects:

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines Monitoring System: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Micralax Citrate/Lauryl sulfoacetate

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 package after CAD. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packages and medicines you no longer need in the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packages and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Micralax Citrate/Lauryl sulfoacetate

The active ingredients are: sodium citrate (450 mg per applicator) and sodium lauryl sulfoacetate (45 mg per applicator).

The other ingredients (excipients) are: sorbitol (E-420), glycerol (E-422), sorbic acid (E-200), and purified water.

Appearance of the product and package contents

Viscous rectal solution presented in 5 ml capacity applicators.

It is presented in boxes 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 last revision of this package leaflet: March 2020

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/