Leaflet: Information for the User

MICRALAX CITRATE/LAURYL SULFOACETATE 450mg/45mg Rectal Solution

Sodium Citrate/ Sodium Lauril Sulfoacetate

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

Follow exactly the administration instructions contained in this leaflet or those given 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 any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after 6 days of treatment.

Micralax Citrato/Lauril sulfoacetato acts as an osmotic laxative, due to the combined action of Sodium Citrate, which retains fluid in the intestine, increasing the volume of water in the feces, and Sodium Lauril Sulfoacetate, a humectant.

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

You should consult a doctor if it worsens or does not improve after 6 days of treatment.

Do not use Micralax Citrate/Lauril Sulfoacetate:

• If you are allergic to Sodium Citrate/Lauril Sulfoacetate or to any of the other components of this medication (listed in section 6).
• If you are suffering from hemorrhoids.
• If you have bleeding colitis.

Warnings and precautions

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

Do not use this medication for more than 6 consecutive days, unless your doctor advises you to do so.

Children and adolescents

This medication should not be used in children under 12 years old, unless your doctor considers it necessary.

Other medications and Micralax Citrate/Lauril Sulfoacetate

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

If you are being treated to lower your blood calcium level with a medication containing sodium polystyrene sulfonate, do not use Micralax, as it may cause intestinal necrosis.

SODIUM POLYSTYRENE SULFONATE:

There have been isolated cases of ileocolic perforation and colon necrosis in patients treated for hypercalcemia.

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

Use of Micralax Citrate/Lauril Sulfoacetate with food and beverages

The consumption of food and beverages does not affect the efficacy of this medication.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

The use of this medication does not affect your ability to drive and/or operate machinery.

Micralax contains sorbic acid

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

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose in adults and adolescents over 12 years old is 1 syringe per day.

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

Administration Form

This medicationis used rectally.

At the chosen time for defecation, and once the cap from the container that closes the end of the syringe has been removed, place it in a vertical position with the tip pointing upwards and press it lightly so that a few drops of Micralax moisten the end of the syringe, making it easier to introduce into the rectum. Once introduced, squeeze the walls of the syringe until it is completely empty and remove it gently without releasing pressure.

Suppress defecation for as long as possible so that the medication can take effect.

Use in Children

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

If You Use More Micralax Citrate/Lauril Sulfoacetate Than You Should

Due to the type of medication involved, it is unlikely that cases of intoxication will occur.

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

Like all medications, Micralax Citrate/Lauril Sulfoacetate may cause adverse effects, although not everyone will experience them.

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

Reporting 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 can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at thePharmacy Take-Back Point. If in doubt, ask your pharmacist how to dispose of unused packaging and medications.By doing so, you will help protect the environment.

Composition of Micralax Citrate/Lauril Sulfoacetate

The active principles are: Sodium Citrate (450 mg per applicator) and Sodium Lauril Sulfoacetate (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 product and contents of the packaging

Viscous rectal solution presented in 5 ml capacity syringes.

Presented in boxes containing 4 and 12 syringes.

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization:

JNTL Consumer Health (Spain), S.L.

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

28033-Madrid

Spain

Responsible for manufacturing:

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

Last review date of this leaflet: March 2020

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/