Leaflet: information for the user

CLISTERAN 450 mg/45 mg rectal solution

Citrato trisódico dihidratado / Laurilsulfoacetato de sodio

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

Follow exactly the administration instructions of the medicine contained in this leaflet or those 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 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 it worsens or does not improve after 6 days.

Clisteran is a laxative medication, administered rectally, which acts by retaining fluid in the intestine, thereby increasing the volume of water in the stool.

It is indicated for local symptomatic relief of occasional constipation and to facilitate intestinal emptying in necessary cases in adults and adolescents over 12 years old.

Consult a doctor if symptoms worsen or do not improve after 6 days.

Do not use Clisteran

-If you are allergic (hypersensitive)totrisodium citrate dihydrate, tosodium laurilsulfoacetateor toany of the other components ofthis medication (included in section 6).

-If you have an acute hemorrhoidal crisis.

-If you have hemorrhagic colitis.

Warnings and precautions

Consult your doctor orpharmacist before starting to use Clisteran.

Bleeding from the rectum or the absence of defecation after 15 or 30 minutes of using the laxative may indicate a serious problem. In such cases, you must interrupt its use and consult the doctor.

Clisteran should not be used for more than 6 days, unless your doctor tells you otherwise.

Children and adolescents

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

Use of Clisteran with other medications

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

The concomitant use of Clisteran, which contains sorbitol, with sodium polystyrene sulfonate may cause intestinal necrosis.

Pregnancy and breastfeeding

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

Drivingandoperatingmachines

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

Clisteran contains benzoic acid

This medication contains 0.042 mg of benzoic acid in each dose unit.

Benzoic acid may cause local irritation.

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.

Adults and adolescents over 12 years old

The recommended dose is: one single-dose package per day, administered rectally.

Administration method

Recline on your left side with both knees bent and arms at rest.

Before inserting the cannula into the rectum, remove the cap that closes the end of the single-dose package, place it in a vertical position, and press the package until some drops of solution come out to facilitate its introduction into the rectum.

Insert the cannula slowly and gently into the rectum, with the tip pointing towards the navel. If resistance is encountered during application, it should be interrupted, as it may be harmful and damaging.

Press the package to empty the entire contents and remove it gently while keeping it pressed.

Each package contains a single dose of the product. This package should be discarded after use.

Consult your doctor if symptoms worsen or persist after 6 days of treatment.

Use in children

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

If you use more Clisteran than you should

Although no effects are expected after rectal administration, if some symptoms of overdose appear, such as diarrhea and fluid loss, discontinue use and consult your doctor.

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 used.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Very rare adverse effects (may affect up to 1 in 10,000 people): abdominal pain, anal irritation, anal itching, and allergic reactions (urticaria).

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is possible adverse effects not listed in this prospectus. 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.

Norequiresspecial storage conditions.

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

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.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition ofClisteran

• The active principles aretrisodium citrate dihydrateand sodium laurilsulfoacetate.Each package (5 ml) contains:450 mg of trisodium citrate dihydrate and 45 mg of sodium laurilsulfoacetate.
• The other components (excipients) are: sorbitol(E-420), sodium carmelose, glycerol (E-422), sorbic acid (E-200), purified water, antifoaming agent of silicon(purified water, dimethicone (E-900), sorbitan stearate (E-491), polysorbate 60 (E-435), anhydrous colloidal silica (E-551) and benzoic acid (E-210)).

Appearance of the product and contents of the packaging

Viscous rectal solution. It is presented in single-dose packages of 5 ml, in boxes of 1 or 4 packages and a clinical package with 200 single-dose packages.

Holder of the marketing authorization and manufacturer responsible

LAINCO, S.A. – Avda. Bizet, 8-12 - 08191 Rubí (Barcelona) Spain

Date of the last review of this leaflet:July 2018

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