CLISTERAN 450 MG/45 MG RECTAL SOLUTION

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

CLISTERAN 450 mg/45 mg rectal solution

sodium citrate dihydrate / sodium lauryl sulfoacetate

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

Follow exactly the instructions for administration provided in this leaflet or as directed by your doctor or pharmacist.

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

Contents of the leaflet

1. What Clisteran is and what it is used for
2. What you need to know before using Clisteran
3. How to use Clisteran
4. Possible adverse effects
5. How to store Clisteran
6. Contents of the pack and other information

1. What Clisteran is and what it is used for

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

It is indicated for the local symptomatic relief of occasional constipation and to facilitate bowel emptying when necessary, 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.

2. What you need to know before using Clisteran

Do not use Clisteran

• If you are allergic (hypersensitive) to trisodium citrate dihydrate, sodium lauryl sulfacetate, or any of the other components of this medicine (listed in section 6).
• If you suffer from acute hemorrhoidal crisis.
• If you have ulcerative colitis (hemorrhagic colitis).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Clisteran.

The presence of rectal bleeding or the absence of defecation within 15 to 30 minutes after using the laxative may indicate a serious condition. In such cases, you must stop using it and consult your doctor.

Clisteran should not be used for longer than 6 days unless otherwise directed by your doctor.

Children and adolescents

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

Use of Clisteran with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

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

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 use of machines

This medicine does not affect the ability to drive and/or operate machinery.

Clisteran contains benzoic acid

This medicine contains 0.042 mg of benzoic acid per dose unit.

Benzoic acid may cause local irritation.

3. How to use Clisteran

Follow exactly the instructions for administering this medicine as described in this leaflet or as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Adults and adolescents over 12 years of age

Recommended dose: one single-dose container per day, administered rectally.

Method of administration

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

Before inserting the cannula into the rectum, remove the cap covering the end of the single-dose container, hold the container in an upright position, and gently press until a few drops of solution emerge to facilitate insertion into the rectum.

Gently and slowly insert the cannula into the rectum, directing the tip toward the navel. If resistance is encountered during administration, stop the procedure, as continuing may be harmful.

Squeeze the container to empty all of its contents, then gently remove it while continuing to apply pressure.

Each container contains a single dose of the product. The container must be discarded after use.

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

Use in children

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

If you use more Clisteran than you should

Although no adverse effects are expected following rectal administration, if symptoms of overdose occur—such as diarrhea and fluid loss—discontinue use immediately and consult your doctor.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount used.

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

4. Possible adverse effects

Like all medicines, this medicine may produce adverse effects, although not everyone will experience them.

Stop taking Clisteran 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, anal irritation, and anal itching.

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 via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Clisteran

No special storage conditions are required.

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

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 containers and unused medicines at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Clisteran

• The active substances are trisodium citrate dihydrate and sodium lauryl sulfoacetate. Each unit (5 ml) contains: 450 mg of trisodium citrate dihydrate and 45 mg of sodium lauryl sulfoacetate.
• The other components (excipients) are: sorbitol (E-420), sodium carmellose, glycerol (E-422), sorbic acid (E-200), purified water, antifoaming agent (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 medicinal product and contents of the pack

Viscous rectal solution. Supplied in single-dose polyethylene containers of 5 ml, in cartons containing 1 or 4 units and clinical pack with 200 single-dose units.

Marketing Authorization Holder and Manufacturer

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

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 Health Products (AEMPS) http://www.aemps.gob.es/