CLISTERAN 450 mg/45 mg RECTAL SOLUTION

Introduction

Leaflet: information for the user

CLISTERAN 450 mg/45 mg rectal solution

Trisodium citrate dihydrate / Sodium lauryl sulfoacetate

Read the entire leaflet carefully before starting to use this medicine because it contains important information for you.

Follow the administration instructions of the medicine contained 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 side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 6 days.

Contents of the leaflet

1. What is Clisteran and what is it used for
2. What you need to know before starting to use Clisteran
3. How to use Clisteran
4. Possible side effects
5. Storage of Clisteran
6. Package contents and additional information

1. What is Clisteran and what is it used for

Clisteran is a laxative medicine administered rectally, which acts by retaining liquid in the intestine, thus increasing the water volume in the stool.

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

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

2. What you need to know before starting to use Clisteran

Do not use Clisteran

• If you are allergic (hypersensitive) to trisodium citrate dihydrate, sodium lauryl sulfoacetate, or any of the other components of this medicine (listed in section 6).
• If you have acute hemorrhoidal crisis.
• If you have 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 after 15 or 30 minutes of using the laxative may indicate a serious problem. In such cases, you should stop using it and consult a doctor.

Clisteran should not be used for more than 6 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.

Using Clisteran with other medicines

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

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

Driving and using machines

The use of this medicine does not affect your ability to drive and/or use machines.

Clisteran contains benzoic acid

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

Benzoic acid may cause local irritation.

3. How to use Clisteran

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

Adults and adolescents over 12 years of age

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

Method of administration

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

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

Insert the cannula slowly and gently into the rectum, with the end pointing towards the navel. If you encounter resistance during application, you should stop, as it may be harmful and damaging.

Squeeze the container to empty its entire contents and remove it gently while keeping it pressed.

Each container holds a single dose of the product. The container 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 of age, unless your doctor considers it necessary.

If you use more Clisteran than you should

Although no effects are expected after rectal administration, if symptoms of overdose appear, such as diarrhea and fluid loss, you should stop using it and consult a doctor.

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 used.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

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

Reporting side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can contribute to providing 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 expiration date shown on the container after CAD. The expiration date is the last day of the month indicated.

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

6. Package contents and additional information

Composition of Clisteran

• The active ingredients are trisodium citrate dihydrate and sodium lauryl sulfoacetate. Each container (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, silicone antifoam (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 package contents

Viscous rectal solution. It is presented in 5 ml single-dose polyethylene containers, in packs of 1 or 4 containers, and a clinical container with 200 single-dose containers.

Marketing authorization holder and manufacturer

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

Date of the last revision of this leaflet:July 2018

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/