Verolax Adultos rectal solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

VEROLAX ADULTS Rectal Solution

Glycerol

Please read all of this leaflet carefully because it contains important information for you.

This medicine can be purchased without a prescription. However, to achieve the best results, it must be used correctly.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If symptoms worsen or persist beyond 7 days, you should consult a doctor.
• If you consider any of the side effects you experience to be severe or if you notice any side effects not mentioned in this leaflet, inform your doctor or pharmacist.

Leaflet contents

1. What VEROLAX is and what it is used for
2. Before you use VEROLAX
3. How to use VEROLAX
4. Possible side effects
5. How to store VEROLAX
6. Further information

1. What VEROLAX is and what it is used for

Glycerol, the active substance in this medicine, is a laxative administered rectally. The laxative effect is achieved due to glycerol's ability to soften stools, which, together with a mild local irritant action, helps stimulate intestinal movements.

It is indicated for the local symptomatic relief of transient and occasional constipation in adults and adolescents aged 12 years and older.

2. Before using VEROLAX

• If you are allergic (hypersensitive) to glycerol or to any of the other components of this medicine.
• If you suffer from any anorectal disease, ulcerative proctocolitis (a type of chronic intestinal inflammation), or inflamed hemorrhoids.
• If you have cramps, colic, nausea, vomiting, or other signs of appendicitis, intestinal obstruction, acute inflammatory bowel diseases, or in general, any condition of abdominal pain of unknown cause.
• Children under 12 years of age.

Take special care with VEROLAX

If you notice blood in the stool, irritation, pain, or symptoms that do not improve, you must stop treatment and consult your doctor.

Do not use this medicine for more than 7 consecutive days unless instructed otherwise by your doctor.

This medicine should be used only under strict medical supervision in patients with serious illnesses, especially cardiovascular diseases (related to the heart or blood vessels).

Use of other medicines

Inform your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.

Use in children

Do not administer to children under 12 years of age.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Driving and operating machinery

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

3. How to use VEROLAX

Follow exactly the administration instructions for VEROLAX as indicated by your doctor.

Consult your doctor or pharmacist if you have any doubts.

The usual dose is:

Adults and adolescents over 12 years of age: 1 single-dose unit per day.

This medicine is administered rectally.

Instructions for correct administration of the medicine:

1. Open the applicator by holding it at the neck and twisting the cap to break the seal.

2. Gently squeeze the applicator so that a few drops of the medicine moisten the tip of the cannula, to facilitate its insertion into the rectum.
3. Insert the cannula of the applicator gently and slowly into the rectum.
4. Administer the contents of the applicator by pressing the sides of the bulb; without releasing pressure, gently withdraw the applicator once administration is complete.

Each applicator is filled with a slight excess of product, which remains inside after use. This ensures that the amount released during administration corresponds to the complete dose, and it is not necessary to empty the applicator completely, facilitating its handling. The applicator must be discarded after use.

If you feel resistance during administration, stop the procedure, as continuing may be harmful.

Do not use this medicine for more than 7 consecutive days. If symptoms do not improve, discontinue treatment and consult your doctor.

If you use more VEROLAX than you should

Cases of intoxication are unlikely due to the route of administration.

Abuse or prolonged use of this medicine may lead to a laxative-dependent bowel syndrome or irritable colon (symptoms or discomfort such as alternating constipation and diarrhea, intestinal spasms, bloating, nausea, and gas).

In case of overdose or accidental ingestion, consult your doctor or pharmacist, or call the Toxicology Information Service at telephone number 91.562.04.20, indicating the medicine and the amount ingested.

4. Possible adverse effects

Like all medicines, VEROLAX may cause adverse effects, although not everybody experiences them.

During the period of use of VEROLAX rectal solution as a laxative, the following adverse effects have been observed, although their frequency could not be established accurately:

itching, pain, and irritation of the anus.

Very rarely, hypersensitivity reactions to chamomile have occurred in allergic patients (e.g. contact dermatitis). After internal use, these reactions could be severe and might include swelling of the face, lips, mouth, tongue, or throat, causing difficulty in swallowing or breathing.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

5. Storage of VEROLAX

Keep out of the reach and sight of children.

No special storage conditions are required.

Do not use VEROLAX after the expiry date stated on the container, after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. ADDITIONAL INFORMATION

Composition of VEROLAX

• The active substance is glycerol. Each single-dose container with 7.5 ml of rectal solution contains 5.4 ml of glycerol.
• The other components (excipients) are: fluid extract of Malva sylvestris, fluid extract of Matricaria chamomilla, wheat starch and purified water.

Appearance of the product and contents of the pack

VEROLAX is presented as a light brown rectal solution.

The medicine is packaged in a single-dose 7.5 ml collapsible tube equipped with a plastic cannula and a closure plug. These are packed in a carton containing 6 single-dose units.

Marketing Authorization Holder

ANGELINI PHARMA ESPAÑA, S.L.

c/ Antonio Machado, 78-80

3rd floor, module A - Edificio Australia

08840 Viladecans, Barcelona (Spain)

Manufacturer

A.C.R.A.F. SpA

Via Vecchia del Pinocchio, 22

60131 Ancona (Italy)

This patient information leaflet was approved in May 2011.