GLYCERIN SUPPOSITORIES CUVE ADULTS

Introduction

Package Leaflet: Information for the User

Glycerin Suppositories Cuve Adults 3g Suppositories

glycerol

Read the entire package leaflet carefully before starting to use this medication, as it contains important information for you.

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package 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 not listed in this package leaflet. See section 4.
• You should consult your doctor if your condition worsens or does not improve after 7 days.

Contents of the Package Leaflet:

1. What Glycerin Suppositories Cuve Adults are and what they are used for
2. What you need to know before starting to use Glycerin Suppositories Cuve Adults
3. How to use Glycerin Suppositories Cuve Adults
4. Possible side effects
5. Storage of Glycerin Suppositories Cuve Adults

Package Contents and Additional Information

1. What Glycerin Suppositories Cuve Adults are and what they are used for

Glycerol, the active ingredient of this medication, is a laxative that is administered rectally. The laxative effect is achieved by the ability of glycerol to soften the stool, which, along with a mild local irritant action, stimulates intestinal movements.

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

You should consult a doctor if your condition worsens or does not improve after 7 days.

2. What you need to know before starting to use Glycerin Suppositories Cuve Adults

Do not use Glycerin Suppositories Cuve Adults:

- If you are allergic to glycerol or any of the other components of this medication (listed in section 6).

- If you have any anorectal disease, hemorrhagic rectocolitis (a type of chronic intestinal inflammation), or inflamed hemorrhoids.

- If you have colic, cramps, nausea, vomiting, or other signs of appendicitis, intestinal obstruction, acute inflammatory bowel diseases, or any abdominal pain of unknown cause.

- In children under 12 years of age.

Warnings and Precautions

Consult your doctor or pharmacist before starting to use Glycerin Suppositories Cuve Adults.

In case of appearance of blood in stool, irritation, pain, or if it does not improve, you should interrupt treatment and consult a doctor.

Do not use this medication for more than 7 consecutive days, unless your doctor indicates otherwise.

This medication will only be used under strict medical control in patients with severe diseases, especially cardiovascular ones (related to the heart or blood vessels).

Children and Adolescents

This medication is contraindicated in children under 12 years of age.

Other Medications and Glycerin Suppositories Cuve Adults

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

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 medication.

Driving and Using Machines

The use of this medication does not affect your ability to drive or operate machines.

3. How to use Glycerin Suppositories Cuve Adults

Follow the administration instructions for this medication contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults and adolescents from 12 years of age:

1 suppository per day, as needed, or as prescribed by the doctor.

Method of administration:

Open the bottle and remove the suppository. Insert it into the anus deeply and keep the buttocks together for a while.

Delay evacuation as long as possible so that the medication can take effect.

If you notice resistance during administration, you should interrupt it, as it may be harmful and damaging, and consult your doctor.

Do not use the medication for more than 7 consecutive days. If symptoms do not improve, you should suspend treatment and consult a doctor.

If you use more Glycerin Suppositories Cuve Adults than you should

It is unlikely that intoxication will occur due to its use.

Prolonged and abusive use of this medication may lead to an irritable bowel syndrome (symptoms such as alternating constipation and diarrhea, intestinal spasms, bloating, nausea, and gas).

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service, phone 91.562.04.20, indicating the medication and the amount ingested.

If you forget to use Glycerin Suppositories Cuve Adults

Do not take a double dose to make up for forgotten doses.

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

During the period of use of Glycerin Suppositories Cuve Adults as a laxative, the following side effects have been observed, whose frequency has not been established with precision:

itching, pain, and irritation of the anus.

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 package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Glycerin Suppositories Cuve Adults

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

Store below 25°C.

Keep the bottle in the box to protect it from light.

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

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medications in the SIGRE Collection Point (or any other medication waste collection system) at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medications. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Glycerin Suppositories Cuve Adults

• The active ingredient is glycerol. Each suppository contains 3 grams of glycerol.
• The other components (excipients) are: sodium carbonate and stearic acid.

Appearance of the Product and Package Contents

Glycerin Suppositories Cuve Adults are transparent, colorless, slightly opaque suppositories with a uniform texture and an ovoid shape, presented in packages of 4 and 12 suppositories.

Marketing Authorization Holder

Pharmex Pharma S.L.U.

C/ Anabel Segura, 16, Edif. 1 Planta 1 dcha.

28108 Alcobendas – Madrid

Spain

Manufacturer

Pharmex Advanced Laboratories, S.L.

Ctra. A-431 Km.19

14720 Almodóvar del Río (Córdoba) Spain

Date of the Last Revision of this Package Leaflet:February 2011

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es).