Glycerin suppositories Cuve Adults

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Glycerin Suppositories Cuve adults 3 g suppositories

glycerol

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

Always follow exactly the instructions for taking this medicine as described 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 more 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 your doctor if your condition worsens or if you do not improve after 7 days.

Contents of the leaflet:

1. What Glycerin Suppositories Cuve adults are and what they are used for
2. What you need to know before using Glycerin Suppositories Cuve adults
3. How to use Glycerin Suppositories Cuve adults
4. Possible side effects
5. How to store Glycerin Suppositories Cuve adults

Contents of the pack and other information

1. What Supositorios de glicerina Cuve adultos is and what it is used for

Glycerol, the active substance of 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, stimulates intestinal movements.

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

You should consult a doctor if symptoms worsen or do not improve after 7 days.

2. What you need to know before using Cuve Adult Glycerin Suppositories

Do not use Cuve Adult Glycerin Suppositories:

• If you are allergic to glycerol or any of the other ingredients of this medicine (listed in section 6).

• If you suffer from any anorectal disease, hemorrhagic rectocolitis (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 when the cause is unknown.

• In children under 12 years of age.

Warnings and precautions

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

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

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

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

Children and adolescents

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

Other medicines and Cuve Adult Glycerin Suppositories

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

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

3. How to use Glycerin Suppositories Cuve adults

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

Recommended dose:

Adults and adolescents aged 12 years and over:

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

Method of administration:

Open the container and remove the suppository. Insert it deeply into the rectum and keep the buttocks pressed together for a period of time.

Delay defecation as long as possible so that the medicine can exert its effect.

If you feel resistance during administration, stop the procedure, as it could be harmful, and consult your doctor.

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

If you use more Glycerin Suppositories Cuve adults than you should

Intoxication symptoms are unlikely to occur due to its use.

Abuse or prolonged use of this medicine may lead to a condition resembling irritable bowel syndrome (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.

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 further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

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

During the period of use of Glycerin Suppositories Cuve adults as a laxative, the following adverse effects have been observed, the frequency of which could not be established accurately:

itching, pain, and irritation of the anus.

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 through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Glycerin Suppositories Cuve adults

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

Store below 25 °C.

Keep the container in the outer carton to protect it from light.

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 (or any other medicine waste collection system) at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the package and other information

Composition of Glycerin Suppositories Cuve adults

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

Appearance of the product and contents of the package

Glycerin Suppositories Cuve adults are transparent, colorless, slightly opaque suppositories with a uniform texture and ovoid shape, supplied in packages containing 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 most recent revision of this leaflet: February 2011

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