PECTOX LISINE 2.7 g ORAL SOLUTION POWDER

Introduction

Leaflet: information for the patient

Pectox Lisina 2.7 g powder for oral solution

Carbocisteine lysine

Read this leaflet carefully before starting to take this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Pectox Lisina is and what it is used for

Pectox Lisina belongs to the group of medicines called mucolytics and expectorants.

Pectox Lisina is indicated for the treatment of mucous secretion disorders that occur in the course of acute and chronic bronchopulmonary diseases.

2. What you need to know before taking Pectox Lisina

Do not take Pectox Lisina:

• if you are allergic to carbocisteine lysine or any of the other components of this medicine (listed in section 6),
• if you have a stomach or duodenal ulcer
• in children under 2 years of age.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Pectox Lisina.

Other medicines and Pectox Lisina

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

No interactions or incompatibilities with other medicines have been observed.

Pregnancy, breastfeeding, and fertility

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

No effects on the ability to drive or use machines have been observed.

Pectox Lisina contains aspartame.This medicine contains 24 mg of aspartame (E-951) per sachet, equivalent to 6 mg/g. Aspartame (E-951) contains a source of phenylalanine, which may be harmful in cases of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates due to the body's inability to eliminate it properly.

3. How to take Pectox Lisina

Follow exactly the administration instructions for this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults and adolescents: 1 sachet of Pectox Lisina (2.7 g of carbocisteine lysine) in 24 hours (1 day).

Children from 2 to 12 years: half a sachet of Pectox Lisina in 24 hours (1 day).

This medicine is taken orally. Dissolve the contents of the sachet in half a glass of water and stir well with a spoon.

If you take more Pectox Lisina than you should

If you have taken more than you should, consult your doctor or pharmacist, or call the Toxicology Information Service, telephone 915 62 04 20, indicating the medicine and the amount taken.

If you forget to take Pectox Lisina

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

If you stop treatment with Pectox Lisina

Your doctor will indicate the duration of your treatment with Pectox Lisina. Do not stop treatment before, as it may be harmful to your health.

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 gets them.

Uncommon side effects (less than 1 in 100 patients):

Gastrointestinal disorders such as: nausea, vomiting, diarrhea, or dyspepsia (gastrointestinal discomfort). In some cases, it may be helpful to reduce the administered dose.

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 Medicines Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Pectox Lisina

This medicine does not require any special storage temperature.

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 CAD. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package contents and additional information

Composition of Pectox Lisina

• The active ingredient is Carbocisteine Lysine. Each sachet contains 2.7 g of carbocisteine lysine.
• The other components (excipients) are: aspartame (E-951), anhydrous citric acid, hydrated colloidal silica, mannitol, natural grapefruit flavor, natural orange flavor, orange juice.

Appearance of the product and package contents

This medicine is presented in packages of 20 sachets containing 3.94 g of powder for oral solution, white-yellowish in color.

Marketing authorization holder and manufacturer

ITALFARMACO, S.A.

San Rafael, 3

28108 Alcobendas (Madrid)

Tel. 916572323

Date of the last revision of this leaflet: July 2021

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/