PECTOX LISINE 2.7 g granules

Introduction

Package Leaflet: Information for the User

Pectox Lysine 2.7 g Granulate

Carbocisteine Lysine

Contents of the Package Leaflet:

1. What is Pectox Lysine and what is it used for.
2. What you need to know before you take Pectox Lysine.
3. How to take Pectox Lysine.
4. Possible side effects.
5. Storage of Pectox Lysine.
6. Contents of the pack and further information.

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

Pectox Lysine belongs to a group of medicines called mucolytics and expectorants.

Pectox Lysine is indicated in:

• Treatment of mucous secretion disorders that occur in the course of acute and chronic bronchopulmonary diseases.

2. What you need to know before you take Pectox Lysine

Do not take Pectox Lysine

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

Warnings and Precautions

Consult your doctor or pharmacist before taking Pectox Lysine.

Taking Pectox Lysine with other medicines

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 and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and Using Machines

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

Pectox Lysine 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 disorder in which phenylalanine accumulates because the body is unable to eliminate it properly.

3. How to take Pectox Lysine

Follow exactly the administration instructions of this medicine given 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 Lysine (2.7 g carbocisteine lysine) every 24 hours (1 day).

Children from 2 to 12 years:half a sachet of Pectox Lysine every 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 Lysine than you should

If you have taken more than you should, talk to 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 Lysine

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

If you stop taking Pectox Lysine

Your doctor will tell you how long to take Pectox Lysine. Do not stop treatment before, as it may be harmful to your health.

If you have any further questions on 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 everybody 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 useful to reduce the administered dose.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Vigilance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Pectox Lysine

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 which is stated on the packaging after CAD. The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Pectox Lysine

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

Appearance of the product and contents of the pack

This medicine is presented in packs of 20 and 8 sachets, each sachet containing 3.94 g of yellow-beige granulate.

Marketing Authorisation Holder and Manufacturer

ITALFARMACO, S.A.

San Rafael, 3

28108 Alcobendas (Madrid)

Tel.: 916572323

Date of 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/