User Information: Package Insert

Pectox lisina 2,7 g granulated

carbocisteina lisina

Pectox Lisina belongs to a group of medications called mucolytics and expectorants.

Pectox Lisina is indicated for:

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

Do not take Pectox Lisina

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

Warnings and precautions

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

Taking Pectox Lisina with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may have to take any other medication.

No interactions or incompatibilities with other medications have been observed.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machines

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

Pectox Lisina contains aspartame.

This medication contains 24 mg of aspartame (E-951) in each sachet, equivalent to 6 mg/g. Aspartame (E-951) contains a source of phenylalanine that may be harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it correctly.

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

The recommended dose is:

Adults and adolescents:1 packet of Pectox Lisina (2.7 gcarbocisteine Lisinate salt) every 24 hours (1 day).

Children from2 to12 years:half a packet of Pectox Lisina every 24 hours (1 day).

This medication is taken orally.Dissolve the contents of the packet in half a glass of water and shake 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 Toxicological Information Service, phone 915 62 04 20, indicating the medication and the amount taken.

If you forget to take Pectox Lisina

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Pectox Lisina

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

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Less common adverse 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 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

This medication does not require any special temperature for conservation.

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

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

Medicines should not be thrown down the drains or in the trash.Deposit the packaging and medicines that you do not need in the SIGRE collection point of the pharmacy. In case of doubtask your pharmacist how to dispose of the packaging and medicines that you do not need. In this way, you will help protect the environment.

Composition of Pectox Lisina

• The active principle is carbocisteine lysine. Each sachet contains2.7 gof carbocisteine lysinate.
• The other components (excipients) are:aspartame (E-951), anhydrous citric acid, hydrated colloidal silica, mannitol, natural orange peel aroma, natural orange aroma, orange juice.

Appearance of the product and contents of the packaging

This medication is presented in packaging of 20 and 8 sachets containing each sachet3.94 gof yellow-beige colored granulate.

Holder of the marketing authorization and responsible for manufacturing

ITALFARMACO, S.A.

San Rafael, 3

28108 Alcobendas (Madrid)

Tel.: 916572323

Last review date of this leaflet: July 2021

The detailed information of this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/