Pectox Lisina 2.7 g powder for oral solution

Spain
Brand name Pectox Lisina 2.7 g powder for oral solution
Form powder for oral solution
Active substance / Dosage
Prescription type Prescription Only Medicine
Registration number 79149
Manufacturer Italfarmaco S.A.
Pectox Lisina 2.7 g powder for oral solution powder for oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Pectox Lisina 2.7 g powder for oral solution

Carbocisteine lysine

Read the entire leaflet carefully before you start taking this medicine, because 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 other people, even if they have the same symptoms as you, because it could harm them.
  • If you experience any adverse effects, consult your doctor or pharmacist, even if they are 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. How to store Pectox Lisina
  6. Contents of the pack and other information

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

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

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

2. What you need to know before starting to take Pectox Lisina

Do not take Pectox Lisina:

  • if you are allergic to carbocysteine lysine or to any of the other ingredients 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

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

No interactions or incompatibilities with other medicines have been observed.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning 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 if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.

3. How to take Pectox Lisina

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Recommended dose is:

Adults and adolescents: 1 sachet of Pectox Lisina (2.7 g of carbocisteine lysinate) 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 at telephone number 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 taking Pectox Lisina

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

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 may cause adverse effects, although not everyone experiences them.

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

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

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 can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Pectox Lisine

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 EXP. The expiry date is 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 at the pharmacy. If 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 pack and other information

Composition of Pectox Lisina

  • The active substance 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 medicine and contents of the pack

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

Marketing Authorization Holder and Manufacturer

ITALFARMACO, S.A.

San Rafael, 3

28108 Alcobendas (Madrid)

Tel. 916572323

Date of the most recent review of this leaflet: July 2021

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