Pectox Lisina 2.7 g granules

Spain
Brand name Pectox Lisina 2.7 g granules
Form granules
Active substance / Dosage
Prescription type Prescription Only Medicine
Registration number 60625
Manufacturer Italfarmaco S.A.
Pectox Lisina 2.7 g granules granules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Pectox lysine 2.7 g granules

carbocysteine lysine

Read the entire 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, consult your doctor or pharmacist.
  • This medicine has been prescribed for you only and must not be given 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 adverse effects not listed in this leaflet. See section 4.

Package leaflet contents:

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

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

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

Pectox Lysine is indicated for:

  • Treatment of mucous secretion disorders occurring during 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.

Taking Pectox Lisina with other medicines

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 and breastfeeding

If you are pregnant or breastfeeding, 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 and/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 properly eliminate it.

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:

Adults and adolescents: 1 sachet of Pectox Lisina (2.7 g carbocysteine lysine salt) every 24 hours (1 day).

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

If you have taken more than the prescribed amount, 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 stop 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, reducing the administered dose may be helpful.

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 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 refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of unused medicines and their containers. 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 lysinate.
  • The other components (excipients) are: aspartame (E-951), anhydrous citric acid, colloidal anhydrous silica, mannitol, natural grapefruit flavor, natural orange flavor, orange juice.

Appearance of the medicine and contents of the pack

This medicine is available in packs of 20 and 8 sachets, each sachet containing 3.94 g of yellowish granules.

Marketing Authorization Holder and Manufacturer

ITALFARMACO, S.A.

San Rafael, 3

28108 Alcobendas (Madrid)

Tel.: 916572323

Date of the most recent revision 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/