PECTOX FORTE 100 mg/mL ORAL SOLUTION

Introduction

Package Leaflet: Information for the Patient

Pectox Forte 100 mg/ml Oral Solution

Carbocisteine

Read this package leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What Pectox Forte is and what it is used for.
2. What you need to know before you take Pectox Forte.
3. How to take Pectox Forte.
4. Possible side effects.

5. Storage of Pectox Forte.

1. Contents of the pack and further information.

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

Pectox Forte contains carbocisteine. Carbocisteine belongs to a group of medicines called mucolytics, although it has a mucoregulatory action, which makes the mucus more fluid and reduces its viscosity to facilitate its elimination.

It is indicated for the treatment of disorders of mucous secretion that occur in acute and chronic processes of the respiratory tract.

Pectox Forte is indicated for adults (18 years and older), adolescents (over 12 years) and children from 2 years of age.

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

Do not take Pectox Forte

• if you are allergic to carbocisteine or any of the other ingredients of this medicine (listed in section 6).
• if you have an active gastroduodenal ulcer.
• in children under 2 years of age.

Warnings and precautions

Consult your doctor or pharmacist before taking Pectox Forte.

• It is not recommended to take it at the same time as a medicine that inhibits the cough reflex.
• During the first few days, it is normal for expectoration to increase, but if symptoms persist for more than 5 days or worsen, you should inform your doctor.

Other medicines and Pectox Forte

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

Do not take this medicine with antitussives (medicines used for dry cough) or with those that reduce bronchial secretions, as it may cause an accumulation of fluidized mucus.

Taking Pectox Forte with food and drinks

See section 3 for instructions on how to take Pectox Forte.

Pregnancy, breastfeeding, and fertility

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. It is not recommended to use this medicine in pregnant or breastfeeding women.

Driving and using machines

Pectox Forte has no or negligible influence on the ability to drive and use machines.

Pectox Forte contains red cochineal A (E-124).This medicine may cause allergic reactions because it contains red cochineal A (E-124). It can cause asthma, especially in patients allergic to acetylsalicylic acid.

Pectox Forte contains methyl parahydroxybenzoate sodium salt (E-219).This medicine may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate sodium salt (E-219).

Pectox Forte contains sodium.This medicine contains 14.2 mg of sodium (main component of table/cooking salt) per ml. This is equivalent to 10% of the maximum recommended daily intake of sodium for an adult.

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3. How to take Pectox Forte

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 (over 12 years):

15 ml of oral solution (1,500 mg of carbocisteine) in a single dose, every 24 hours.

Pediatric population:

Children from 6 to 12 years:

7.5 ml of oral solution (750 mg of carbocisteine) in a single dose, every 24 hours.

Children from 2 to 5 years:

5 ml of oral solution (500 mg of carbocisteine) in a single dose, every 24 hours.

This medicine is taken orally.

This medicine comes with a dosing cup that has the following measures marked: 2.5 ml, 4 ml, 5 ml, 7.5 ml, 8 ml, 8.5 ml, and 10 ml. The oral solution is drunk directly from the dosing cup or after pouring the contents of the dosing cup into a glass with a sufficient amount of water or other liquid. Take this medicine preferably before meals. It is recommended to drink plenty of liquid during the day.

If symptoms worsen or do not improve after 5 days, you should consult your doctor.

If you take more Pectox Forte than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicology Information Service, phone 915 62 04 20, indicating the medicine and the amount ingested.

If you forget to take Pectox Forte

If you forget to take a dose, take it as soon as you can.

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

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

If you stop taking Pectox Forte

Your doctor will indicate the duration of the treatment. Do not stop your treatment before, even if you feel better, as it will not have the expected efficacy.

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

4. Possible side effects

Like all medicines, Pectox Forte can cause side effects, although not everybody gets them.

Uncommon side effects (may affect up to 1 in 100 people):

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

Rare side effects (may affect up to 1 in 1,000 people):

Hypersensitivity reactions (allergic reactions) accompanied by urticaria (redness and inflammation of the skin).

Very rare side effects (may affect less than 1 in 10,000 people):

Bronchospasm (asthma).

In these cases, it is advised to interrupt the treatment as soon as possible.

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 package leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Pectox Forte

No special storage conditions are required.

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

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 have any further questions on the disposal of the packaging or unused medicine, ask your pharmacist. This will help protect the environment.

6. Contents of the pack and further information

Composition of Pectox Forte

• The active substance is carbocisteine. Each ml of oral solution contains 100 mg of carbocisteine.
• The other ingredients (excipients) are: sodium saccharin, methyl parahydroxybenzoate sodium salt (E-219), raspberry flavor, red cochineal A (E-124), sodium hydroxide, citric acid, disodium phosphate, sodium cyclamate, and purified water.

Appearance of the product and pack contents

This medicine comes in a transparent PET bottle containing 240 ml or 120 ml of oral solution of red color and raspberry flavor and odor, accompanied by a 10 ml dosing cup.

Marketing authorization holder and manufacturer

ITALFARMACO S.A.

San Rafael, 3 – 28108 Alcobendas (Madrid)

Tel.: 91 657 2323

Date of the last revision of this package leaflet:August 2021

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