Pectox Forte 100 mg/ml oral solution
SpainTable of Contents
Package Leaflet: Information for the User
Introduction
Package Leaflet: Information for the Patient
Pectox Forte 100 mg/ml Oral Solution
Carbocysteine
Read this entire leaflet carefully before you start using 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, since 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.
Leaflet Contents
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What Pectox Forte is and what it is used for.
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What you need to know before taking Pectox Forte.
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How to take Pectox Forte.
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Possible side effects.
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Storage of Pectox Forte.
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Contents of the pack and other information.
1. What Pectox Forte is and what it is used for
Pectox Forte contains carbocisteine. Carbocisteine belongs to a group of medicines known as mucolytics, although it has a mucoregulatory action, fluidifying mucus and reducing its viscosity to facilitate elimination.
It is indicated for the treatment of mucous secretion disorders occurring in acute and chronic respiratory tract conditions.
Pectox Forte is indicated for use in adults (18 years and older), adolescents (over 12 years of age), and children from 2 years of age.
2. What you need to know before taking Pectox Forte
Do not take Pectox Forte
- if you are allergic to carbocysteine or to any of the other ingredients of this medicine (listed in section 6).
- if you have active gastroduodenal ulcer.
- in children under 2 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before taking Pectox Forte.
- It is not recommended to take this medicine at the same time as a medication that suppresses the cough reflex.
- During the first few days, it is normal for expectoration to increase; however, if symptoms persist for more than 5 days or worsen, you must inform your doctor.
Other medicines and Pectox Forte
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Do not take this medicine with antitussives (medicines used for dry cough) or with medicines that reduce bronchial secretions, as this may cause an accumulation of liquefied 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 become pregnant, consult your doctor or pharmacist before using this medicine. The use of this medicine is not recommended in pregnant or breastfeeding women.
Driving and using machines
The effect of Pectox Forte on the ability to drive and use machines is none or negligible.
Pectox Forte contains cochineal red A (E-124). This medicine may cause allergic reactions because it contains cochineal red A (E-124). It may cause asthma, especially in patients allergic to acetylsalicylic acid.
Pectox Forte contains sodium methyl parahydroxybenzoate (E-219). This medicine may cause allergic reactions (possibly delayed) because it contains sodium methyl parahydroxybenzoate (E-219).
Pectox Forte contains sodium. This medicine contains 14.2 mg of sodium (main component of table/cooking salt) in each ml. This corresponds to 10% of the maximum recommended daily sodium intake for an adult.
3. How to take Pectox Forte
Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
The recommended dose is:
Adults and adolescents (over 12 years of age):
15 ml of oral solution (1,500 mg of carbocisteine) as a single dose every 24 hours.
Paediatric population:
Children from 6 to 12 years of age:
7.5 ml of oral solution (750 mg of carbocisteine) as a single dose every 24 hours.
Children from 2 to 5 years of age:
5 ml of oral solution (500 mg of carbocisteine) as a single dose every 24 hours.
This medicine is taken orally.
This medicine comes with a dosing cup marked with the following measurements: 2.5 ml, 4 ml, 5 ml, 7.5 ml, 8 ml, 8.5 ml and 10 ml. The oral solution should be 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 another liquid. Take this medicine preferably before meals. It is recommended to drink plenty of fluids throughout the day.
If symptoms worsen or do not improve after 5 days, you must 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 at telephone number 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 possible.
Do not take a double dose to make up for forgotten doses.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
If you stop treatment with Pectox Forte
Your doctor will indicate the duration of treatment. Do not stop treatment earlier, even if you feel better, as the expected efficacy will not be achieved.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Pectox Forte can cause adverse effects, although not everyone will experience them.
Uncommon adverse effects (may affect between 1 and 10 out of 1,000 patients):
Gastrointestinal disorders such as: nausea, vomiting, diarrhoea, or dyspepsia (gastrointestinal discomfort). In some cases, reducing the administered dose may be helpful.
Rare adverse effects (may affect between 1 and 10 out of 10,000 patients):
Hypersensitivity reactions (allergic reactions) accompanied by urticaria (skin redness and swelling).
Very rare adverse effects (may affect fewer than 1 in 10,000 patients):
Bronchospasm (asthma).
In such cases, it is recommended to discontinue treatment as soon as possible.
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 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 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 a SIGRE Point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Pectox Forte
- The active substance is carbocisteine. Each ml of oral solution contains 100 mg of carbocisteine.
- The other components (excipients) are: sodium saccharin, sodium methyl parahydroxybenzoate (E-219), raspberry flavouring, carmine red A (E-124), sodium hydroxide, citric acid, dibasic sodium phosphate, sodium cyclamate, and purified water.
Appearance of the medicine and contents of the pack
This medicine is supplied in a transparent PET bottle containing 240 ml or 120 ml of red oral solution with raspberry odour and flavour, 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 most recent revision of this leaflet: August 2021
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/