Pectox 50 mg/ml oral solution
SpainTable of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
PECTOX 50 mg/ml ORAL SOLUTION
Carbocisteine
Read the entire leaflet carefully before starting to take this medicine, as it contains important information for you.
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Package leaflet contents:
- What Pectox is and what it is used for.
- What you need to know before taking Pectox.
- How to take Pectox.
- Possible side effects.
- Storage of Pectox.
- Contents of the pack and other information.
1. What Pectox is and what it is used for
Pectox belongs to a group of medicines called mucolytics, and is used to liquefy excessive and/or thick bronchial secretions.
2. What you need to know before starting to take Pectox
Do not take Pectox
- If you are allergic to carbocysteine 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.
Taking Pectox with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
If you are taking cough suppressants or medicines that reduce bronchial secretions, consult your doctor before taking Pectox together with these, as it may cause an accumulation of liquefied mucus.
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 use of machines
No effects on the ability to drive and/or use machines have been observed.
Pectox contains Cochineal Red A (E-124)
This medicine may cause allergic reactions because it contains Cochineal Red A (E-124). It may trigger asthma, especially in patients allergic to acetylsalicylic acid.
Pectox contains sodium methyl parahydroxybenzoate (E-219)
It may cause allergic reactions (possibly delayed) because it contains sodium methyl parahydroxybenzoate (E-219).
Pectox contains sodium
This medicine contains 7.72 mg of sodium (main component of table/cooking salt) per ml. This corresponds to 17% of the maximum daily recommended sodium intake for an adult.
3. How to take Pectox
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.
Remember to take your medicine.
This medicine is taken orally, either alone or diluted in water or another liquid, and preferably before meals. 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 recommended dose is:
- Adults and adolescents (> 12 years): 15 ml (750 mg carbocysteine) every 8 hours.
- Children from 6 to 12 years: 5 ml (250 mg carbocysteine) every 8 hours.
- Children from 2 to 5 years: 2.5 ml (125 mg carbocysteine) every 6–12 hours.
It is recommended to drink plenty of fluids throughout the day.
If you think that the effect of Pectox is too strong or too weak, tell your doctor or pharmacist.
If you take more Pectox 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
Do not take a double dose to make up for forgotten doses.
If you stop taking Pectox
Your doctor will advise you on how long to take Pectox. Do not stop treatment earlier, as this could 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, Pectox may have adverse effects, although not everyone experiences them.
Uncommon adverse effects (affect between 1 and 10 out of 1,000 patients):
Gastrointestinal disturbances such as nausea, diarrhoea, gastric discomfort, especially at high doses, which usually disappear upon reducing the administered dose.
Rare adverse effects (affect between 1 and 10 out of 10,000 patients):
Hypersensitivity reactions (allergic reactions), accompanied by urticaria (redness and swelling of the skin).
Very rare adverse effects (affect fewer than 1 in 10,000 patients):
Bronchospasm (asthma); in such case, it is recommended to discontinue the medication and consult a doctor.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not mentioned in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products, Website: www.notificaram.es.
By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Pectox
No special storage temperature is 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 is the last day of the month indicated.
Medicines must not be disposed of via wastewater drains or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.
6. Contents of the pack and other information
Composition of Pectox
- The active substance is carbocysteine. Each 100 ml of oral solution contains 5 g of Carbocysteine.
- The other components (excipients) are: sodium saccharin, sodium methyl p-hydroxybenzoate (E-219), raspberry flavour, carmine red A (E-124), sodium hydroxide, hydroxyethylcellulose, dibasic sodium phosphate, sodium cyclamate, citric acid and purified water q.s.
Appearance of the medicine and contents of the pack
This medicine is a red-coloured solution presented in 120 ml and 240 ml oral solution containers, accompanied by a dosing cup.
Marketing Authorisation Holder and Manufacturer:
ITALFARMACO S.A.
San Rafael 3, 28108-Alcobendas (Madrid)
Tel. 916572323
Date of the most recent review of this leaflet: August 2021
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es