Intermucol 750 mg oral solution
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient/user
INTERMUCOL 750 mg ORAL SOLUTION
Carbocisteine
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist.
- Keep this leaflet, as you may need to read it again.
- If you need advice or more information, consult your pharmacist.
- If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet.
- You should consult a doctor if you worsen or do not improve within 5 days.
Leaflet contents:
- What INTERMUCOL is and what it is used for
- What you need to know before taking INTERMUCOL
- How to take INTERMUCOL
- Possible adverse effects
- How to store INTERMUCOL
- Contents of the pack and other information
1. What INTERMUCOL is and what it is used for
It belongs to a group of medicines called mucolytics, which work by reducing the viscosity of mucus, making it thinner and easier to expel.
It is indicated for the relief of excess mucus and phlegm occurring in influenza-like illnesses, catarrh, or the common cold.
You should consult a doctor if symptoms worsen or do not improve after 5 days.
2. What you need to know before starting to take INTERMUCOL
Do not take INTERMUCOL
- if you are allergic to carbocisteine and its derivatives or to any of the other ingredients of this medicine (listed in section 6)
- if you have a stomach or duodenal ulcer
- if you have asthma or any severe respiratory disease.
- This medicine is contraindicated in children under 2 years of age.
Warnings and precautions
Consult your doctor or pharmacist before starting to take INTERMUCOL.
During the first days of treatment, you may notice an increase in mucus and phlegm, which will gradually decrease throughout treatment.
Use of INTERMUCOL with other medicines
Inform 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 (for dry cough) or those that reduce bronchial secretions, as this may cause an accumulation of liquefied mucus.
Children and adolescents
This medicine should not be administered to individuals aged between 2 and 12 years.
Pregnancy, breastfeeding, and fertility:
The use of this medicine is not recommended in pregnant women.
IMPORTANT FOR WOMEN
If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. Taking medicines during pregnancy may be harmful to the embryo or fetus and should be monitored by your doctor.
Driving and use of machines
Use with caution in individuals whose activities require attention and who have experienced dizziness or vertigo during treatment with this medicine.
INTERMUCOL contains Cochineal Red A, methyl parahydroxybenzoate, and sodium.
This medicine may cause allergic reactions because it contains Cochineal Red A (E-124). It may provoke asthma, especially in patients allergic to acetylsalicylic acid.
It may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate (E-218).
Patients on low-sodium diets should be aware that this medicine contains 117 mg (5.09 mmol) of sodium per sachet.
3. How to take INTERMUCOL
Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.
This medicine is taken orally.
Adults and children over 12 years of age: The recommended dose is one sachet (750 mg of carbocisteine) taken orally, three times a day.
The contents should be taken directly from the sachet.
Do not take more than 3 sachets (2.25 g of carbocisteine) in 24 hours (1 day).
It is recommended to drink a glass of water after each dose and plenty of fluids throughout the day.
If symptoms worsen or do not improve after 5 days, or if fever, skin rash, persistent headache or sore throat occur, consult a doctor.
If you take more INTERMUCOL 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 INTERMUCOL
Do not take a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, INTERMUCOL may cause adverse effects, although not everyone experiences them.
Frequent adverse effects (may affect up to 1 in 10 people):
Gastrointestinal disorders such as: nausea, vomiting, diarrhoea, abdominal pain or dyspepsia (gastrointestinal discomfort). In some cases, reducing the administered dose may be helpful.
Rare adverse effects (may affect up to 1 in 1,000 people):
Hypersensitivity reactions (allergic reactions), bronchospasm (asthma), gastrointestinal bleeding, headache, vertigo, dizziness, skin rashes, pruritus (itching).
Very rare adverse effects (may affect up to 1 in 10,000 people):
Bronchospasm (asthma), fixed drug eruption (erythema).
In these cases, it is advisable to discontinue treatment as soon as possible.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.
5. Storage of INTERMUCOL
Keep this medicine out of the sight and reach of children.
Do not store above 30°C.
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 should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.
6. Contents of the pack and other information
Composition of INTERMUCOL
- The active substance is carbocisteine. Each sachet contains 750 mg of carbocisteine.
- The other components (excipients) are: sodium saccharin, methyl parahydroxybenzoate (E-218), raspberry flavour, Cochineal Red A (E-124), sodium carmellose, sodium hydroxide, purified water, and 1 N sodium hydroxide solution (to adjust pH).
Sodium saccharin, sodium carmellose, sodium hydroxide, and 1 N sodium hydroxide solution contribute 117 mg (5.09 mmol) of sodium per sachet.
Appearance of the product and contents of the pack
Pack containing 12 sachets of 15 ml of red oral solution.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
INTERPHARMA, S.A.
C/ Santa Rosa, 6
08921 Santa Coloma de Gramenet (Barcelona)
Manufacturer:
Laboratorios Alcalá Farma, S.L.
Ctra. M-300, Km. 29.920
28802 Alcalá de Henares (Madrid)
Date of the most recent revision of this leaflet: March 2012
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/