Patient Information Leaflet

INTERMUCOL 750 mg ORAL SOLUTION

Carbocisteine

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

Follow exactly the administration instructions contained 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.
• You should see a doctor if your symptoms worsen or do not improve after 5 days.

1. What is INTERMUCOL and what it is used for

2. What you need to know before taking INTERMUCOL

3. How to take INTERMUCOL

4. Possible side effects

5. Storage of INTERMUCOL

6. Contents of the pack and additional information

It belongs to the group of medications known as mucolytics, whichact by reducing the viscosity of mucus, liquefying it and facilitating its elimination.

It is indicated for the relief of excess mucus and phlegm that appears in gripal, catarrah, or common cold processes.

Consult a doctor if it worsens or does not improve after 5 days.

Do not take INTERMUCOL

• if you are allergic to carbocisteine and its derivatives or to any of the other components of this medication (listed in section 6)
• if you have a stomach or duodenal ulcer
• if you have asthma or any severe respiratory disease
• This medication is contraindicated in children under 2 years old.

Warnings and precautions

Consult your doctor or pharmacist before starting to take INTERMUCOL.

During the first few days of treatment, you may notice an increase in mucus and phlegm, which will decrease over time.

Use of INTERMUCOL with other medications

Inform your doctor or pharmacist that you are using, have used recently, or may need to use any other medication.

Do not take this medication with antitussives (for dry cough) or those that reduce bronchial secretions, as it may cause a buildup of fluidified mucus.

Children and adolescents

This medication should not be administered to children aged 2 to 12 years.

Pregnancy, breastfeeding, and fertility:

This medication is not recommended for pregnant women.

IMPORTANT FOR WOMEN

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication. The consumption of medications during pregnancy can be hazardous to the embryo or fetus and should be monitored by your doctor.

Driving and operating machinery

Use with caution in individuals whose activity requires attention and who have experienced dizziness or vertigo during treatment with this medication.

INTERMUCOL contains Carmine Red A, methyl parahydroxybenzoate, and sodium.

This medication may cause allergic reactions because it contains Carmine Red A (E-124). It may cause asthma, especially in patients allergic to acetylsalicylic acid.

It may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate (E-218).

Patients with low-sodium diets should note that this medication contains 117 mg (5.09 mmol) of sodium per dose.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

This medication is taken orally.

Adults and children over 12 years:The recommended dose is one packet (750 mg of carbocisteine) taken orally, three times a day.

The contents are taken directly from the packet.

Do not take more than 3 packets (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 liquid throughout the day.

If symptoms worsen or do not improve within 5 days, or if a fever, skin rash, persistent headache, or sore throat occurs, consult a doctor.

If you take more INTERMUCOL than you should

If you have taken more than you should, consult your doctor, pharmacist, or call the Toxicological Information Service, phone 915 62 04 20, indicating the medication and the amount taken.

If you forgot to take INTERMUCOL

Do not take a double dose to compensate for the missed doses.

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

Like all medications, INTERMUCOL may produce adverse effects, although not all people will experience them.

Frequent Adverse Effects (may affect up to 1 in 10 people):

Gastrointestinal disorders such as: nausea, vomiting, diarrhea, 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, dizziness, vertigo, skin rash, pruritus (itching).

Very Rare Adverse Effects (may affect up to 1 in 10,000 people):

Bronchospasm (asthma), fixed drug eruption (fixed redness of the skin).

In these cases, it is recommended to discontinue treatment as soon as possible.

If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus.

Keep this medication out of the sight and reach of children.

Do not store at a temperature above30°C.

Do not use this medication after the expiration date that appears on the packaging after CAD.The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection pointat the pharmacy.If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of INTERMUCOL

• The active ingredient is carbocisteine. Each sachet contains 750 mg of carbocisteine.
• The other components (excipients) are: Sodium saccharin, methyl parahydroxybenzoate (E-218), raspberry essence, Red C (E-124), sodium caramel, sodium hydroxide, purified water, 1 N sodium hydroxide solution (to adjust the pH).

Sodium saccharin, sodium caramel, 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 packaging

Package with 12 sachets of 15 ml oral solution of red color.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

INTERPHARMA, S.A.

C/ Santa Rosa, 6.

08921 Santa Coloma de Gramenet (Barcelona)

Responsible for manufacturing:

Laboratorios Alcalá Farma, S.L.

Ctra. M-300, Km. 29,920

28802 Alcalá de Henares (Madrid)

Last review date of this leaflet: March 2012

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/