INTERMUCOL 750 mg ORAL SOLUTION

2. What you need to know before taking INTERMUCOL

Do not take INTERMUCOL

• if you are allergic to carbocisteine and its derivatives or to any of the other components 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 few days of treatment, you may observe an increase in mucus and phlegm, which will decrease throughout the treatment.

Use of INTERMUCOL with other medicines

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

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

Children and adolescents

This medicine should not be administered to children between 2 and 12 years of age.

Pregnancy, breastfeeding, and fertility:

It is not recommended to take this medicine during pregnancy.

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 medicine. The use of medicines during pregnancy can be hazardous to the embryo or fetus and should be monitored by your doctor.

Driving and using machines

It should be used with caution in people whose activity requires attention and who have observed dizziness or vertigo during treatment with this medicine.

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

This medicine may cause allergic reactions because it contains Red cochineal 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 medicine contains 117 mg (5.09 mmol) of sodium per sachet.

3. How to take INTERMUCOL

Follow the administration instructions for the medicine contained in this leaflet or as indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

This medicine is taken orally.

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

The contents are 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 intake and plenty of liquid throughout the day.

If your symptoms worsen or do not improve after 5 days, or if you experience: fever, skin rash, persistent headache, or sore throat, you should 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 Toxicology Information Service, phone 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 forgotten doses.

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

4. Possible side effects

Like all medicines, INTERMUCOL can cause side effects, although not everyone will experience them.

Common side 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, it may be helpful to reduce the administered dose.

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

Hypersensitivity reactions (allergic reactions), bronchospasm (asthma), gastrointestinal bleeding, headache, vertigo, dizziness, skin rash, pruritus (itching).

Very rare side effects (may affect up to 1 in 10,000 people):

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

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

If you experience side effects, consult your doctor or pharmacist, even if they are 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 is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicine in the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package contents and additional information

Composition of INTERMUCOL

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

Sodium saccharin, sodium carmellose, sodium hydroxide, and sodium hydroxide 1N solution provide 117 mg (5.09 mmol) of sodium per sachet.

Appearance of the product and package contents

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

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 last revision of this leaflet: March 2012

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