Leaflet: information for the user

AcetilcisteinaAARISTO 600 mg Effervescent Tablets

Read this leaflet carefully because it contains important information for you

This medicine can be obtained without a prescription, for the treatment of minor ailments without the intervention of a doctor. Nevertheless, you should use Acetilcisteina EDIGEN 600 mg effervescent tablets with care to obtain the best results.

• Keep this leaflet. You may have to read it again.
• If you need additional information or advice, consult your pharmacist.
• If the symptoms worsen, or if they persist after 5 days of treatment, or if you experience: fever, skin eruptions, persistent headache or sore throat, you should consult a doctor.

Information in this leaflet:

1. What Acetilcisteina ARISTO 600 mg effervescent tablets are and for what they are used
2. Before taking Acetilcisteina ARISTO 600 mg effervescent tablets
3. How to take Acetilcisteina ARISTO 600 mg effervescent tablets
4. Possible side effects
5. Storage of Acetilcisteina ARISTO 600 mg effervescent tablets
6. Additional information for the patient

Each effervescent tablet contains 600 mg of acetilcysteine as the active ingredient

The other components (excipients) are: ascorbic acid, anhydrous citric acid, anhydrous sodium carbonate, sodium cyclamate, dihydrated sodium citrate, sodium hydrogen carbonate, anhydrous lactose, mannitol (E-421), flavor of blackberry ((corn starch, gum arabic E414, propylene glycol E1520, ascorbic acid E300)and dihydrated sodium saccharin.

Marketing Authorization Holder:

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid. Spain

Responsible for manufacturing:

SALUTAS PHARMA GmbH

Otto Von Guericke Allee, 1.

Barleben 39179

GERMANY

And

LABORATORIOS MEDICAMENTOS INTERNACIONALES S.A

C/Solana 26

Torrejón de Ardoz

Madrid

It is presented in the form of round, white, smooth, and raspberry-scented effervescent tablets.

Each package contains 10 or 20 effervescent tablets.

Acetylcysteine acts by reducing the viscosity of mucus, fluidifying it, and facilitating its elimination.

This medication is indicated to reduce the viscosity of mucus and phlegm, facilitating its expulsion, in catarrhal and gripal processes.

Do not takeAcetilcisteina ARISTO600 mg effervescent tablets if:

• You are allergic toacetilcisteínaand its derivatives, or to any of the components of this medication
• You have: stomach or duodenal ulcer

Be especially careful withAcetilcisteina ARISTO600 mgeffervescent tablets:

• If you are asthmatic or have a severe respiratory disease, you should consult your doctor before taking this medication.

• The possible sulfurous smell (like rotten eggs) of the medication is due to the active ingredient, but it does not indicate that the medication is spoiled.

• If you experience stomach discomfort after taking the medication, you should discontinue treatment and consult your doctor.

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

Pregnancy:

Consult your doctor or pharmacist before taking a medication.

Breastfeeding:

Consult your doctor or pharmacist before taking a medication.

Women who are breastfeeding should consult their doctor before taking this medication.

Use in children:

Contraindicated in children under two years old.

For children between 2 and 7 years old, administer Acteilcisteina Aristo 100mg or Acetilcisteina 200 mg.

Driving and operating machinery:

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

Important information about some of the components ofAcetilcisteina ARISTO600 mg effervescent tablets

This medication contains lactose. If your doctor has indicated that you have a certain sugar intolerance, consult with them before taking this medication.

This medication contains 138.145 mg of sodium per tablet, which should be taken into account in patients with low-sodium diets.

Concomitant use of other medications:

Do not administer concurrently with cough medications or with those that reduce bronchial secretions (such as antihistamines and anticholinergics), as it may cause a buildup of fluidified mucus.

Space your intake at least two hours after the ingestion of minerals such as iron, calcium, and some antibiotics (amphotericin B, ampicillin sodium, cephalosporins, lactobionate, erythromycin, and some tetracyclines).

Inform your doctor or pharmacist if you are using or have recently used any other medication, including those obtained without a prescription.

AcetilcisteinaARISTO600 mg effervescent tablets is a medication taken orally.

Follow these instructions, unless your doctor has given you different instructions.

The usual doses ofacetilcysteineare:

• Adults: administer 1 effervescent tablet (600 mg) in a single dose. Do not exceed a dose of 1 effervescent tablet (600 mg) per day.

The effervescent tablets must be dissolved in a glass of water. Do not ingest until the bubbling has completely stopped.

It is recommended to drink an abundant amount of liquid during the day.

If symptoms worsen, or if they persist after5 daysof treatment, or if any of the following occur: fever, skin eruptions, persistent headache or sore throat, consult a doctor.

If you estimate that the action ofAcetilcisteinaARISTO600 mg effervescent tablets is too strong or too weak, inform your doctor or pharmacist.

If you take moreAcetilcisteinaARISTO600 mg effervescent tablets than you should:

If you have taken moreAcetilcisteinaARISTO600 mg effervescent tablets than you should, consult your doctor or pharmacist immediately, or call the Toxicological Information Service, phone: 915 620 420, indicating the medication and the amount ingested.

If you forgot to takeAcetilcisteinaARISTO600 mg effervescent tablets:

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

Like all medications,AcetilcisteinaARISTO600 mg Effervescent Tablets may have adverse effects.

In rare instances (less than 1 in every 1000 but more than 1 in every 10,000patients)it may appear drowsiness, nausea, vomiting, headache, stomach pain and burning, diarrhea, skin rash and ringing in the ears.

If you observe these or any other effect not described in this leaflet, consult your doctor or pharmacist.

Keep out ofsight and reachof children.

Do not store at a temperature above 30°C

Expiration:

Do not useAcetilcisteinaARISTO600 mg effervescent tablets after the expiration date indicated on the packaging.

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

Some respiratory and catarrhal processes may be accompanied by the accumulation of mucus in the respiratory passages. In some cases, this mucus becomes thick and adheres to the walls of these passages.

This explains why, in these processes, coughing occurs as a defense mechanism of the body against the appearance of mucosities, to expel phlegm and clear the respiratory passages.

Acetilcisteina ARISTO 600 mg effervescent tablets fluidifies the adhered mucus, detaching it. At the end of the catarrhal or gripal process, there is a decrease in mucosities and, therefore, in the cough necessary to eliminate it.

Last revision date of this leaflet:July 2012

The detailed and updated information of this medication is available on the webpage of the Spanish Agency of Medicaments and Sanitary Products (AEMPS)http://www.aemps.gob.es/