ACETYLCYSTEINE TARBIS 200 mg ORAL SOLUTION GRANULES

Introduction

Package Leaflet: Information for the User

Acetilcisteína Tarbis 200 mg Granules for Oral Solution EFG

Read all of this leaflet carefully before you start takingusing this medicine,because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• 1. If you have any further questions, ask your doctor, pharmacist, or nurse.

• This medicine has been prescribed for you only, and you should not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Acetilcisteína Tarbis and what is it used for.
2. What you need to know before you start taking Acetilcisteína Tarbis.
3. How to take Acetilcisteína Tarbis.
4. Possible side effects.
5. Storing Acetilcisteína Tarbis.
6. Contents of the pack and further information.

1. What is Acetilcisteína Tarbis and what is it used for

Acetilcisteína, the active substance of this medicine, belongs to a group of medicines called mucolytics and is used to make bronchial secretions less thick and sticky.

This medicine is indicated to facilitate the elimination of excess mucus and phlegm in respiratory processes that involve excessive or thick mucous secretion, such as acute and chronic bronchitis, Chronic Obstructive Pulmonary Disease (COPD), emphysema, pulmonary complications of cystic fibrosis, and other related conditions.

2. What you need to know before you start taking Acetilcisteína Tarbis

Do not take Acetilcisteína Tarbis

• If you are allergic to acetilcisteína or any of the other ingredients of this medicine (listed in section 6).
• In children under 2 years of age.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take acetilcisteína.

If you have asthma or a severe respiratory disease, you should consult your doctor before taking this medicine.

The possible sulfur-like odor (like rotten eggs) of the medicine is characteristic of the active substance, but it does not indicate that the medicine is in poor condition.

If you experience stomach upset when taking the medicine, you should stop treatment and consult your doctor or pharmacist. Caution is recommended in patients with peptic ulcer or a history of peptic ulcer.

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

It should be administered with caution in long-term treatment in patients with histamine intolerance.

Children and Adolescents

It is contraindicated in children under 2 years of age.

Other Medicines and Acetilcisteína Tarbis

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Concomitant therapy with nitroglycerin may cause headache and hypotension should be monitored, which can be severe.

Concomitant administration with the antiepileptic carbamazepine may cause a decrease in the efficacy of carbamazepine.

Do not take it together with antitussive medicines (for cough) or those that reduce bronchial secretions (such as antihistamines and anticholinergics), as it may cause an accumulation of fluidified mucus.

When taking any medicine that contains minerals such as iron or calcium, or any medicine with antibiotics (such as amphotericin B, ampicillin sodium, cephalosporins, lactobionate, erythromycin, and some tetracyclines), you should separate its intake from the intake of acetilcisteína by at least 2 hours.

It is not recommended to dissolve acetilcisteína with other medicines.

Taking Acetilcisteína Tarbis with Food and Drinks

Taking food and drinks does not affect the efficacy of this medicine.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

You should avoid taking it during breastfeeding.

Driving and Using Machines

There is no evidence of effects on the ability to drive and use machines.

Warning about Excipients

This medicine contains less than 1mmol of sodium (23 mg) per dose; this is essentially "sodium-free".

3. How to Take Acetilcisteína Tarbis

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults, adolescents, and children over 7 years:

200 mg of acetilcisteína (1 sachet of acetilcisteína 200 mg, 3 times a day), every 8 hours. Do not exceed the dose of 3 sachets (600 mg of acetilcisteína) per day.

Pulmonary Complications of Cystic Fibrosis

The recommended dose is:

Adults, adolescents, and children over 7 years:

200 to 400 mg of acetilcisteína every 8 hours (1 to 2 sachets of acetilcisteína 200 mg, 3 times a day).

Acetilcisteína is taken orally.

The sachets are taken dissolved in a glass of water, mixing with a spoon. It is recommended to drink plenty of liquid throughout the day.

It is contraindicated in children under 2 years of age.

If you take more Acetilcisteína Tarbis than you should

If you take more acetilcisteína than you should, you may notice: nausea, vomiting, heartburn, and stomach pain, diarrhea, or any other adverse effect described in section 4. Possible side effects.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicological Information Service, phone 915 620 420, indicating the medicine and the amount taken.

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

If you forget to take Acetilcisteína Tarbis

Do not take a double dose to make up for a forgotten dose.

If you stop taking Acetilcisteína Tarbis

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

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects may occur:

Uncommon (may affect up to 1 in 100 people): hypersensitivity, headache, ringing in the ears, tachycardia, vomiting, diarrhea, stomatitis, abdominal pain, nausea, urticaria, skin rash, angioedema, itching, increased body temperature, hypotension.

Rare (may affect up to 1 in 1,000 people): somnolence, bronchospasm, respiratory distress, gastrointestinal disorders.

Very rare (may affect up to 1 in 10,000 people): allergic reactions, anaphylactic shock, hemorrhage, severe skin reactions such as Stevens-Johnson syndrome and Lyell syndrome, sometimes identified with the concomitant use of another drug.

Frequency not known (cannot be estimated from the available data): facial swelling.

If you experience any skin or mucous membrane disorders, you should immediately stop taking acetilcisteína and seek medical attention.

Reporting of Side Effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Acetilcisteína Tarbis

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

No special storage conditions are required.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the Pack and Further Information

Composition of Acetilcisteína Tarbis

The active substance is acetilcisteína. Each sachet contains 200 mg of acetilcisteína.

The other ingredients (excipients) are: mannitol, colloidal anhydrous silica, sodium saccharin, orange flavor, and β-carotene colorant.

Appearance of the Product and Contents of the Pack

Acetilcisteína Tarbis 200 mg is presented in paper and aluminum sachets with an internal polyethylene coating. Each pack contains 30 sachets of white granules, slightly orange in color, with a characteristic odor.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Tarbis Farma, S.L.

Gran Vía Carlos III 94

08028 Barcelona

Spain

Manufacturer

Farmasierra Manufacturing S.L.

Carretera de I

28709 – San Sebastián de los R

Madrid. E

Date of the Last Revision of this Leaflet:July 2007

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