Package Leaflet: Information for the User

Acetilcisteína Tarbis 200 mg Powder for Oral Solution EFG

Read this leaflet carefully before you start taking 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 questions, ask your doctor, pharmacist or nurse.

-This medicine has been prescribed for you only. Do not pass it on to others even if their symptoms are the same as yours. It may harm them.

• If you experience any side effects, talk to your doctor, pharmacist or nurse. See section 4.

Contents of the package leaflet

1. What Acetilcisteína Tarbis is and what it is 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. Storage of Acetilcisteína Tarbis.
6. Contents of the pack and additional information.

Acetilcisteína, the active ingredient of this medication, belongs to a group of medications called mucolitics and is used to liquefy excessive and/or thick bronchial secretions.

This medication 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 pathologies.

Do not take Acetilcisteína Tarbis

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take acetilcisteína.

If you are asthmatic or have a severe respiratory disease, you must consult with 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 while taking the medication, discontinue treatment and consult your doctor or pharmacist. Caution is recommended in patients with peptic ulcers or a history of peptic ulcers.

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

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 old.

Other medications and Acetilcisteína Tarbis

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

The concomitant therapy with nitroglycerin may cause headaches and hypotension, which can be severe.

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

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

When taking medications containing minerals such as iron or calcium, or medications with antibiotics (such as amphotericin B, ampicillin sodium, cephalosporins, lactobionate, erythromycin, and some tetracyclines), you should separate your intake of acetilcisteína by at least 2 hours.

It is not recommended to dissolve acetilcisteína with other medications.

Taking Acetilcisteína Tarbis with food and beverages

The intake of food and beverages does not affect the efficacy of this medication.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

It should be avoided during breastfeeding.

Driving and operating machines

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

Warning about excipients

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults, adolescents, and children over 7 years old:

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

Cystic Fibrosis Pulmonary Complications

The recommended dose is:

Adults, adolescents, and children over 7 years old:

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

Acetilcisteína is taken orally.

The tablets are taken dissolved in a glass of water, mixing with a spoon. It is recommended to drink a large amount of liquid during the day.

It is contraindicated in children under 2 years old.

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 Adverse 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 medication and the amount taken.

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

If You Forget to Take Acetilcisteína Tarbis

Do not take a double dose to make up for the missed dose.

If You Interrupt Treatment with Acetilcisteína Tarbis

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

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

The following adverse effects may occur:

Rarely(may affect up to 1 in 100 people): hypersensitivity, headache, tinnitus, tachycardia, vomiting, diarrhea, stomatitis, abdominal pain, nausea, urticaria, skin rash, angioedema, pruritus, increased body temperature, hypotension.

Uncommon(may affect up to 1 in 1,000 people): drowsiness, bronchospasm, respiratory difficulty, digestive discomfort.

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 simultaneous use of another medication.

Unknown frequency (cannot be estimated from available data): facial swelling.

In case of any skin or mucous membrane alteration, discontinue acetilcysteine administration immediately and seek medical assistance.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

No special storage conditions are required.

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 the packaging and the

medicines you no longer need at the SIGRE collection pointat the pharmacy. Ask your pharmacist how to dispose of the packaging and the medicines you no longer need. By doing so, you will help protect the environment.

Composition of Acetilcisteína Tarbis

The active ingredient is acetilcisteína. Each blister pack contains 200 mg of acetilcisteína.

The other components (excipients) are: mannitol, anhydrous colloidal silica, sodium saccharin, orange aroma, and β-carotene coloring.

Appearance of the product and contents of the packaging

Acetilcisteína Tarbis 200 mg is presented in the form of paper and aluminum blisters with an internal polyethylene coating. Each package contains 30 white, slightly orange-colored granules with a characteristic odor.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization

Tarbis Farma, S. L.

Gran Vía Carlos III 94

08028 Barcelona

Spain

Responsible manufacturer

Farmasierra Manufacturing S. L.

Carretera de Irún km 26,200.

28709 – San Sebastián de los Reyes.Madrid.Spain

Date of the last review of this leaflet:July 2007

The detailed information about this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)

(http://www.aemps.gob.es).