Prospect: information for the user

Acetilcisteína Teva 600 mg effervescent tablets EFG

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only to you, and you must not give it to others, even if they present the same symptoms of disease as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1.What isAcetilcisteína Tevaand for what it is used

2.What you need to know before starting to takeAcetilcisteína Teva

3.How to takeAcetilcisteína Teva

4.Possible adverse effects

5.Storage ofAcetilcisteína Teva

6.Contents of the package and additional information

Acetilcisteína belongs to a group of medications known as mucolitics.

Acetilcisteína Teva is used to thin out excessive and/or thick bronchial secretions.

It is indicated for the supportive treatment of respiratory processes that involve excessive or thick mucous secretion such as:

• acute and chronic bronchitis,
• chronic obstructive pulmonary disease (COPD),
• emphysema (inflammation of the lung alveoli, which reduces respiratory function),
• atelectasis (collapse of a lung region or massive collapse of one or both lungs) due to mucous obstruction, complications of cystic fibrosis, and other related pathologies.

Do not take Acetilcisteina Teva

• If you are allergic (hypersensitive) to acetilcisteina or to any of the other components of this medication.
• If you have a stomach ulcer.
• If you have asthma or other severe respiratory failure, as it may increase the obstruction of the respiratory passages.
• Do not administer acetilcisteine to children under 2 years old

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication.

Rarely reported severe skin reactions such as Stevens-Johnson syndrome and Lyell syndrome, associated in time with the administration of acetilcisteine. If you produce skin or mucous membrane changes, you should seek medical advice quickly and stop taking acetilcisteine.

The presence of a slight sulfurous odor does not indicate the alteration of the preparation, but is a characteristic of the active principle.

Other medications and Acetilcisteína Teva

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to use any other medication.No interactions or incompatibilities with other medications have been detected, although it is recommended that you do not take this medication with antitussives (medications used to calm cough) or with medications that reduce bronchial secretions (e.g. atropine).

Pregnancy and breastfeeding

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

Pregnancy

Your doctor will assess the need to use this medication. It should only be used during pregnancy when, in your doctor's opinion, the benefits outweigh the possible risks.

Breastfeeding

Your doctor will assess the need to use this medication. It should only be used during breastfeeding when, in your doctor's opinion, the benefits outweigh the possible risks.

Driving and operating machines

No effects have been described.

Acetilcisteina Teva contains sodium

This medication contains 193.89 mg of sodium (main component of table salt/for cooking) per tablet. This is equivalent to 9.69% of the recommended intake for an adult.

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

Remember to take your medication.

Your doctor will indicate the duration of treatment with this medication. Do not discontinue treatment prematurely, as this may prevent the desired effect from being achieved.

Acetilcisteína Teva tablets are for oral administration by introducing the tablet into a glass with a small amount of water. This results in a pleasant-tasting solution that can be drunk directly from the glass.

Adults and children over 7 years:

The recommended average dose is 600 mg of acetilcisteína, which is equivalent to 1 effervescent tablet of Acetilcisteína Teva per day.

In children aged 2 to 7 years, a dose of 600 mg is not recommended.

Do not administer acetilcisteína to children under 2 years of age.

If you take more Acetilcisteína Teva than you should

In the event of an overdose or accidental ingestion, consult your doctor or pharmacist immediately or the Toxicological Information Service, phone: 91 5620420.

If you forget to take Acetilcisteína Teva

Do not take a double dose to compensate for the missed dose. If you forget a dose, wait for the next one.

If you interrupt treatment with Acetilcisteína Teva

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 may experience them.

Immune System Disorders

Rare:allergic reactions, for example, itching, urticaria, hives, bronchospasm

Nervous System Disorders

Rare:headache

Vestibular Disorders

Rare:tinnitus (ringing in the ears)

Gastrointestinal Disorders:

Rare:abdominal pain, nausea, vomiting, and diarrhea.

Skin and Subcutaneous Tissue Disorders

Very Rare:allergic reactions accompanied by urticaria

Respiratory, Thoracic, and Mediastinal Disorders

Very Rare:shortness of breath, bronchospasm, (especially in patients with hyperreactive bronchial tubes in asthma)

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep out of sight and reach of children.

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

Store in the original packaging. Do not store at a temperature above 30 °C.

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

Composition of Acetilcisteína Teva

The active ingredient is acetilcisteina. Each tablet contains 600 mg of acetilcisteina.

The other components (excipients) are: Anhydrous citric acid (E330), maltodextrin, sodium hydrogen carbonate (E321), orange flavoring, L-leucine, and sodium saccharin (E 954).

Appearance of the product and content of the packaging

Acetilcisteína Teva is presented in the form of effervescent tablets, white in color, round, flat, and in packs of 20 tablets.

Holder of the marketing authorization and responsible manufacturer

Holder:

Teva Pharma, S.L.U

C/ Anabel Segura 11, Edificio Albatros B 1st floor

28108 Alcobendas Madrid

Spain

Responsible manufacturer

E-Pharma Trento S.p.A.

Frazione Ravina

Via Provina, 2

38123 Trento –Italy

Last review date of this leaflet: July 2013

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