ACETYLCYSTEINE TEVA 600 mg EFFERVSCENT TABLETS

Introduction

Package Leaflet: Information for the User

Acetilcisteina Teva 600 mg Effervescent Tablets EFG

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What is Acetilcisteina Teva and what is it used for
2. What you need to know before you take Acetilcisteina Teva
3. How to take Acetilcisteina Teva
4. Possible side effects
5. Storage of Acetilcisteina Teva
6. Contents of the pack and further information

1. What is Acetilcisteina Teva and what is it used for

Acetilcisteina belongs to a group of medicines called mucolytics.

Acetilcisteina Teva is used to make bronchial secretions thinner and less sticky.

It is used as an adjunctive treatment for respiratory processes with excessive or thick mucous hypersecretion, such as:

• bronchitis (inflammation of the bronchi) acute and chronic,
• 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 diseases.

2. What you need to know before you take Acetilcisteina Teva

Do not take Acetilcisteina Teva

• If you are allergic (hypersensitive) to acetilcisteina or any of the other ingredients of this medicine.
• If you have a gastroduodenal ulcer.
• If you have asthma or other severe respiratory insufficiency, as it may increase airway obstruction.
• Do not administer acetilcisteina to children under 2 years of age.

Warnings and precautions

Consult your doctor or pharmacist before taking this medicine.

Very rarely, severe skin reactions such as Stevens-Johnson syndrome and Lyell syndrome have been reported, associated with the administration of acetilcisteina. If skin changes or mucous membrane changes occur, seek medical advice immediately and stop taking acetilcisteina.

The possible presence of a slight sulfurous odor does not indicate that the preparation is altered, but is characteristic of the active ingredient.

Other medicines and Acetilcisteina Teva

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

No interactions or incompatibilities with other medicines have been detected, although it is recommended that you do not take this medicine with antitussives (cough medicines) or with medicines that reduce bronchial secretions (e.g., atropine).

Pregnancy and breastfeeding

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.

Pregnancy

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

Driving and using machines

No effects have been described in this regard.

Acetilcisteina Teva contains sodium

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

3. How to take Acetilcisteina Teva

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

Your doctor will indicate the duration of treatment with this medicine. Do not stop treatment before completing it, as you will not achieve the desired effect.

The tablets of Acetilcisteina Teva are for oral administration, introducing the tablet into a glass with a little water. A pleasant-tasting solution is obtained, which can be drunk directly from the glass.

Adults and children over 7 years:

The recommended average dosage is 600 mg of acetilcisteina, i.e., 1 effervescent tablet of Acetilcisteina Teva per day.

In children from 2 to 7 years, the dose of 600 mg is not recommended.

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

If you take more Acetilcisteina Teva than you should

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

If you forget to take Acetilcisteina Teva

Do not take a double dose to make up for forgotten doses. If you forget a dose, wait for the next one.

If you stop taking Acetilcisteina Teva

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.

Immune system disorders

Uncommon:hypersensitivity reactions, for example, pruritus, urticaria, rash, bronchospasm

Nervous system disorders

Uncommon:headache

Ear and labyrinth disorders

Uncommon:tinnitus (ringing in the ears)

Gastrointestinal disorders:

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

Skin and subcutaneous tissue disorders

Very rare:hypersensitivity reactions accompanied by urticaria

Respiratory, thoracic, and mediastinal disorders

Rare:dyspnea (difficulty breathing), bronchospasm (especially in patients with hyperreactive bronchial system in bronchial asthma)

Reporting of side effects

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

5. Storage of Acetilcisteina Teva

Keep out of the sight and reach of children.

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.

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

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Contents of the pack and further information

Composition of Acetilcisteina Teva

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

The other ingredients (excipients) are: anhydrous citric acid (E330), maltodextrin, sodium hydrogen carbonate (E321), orange flavor, L-leucine, and sodium saccharin (E954).

Appearance of the product and pack contents

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

Marketing authorization holder and manufacturer

Holder:

Teva Pharma, S.L.U.

C/ Anabel Segura 11, Edificio Albatros B 1ª planta

28108 Alcobendas Madrid

Spain

Manufacturer:

E-Pharma Trento S.p.A.

Frazione Ravina

Via Provina, 2

38123 Trento – Italy

Date of last revision of this leaflet: July 2013

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/