Leaflet: information for the user

Acetilcisteína pensa 200 mg powder for oral solution EFG

Read this leaflet carefully before starting to take this medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms, as it may harm them.
• If you consider that any of the adverse effects you are experiencing are serious or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

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

2. Before taking Acetilcisteína Pensa

3. How to take Acetilcisteína Pensa

4. Possible adverse effects

5. Storage of Acetilcisteína Pensa

6. Additional information

Acetilcisteína belongs to a group of medications known as mucolitics.

Acetilcisteína Pensa 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 mucus, such as:

• acute and chronic bronchitis (inflammation of the bronchioles),
• chronic obstructive pulmonary disease,
• emphysema (inflammation of the alveoli of the lungs, which reduces respiratory function),
• atelectasis (reduction of lung volume) due to mucous obstruction.

Do not take Acetilcisteína Pensa

• if you are allergic (hypersensitive) to acetilcisteína or to any of the other components of Acetilcisteína Pensa.

• if you have a stomach or duodenal ulcer.
• if you have asthma or other severe respiratory insufficiency.
• if you are a child under 2 years old.

Be especially careful with Acetilcisteína Pensa

• the presence of a slight sulfurous odor in the preparation does not indicate that it is altered, but is a characteristic of the active principle acetilcisteína.

Use of other medications

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

No incompatibilities have been detected with other medications, although it is recommended not to take this medication with:

Taking Acetilcisteína Pensa with food and beverages

No interactions have been described if Acetilcisteína Pensa is taken with food and beverages.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any 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 machinery

No effects have been described on the ability to drive and/or operate machinery.

Important information about some of the components of Acetilcisteína Pensa

This medication may be harmful to people with phenylketonuria because it contains aspartame, which is a source of phenylalanine.

This medication may cause allergic reactions because it contains Yellow 5 (E-110). It may provoke asthma, especially in patients allergic to acetylsalicylic acid.

Follow exactly the administration instructions for Acetilcisteína Pensa as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Remember to take your medication.

Your doctor will inform you of the duration of treatment with Acetilcisteína Pensa.Do not discontinue treatment beforehand, as this will not achieve the desired effect.

Adults and children over 7 years: The recommended daily dose is 200 mg of acetilcisteína 3 times a day (1 tablet of Acetilcisteína Pensa 3 times a day), not exceeding a daily dose of 600 mg.

For children under 7 years, recommended doses are lower and this presentation is not suitable, although this presentation may be used in cases of pulmonary complications of cystic fibrosis.

In cases of pulmonary complications of cystic fibrosis, the recommended average dose of acetilcisteína is as follows:

• Adults and children over 7 years: 200 to 400 mg of acetilcisteína every 8 hours.
• Children between 2 and 7 years: 200 mg of acetilcisteína every 8 hours.

Administration form:

Acetilcisteína Pensa is administered orally. The contents of the sachets should be dissolved in sufficient water, and it should be ingested when it has completely dissolved.

If you take more Acetilcisteína Pensa than you should

If you have taken more Acetilcisteína Pensa than you should, consult your doctor or pharmacist.

In case of excessive or accidental intake of Acetilcisteína Pensa, go to a Medical Center or consult the Toxicological Information Service, phone 91 562 04 20, indicating the product and the amount ingested.

If you forget to take Acetilcisteína Pensa

Do not take a double dose to compensate for the missed doses. Take the missed dose as soon as possible. However, if there is little time left for the next dose, wait until then to continue treatment.

If you interrupt treatment with Acetilcisteína Pensa

Do not discontinue treatment beforehand, as this will not achieve the desired effect.

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

Like all medications, Acetilcisteína Pensamay produce adverse effects, although not all people will experience them.

Occasionally, mild and transient adverse effects have appeared, with the most common being gastrointestinal disturbances: nausea, vomiting, and diarrhea.

Rarely, allergic reactions accompanied by skin redness and difficulty breathing have occurred. If these symptoms appear, it is recommended to discontinue treatment and consult a doctor.

If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Keep out of reach and sight of children.

Do not store at a temperature above30°C.

Expiration Date:

Do not use Acetilcisteína Pensa 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 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. In this way, you will help protect the environment.

Composition of Acetilcisteína Pensa

Appearance of the product and contents of the packaging

Acetilcisteína Pensais presented in the form of sachets containing 200 mg of acetilcisteína. It is presented in packaging containing 30 sachets.

Holder of the marketing authorization

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible for manufacturing

Laboratorios Cinfa, S.A.

C/ Olaz-Chipi, 10 – Industrial Estate Areta

31620 Huarte- Pamplona

This leaflet was approved in May 2011

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/