Acetylcysteine Pensa 200 mg powder for oral solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Acetylcysteine pensa 200 mg powder for oral solution EFG

Read the entire leaflet carefully before you start taking this medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms, as it may harm them.
• If you consider any of the side effects you experience to be severe, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents

1. What Acetylcysteine Pensa is and what it is used for
2. Before you take Acetylcysteine Pensa
3. How to take Acetylcysteine Pensa
4. Possible side effects
5. How to store Acetylcysteine Pensa
6. Further information

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

Acetylcysteine belongs to a group of medicines called mucolytics.

Acetylcysteine Pensa is used to liquefy excessive and/or thick bronchial secretions. It is indicated as supportive treatment in respiratory conditions associated with hypersecretion, or excessive or thick mucus, such as:

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

2. Before taking Acetylcysteine Pensa

Do not take Acetylcysteine Pensa

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

• if you have a stomach or duodenal ulcer.

• if you have asthma or another severe respiratory insufficiency.

• if you are a child under 2 years of age.

Exercise special caution with Acetylcysteine Pensa

• The presence of a slight sulfurous odor in the preparation does not indicate deterioration, but is characteristic of the active substance, acetylcysteine.

Use of other medicines

Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.

No incompatibilities with other medicines have been reported, although it is recommended not to take this medicine concomitantly with:

• Antitussives (medicines used to suppress cough).
• Medicines that reduce bronchial secretions (atropine).

Taking Acetylcysteine Pensa with food and drinks

No interference has been described when taking Acetylcysteine Pensa with food or drinks.

Pregnancy and lactation

Consult your doctor or pharmacist before using any medication.

Pregnancy:

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

Lactation:

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

Driving and Use of Machinery

It has not been reported that acetylcysteine affects the ability to drive and/or operate machinery.

Important information about some components of Acetilcisteína Pensa

This medicine may be harmful to individuals with phenylketonuria, as it contains aspartame, a source of phenylalanine.

This medicine may cause allergic reactions because it contains sunset yellow FCF (E-110). It may provoke asthma, particularly in patients allergic to acetylsalicylic acid.

3. How to take Acetylcysteine Pensa

Follow exactly the administration instructions for Acetylcysteine Pensa provided by your doctor. Consult your doctor or pharmacist if you have any doubts.

Remember to take your medicine.

Your doctor will indicate how long you should continue treatment with Acetylcysteine Pensa. Do not stop treatment early, as doing so may prevent you from achieving the desired effect.

Adults and children over 7 years of age: The recommended daily dose is 200 mg of acetylcysteine three times a day (1 sachet of Acetylcysteine Pensa three times a day), without exceeding the daily dose of 600 mg.

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

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

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

Method of administration:

Acetylcysteine Pensa is administered orally. The contents of the sachets should be dissolved in a sufficient amount of water and taken once completely dissolved.

If you take more Acetylcysteine Pensa than you should

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

In case of accidental or excessive intake of Acetylcysteine Pensa, go to a Medical Center or contact the Toxicology Information Service at telephone number 91 562 04 20, indicating the product and the amount ingested.

If you forget to take Acetylcysteine Pensa

Do not take a double dose to make up for a missed dose. Take the missed dose as soon as possible. However, if it is almost time for your next dose, wait and continue your treatment as scheduled.

If you stop treatment with Acetylcysteine Pensa

Do not stop treatment early, as you will not achieve the intended effect.

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

4. Possible adverse effects

Like all medicines, Acetylcysteine Pensa may produce adverse effects, although not everyone will experience them.

Occasionally, mild and transient adverse effects have occurred, the most frequent being stomach and intestinal disturbances: nausea, vomiting, and diarrhoea.

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

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

5. Storage of Acetylcysteine Pensa

Keep out of the reach and sight of children.

Do not store above 30°C.

Expiry:

Do not use Acetylcysteine Pensa after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This way, you will help protect the environment.

6. Additional Information

Composition of Acetylcysteine Pensa

• The active substance is acetylcysteine.
• The other components are: aspartame (E-951), mannitol (E-421), anhydrous colloidal silica, orange-yellow S dye (E-110), and orange flavor.

Appearance of the medicinal product and contents of the pack

Acetylcysteine Pensa is presented in sachets containing 200 mg of acetylcysteine. It is available in packs containing 30 sachets.

Marketing Authorization Holder

Towa Pharmaceutical, S.A.
C/ de Sant Martí, 75-97
08107 Martorelles (Barcelona)
Spain

Manufacturer

Laboratorios Cinfa, S.A.
C/ Olaz-Chipi, 10 – Polígono Industrial Areta
31620 Huarte- Pamplona

This leaflet was approved in May 2011

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/