Acetylcysteine Pensa 600 mg powder for oral solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Acetylcysteine pensa 600 mg oral solution powder for reconstitution 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. Do not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you consider any of the side effects you experience to be severe, or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Contents of the leaflet

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

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

Acetylcysteine belongs to a group of medicines called mucolytics.

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

• acute and chronic bronchitis (inflammation of the bronchi),
• chronic obstructive pulmonary disease,
• emphysema (inflammation of the lung alveoli, leading to reduced respiratory function),

atelectasis (reduced 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 excipients in Acetylcysteine Pensa.

• if you have gastroduodenal ulcer.

• if you have asthma or severe respiratory insufficiency.

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

Take special care with Acetylcysteine Pensa:

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

Use of other medicines:

Inform your doctor or pharmacist if you are using or have recently used 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 together with:

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

Taking Acetilcisteína Pensa with food and drinks:

No interference has been reported when taking Acetilcisteína Pensa with food and 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 opinion, the benefits outweigh the potential risks.

Breast-feeding:

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

Driving and use of machines:

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

Important information about some of the components of Acetylcysteine Pensa:

This medicine may be harmful to patients 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, especially in patients allergic to acetylsalicylic acid.

3. How to take Acetylcysteine Pensa

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

Remember to take your medicine.

Your doctor will indicate the duration of treatment with Acetylcysteine Pensa. Do not stop the treatment early, as otherwise the intended effect will not be achieved.

Adults and children over 7 years of age: The recommended daily dose is 600 mg of acetylcysteine per day (1 sachet of Acetylcysteine Pensa once daily).

The 600 mg dose is not recommended for children under 7 years of age.

Method of administration:

Acetylcysteine Pensa is administered orally. The contents of the sachets must 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, go to a Medical Center and/or contact the Toxicology Information Service, telephone 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 missed doses.

However, if there is only a short time remaining before the next dose, wait until that time and continue the treatment as scheduled.

If you interrupt treatment with Acetylcysteine Pensa:

Do not stop the treatment early, as otherwise the intended effect will not be achieved.

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 experiences them.

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

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

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect 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 in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This 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 colour (E-110), and orange flavour.

Nature of the product and contents of the pack

Acetylcysteine Pensa is presented in sachets containing 600 mg of acetylcysteine. It is available in packs containing 20 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 medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/