Acetylcysteine Pensa 600 mg Powder for Oral Solution

Introduction

Package Leaflet: Information for the User

Acetylcysteine Pensa 600 mg Powder for Oral Solution EFG

Read the entire package leaflet carefully before starting to take the medicine.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed to you, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you consider that any of the side effects you are suffering from is serious or if you notice any side effect not mentioned in this package leaflet, inform your doctor or pharmacist.

Contents of the Package Leaflet

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

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

Acetylcysteine belongs to the group of medicines called mucolytics.

Acetylcysteine Pensa is used to fluidify excessive and/or thick bronchial secretions. It is indicated in the supportive treatment of respiratory processes that involve hypersecretion, excessive or thick mucus, such as:

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

atelectasis (decrease in lung volume) due to mucous obstruction.

2. Before taking Acetylcysteine Pensa

Do not take Acetylcysteine Pensa:

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

• if you have a gastroduodenal ulcer.
• if you are asthmatic or have severe respiratory failure.
• if you are a child under 2 years of age.

Be careful with Acetylcysteine Pensa:

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

Use of other medicines:

Tell your doctor or pharmacist if you are using or have recently used any other medicine, even those purchased without a prescription.

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

• Antitussives (medicines used to calm coughing).
• Medicines that decrease bronchial secretions (Atropine).

Taking Acetylcysteine Pensa with food and drinks:

No interactions have been described if Acetylcysteine Pensa is taken with food and drinks.

Pregnancy and breastfeeding:

Consult your doctor or pharmacist before using any medicine.

Pregnancy:

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

Driving and using machines:

It has not been described that Acetylcysteine Pensa affects the ability to drive and/or use machines.

Important information about some of the components of Acetylcysteine Pensa:

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

This medicine may cause allergic reactions because it contains orange yellow S (E-110). It can cause asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take Acetylcysteine Pensa

Follow the administration instructions of 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 suspend treatment before, as the expected effect will not be achieved.

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

In children under 7 years, the dose of 600 mg is not recommended.

Form of administration:

Acetylcysteine Pensa is administered orally. The contents of the sachets should be dissolved in sufficient water and ingested when 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 excessive or accidental intake of Acetylcysteine Pensa, go to a Medical Center and/or consult the Toxicology Information Service, phone 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 forgotten doses.

However, if there is little time left for the next dose, wait until then to continue treatment.

If you interrupt treatment with Acetylcysteine Pensa:

Do not suspend treatment before, as the expected effect will not be achieved.

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

4. Possible side effects

Like all medicines, Acetylcysteine Pensa can cause side effects, although not everyone gets them.

Occasionally, mild and transient side effects have appeared, the most frequent being stomach and intestine disorders: nausea, vomiting, and diarrhea.

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

If you consider that any of the side effects you are suffering from is serious or if you notice any side effect not mentioned in this package 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 date:

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

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need in the SIGRE point at the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Additional information

Composition of Acetylcysteine Pensa

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

Appearance of the product and packaging content

Acetylcysteine Pensa is presented in the form of sachets containing 600 mg of acetylcysteine. It is presented in packaging 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 package leaflet was approved in May 2011

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/