Acetylcysteine Pensa 200 mg Powder for Oral Solution

Introduction

Package Leaflet: Information for the User

Acetylcysteine Pensa 200 mg Powder for Oral Solution EFG

Read all of this leaflet carefully before you start taking this medicine.

• 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, do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

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. Further information

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

Acetylcysteine belongs to a group of medicines called mucolytics.

Acetylcysteine Pensa is used to thin out excessive and/or thick bronchial secretions. It is indicated for supportive treatment of respiratory processes with 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 any of the other components of Acetylcysteine Pensa.

• if you have stomach or duodenal ulcers.
• if you have asthma or other severe respiratory insufficiency.
• 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 other medicines, including those obtained 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 coughs).
• 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 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

It has not been described that acetylcysteine 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 exactly as 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 treatment before, as you will not achieve the desired effect.

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

For children under 7 years, the recommended doses are lower and this presentation is not suitable, although this presentation can be used in cases of pulmonary complications of 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: 200 to 400 mg of acetylcysteine every 8 hours.
• Children between 2 and 7 years: 200 mg of acetylcysteine every 8 hours.

Method 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 or consult 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 forgotten doses. Take the forgotten dose as soon as possible. However, if it is close to the time for the next dose, wait until then to continue treatment.

If you stop treatment with Acetylcysteine Pensa

Do not stop treatment before, as you will not achieve the expected effect.

If you have any other questions 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 intestinal 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 stop treatment and consult a doctor.

If you consider that any of the side effects you are experiencing is serious or if you notice any side effect not mentioned 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.

Expiration date:

Do not use Acetylcysteine Pensa after the expiration date stated on the packaging after "CAD". The expiration 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 at the pharmacy's SIGRE point . 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. Further 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 coloring (E-110), and orange flavor.

Appearance of the product and packaging content

Acetylcysteine Pensa is presented in the form of sachets containing 200 mg of acetylcysteine. It is presented in packaging 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 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/