ACETYLCYSTEINE PENSA 600 mg EFFERVSCENT TABLETS

Introduction

Package Leaflet: Information for the User

Acetylcysteine Pensa 600 mg Effervescent Tablets EFG

Read the entire package leaflet carefully before starting to take this medication.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you, and you should not give it to others, even if they have the same symptoms, as it may harm them.
• 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 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 medications 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 excessive or thick mucous hypersecretion, such as:

• bronchitis (inflammation of the bronchi) acute and chronic,
• chronic obstructive pulmonary disease (COPD),
• emphysema (inflammation of the lung alveoli, which reduces respiratory function),
• atelectasis (collapse of a lung region or massive collapse of one or both lungs) due to mucous obstruction, complications of cystic fibrosis, and other related pathologies.

2. Before taking Acetylcysteine Pensa

Do not take Acetylcysteine Pensa

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

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

Be careful with Acetylcysteine Pensa

If you have respiratory problems.

Use of other medications

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

No interactions or incompatibilities with other medications have been detected, although it is recommended that you do not take this medication with:

• antitussives (medications used to calm cough)
• medications that reduce bronchial secretions (e.g., Atropine).

Taking Acetylcysteine Pensa with food and drinks

No interference has been described if Acetylcysteine Pensa is taken with food and drinks.

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 potential 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 potential 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 medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication contains 138.83 mg of sodium per dose (600 mg), which should be taken into account in patients with low-sodium diets.

The possible presence of a slight sulfurous odor does not indicate the alteration of the preparation, but is characteristic of the active ingredient.

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 medication.

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 average dosage is 600 mg of acetylcysteine per day, orally, and in a single daily dose of 600 mg.

Pulmonary complications of cystic fibrosis:

The recommended average dosage for acetylcysteine in these cases is as follows:

Adults and children over 7 years: 200 to 400 mg of acetylcysteine every 8 hours.

Children from 2 to 7 years: 200 mg of acetylcysteine every 8 hours.

Method of administration

Acetylcysteine Pensa tablets are for oral administration by introducing the tablet into a glass with a little water. This results in a pleasant-tasting solution that can be drunk directly from the glass.

If you take more Acetylcysteine Pensa than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20 (indicating the medication and the amount ingested).

If you forget to take Acetylcysteine Pensa

Do not take a double dose to make up for forgotten doses. In case of forgetting a dose, wait for the next one.

If you interrupt treatment with Acetylcysteine Pensa

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

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

4. Possible side effects

Like all medications, Acetylcysteine Pensa can cause side effects, although not everyone experiences them.

Occasionally, mild and transient side effects have appeared, the most frequent being stomach and intestinal disorders (nausea, vomiting, and diarrhea).

Rarely, allergic reactions occur, accompanied by urticaria and difficulty breathing (bronchospasm, bronchoconstriction), in which case it is recommended to discontinue 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 package leaflet, inform your doctor or pharmacist.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not mentioned in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: http://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Acetylcysteine Pensa

Keep Acetylcysteine Pensa out of the reach and sight of children.

Do not store above 30°C. Store in the original package.

Do not use Acetylcysteine Pensa after the expiration date that appears on the package after "CAD". The expiration date is the last day of the month indicated.

Medications should not be thrown down the drain or into the trash. Deposit the packages and medications you no longer need in the SIGRE point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packages and medications you no longer need. This way, you will help protect the environment.

6. Additional information

Composition of Acetylcysteine Pensa

The active ingredient is acetylcysteine. Each tablet contains 600 mg of acetylcysteine. The other components are: anhydrous citric acid, ascorbic acid, sodium hydrogen carbonate, anhydrous sodium carbonate, anhydrous lactose, mannitol (E-421), lemon flavor, sodium cyclamate, sodium saccharin, sodium citrate dihydrate.

Appearance of the product and package contents

Acetylcysteine Pensa 600 is presented in the form of round, white, effervescent tablets with a smooth surface and a notch on one side. Tube with 20 effervescent tablets. The tubes are made of polypropylene, closed with a polyethylene cap filled with a molecular sieving desiccant.

Marketing Authorization Holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer

HERMES PHARMA GmbH

Hans-Urmiller-Ring 52

82515 Wolfrathausen, Germany

Other presentations

Acetylcysteine Pensa 200 mg effervescent tablets EFG. Tube with 30 tablets.

This package leaflet was approved in April 2012

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/