ACETYLCYSTEINE PENSA 200 mg EFFERVSCENT TABLETS

Introduction

Package Leaflet: Information for the User

Acetylcysteine Pensa 200 mg Effervescent Tablets 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 of the side effects, or if you notice any side effects not listed in this leaflet, please tell 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. 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 as a supportive treatment for 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 conditions.

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 cautious with Acetylcysteine Pensa

If you have respiratory problems.

Use of other medicines

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

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

• cough suppressants (medicines used to calm cough).
• medicines 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 taking any medicine.

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 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 Pensa affects the ability to drive and/or use machines.

Important information about some of the components of Acetylcysteine Pensa

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

This medicine contains 99.31 mg of sodium per dose (200 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 acetylcysteine.

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 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 average dosage is 600 mg of acetylcysteine per day, orally, and in one daily dose of 600 mg or 3 doses of 200 mg every 8 hours.

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

The 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 medicine 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 stop treatment with Acetylcysteine Pensa

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

If you have any other doubts about the use of this medicine, 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 occur, accompanied by hives 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 suffering from 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.

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

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.

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

6. Further information

Composition of Acetylcysteine Pensa

The active ingredient is acetylcysteine. Each tablet contains 200 mg of acetylcysteine.

The other ingredients are: anhydrous citric 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 is presented in the form of round, white, effervescent tablets with a flawless surface. Tube with 30 effervescent tablets.

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 600 mg effervescent tablets EFG. Tube with 20 effervescent tablets.

This leaflet was approved in April 2012

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/