Acetylcysteine Pensa 600 mg effervescent tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Acetylcysteine Pensa 600 mg effervescent tablets 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 it may harm them.
• If you consider any of the side effects you experience to be severe, or if you notice any side effects not listed 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 you take Acetylcysteine Pensa
3. How to take Acetylcysteine Pensa
4. Possible side effects
5. How to store Acetylcysteine Pensa
6. Further information

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

Acetylcysteine belongs to a group of medicines called mucolytics.

Acetilcisteína Pensa is used to liquefy excessive and/or thick bronchial secretions.

It is indicated as supportive treatment in respiratory conditions associated with excessive or thick mucus secretion, such as:

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

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 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

If you have respiratory problems.

Use of other medicines

Inform 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 reported. However, it is recommended that you do not take this medicine together with:

• antitussives (medicines used to suppress cough)
• medicines that reduce bronchial secretions (e.g. Atropine).

Taking Acetylcysteine Pensa with food and drink

No interference has been reported when taking Acetylcysteine Pensa with food or drink.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

Pregnancy

Your doctor will assess the need for using this medicine. It should only be used during pregnancy when, in the opinion of your doctor, the benefits outweigh the potential risks.

Breast-feeding

Your doctor will assess the need for using 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 Acetilcisteína Pensa

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

This medicine contains 138.83 mg of sodium per dose (600 mg), which should be taken into consideration in patients on low-sodium diets.

The possible presence of a slight sulfurous odour does not indicate degradation of the product, but is characteristic of the active substance.

3. How to take Acetylcysteine Pensa

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

Remember to take your medication.

Your doctor will determine the duration of treatment with Acetylcysteine Pensa. Do not stop treatment prematurely, as doing so may prevent you from achieving the desired effect.

Adults and children over 7 years of age: The recommended average dosage is 600 mg of acetylcysteine per day, taken orally as a single daily dose of 600 mg.

Pulmonary complications of cystic fibrosis:

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

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

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

Method of administration

Acetylcysteine Pensa tablets are for oral administration by placing the tablet into a glass containing a small amount of water. This produces a solution with a pleasant taste that can be drunk directly from the glass.

If you take more Acetylcysteine Pensa than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 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 missed doses. If you miss a dose, wait until the next scheduled dose.

If you stop treatment with Acetylcysteine Pensa

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

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

4. Possible adverse effects

Like all medicines, Acetylcysteine Pensa may produce adverse effects, although not everyone will experience them.

Occasionally, adverse effects of mild and transient nature have been reported, the most frequent being gastrointestinal disturbances (nausea, vomiting, and diarrhoea).

Rarely, allergic reactions may occur, accompanied by urticaria and breathing difficulties (bronchospasm, bronchoconstriction); in such cases treatment should be discontinued and a doctor consulted.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: http://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

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 packaging.

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 must not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Information provided

Composition of Acetylcysteine Pensa

The active substance 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, disodium citrate dihydrate.

Appearance of the product and contents of the package

Acetylcysteine Pensa 600 is presented as round, white effervescent tablets with a smooth, flawless surface and a score on one side. Tube containing 20 effervescent tablets. The tubes are made of polypropylene and closed with a polyethylene cap filled with a pure molecular sieve 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 Wolfratshausen, Germany

Other presentations

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

This leaflet was approved in April 2012

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/