Leaflet: information for the user

Acetilcisteína pensa 600 mg effervescent tablets EFG

Read this leaflet carefully before starting to take this medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for 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 leaflet, inform your doctor or pharmacist.

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

2. Before taking Acetilcisteína Pensa

3. How to take Acetilcisteína Pensa

4. Possible side effects

5. Storage of Acetilcisteína Pensa

6. Additional information

Acetilcisteína belongs to a group of medications known as mucolitics.

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

It is indicated in the supportive treatment of respiratory processes that are accompanied by excessive or thick mucous secretion such as:

• acute and chronic bronchitis,
• chronic obstructive pulmonary disease (COPD),
• emphysema (inflammation of the alveoli of the lungs, 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.

Do Not Take Acetilcisteína Pensa

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

• If you have a duodenal ulcer.
• If you are asthmatic or have severe respiratory insufficiency.
• If you are a child under 2 years old.

Be Cautious with Acetilcisteína Pensa

If you have respiratory problems.

Use of Other Medications

Inform 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 (medicines used to calm cough)

- medications that reduce bronchial secretions (e.g. Atropina).

Taking Acetilcisteína Pensa with Food and Drinks

No interactions have been described if Acetilcisteína 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 possible 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 possible risks.

Driving and Operating Machines

No effect on the ability to drive and/or operate machines has been described for Acetilcisteína Pensa.

Important Information About Some Components of Acetilcisteína 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 a characteristic of the active principle.

Follow exactly the administration instructions for Acetilcisteína 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 Acetilcisteína Pensa. Do not discontinue treatment before, as this will not achieve the desired effect.

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

Pulmonary complications of cystic fibrosis:

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

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

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

Administration form

Acetilcisteína 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 Acetilcisteína Pensa than you should

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

If you forget to take Acetilcisteína Pensa

Do not take a double dose to compensate for the missed dose. If you forget a dose, wait for the next one.

If you interrupt treatment with Acetilcisteína Pensa

Do not discontinue treatment before, as this will not achieve the desired effect.

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

Like all medications, Pensa Acetilcisteína may produce adverse effects, although not all people will experience them.

Occasionally, mild and transient adverse effects have appeared, with the most common being gastrointestinal disturbances (nausea, vomiting, and diarrhea).

Rarely, allergic reactions have occurred, accompanied by hives and difficulty breathing (bronchospasm, bronchoconstriction), in which case it is recommended to discontinue treatment and consult a doctor.

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

Reporting 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 can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: http://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not store at a temperature above 86°F (30°C). Store in the original packaging.

Do not use Acetilcisteína Pensa after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medicines you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Acetilcisteína Pensa

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

Appearance of the product and contents of the package

Acetilcisteína Pensa 600 ispresented in the form of round, white, effervescent tablets with a smooth surface, and a groove on one face. Tube with 20 effervescent tablets.The tubes are made of polypropylene, closed with a polyethylene plug filled with a molecular sieve desiccant.

Holder of the marketing authorization

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible for manufacturing

HERMES PHARMA GmbH

Hans-Urmiller-Ring 52

82515 Wolfrathausen, Germany

Other presentations

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

This prospectus was approved in April 2012

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/