ACETYLCYSTEINE RATIOPHARM 600 mg EFFERVSCENT TABLETS

Introduction

Leaflet: Information for the user

Acetilcisteína ratiopharm 600 mg effervescent tablets EFG

Read the entire leaflet carefully before starting to take the medicine, as it contains important information for you.

• 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 to you only, and you should not give it to others, even if they have the same symptoms, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What is Acetilcisteína ratiopharm and what is it used for
2. What you need to know before taking Acetilcisteína ratiopharm
3. How to take Acetilcisteína ratiopharm
4. Possible side effects
5. Storage of Acetilcisteína ratiopharm
6. Package contents and additional information

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

Acetilcisteína ratiopharm 600 mg is a medicine that belongs to the group of mucolytic/expectorant medicines.

Acetilcisteína is indicated as a complementary treatment in respiratory processes that involve excessive or thick mucus, such as acute and chronic bronchitis, chronic obstructive pulmonary disease (COPD), emphysema, atelectasis due to mucous obstruction: pulmonary complications of cystic fibrosis and other related pathologies.

2. What you need to know before taking Acetilcisteína ratiopharm

Do not take Acetilcisteína ratiopharm if

• you are allergic to acetilcisteína or any of the other components of this medicine (listed in section 6)
• you have a gastrointestinal ulcer
• you have asthma or severe respiratory failure
• you have phenylketonuria

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine.

Very rarely, severe skin reactions such as Stevens-Johnson syndrome and Lyell syndrome have been reported, associated with the administration of acetilcisteína. If skin changes or mucous membrane changes occur, medical advice should be sought immediately and acetilcisteína should be discontinued.

The detection of a sulfur smell does not indicate that the preparation is altered; this smell is characteristic of the active ingredient.

Other medicines and Acetilcisteína ratiopharm

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medicine.

No significant interactions with other medicines or analytical interference have been described, although it is recommended not to associate with antitussives or medicines that decrease bronchial secretions (atropine).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Administration of this medicine during pregnancy or breastfeeding should be done under medical supervision.

Acetilcisteína ratiopharm contains aspartame, sodium, and sucrose

This medicine contains 20 mg of aspartame per effervescent tablet. Aspartame contains a source of phenylalanine that may be harmful in cases of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it properly.

This medicine contains 150.23 mg of sodium (main component of table salt/cooking salt) in each effervescent tablet. This is equivalent to 7.51% of the maximum daily sodium intake recommended for an adult.

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

3. How to take Acetilcisteína ratiopharm

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Acetilcisteína ratiopharm is for oral administration.

Remember to take your medicine.

Your doctor will indicate the duration of your treatment with Acetilcisteína ratiopharm.

Do not stop treatment before consulting your doctor.

The normal dose is:

Adults and children over 7 years: 600 mg per day, administered in 1 daily dose (600 mg) or in 3 doses (200 mg), every 8 hours.

Children from 2 to 7 years: 300 mg per day, divided into 3 doses (100 mg), every 8 hours.

In children under 7 years, for a better dose adjustment, the use of Acetilcisteína ratiopharm 200 mg sachets is recommended.

Do not administer this medicine to children under 2 years.

Cystic fibrosis

Adults and children over 7 years: 200-400 mg every 8 hours.

Children from 2 to 7 years: 200-400 mg every 8 hours.

In this indication, for a better dose adjustment, the use of Acetilcisteína ratiopharm 200 mg powder for oral solution is recommended.

Do not administer this medicine to children under 2 years.

Dissolve the effervescent tablet in a glass of water, thus obtaining a solution with a pleasant taste that can be drunk directly from the glass. The tablet is not intended to be divided into equal parts.

If you take more Acetilcisteína ratiopharm than you should

If you have taken more than you should, consult your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, consult the Toxicology Information Service, Telephone (91) 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Acetilcisteína ratiopharm

Do not take a double dose to make up for forgotten doses.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Immune system disorders

Uncommon:hypersensitivity reactions, for example, pruritus, urticaria, rash, bronchospasm

Nervous system disorders

Uncommon:headache

Ear and labyrinth disorders

Uncommon:tinnitus (ringing in the ears)

Gastrointestinal disorders:

Uncommon:abdominal pain, nausea, vomiting, and diarrhea

Skin and subcutaneous tissue disorders

Very rare:hypersensitivity reactions accompanied by urticaria

Respiratory, thoracic, and mediastinal disorders

Rare:dyspnea (difficulty breathing), bronchospasm (especially in patients with hyperreactive bronchial system in bronchial asthma)

Reporting of side effects

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

5. Storage of Acetilcisteína ratiopharm

Keep this medicine out of the sight and reach of children.

Do not use Acetilcisteína ratiopharm after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not store above 25°C.

Keep in the original packaging to protect from moisture.

Keep the packaging tightly closed.

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

6. Package contents and additional information

Composition of Acetilcisteína ratiopharm 600 mg effervescent tablets EFG

• The active ingredient is acetilcisteína. Each effervescent tablet contains 600 mg of acetilcisteína.

• The other ingredients are: anhydrous citric acid, sodium hydrogen carbonate, lemon flavor (contains sucrose), polyvinylpyrrolidone, adipic acid, aspartame (E-951), and isopropanol.

Appearance of the product and package contents

Acetilcisteína ratiopharm 600 mg are white to slightly yellowish effervescent tablets, round and biplanar with a notch on one side and a lemon odor. The tablet is not intended to be divided into equal parts.

Each package contains 20 effervescent tablets.

Marketing authorization holder and manufacturer

Holder

ratiopharm España, S.A.

c/ Anabel Segura 11, Edificio Albatros B 1ª planta

28108 Alcobendas, Madrid (Spain)

Manufacturer:

Merckle GmbH

Ludwig Merckle Strasse, 3

D-89143 Blaubeuren

Germany

Date of the last revision of this leaflet: January 2014

"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/"