Leaflet: information for the user

Acetilcisteína ratiopharm 600 mg effervescent tablets EFG

Read this leaflet carefully before you start taking the medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before starting to take Acetilcisteína ratiopharm

3. How to take Acetilcisteína ratiopharm

4. Possible side effects

5. Storage of Acetilcisteína ratiopharm

6. Contents of the pack and additional information

Acetilcisteína ratiopharm 600 mg is a medication that belongs to the group of medications known as mucolytics/expectorants.

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

Do not take Acetilcisteína ratiopharm if

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

Warnings and precautions

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

Rarely reported severe skin reactions such as Stevens-Johnson syndrome and Lyell syndrome, associated in time with the administration of acetilcisteína, have been noted. If you experience skin or mucous membrane changes, seek medical advice quickly and discontinue acetilcisteína.

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

Other medications and Acetilcisteína ratiopharm

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

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

Pregnancy and breastfeeding

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

The administration of this medication during pregnancy or breastfeeding should be done under medical supervision.

Acetilcisteína ratiopharm contains aspartame, sodium, and saccharose

This medication 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 disorder in which phenylalanine accumulates due to the body's inability to eliminate it correctly.

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

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

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

Ratiopharm Acetylcysteine is for oral administration.

Remember to take your medication.

Your doctor will indicate the duration of your treatment with Ratiopharm Acetylcysteine.

Do not discontinue 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 three doses (200 mg), every 8 hours.

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

In children under 7 years, for better dose adjustment, it is recommended to use Ratiopharm Acetylcysteine 200 mg sachets.

Do not administer this medication 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 better dose adjustment, it is recommended to use Ratiopharm Acetylcysteine 200 mg powder for oral solution.

Do not administer this medication to children under 2 years.

Dissolve the effervescent tablet in a glass of water, in this way, a pleasant-tasting solution is obtained that can be drunk directly from the glass. The tablet is not intended to be divided into equal parts.

If you take more Ratiopharm Acetylcysteine 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 Toxicological Information Service, Telephone (91) 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Ratiopharm Acetylcysteine

Do not take a double dose to compensate for the missed doses.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Immune System Disorders

Rare:allergic reactions, for example, itching, urticaria, hives, bronchospasm

Nervous System Disorders

Rare:headache

Vestibular Disorders

Rare:tinnitus (ringing in the ears)

Gastrointestinal Disorders:

Rare:abdominal pain, nausea, vomiting, and diarrhea.

Skin and Subcutaneous Tissue Disorders

Very Rare:allergic reactions accompanied by urticaria

Respiratory, Thoracic, and Mediastinal Disorders

Very Rare:shortness of breath, bronchospasm, (especially in patients with hyperreactive bronchial tubes in asthma)

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. 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 on the safety of this medication.

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

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

Do not store at a temperature above 25 °C.

Keep in the original packaging to protect it from moisture.

Keep the packaging perfectly closed.

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Acetilcistetina ratiopharm 600 mg effervescent tablets EFG

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

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

Appearance of the product and content of the packaging

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

Each package contains 20 effervescent tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder

ratiopharm España, S.A

c/ Anabel Segura 11, Edificio Albatros B 1st floor

28108 Alcobendas, Madrid (Spain)

Responsible for manufacturing:

Merckle GmbH

Ludwig Merckle Strasse, 3

D- 89143. Blaubeuren

Germany

Last review date of this leaflet: January 2014

“Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/”