ACETYLCYSTEINE TEVA-RATIOPHARM 200 mg ORAL SOLUTION POWDER

Introduction

Package Leaflet: Information for the User

Acetilcisteína Teva-ratiopharm 200 mg Powder for Oral Solution EFG

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

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

Contents of the Package Leaflet:

1. What is Acetilcisteína Teva-ratiopharm and what is it used for
2. What you need to know before taking Acetilcisteína Teva-ratiopharm
3. How to take Acetilcisteína Teva-ratiopharm
4. Possible side effects
5. Storage of Acetilcisteína Teva-ratiopharm
6. Package Contents and Additional Information

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

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

Acetilcisteína is indicated as a complementary treatment in respiratory processes that involve an increase in mucus 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 conditions.

2. What you need to know before taking Acetilcisteína Teva-ratiopharm

Do not take Acetilcisteína Teva-ratiopharm:

• If you are allergic to acetilcisteína or any of the other components of this medicine (listed in section 6)
• If you have a gastrointestinal ulcer.
• If you have severe asthma or respiratory failure
• The use of this medicine is contraindicated in children under 2 years of age

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.

Never take a medicine on your own initiative without your doctor's recommendation.

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 Teva-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 Teva-ratiopharm contains sucrose, glucose, lactose, and sodium.

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.

This medicine contains 2.74 g of sucrose per dose, which should be taken into account in the treatment of patients with diabetes mellitus.

This medicine contains glucose and 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 less than 1 mmol of sodium (23 mg) per sachet; it is essentially "sodium-free".

3. How to take Acetilcisteína Teva-ratiopharm

Follow the administration instructions for this medicine exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Acetilcisteína Teva-ratiopharm is for oral administration

Remember to take your medicine.

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

Do not stop treatment before consulting your doctor.

The normal dose is:

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

Children from 2 to 7 years of age: 300 mg per day, divided into 3 doses of ½ sachet (100 mg) every 8 hours.

Do not administer this medicine to children under 2 years of age.

Cystic Fibrosis

Adults and children over 7 years of age: 1 to 2 sachets (200-400 mg) every 8 hours.

Children from 2 to 7 years of age: 1 to 2 sachets (200-400 mg) every 8 hours.

Do not administer this medicine to children under 2 years of age.

Dissolve the contents of the sachet in a glass of water and stir until completely dissolved. This will result in a pleasant-tasting solution that can be drunk directly from the glass.

If you take more Acetilcisteína Teva-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 Teva-ratiopharm:

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

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

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 side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Acetilcisteína Teva-ratiopharm

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

Do not use this medicine 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 30°C.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Acetilcisteína Teva-ratiopharm 200 mg Powder for Oral Solution EFG

• The active ingredient is acetilcisteína. Each single-dose sachet contains 200 mg.
• The other ingredients are: sucrose, orange flavor (contains glucose and anhydrous lactose), anhydrous colloidal silica E-551, tartaric acid, and sodium chloride.

Appearance of the Product and Package Contents

Acetilcisteína Teva-ratiopharm 200 mg is a powder for oral solution. It is presented in packages of 30 single-dose sachets.

Marketing Authorization Holder and Manufacturer

Holder

Teva Pharma, S.L.U

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

28108 Alcobendas, Madrid (Spain)

Manufacturer:

Merckle GmbH,

Ludwig-Merckle-Strasse 3

89143 Blaubeuren

Germany

Date of the Last Revision of this Leaflet:January 2014

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

You can access detailed and updated information about this medicine by scanning the QR code included in the packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/63267/P_63267.html

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