Leaflet: information for the user

Acetilcisteína Teva-ratiopharm 200 mg powder for oral solution EFG

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

• Keep this leaflet. 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 other people, 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 Teva-ratiopharm is and what it is used for

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

3. How to take Acetilcisteína Teva-ratiopharm

4. Possible side effects

5. Storage of Acetilcisteína Teva-ratiopharm

6. Contents of the pack and additional information

Acetilcisteína is a medication that belongs to the group of mucolytic/expectorant medications.

Acetilcisteína is indicated as a complementary treatment in respiratory processes that are accompanied by an increase in mucus or thick mucus such as acute and chronic bronchitis, chronic obstructive pulmonary disease (COPD), emphysema, atelectasis due to mucosal obstruction, pulmonary complications of cystic fibrosis and other related pathologies.

Do not take Acetilcisteína Teva-ratiopharm:

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

Warnings and precautions

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

Severe skin reactions such as Stevens-Johnson syndrome and Lyell syndrome have been rarely reported, associated in time with the administration of acetilcisteína. If you produce skin or mucous membrane changes, you should obtain medical advice quickly and stop taking acetilcisteína.

You should never take a medication on your own initiative without your doctor's recommendation.

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 Teva-ratiopharm

Inform your doctor or pharmacist if you are using, have used recently, or may have 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 with medications that decrease bronchial secretions (atropine)

Pregnancy and lactation

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

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

Acetilcisteína Teva-ratiopharm contains saccharose, glucose, lactose, and sodium.

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

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

This medication contains glucose and lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.

This medication contains less than 1 mmol of sodium (23 mg) per dose; that is, it is essentially "sodium-free".

Follow the administration instructions for this medication 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 medication.

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

Do not discontinue 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 three doses of 1 sachet (200 mg) every 8 hours.

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

Do not administer this medication 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 aged 2 to 7 years: 1 to 2 sachets (200-400 mg) every 8 hours.

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

Dissolve the contents of the sachet in a glass of water and shake until completely dissolved. In this way, a pleasant-tasting solution is obtained 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 Toxicological Information Service, Telephone (91) 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Acetilcisteína Teva-ratiopharm:

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

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

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

Immune System Disorders

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

Respiratory, Thoracic, and Mediastinal Disorders

Rare: dyspnea (difficulty breathing), 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 Medicines for Human Use: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not use this medication 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 30 °C.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE 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 Teva-ratiopharm 200 mg powder for oral solution EFG

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

Appearance of the product and contents of the packaging

Acetilcistetina Teva-ratiopharm 200 mg is an oral powder solution. It is presented in packs of 30 single-dose sachets.

Holder of the marketing authorization and responsible manufacturer

Holder

Teva Pharma, S.L.U

c/ AnabelSegura 11, Edificio Albatros B 1st floor

28108 Alcobendas, Madrid (Spain)

Responsible manufacturer:

Merckle GmbH,

Ludwig-Merckle-Strasse 3

89143 Blaubeuren

Germany

Last review date of this leaflet:January 2014

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

You can access detailed and updated information on this medicine by scanning the QR code included in the carton 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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