Acetylcysteine Teva-Ratiopharm 600 mg effervescent tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Acetylcysteine Teva-ratiopharm 600 mg effervescent tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because 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 must not be given to other people, even if they have the same symptoms, as it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

1. What Acetylcysteine Teva-ratiopharm is and what it is used for
2. What you need to know before taking Acetylcysteine Teva-ratiopharm
3. How to take Acetylcysteine Teva-ratiopharm
4. Possible adverse effects
5. How to store Acetylcysteine Teva-ratiopharm
6. Contents of the pack and other information

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

Acetilcisteína Teva-ratiopharm 600 mg is a medicine that belongs to a group of medicines called mucolytics/expectorants.

Acetylcysteine is indicated as an adjunctive treatment in respiratory conditions associated with increased excessive or thick mucus, such as acute and chronic bronchitis, chronic obstructive pulmonary disease (COPD), emphysema, atelectasis due to mucus obstruction, pulmonary complications of cystic fibrosis, and other related disorders.

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

Do not take Acetylcysteine Teva-ratiopharm

• if you are allergic to acetylcysteine or to any of the other ingredients of this medicine (listed in section 6)
• if you have gastrointestinal ulcer,
• if you suffer from asthma or severe respiratory insufficiency,
• if 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's syndrome, temporally associated with acetylcysteine administration, have been reported. If you develop skin or mucosal changes, seek medical advice immediately and stop taking acetylcysteine.

The detection of a sulfur-like odor does not indicate that the preparation is altered; this odor is characteristic of the active substance.

Other medicines and Acetylcysteine Teva-ratiopharm

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

No significant interactions with other medicines or analytical interferences have been described; however, concomitant use with antitussives or medicines that reduce bronchial secretions (e.g., atropine) is not recommended.

Pregnancy and breastfeeding

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

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

Acetylcysteine Teva-ratiopharm contains aspartame, sodium, and sucrose

This medicine contains 20 mg of aspartame per effervescent tablet. Aspartame is a source of phenylalanine, which may be harmful in patients with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot properly eliminate it.

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

This medicine contains sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Acetilcisteína Teva-ratiopharm

Follow exactly the administration instructions given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Acetilcisteína Teva-ratiopharm is for oral use.

Remember to take your medicine.

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

Do not stop treatment before consulting your doctor.

The usual dose is:

Adults and children over 7 years old: 600 mg daily administered as one daily dose (600 mg) or divided into three doses (200 mg) every 8 hours.

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

In children under 7 years of age, for better dose adjustment, use of Acetilcisteína Teva-ratiopharm 200 mg powder for oral solution is recommended.

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

Cystic fibrosis

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

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

For this indication, to allow better dose adjustment, use of Acetilcisteína Teva-ratiopharm 200 mg powder for oral solution is recommended.

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

Dissolve the effervescent tablet in a glass of water; this produces a pleasantly flavored solution that can be drunk directly from the glass. The tablet is not intended to be divided into equal parts.

If you take more Acetilcisteína Teva-ratiopharm than you should

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

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

If you forget to take Acetilcisteína Teva-ratiopharm

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

4. Possible adverse effects

Like all medicines, this medicine may produce adverse effects, although not everyone experiences 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 diarrhoea

Skin and subcutaneous tissue disorders

Very rare: hypersensitivity reactions accompanied by urticaria

Respiratory, thoracic and mediastinal disorders

Rare: dyspnoea (difficulty breathing), bronchospasm (especially in patients with hyperreactive bronchial systems such as bronchial asthma)

Reporting of 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 may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: http://www.notificaram.es/. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Acetylcysteine Teva-ratiopharma

Keep this medicine out of sight and reach of children.

Do not use Acetylcysteine Teva-ratiopharm after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 25 °C.

Keep in the original packaging to protect from moisture.

Keep the container tightly closed.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point at your pharmacy. If you are in doubt, please ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Acetylcysteine Teva-ratiopharm 600 mg effervescent tablets EFG

• The active substance is acetylcysteine. Each effervescent tablet contains 600 mg of acetylcysteine.

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

Appearance of the medicine and contents of the pack

Acetylcysteine Teva-ratiopharm 600 mg are white to slightly yellowish, round, biconvex effervescent tablets with a groove on one side and a lemon odour. The tablet is not intended to be divided into equal parts.

Each pack contains 20 effervescent tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Teva Pharma, S.L.U.

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

28108 Alcobendas, Madrid (Spain)

Manufacturer:

Merckle GmbH

Ludwig Merckle Strasse, 3

D-89143 Blaubeuren

Germany

Date of the most recent review of this summary: January 2014

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included on the packaging. You may also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/63268/P_63268.html