Acetylcysteine Teva-Ratiopharm 200 mg powder for oral solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Acetylcysteine Teva-ratiopharm 200 mg powder for oral solution EFG

Read the entire 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, ask 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 may 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 side 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

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

Acetylcysteine is indicated as adjunctive treatment in respiratory conditions characterized by increased mucus production 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 conditions.

2. What you need to know before starting to take 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
• 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 in temporal association with the administration of acetylcysteine. If you experience skin changes or mucosal lesions, seek medical advice immediately and discontinue taking acetylcysteine.

Never take a medication on your own initiative without a recommendation from your doctor.

The presence of a sulfur-like odor does not indicate that the product is degraded; this odor is characteristic of the active substance.

Other medicines and Acetylcysteine Teva-ratiopharm

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

No significant interactions with other medicines or analytical interferences have been reported. However, concomitant use with antitussives or with 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 done under medical supervision.

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

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

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

This medicine contains glucose and lactose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per sachet; therefore, it is essentially “sodium-free”.

3. How to take Acetylcysteine Teva-ratiopharm

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

Acetylcysteine Teva-ratiopharm is for oral use.

Remember to take your medicine.

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

Do not stop treatment before consulting your doctor.

The usual dose is:

Adults and children over 7 years of age: 600 mg per day, either as a single daily dose of 3 sachets (600 mg) or divided into three doses of 1 sachet (200 mg) every 8 hours.

Children from 2 to 7 years of age: 300 mg per day, divided into three 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 produces a pleasantly flavored solution that can be drunk directly from the glass.

If you take more Acetylcysteine 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, stating the name of the medicine and the amount ingested.

If you forget to take Acetylcysteine Teva-ratiopharm:

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

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

4. Possible adverse effects

Like other 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 (acouphenes)

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it involves possible adverse effects not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Acetylcysteine Teva-ratiopharm

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry 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. Dispose of empty containers and unused medicines at the SIGRE collection point in your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Acetilcistetina Teva-ratiopharm 200 mg powder for oral solution EFG

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

Appearance of the medicine and contents of the pack

Acetilcistetina Teva-ratiopharm 200 mg is a powder for oral solution. It is supplied in packs of 30 single-dose sachets.

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

89143 Blaubeuren

Germany

Date of the most recent revision of this leaflet: January 2014

“Detailed 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 on this medicine by scanning with your mobile phone (smartphone) the QR code included in the packaging. 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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