ACETYLCYSTEINE STADA 600 mg EFFERVSCENT TABLETS

Introduction

Package Leaflet: Information for the User

Acetilcisteína Stada 600 mg Effervescent Tablets EFG

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

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 5 days.

Contents of the Package Leaflet

1. What is Acetilcisteína Stada 600 mg and what is it used for
2. What you need to know before taking Acetilcisteína Stada 600 mg
3. How to take Acetilcisteína Stada 600 mg
4. Possible side effects
5. Storage of Acetilcisteína Stada 600 mg
6. Package Contents and Additional Information

1. What is Acetilcisteína Stada 600 mg and what is it used for

Acetilcisteína acts by decreasing the viscosity of mucus, making it more fluid and easier to eliminate. This medication is indicated to reduce the viscosity of mucous secretions, making them easier to expel, in catarrhal and flu-like processes in adults over 18 years of age.

You should consult your doctor if your condition worsens or does not improve after 5 days.

2. What you need to know before taking Acetilcisteína Stada 600 mg

Do not take Acetilcisteína Stada 600 mg:

• If you are allergic to acetilcisteína or any of the other components of this medication (listed in section 6).
• If you have a gastroduodenal ulcer.
• If you have asthma or other severe respiratory insufficiency, as it may increase respiratory tract obstruction.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Acetilcisteína Stada 600 mg.

The possible presence of a slight sulfurous odor does not indicate that the preparation has been altered, but is rather a characteristic of the active ingredient.

Taking Acetilcisteína Stada 600 mg with other medications

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

No interactions or incompatibilities with other medications have been detected, although it is recommended that you do not take this medication with antitussives (medications used to calm cough) or medications that decrease bronchial secretions (e.g., 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 medication.

Although studies conducted in animals have not shown potential fetal harm, it is recommended to administer Acetilcisteína Stada 600 mg under medical supervision during pregnancy.

Since it is unknown whether acetilcisteína passes into breast milk, it is recommended to administer Acetilcisteína Stada 600 mg under medical supervision during breastfeeding.

Driving and Using Machines

No effects have been described in this regard.

Acetilcisteína Stada 600 mg Effervescent Tablets contain sorbitol, lactose, and sodium

This medication contains 0.13 mg of sorbitol in each tablet.

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

This medication contains 139 mg of sodium (main component of table salt) in each tablet. This is equivalent to 6.95% of the maximum recommended daily sodium intake for an adult.

3. How to take Acetilcisteína Stada 600 mg

Follow the administration instructions for this medication indicated in this package leaflet or by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

Your doctor will indicate the duration of treatment with Acetilcisteína Stada 600 mg. Do not stop treatment before completing it, as you may not achieve the desired effect.

If you think the effect of Acetilcisteína Stada 600 mg is too strong or too weak, inform your doctor or pharmacist.

The Acetilcisteína Stada 600 mg tablets are for oral administration, introducing the tablet into a glass with a little water. This will produce a pleasant-tasting solution that can be drunk directly from the glass.

Adults:

The recommended dose is 600 mg of acetilcisteína, i.e., 1 effervescent tablet of Acetilcisteína Stada 600 mg per day.

Use in Children and Adolescents:

• This medication is not recommended for children under 18 years of age.

If you take more Acetilcisteína Stada 600 mg than you should

Consult your doctor, pharmacist, or call the Toxicology Information Service, phone 915 620 420, indicating the medication and the amount taken.

It is recommended to bring the package and package leaflet of the medication to the healthcare professional.

Acetilcisteína has been administered to humans at doses of up to 500 mg/Kg/day without causing side effects, so it is possible to rule out the possibility of intoxication due to overdose of this active ingredient.

If you forget to take Acetilcisteína Stada 600 mg

Do not take a double dose to make up for forgotten doses. In case of forgetting a dose, wait for the next one. But do not take double doses to make up for the forgotten dose.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Occasionally, mild and transient side effects have been described, with the most frequent being gastrointestinal (nausea, vomiting, and diarrhea).

Rarely, hypersensitivity reactions have been reported, accompanied by urticaria and bronchospasm, in which case it is recommended to interrupt treatment and consult a doctor.

Reporting Side Effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System: http://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Acetilcisteína Stada 600 mg

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

Do not use this medication after the expiration date shown on the package after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

Medications should not be disposed of through wastewater or household waste. Deposit the packages and medications you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packages and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Acetilcisteína Stada 600 mg

• The active ingredient is acetilcisteína. Each tablet contains 600 mg of acetilcisteína.
• The other components (excipients) are: anhydrous citric acid, sodium hydrogen carbonate, anhydrous sodium carbonate, mannitol, anhydrous lactose, ascorbic acid, sodium cyclamate, sodium saccharin dihydrate, sodium citrate dihydrate, and blackberry flavor "B" (contains sorbitol).

Appearance of the Product and Package Contents

Acetilcisteína Stada 600 mg are effervescent tablets, white, round, with a score line, smooth, and with a blackberry odor.

Acetilcisteína Stada 600 mg effervescent tablets are available in packages with a tube or in laminated aluminum paper strips containing 20 effervescent tablets.

Only certain package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer:

HERMES PHARMA GmbH

Hans-Urmiller-Ring 52

82515 Wolfratshausen

Germany

Date of the Last Revision of this Package Leaflet: February 2020

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/