


Ask a doctor about a prescription for ACETYLCYSTEINE STADA 600 mg EFFERVSCENT TABLETS
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.
Contents of the Package Leaflet
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.
Do not take Acetilcisteína Stada 600 mg:
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.
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:
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.
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.
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.
Composition of Acetilcisteína Stada 600 mg
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
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/
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