Package Insert: Information for the User

Acetilcisteína Stada 600 mg Effervescent Tablets EFG

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

Follow exactly the administration instructions contained in this package insert or those provided by your doctor or pharmacist.

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

Acetilcisteína works by reducing the viscosity of mucus, liquefying it and facilitating its elimination. This medication is indicated to reduce the viscosity of mucous secretions, facilitating their expulsion, in catarrhal and influenza-like processes in adults over 18 years old.

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

Do not take Acetilcisteína Stada 600 mg:

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

Warnings and precautions

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

The possible presence of a mild sulfurous odor does not indicate alteration of the preparation, but is a characteristic of the active ingredient.

Taking Acetilcisteína Stada 600 mg with other medications

Inform your doctor or pharmacist if you are using, have used recently, 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 coughs) or with medications that decrease bronchial secretions (e.g. Atropine).

Pregnancy and breastfeeding

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

Although animal studies have not shown fetal damage, it is recommended to administer Acetilcisteína Stada 600 mg under medical supervision during pregnancy.

Since the passage of acetilcisteína to breast milk is unknown, it is recommended to administer Acetilcisteína Stada 600 mg under medical supervision during breastfeeding.

Driving and operating machines

No effects have been described.

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 indicated 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/for cooking) in each tablet. This is equivalent to 6.95% of the maximum daily sodium intake recommended for an adult.

Follow exactly the administration instructions for this medication as indicated in this leaflet or by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

Your doctor will inform you of the duration of treatment with Acetilcisteína Stada 600 mg. Do not discontinue treatment prematurely, as this may prevent the desired effect from being achieved.

If you estimate that the action of Acetilcisteína Stada 600 mg is too strong or too weak, inform your doctor or pharmacist.

Acetilcisteína Stada 600 mg tablets are for oral administration by introducing the tablet into a glass with a small amount of water. This results in a pleasant-tasting solution that can be drunk directly from the glass.

Adults:

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

Use in children and adolescents:

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

If you take more Acetilcisteína Stada 600 mg than you should

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

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

Acetilcisteine has been administered to humans at doses of up to 500 mg/Kg/day without causing side effects, making it possible to exclude the possibility of intoxication due to overdose of this active principle.

If you forgot to take Acetilcisteína Stada 600 mg

Do not take a double dose to compensate for the missed dose. If a dose is forgotten, wait for the next one. However, do not take double doses to compensate for the missed dose.

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

Occasionally, adverse effects of a mild and transient nature have been described, the most frequent being gastrointestinal (nausea, vomiting, and diarrhea).

Rarely, hypersensitivity reactions occur, accompanied by urticaria and bronchospasms, in which case it is recommended to interrupt treatment and consult a doctor.

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: http://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.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

C omposition 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, citric acid dihydrate, and "B" blackberry flavor (contains sorbitol).

Appearance of the product and contents of the packaging

Acetilcisteína Stada 600 mg are effervescent tablets, white in color, round, with a groove, smooth, and with a blackberry odor.

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

Only some packaging sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for manufacturing:

HERMES PHARMA GmbH

Hans-Urmiller-Ring 52

82515 Wolfratshausen

Germany

Last review date of this leaflet: February 2020

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/