Acetylcysteine Stada 600 mg effervescent tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Acetylcysteine Stada 600 mg effervescent tablets EFG

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

Follow exactly the instructions for taking this medicine as described in this leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• 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.
• You should consult a doctor if your condition worsens or if you do not improve after 5 days.

Contents of this leaflet

1. What Acetylcysteine Stada 600 mg is and what it is used for
2. What you need to know before taking Acetylcysteine Stada 600 mg
3. How to take Acetylcysteine Stada 600 mg
4. Possible adverse effects
5. How to store Acetylcysteine Stada 600 mg
6. Contents of the pack and other information

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

Acetylcysteine reduces the viscosity of mucus, liquefies it, and facilitates its elimination. This medicine is indicated to reduce the viscosity of mucous secretions and aid their expulsion in catarrhal and influenza-like conditions in adults over 18 years of age.

You should consult your doctor if you worsen or do not improve after 5 days.

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

Do not take Acetylcysteine Stada 600 mg:

• If you are allergic to acetylcysteine or to any of the other ingredients of this medicine (listed in section 6).
• If you have gastroduodenal ulcer.
• If you have asthma or another severe respiratory insufficiency, as it may increase airway obstruction.

Warnings and precautions

Consult your doctor or pharmacist before taking Acetylcysteine Stada 600 mg.

The possible presence of a slight sulfurous odor does not indicate deterioration of the product, but is characteristic of the active substance.

Taking Acetylcysteine Stada 600 mg with other medicines

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

No interactions or incompatibilities with other medicines have been reported. However, it is recommended that you do not take this medicine concomitantly with antitussives (medicines used to suppress cough) or with medicines that reduce bronchial secretions (e.g. Atropine).

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.

Although animal studies have not shown fetal harm, administration of Acetylcysteine Stada 600 mg during pregnancy is recommended only under medical supervision.

Since it is unknown whether acetylcysteine passes into breast milk, administration of Acetylcysteine Stada 600 mg during breastfeeding is recommended only under medical supervision.

Driving and using machines

No effects on driving or operating machinery have been reported.

Acetylcysteine Stada 600 mg effervescent tablets contain sorbitol, lactose and sodium

This medicine contains 0.13 mg of sorbitol per tablet.

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

This medicine contains 139 mg of sodium (main component of table/cooking salt) per tablet. This corresponds to 6.95% of the maximum daily sodium intake recommended for an adult.

3. How to take Acetylcysteine Stada 600 mg

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

Your doctor will determine the duration of treatment with Acetylcysteine Stada 600 mg. Do not stop treatment prematurely, as doing so may prevent achieving the desired effect.

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

The Acetylcysteine Stada 600 mg tablets are for oral use: place the tablet in a glass containing a small amount of water. This produces a pleasantly flavored solution that can be drunk directly from the glass.

Adults:

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

Use in children and adolescents:

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

If you take more Acetylcysteine Stada 600 mg than you should

Contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number 915 620 420, stating the medicine and the amount taken.

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

Acetylcysteine has been administered to humans at doses up to 500 mg/kg/day without causing adverse effects, making it unlikely that an overdose of this active substance would lead to poisoning.

If you forget to take Acetylcysteine Stada 600 mg

Do not take a double dose to make up for forgotten doses. If you miss a dose, wait until the next scheduled dose. Never take a double dose to compensate for a missed dose.

4. Possible adverse effects

Like all medicines, this medicine may produce adverse effects, although not everyone will experience them.

Occasionally, adverse effects have been reported, which are mild and transient in nature, the most frequent being gastrointestinal (nausea, vomiting, and diarrhoea).

Rarely, hypersensitivity reactions may occur, accompanied by urticaria and bronchospasm; in such cases treatment should be discontinued and medical advice sought.

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 can 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 Stada 600 mg

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 refers to the last day of the month indicated.

Do not store above 30°C.

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

6. Contents of the pack and other information

Composition of Acetylcysteine Stada 600 mg

• The active substance is acetylcysteine. Each tablet contains 600 mg of acetylcysteine.
• The other components (excipients) are: anhydrous citric acid, sodium hydrogen carbonate, anhydrous sodium carbonate, mannitol, anhydrous lactose, ascorbic acid, sodium cyclamate, sodium saccharin dihydrate, disodium citrate dihydrate, and blackberry flavour “B” (contains sorbitol).

Appearance of the product and contents of the pack

Acetylcysteine Stada 600 mg are effervescent tablets, white in colour, round, with a breakline, smooth surface and blackberry odour.

Acetylcysteine Stada 600 mg effervescent tablets are available in packs containing one bottle or in blisters made of laminated aluminium foil containing 20 effervescent tablets.

Only certain pack 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 most recent review of this leaflet: February 2020

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