ACETYLCYSTEINE GENKERN 600 mg EFFERVSCENT TABLETS

Introduction

Package Leaflet: Information for the User

Acetylcysteine Genkern 600 mg Effervescent Tablets

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

Follow exactly the administration instructions of the medicine contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package leaflet, 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 it worsens or does not improve after 5 days.

Contents of the Package Leaflet

1. What is Acetylcysteine Genkern and what is it used for
2. What you need to know before taking Acetylcysteine Genkern
3. How to take Acetylcysteine Genkern
4. Possible side effects
5. Storage of Acetylcysteine Genkern
6. Contents of the pack and further information

1. What is Acetylcysteine Genkern and what is it used for

Acetylcysteine belongs to a group of medicines called mucolytics, which work by decreasing the viscosity of mucus, making it more fluid and facilitating its elimination.

This medicine is indicated to facilitate the elimination of excess mucus and phlegm, in colds and flu, for adults.

You should consult a doctor if it worsens or does not improve after 5 days of treatment.

2. What you need to know before taking Acetylcysteine Genkern

Do not take Acetylcysteine Genkern:

• If you are allergic to acetylcysteine or to any of the other components of this medicine (listed in section 6).
• Do not administer to children under 2 years of age.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine.

If you have asthma or a severe respiratory disease, you should consult your doctor before taking this medicine.

The possible sulfurous odor (like rotten eggs) of the medicine is characteristic of the active ingredient, but it does not indicate that the medicine is in poor condition.

If you experience stomach discomfort when taking the medicine, stop treatment and consult your doctor or pharmacist. Caution is recommended in patients with peptic ulcer or history of peptic ulcer.

During the first days of treatment, you may notice an increase in mucus and phlegm, which will decrease throughout the treatment.

Children and adolescents

Children and adolescents should not take this medicine. There are other presentations more suitable for this population.

Taking Acetylcysteine Genkern with other medicines

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

Concomitant therapy with nitroglycerin may produce headache and hypotension should be monitored, which can be severe.

Concomitant administration with the antiepileptic carbamazepine may cause a decrease in the efficacy of carbamazepine.

Do not take concomitantly with antitussive medicines (for cough) or with those that decrease bronchial secretions (such as antihistamines and anticholinergics), as it may cause an accumulation of fluidified mucus.

When taking any medicine that contains minerals such as iron or calcium, or any medicine with antibiotics such as (amphotericin B, ampicillin sodium, cephalosporins, lactobionate, erythromycin, and some tetracyclines), you should separate the intake of this medicine from the intake of that medicine by at least 2 hours.

It is not recommended to dissolve this medicine with other medicines.

Taking Acetylcysteine Genkern with food and drinks

The intake of food and drinks does not affect the efficacy of this medicine.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

It should not be taken during breastfeeding.

Driving and using machines

There is no evidence of effects on the ability to drive and use machines.

Acetylcysteine Genkern contains sodium and sorbitol (E-420)

This medicine contains 356.8 mg of sodium (main component of table salt/cooking salt) in each effervescent tablet. This is equivalent to 17.8% of the maximum daily sodium intake recommended for an adult.

This medicine contains 695 mg of sorbitol in each effervescent tablet. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to certain sugars, or have been diagnosed with an intolerance to certain sugars, or have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disease in which the patient cannot break down fructose, consult your doctor before taking this medicine.

3. How to take Acetylcysteine Genkern

Follow exactly the administration instructions of the medicine contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.

The recommended dose is:

Adults: 1 tablet, 1 time a day. Do not exceed the dose of 1 tablet per day.

How to take:

This medicine is taken orally.

Dissolve in a glass of water, do not drink until the effervescence has completely stopped. It is recommended to drink plenty of liquid throughout the day.

You should consult a doctor if it worsens or does not improve after 5 days of treatment.

Use in children and adolescents

Children and adolescents should not take this medicine. There are other presentations more suitable for this population.

If you take more Acetylcysteine Genkern than you should

If you take more acetylcysteine than you should, you may notice: nausea, vomiting, burning and stomach pain, diarrhea, or any other side effect described in section 4. Possible side effects.

In case of overdose or accidental ingestion, consult your doctor or pharmacist, or call the Toxicology Information Service, phone: 91.562.04.20, indicating the medicine and the amount taken.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects may occur:

Uncommon (may affect up to 1 in 100 patients): hypersensitivity, headache, ringing in the ears, tachycardia, vomiting, diarrhea, stomatitis, abdominal pain, nausea, urticaria, skin rash, angioedema, pruritus, increased body temperature, hypotension.

Rare (may affect up to 1 in 1,000 patients): somnolence, bronchospasm, respiratory distress, gastrointestinal disorders.

Very rare (may affect up to 1 in 10,000 patients): allergic reactions, anaphylactic shock, hemorrhage, severe skin reactions such as Stevens-Johnson syndrome and Lyell syndrome, sometimes identified with the concomitant use of another medicine.

Frequency not known (cannot be estimated from the available data): facial swelling.

In case of any alteration in the skin or mucous membranes, the administration of acetylcysteine should be interrupted immediately and medical assistance should be sought.

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Acetylcysteine Genkern

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

This medicine does not require any special storage temperature. Keep in the original packaging to protect it from light.

Do not use this medicine after the expiration date stated on the packaging after EXP. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines that are no longer needed in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and further information

The active ingredient is acetylcysteine. Each effervescent tablet contains 600 mg of acetylcysteine.

The other components (excipients) are: Ascorbic acid, sodium carbonate, sodium hydrogen carbonate, citric acid, sorbitol (E-420), macrogol, sodium citrate, sodium saccharin, and lemon flavor.

Appearance of the product and contents of the pack

The effervescent tablets are round, white, and approximately 25 mm in diameter.

Acetylcysteine Genkern is packaged in four-layer laminated paper bags (paper/polyethylene/aluminum/ionomer) in a hermetically sealed strip in boxes of 20 effervescent tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa – Barcelona

Spain

Manufacturer:

PharmaEstica Manufacturing OÜ

Vanapere tee 3, Pringi küla, Viimsi Vald,

74011 Harju Maakond,

Estonia

Date of the last revision of this package leaflet: October 2024

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