ACETYLCYSTEINE KERN PHARMA 600 mg EFFERVSCENT TABLETS

Introduction

Package Leaflet: Information for the User

Acetilcisteína Kern Pharma 600 mg Effervescent Tablets

Acetilcisteína

Read this package leaflet carefully before starting to take 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, 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 it is a side effect not listed in this package leaflet. See section 4.

Should you consult a doctor if it worsens or does not improve after 5 days.

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

Contents of the package leaflet:

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

1. What is Acetilcisteína Kern Pharma and what is it used for

Acetilcisteína, the active substance of this medicine, belongs to a group of medicines called mucolytics, which act 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.

Should consult a doctor if it worsens or does not improve after 5 days.

2. What you need to know before taking Acetilcisteína Kern Pharma

Do not take Acetilcisteína Kern Pharma

• If you are allergic to acetilcisteína 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 Acetilcisteína Kern Pharma.

If you are asthmatic or suffer from 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 substance, 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 observe an increase in mucus and phlegm, which will decrease throughout the treatment.

Use of Acetilcisteína Kern Pharma 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 Acetilcisteína Kern Pharma by at least 2 hours.

It is not recommended to dissolve Acetilcisteína Kern Pharma with other medicines.

Taking Acetilcisteína Kern Pharma with food, drinks, and alcohol

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.

Its intake should be avoided during breastfeeding.

Driving and using machines

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

Acetilcisteína Kern Pharma contains lactose, sodium, and sorbitol.

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

This medicine contains 138.83 mg of sodium (main component of table/cooking salt) per tablet. This is equivalent to 6.94% of the maximum daily sodium intake recommended for an adult.

This medicine contains 0.52 mg of sorbitol (E-420) per tablet.

3. How to take Acetilcisteína Kern Pharma

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

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

How to take:

Acetilcisteína Kern Pharma 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.

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

Use in children and adolescents

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

If you take more Acetilcisteína Kern Pharma than you should

If you take more Acetilcisteína Kern Pharma than you should, you may notice: nausea, vomiting, heartburn, 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 Toxicological 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.

If you forget to take Acetilcisteína Kern Pharma

Do not take a double dose to make up for forgotten doses. Take the forgotten dose as soon as possible. However, if it is close to the time for the next dose, wait until then to continue treatment.

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

If you stop taking Acetilcisteína Kern Pharma

Do not stop treatment prematurely, as you will not achieve the expected effect.

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

4. Possible side effects

Like all medicines, Acetilcisteína Kern Pharma 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, tinnitus, 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 intake of another drug.

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

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

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if it is a side effect not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Health 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 Acetilcisteína Kern Pharma

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

Do not take Acetilcisteína Kern Pharma after the expiration date indicated on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not store above 30°C.

Keep in the original packaging.

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

6. Contents of the pack and further information

Composition of Acetilcisteína Kern Pharma

• The active substance is acetilcisteína. Each tablet contains 600 mg of acetilcisteína.

The other components (excipients) are: anhydrous citric acid (E-330), ascorbic acid (E-300), sodium hydrogen carbonate (E-500), anhydrous sodium carbonate (E-500), anhydrous lactose, mannitol (E-421), lemon flavor (contains sorbitol (E-420)),

• sodium cyclamate, sodium saccharin (E-954), sodium citrate dihydrate (E-331).

Appearance of the product and contents of the pack

Acetilcisteína Kern Pharma 600 mg is presented in the form of round, white, effervescent tablets with a smooth surface and no defects, and with a score line on one side. They are presented in a tube containing 20 effervescent tablets.

Marketing authorization holder and manufacturer

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

This package leaflet was approved in March 2021

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