Prospect: Information for the User

Acetilcisteína Kern Pharma 600 mg Effervescent Tablets

Acetilcisteína

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

Follow exactly the administration instructions for the medicine contained in this prospect or those indicated by your doctor or pharmacist.

- Keep this prospect, as you may need to read it again.

- If you need advice or more information, consult your pharmacist.

- If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

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

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

2. What you need to know before starting to take Acetilcisteína Kern Pharma

3. How to take Acetilcisteína Kern Pharma

4. Possible adverse effects

5. Storage of Acetilcisteína Kern Pharma

6. Contents of the package and additional information

Acetilcisteína, the active ingredient of this medication, belongs to a group of medications called mucolitics, which act by reducing the viscosity of mucus, liquefying it and facilitating its elimination.

This medication 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.

Do not take Acetilcisteína Kern Pharma

- If you are allergic to acetilcisteína, or to any of the other components of this medication (listed in section 6).

- Do not administer to children under 2 years.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Acetilcisteína Kern Pharma.

If you are asthmatic or have a severe respiratory disease, you must consult with your doctor before taking this medication.

The possible sulfurous smell (like rotten eggs) of the medication is due to the active ingredient, but it does not indicate that the medication is in poor condition.

If you experience stomach discomfort while taking the medication, discontinue treatment and consult your doctor or pharmacist. Caution is recommended for patients with peptic ulcers or a history of peptic ulcers.

During the first days of treatment, you may observe an increase in mucus and phlegm, which will decrease over time.

Use of Acetilcisteína Kern Pharma with other medications

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

Concomitant therapy with nitroglycerin may cause headaches and hypotension, which can be severe.

Concomitant administration with the antiepileptic carbamazepine may reduce the efficacy of carbamazepine.

Do not take concurrently with cough medications or those that reduce bronchial secretions (such as antihistamines and anticholinergics), as it may cause a buildup of fluidified mucus.

When taking medications containing minerals such as iron or calcium, or antibiotics like amfotericina B, ampicilina sódica, cefalosporins, lactobionato, eritromicina, and some tetracyclines, you must separate your intake from Acetilcisteina Kern Pharma by at least 2 hours.

Do not dissolve Acetilcisteina Kern Pharma with other medications.

Taking Acetilcisteina Kern Pharma with food, drinks, and alcohol

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

Pregnancy, breastfeeding, and fertility

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

It is recommended to avoid taking this medication during breastfeeding.

Driving and operating machines

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

Acetilcisteína Kern Pharma contains lactose, sodium, and sorbitol.

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 138.83 mg of sodium (main component of table salt/for cooking) in each tablet. This corresponds to 6.94% of the recommended daily maximum sodium intake for an adult.

This medication contains 0.52 mg of sorbitol (E-420) in each tablet.

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

The recommended dose is:

Adults: 1 tablet, once a day. Do not exceed 1 tablet per day.

How to take:

Acetilcisteina 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 a large amount of liquid during the day.

You should consult a doctor if you worsen or do not improve after 5 days of treatment.

Use in children and adolescents

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

If you take more Acetilcisteina Kern Pharma than you should

If you take more Acetilcisteina Kern Pharma than you should, you may notice: nausea, vomiting, heartburn and stomach pain, diarrhea or any other adverse effect described in section 4. Possible adverse 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 medication and the amount taken.

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

If you forgot to take Acetilcisteína Kern Pharma

Do not take a double dose to compensate for the missed dose. Take the missed dose as soon as possible. However, if there is little time left for the next dose, wait until then to continue treatment.

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

If you interrupt treatment with Acetilcisteína Kern Pharma

Do not suspend treatment beforehand, as you will not achieve the desired effect.

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

Like all medications, Acetilcisteína Kern Pharma may produce adverse effects, although not all people will experience them.

The following adverse effects may occur:

Infrequent (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): drowsiness, bronchospasm, respiratory difficulty, digestive discomfort.

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, which may be identified in some cases with the simultaneous use of another medication.

Unknown frequency (cannot be estimated from available data): facial swelling.

In the event of any skin or mucous membrane alteration, discontinue acetilcisteína administration immediately and seek medical assistance.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting adverse 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 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.

Store in the original packaging.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Acetilcisteína Kern Pharma

- The active ingredient 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 aroma (contains sorbitol (E-420)),

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

Appearance of the product and content of the packaging

Acetilcisteína Kern Pharma 600 mg is presented in the form of effervescent tablets, round, white, with a smooth surface and no defects, and with a groove on one face. It is presented in a tube containing 20 effervescent tablets.

Holder of the marketing authorization and responsible for manufacturing

Kern Pharma, S.L.

Venus, 72–Colón II Industrial Estate

08228 Terrassa - Barcelona

Spain

This prospectus was approved in March 2021

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