Acetylcysteine Kern Pharma 600 mg effervescent tablets

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Acetylcysteine Kern Pharma 600 mg effervescent tablets

Acetylcysteine

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

Follow exactly the instructions for administration of the medicine contained 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 effects, consult your doctor or pharmacist, even if they are

adverse effects not listed in this leaflet. See section 4.

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

Contents of the leaflet:

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

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

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

This medicine is indicated to help eliminate excess mucus and phlegm in colds and flu, for adults.

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

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

Do not take Acetylcysteine Kern Pharma

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Acetylcysteine Kern Pharma.

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

The possible sulfur-like odor (resembling rotten eggs) of the medicine is characteristic of the active substance and does not indicate that the medicine is in poor condition.

If you experience stomach discomfort after taking the medicine, discontinue treatment and consult your doctor or pharmacist. Caution is advised 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 gradually decrease over the course of treatment.

Use of Acetylcysteine Kern Pharma with other medicines

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

Concomitant therapy with nitroglycerin may cause headache, and the occurrence of hypotension—which may be severe—should be monitored.

Concomitant administration with the antiepileptic carbamazepine may lead to a reduction in carbamazepine efficacy.

Do not take simultaneously with antitussive medicines (for cough) or with those that reduce bronchial secretions (such as antihistamines and anticholinergics), as this may cause accumulation of liquefied mucus.

When taking medicines containing minerals such as iron or calcium, or medicines containing antibiotics such as amphotericin B, sodium ampicillin, cephalosporins, lactobionate, erythromycin, and some tetracyclines, administration should be separated from that of Acetylcysteine Kern Pharma by at least 2 hours.

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

Taking Acetylcysteine Kern Pharma with food, drinks, and alcohol

Taking food and drinks does not affect the effectiveness of this medicine.

Pregnancy, breastfeeding, and fertility

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.

Its use should be avoided during breastfeeding.

Driving and using machines

There is no evidence of effects on the ability to drive or operate machinery.

Acetylcysteine Kern Pharma contains lactose, sodium, and sorbitol.

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

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

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

3. How to take Acetylcysteine Kern Pharma

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

The recommended dose is:

Adults: 1 tablet, once daily. Do not exceed the dose of 1 tablet per day.

How to take:

Acetylcysteine Kern Pharma is taken orally.

Dissolve in a glass of water; do not drink until effervescence has completely stopped. It is advisable to drink plenty of fluids throughout the day.

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

Use in children and adolescents

Children and adolescents must not take this medicine. There are other formulations more suitable for this population.

If you take more Acetylcysteine Kern Pharma than you should

If you take more Acetylcysteine Kern Pharma than you should, you may experience: nausea, vomiting, stomach burning and 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 Toxicology Information Service at telephone number: 91.562.04.20, indicating the medicine and the amount taken.

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

If you forget to take Acetylcysteine Kern Pharma

Do not take a double dose to make up for forgotten doses. Take the missed dose as soon as possible. However, if it is almost time for your next dose, wait until then and continue with your regular schedule.

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

If you stop treatment with Acetylcysteine Kern Pharma

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

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

4. Possible adverse effects

Like all medicines, Acetylcysteine Kern Pharma may cause adverse effects, although not everyone will experience them.

The following adverse effects may occur:

Uncommon (may affect up to 1 in 100 patients): hypersensitivity, headache, tinnitus, tachycardia, vomiting, diarrhoea, 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, breathing difficulty, gastrointestinal discomfort.

Very rare (may affect up to 1 in 10,000 patients): allergic reactions, anaphylactic shock, haemorrhage, severe skin reactions such as Stevens-Johnson syndrome and Lyell's syndrome, occasionally identified with concomitant intake of another medicinal product.

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

If any changes occur in the skin or mucous membranes, administration of acetylcysteine must be stopped immediately 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 an adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Acetylcysteine Kern Pharma

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

Do not use Acetylcysteine Kern Pharma 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.

Keep in the original packaging.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their packaging to your pharmacy’s SIGRE point. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the container and additional information

Composition of Acetylcysteine Kern Pharma

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

• 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 flavour (containing sorbitol (E-420)),
  sodium cyclamate, sodium saccharin (E-954), disodium citrate dihydrate (E-331).

Appearance of the product and contents of the container

Acetylcysteine Kern Pharma 600 mg is presented as effervescent tablets, round, white, with a smooth surface and no defects, and with a score on one side. It is supplied in a bottle containing 20 effervescent tablets.

Marketing Authorization Holder and Manufacturer

Kern Pharma, S.L.
Venus, 72 – Pol. Ind. Colón II
08228 Terrassa - Barcelona
Spain

This leaflet was approved in March 2021

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