Acetylcysteine Normon 600 mg Dispersible Tablets

Introduction

Package Leaflet: Information for the Patient

Acetilcisteína Normon600 mg dispersible tablets EFG

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

• Keep this package leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, as it may harm them, even if they have the same symptoms as you.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

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

1. What is Acetilcisteína Normon and what is it used for

Acetilcisteína, the active substance of this medicine, belongs to a group of medicines called mucolytics and is used to thin out excessive and/or thick bronchial secretions.

Acetilcisteína Normon is indicated to facilitate the elimination of excess mucus and phlegm in respiratory processes with excessive or thick mucous secretion, such as acute and chronic bronchitis, chronic obstructive pulmonary disease (COPD), emphysema, pulmonary complications of fibrosis, and other related conditions.

2. What you need to know before taking Acetilcisteína Normon

Do not take Acetilcisteína Normon

• If you are allergic to acetilcisteína or 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

Consult your doctor or pharmacist before taking Acetilcisteína Normon:

If you are asthmatic or have 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 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. Caution is recommended in patients with peptic ulcer or history of peptic ulcer.

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

It should be administered with caution in long-term treatment in patients with histamine intolerance.

Children

It is contraindicated in children under 2 years of age.

Other Medicines and Acetilcisteína Normon

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicine.

Concomitant therapy with nitroglycerin may cause 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 those that decrease bronchial secretions (such as antihistamines and anticholinergics), as it may cause an accumulation of thinned 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 from the intake of these medicines by at least 2 hours.

Dissolving acetilcisteína with other medicines is not recommended.

Taking Acetilcisteína Normon with Food and Drinks

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

Pregnancy and Breastfeeding

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 use should be avoided during breastfeeding.

Driving and Using Machines

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

Acetilcisteína Normon contains Aspartame

This medicine contains 35 mg of aspartame in each tablet.

Aspartame is a source of phenylalanine, which may be harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it properly.

3. How to Take Acetilcisteína Normon

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 dispersible tablets should be dissolved in a glass of water and ingested when they have dissolved completely. It is recommended to drink plenty of liquid throughout the day.

The recommended daily dose for adults and children over 7 years is 600 mg of acetilcisteína, 1 tablet of Acetilcisteína Normon 600 mg once a day (600 mg of acetilcisteína once a day), or 3 doses of 200 mg every 8 hours (for this last option, other formulations are more suitable) without exceeding the daily dose of 600 mg.

Use in Children

Children between 2 and 7 years:

The dose of 600 mg is not recommended.

Other formulations are more suitable for administering to this population.

It is contraindicated in children under 2 years of age.

If you Take More Acetilcisteína Normon than you Should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

If you have any further questions 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, 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 use of another drug.

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

If you experience any skin or mucous membrane disorders, you should immediately stop taking acetilcisteína and seek medical attention.

Reporting of Side Effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are 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 Normon

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

This medicine does not require any special storage conditions.

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

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Contents of the Pack and Further Information

Composition of Acetilcisteína Normon

• The active substance is Acetilcisteína. Each dispersible tablet contains 600 mg of acetilcisteína.
• The other ingredients (excipients) are: microcrystalline cellulose, hydroxypropylcellulose (E-463), crospovidone, aspartame (E-951), calcium carbonate (E-170), lemon flavor, orange flavor, and magnesium stearate.

Appearance and Packaging of the Product

Acetilcisteína Normon 600 mg are white or almost white, round, flat, and beveled dispersible tablets.

Acetilcisteína Normon is available in blister packs of 20 or 30 dispersible tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of the Last Revision of this Package Leaflet: April 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/

You can access detailed and updated information about this medicine by scanning the QR code included in the package leaflet and packaging with your smartphone.

You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/85923/P_85923.html