Package Insert: Information for the Patient

Acetilcisteína Normon600 mg Dispersible Tablets EFG

Read this package insert carefully before taking this medicine, as it contains important information for you.

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

Acetilcisteína, the active ingredient of this medication,belongs to a group of medications called mucolitics and is used to thin out excessive and/or thick bronchial secretions.

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

Do not take Acetilcisteína Normon

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Acetilcisteína Normon:

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. Caution is recommended in 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.

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

Children

It is contraindicated in children under 2 years.

Other medications and Acetilcisteína Normon

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

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

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

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

When taking medications containing minerals such as iron or calcium, or antibiotics such as amfotericin B, ampicillin sodium, cephalosporins, lactobionate, erythromycin, and some tetracyclines, you should separate your intake of acetilcisteína by at least 2 hours.

Do not dissolve acetilcisteína with other medications.

TakingAcetilcisteína Normonwith food and drinks

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

Pregnancy and lactation

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

It should be avoided during lactation.

Driving and operating machines

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

Acetilcisteína Normoncontains aspartame

This medication contains 35 mg of aspartame in each tablet.

Aspartame contains a source of phenylalanine that may be harmful in cases of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates due to the body's inability to eliminate it correctly.

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 dispersible tablets must be dissolved in a glass of water, and must be ingested when they have completely dissolved. It is recommended to drink an abundant amount of liquid throughout the day.

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

Use in children

Children between 2 and 7 years old:

The 600 mg dose is not recommended.

There are other formulations that are more suitable for administering to this population.

It is contraindicated in children under 2 years old.

If you take more Acetilcisteína Normonthan you should

If you take more acetilcisteína than you should, you may experience: 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 immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

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

Like all medications, this medication may produce adverse effects, although not all people may experience them.

The following adverse effects may occur:

Rare (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.

Uncommon (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, sometimes identified with the simultaneous use of another medication.

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

In the event of any skin or mucous membrane alteration, discontinue acetilcysteine 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 a possible adverse effect not listed in this prospectus. You may also report them directly through the Spanish System for Pharmacovigilance of Medications 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.

This medication does not require special conservation conditions.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition of Acetilcisteína Normon

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

Appearance of the product and content of the packaging

Acetilcisteína Normon600 mg are white or almost white, round, flat, and bisected dispersible tablets.

Acetilcisteína Normonis presented in blister packs of 20 or 30 dispersible tablets.

Only some sizes of packaging may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing:

LABORATORIOS NORMON, S.A.

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

Date of the last review of this leaflet: April 2021

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

You can access detailed and updated information about this medicine by scanning the QR code included in the 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