Package Insert: Information for the Patient

Normofludil®Forte 600 mg Dispersible Tablets
Acetylcysteine

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

Follow exactly the administration instructions contained in this package insert or those indicated by your doctor or pharmacist.

• Keep this package insert, as you may need to refer to 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 not listed in this package insert. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 5 days.

Acetilcisteine, the active ingredient of this medication, belongs to a group of medications called mucolytics, 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 Normofludil forte

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Normofludil forte.

• If you are asthmatic or have a severe respiratory disease, you must consult 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 spoiled.
• If you experience stomach discomfort while taking the medication, you should discontinue treatment and consult your doctor or pharmacist.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.

Children and adolescents

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

Other medications and Normofludil forte

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take 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 reduce the efficacy of carbamazepine.

Do not administer concomitantly with cough medications or those that reduce 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 amphotericin B, ampicillin sodium, cephalosporins, lactobionate, erythromycin, and some tetracyclines, you should separate your intake from Normofludil forte by at least 2 hours.It is not recommended to dissolve Normofludil forte with other medications.

Taking Normofludil forte with food and beverages

The intake of food and beverages 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 is recommended to avoid taking this medication during lactation.

Driving and operating machinery

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

Normofludil forte contains 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 disorder in which phenylalanine accumulates due to the inability of the body to eliminate it correctly.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacistor ask your doctor or pharmacist if you are unsure.

The recommended dose is:

For adults: One tablet, once a day. Do not exceed one tablet per day.

Normofludil forte is taken orally.

Dissolve one dispersible tablet in a glass of water. Stir with a spoon before administration. The resulting solution is taken directly from the glass.

It is recommended to drink an abundant 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 Normofludil forte than you should

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

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.

If you forgot to take Normofludil forte

Do not take a double dose to compensate for the missed doses. If you forget a dose, wait for the next one.

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

Unknown frequency (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 can 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 conditions for conservation.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. By doing so, you will help protect the environment.

Composition of Normofludil forte

• The active ingredient is acetylcysteine. Each tablet contains 600 mg of acetylcysteine.
• The other components (excipients) are: microcrystalline cellulose, hydroxypropylmethylcellulose, crospovidone, aspartame (E-951), calcium carbonate, lemon essence, orange essence, and magnesium stearate.

Appearance of the product and size of the packaging:

White or almost white, round, flat, and bisected tablets.

Normofludil forte is presented inblister packs of 20 tablets.

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:January 2023

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